THE NATIONAL CANCER CONTROL PROGRAMME
ANNUAL REPORT 2013
REPUBLIC OF SLOVENIA
MINISTRY OF HEALTH
INDEX
1.
2.
Summary of the 2013 Annual Report ................................................................................ 3
Cancer burden .................................................................................................................. 11
2.1. Long-term cancer burden indicators in Slovenia: incidence, mortality and survival
11
2.2. Survival of cancer patients ....................................................................................... 14
2.3. More common cancer sites in Slovenia.................................................................... 17
3. Basic indicators for monitoring primary prevention ........................................................ 18
3.1. Tobacco .................................................................................................................... 18
3.2. Drinking habits (excessive drink of alcohol) ........................................................... 20
3.3. Diet: fruit and vegetable consumption ..................................................................... 21
3.4. Obesity ..................................................................................................................... 23
3.5. Level of physical activity ......................................................................................... 25
3.6. Cancer-related infections .......................................................................................... 26
3.6.1. Incidence rate of hepatitis B (HBV) ............................................................... 27
3.6.2. Incidence of hepatitis C (HCV) ......................................................................... 28
3.6.3. Human papillomavirus (HPV) vaccination ..................................................... 30
4. Secondary prevention – ZORA, DORA, SVIT ................................................................ 32
4.1. Cervical cancer screening programme ZORA ......................................................... 32
Brief description of the programme ................................................................................. 32
Indicators of the ZORA national programme .................................................................. 33
Important achievements and programme challenges in the future ................................... 36
4.2. Breast Cancer Screening Programme – DORA Programme .................................... 38
Brief description of the programme ................................................................................. 38
Quality Indicators of DORA NP ...................................................................................... 39
Important achievements and programme challenges in the future ................................... 42
4.3. Colorectal cancer screening – SVIT Programme ..................................................... 43
Short description of the programme ................................................................................. 43
Svit programme indicators ............................................................................................... 45
5. Diagnosis and treatment of cancer ................................................................................... 50
5.1. Primary healthcare .................................................................................................... 50
5.2. Secondary and tertiary healthcare ............................................................................ 50
5.3. Indicators .................................................................................................................. 54
5.4. Radiation equipment and associated waiting periods............................................... 59
5.5. Histological diagnosis .............................................................................................. 60
6. Comprehensive rehabilitation of cancer patients ............................................................. 61
7. Palliative care of cancer patients ...................................................................................... 62
8. Research ........................................................................................................................... 63
8.1. Public funds earmarked for cancer research............................................................. 63
8.2. Cancer research ........................................................................................................ 63
9. IT support ......................................................................................................................... 73
1. Summary of the 2013 Annual Report
The National Cancer Control Programme (hereinafter: NCCP) is a comprehensive programme
of cancer control measures and activities carried out in the Republic of Slovenia. It has been
confirmed by the Government of the Republic of Slovenia. The Minister of Health has
established an NCCP programme council and appointed an NCCP coordinator who
coordinates the activities defined in the programme.
The objectives of the NCCP are:
1. to decelerate the increase in cancer incidence rates,
2. to reduce the cancer mortality rate,
3. to increase the cancer survival rate,
4. to improve the quality of the patients’ lives by providing comprehensive
rehabilitation and to increase the number of patients in the advanced stage of
illness receiving palliative care.
The content of the 2012 Annual Report on the Implementation of the NCCP is to present to
what extent the objectives have been achieved and where Slovenia has been successful in its
activities and where it has not. The challenges and activities required to achieve the
programme objectives are also integral parts of this report.
In order to objectively monitor the programme targets, cancer burden indicators (incidence,
mortality and survival rates) need to be monitored in the Cancer Registry. The following
measures need to be undertaken: primary and secondary prevention that has been proven to
be effective, early and professionally justified diagnostics and treatment, research
activities with regard to the nature of illness (as many patients as possible need to be involved
in clinical research, and preclinical and epidemiological research need to be carried out). In
order to achieve the fourth target, comprehensive rehabilitation and palliative care must be
provided to patients.
CANCER BURDEN
The graphs below shows the trend of incidence and mortality rates for all types of cancer.
The data show that the incidence rate is in the increase, while the mortality rate has been
falling. The objective of reducing the mortality rate has been achieved, but our aim is to
reduce it even further with the measures defined in the NCCP. Nevertheless, this indicator
will be further monitored in the subsequent annual reports. Although the target of decreasing
the incidence rate has not been achieved for all types of cancer, the decrease is evident in the
lung cancer incidence rate among men, which is the result of effective measures in reducing
the use of tobacco products, and in the cervical cancer incidence rate, which is the result of an
effective and high quality population screening programme (ZORA).
MOŠKI
700
600
600
500
Stopnja na 100.000
Stopnja na 100.000
ŽENSKE
700
+1,6% letno
400
300
200
-0,7% letno
500
+1,2% letno
400
300
-1,1% letno
200
100
100
Incidenca, SSS
Umrljivost, SSS
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994
1993
1992
1991
1990
1989
1988
1987
1986
0
1985
Leto
Incidenca, groba stopnja
Umrljivost, groba stopnja
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994
1993
1992
1991
1990
1989
1988
1987
1986
1985
0
Leto
Incidenca, groba stopnja
Umrljivost, groba stopnja
Incidenca, SSS
Umrljivost, SSS
Pictures below show 5-year relative survival (with 95% confidence interval) of patients
diagnosed with selected cancers in periods 2000–2004 and 2005–2009. Recently, the survival
rate for all cancer patients has increased primarily on account of colorectal cancer and
prostate cancer in men and breast cancer, colorectal and cervical cancer in women. The higher
survival rate for breast cancer and colon cancer probably could be attributed to an improved
lifestyle, while the higher survival rate in women with cervical cancer probably results from
early diagnostics due to the introduction of the ZORA national screening programme
(recently, more female patients have been diagnosed at lower stages of the disease).
Regarding prostate cancer, improved reporting of out-patient treatment of prostate cancers
(those with more favourable prognostic features) can be observed, as the survival rate of this
type of cancer has spuriously increased by as much as 15 %.
Basic epidemiologic data on all and more common cancer sites are available at:
http://www.slora.si/en/osnovni-podatki-o-posameznem-raku1
PRIMARY PREVENTION
Primary prevention of cancer is the reduction or elimination of exposure to factors that have
an impact on the occurrence of cancer cases, and is one of the key elements of the NCCP.
Among the activities within primary prevention, indicators are used to monitor the following
factors: behavioural factors, environmental risk factors and cancer-related infections.
Behavioural factors
A healthy lifestyle could reduce cancer disease by at least 30 %. The key behavioural factors
that could significantly contribute to reducing cancer incidence are non-smoking and the
reduction in risky and harmful alcohol use, healthy nutrition, sufficient physical activity
supporting good health and the reduction of excess weight and obesity. Within the activities of
primary prevention that refer to a healthy lifestyle, the following indicators are being
monitored: smoking habits, over-consumption of alcohol, fruit and vegetable intake, obesity
and the level of physical activity.
Smoking habits
In the 2001–2008 period, the number of smokers was reduced significantly in statistical
terms in general and by both sexes. In 2008, the Eurobarometer telephone survey revealed
that Slovenia was one of the European Union countries with the lowest percentage of smokers
among the population aged 15 or more. However, differences are evident in the percentage of
smokers with regard to their education and social class. Throughout the entire follow-up
period, the number of smokers was the highest among people with the lowest level of
education and from the lowest social classes.
In this area, Slovenia adopted numerous systemic measures, the results of which have already
become evident. As early as 1996, the Restriction of the Use of Tobacco Products Act was
adopted; by adopting amendments to the act in 2007, Slovenia ranked among the group of
countries that introduced a total smoking ban in all enclosed public places and workplaces.
In 2012 22,6% of Slovene inhabitants 25 to 64 years old were smoking. Like in the past years
the proportion of smokers is significantly higher in men (24,8%) than in women (20,3%). In
the last four year period, between 2008 and 2012, the proportion of smokers in men did not
change significantly but this change was significantly higher in women (17,6% to 20,3%).
Over-consumption of alcohol
Among the European countries, Slovenia stands out with regard to the consequences of
harmful and risky alcohol use. However, it is encouraging to note that the number of
excessive drinkers in the population significantly fell in the 2001–2012 period for both
sexes and in all age groups, education groups and social groups. The rate of excessive
drinkers is higher among men, among people from older age groups including both sexes (55
to 64 years) and among people with lower education and from lower social classes. Apart from
the implementation of the Act Restricting the Use of Alcohol, a comprehensive policy needs
to be adopted and implemented in order to reduce harmful and risky alcohol use and its
consequences, while the measures should be focused in particular on the young population.
5
Healthy nutrition and fruit and vegetable intake
The implementation of the National Nutrition Policy Programme also provides conditions for
a healthy lifestyle. However, we are only partially satisfied with the results of the first
nutrition programme, carried out in the 2005–2010 period, and expect that a new programme
will be adopted. It will be even more focused on measures to prevent the increase in body
mass, to reduce the body mass of the population, and to strengthen supportive environments to
promote balanced nutrition and physical activity for the health of the entire population in the
Republic of Slovenia, in particular of the most vulnerable groups. Among the positive steps
regarding nutrition are, for example, reduced intake of salt, reduced consumption of sweet
drinks and increased olive oil consumption. There was a negative trend in fruit and vegetable
intake in that the percentage of adults consuming fruit and vegetables once or more a day
decreased in the period from 2001 to 2012; this applies to the population in general, to both
sexes and to practically all education groups, and must be reversed. Far more threatened by
insufficient vegetable and food intake are those with a lower education level and socially
disadvantaged groups.
Level of physical activity
With regard to the recommendations of the WHO, the percentage of people considered to be
sufficiently active has remained approximately the same throughout the entire follow-up
period. In order to control overweight and the burden of chronic diseases, the overall amount
of physical activity will need to be increased and the eating habits of most people improved.
The National Health Enhancing Physical Activity Programme, the activities of which will be
completed this year, requires the adoption of a new political document and stronger interministerial support as well as a more consistent implementation of measures to increase
physical activity among all population groups at all levels.
In 2012 the proportion of inhabitants physically active at least 150 minutes per week was
36,6% (in 2001 23%). There are no differences between men and women. This is an important
change, since in 2001 the proportion of physically active women was significantly lower than
men.
Obesity
In the period from 2001 to 2012, the obesity rate increased from 15 % to 17.4 %, primarily on
account of increased obesity among men. In the follow-up period, the obesity rate was higher
among men than among women. The obesity rate is also significantly higher among people
with a lower level of education and among people from lower social classes.
Priority tasks and measures relating to healthy-lifestyle behaviours that need to be
supported by monitoring are:
 improved health and a decrease in inequalities regarding health (reduction of social
differences) must become the objective of Slovenia’s Development Strategy, by
implementing appropriate measures in sectoral policies and by monitoring the
indicators relevant to the attainment of sectoral objectives;
 the development and implementation of new approaches aimed at educating nonsmoking generations;
6



a consistent implementation of the Restriction of the Use of Tobacco Products Act and
the introduction of measures in accordance with new professional findings on the
effectiveness of individual measures;
the adoption and implementation of a comprehensive policy aimed at reducing harmful
and risky alcohol use through implementation plans;
the adoption and implementation of the National Nutrition Policy Programme and the
National Health Enhancing Physical Activity Programme 2012–2022, with the
objective of strengthening health and introducing systemic measures to reduce social
differences regarding nutrition and physical activity, and the adoption of legislation,
tax and price policies to provide better accessibility to healthy nutrition and a healthy
lifestyle to all population groups, in particular to the most vulnerable populations.
Environmental factors
Exposure to environmental carcinogens is estimated to cause less than 5 % of cancers.
Exposure to dust particles PM101, which people generate with their activities and can be the
result of emissions from power-generation facilities, the industry, traffic, agriculture and
individual fireplaces, is significant. Particularly dangerous for people's health are particles
smaller than 10 µm, as they are connected with the occurrence of lung cancer. Analyses show
that approximately 50 % of the population is exposed to annual concentrations that exceed the
WHO recommendations (20 µg PM10/mł); in particular, it includes inhabitants of larger towns,
such as Ljubljana and Maribor, and inhabitants living in the surroundings of larger towns or
power-generation facilities.
Cancer-related infections
Certain infectious diseases are also connected with the occurrence of cancer. According to the
World Health Organisation, infectious diseases cause approximately 6 % of cancer deaths in
the developed world. Viral hepatitis types B and C are associated with the occurrence of liver
cancer, while the infection with human papilloma virus is associated with cervical cancer and
cancer of the larynx. Regarding the incidence of hepatitis B and C, Slovenia is among the
countries with a low incidence rate. Preventive measures include vaccination and prevention
of infections. In Slovenia, vaccination against infections with Hepatitis B virus and against
the infection with certain types of human papilloma virus (HPV) is integrated into the National
Immunisation Programme. The introduced measures are a step forward to more effective
primary prevention against cancer-related infections.
SECONDARY PREVENTION
Slovenia runs all three screening programmes that have proved to be effective: ZORA
(cervical cancer), DORA (breast cancer) and SVIT (colorectal cancer). The political
commitment of the Member States of the European Union is to implement these programmes.
The programme of prevention and early detection of cervical cancer (ZORA) is the oldest
programme. Its indicators comply with the WHO recommendations, while the effects of the
programme's implementation are reduced incidence and mortality rates, as shown in the tables
below.
1
particulate matters up to 10 micrometers in size
7
25
SLOVENIJA (vse regije)
NOTRANJSKO-KRAŠKA
20
Stopnja na 100.000
OBALNO-KRAŠKA
PODRAVSKA
OSREDNJESLOVENSKA
SPODNJEPOSAVSKA
POMURSKA
Statistična regija
ZASAVSKA
GORENJSKA
15
10
5
KOROŠKA
JV SLOVENIJA
0
2000
SAVINJSKA
GORIŠKA
0
10
2008-2011
20
30
2007-2010
40
2006-2009
50
60
70
80
90
Triletna pregledanost (%)
2001
2002
2003
2004
2005
Incidenca - groba stopnja
Incidenca - SSS
2006
2007
2008
2009
2010
The breast cancer early detection programme (DORA) has achieved good results and has even
exceeded the recommended quality indicators; however, it only involves women from central
Slovenia. Women from other regions have the possibility of undergoing clinical examination
and mammography but these are not standardised, and there is no routine monitoring of
quality indicators. Women need to make their appointments themselves. In 2013, every
measure necessary needs to be undertaken to extend the programme across the entire territory
of Slovenia
The newest screening programme, the colorectal cancer detection programme SVIT, has been
carried out for four years. In comparison to other countries, the SVIT programme has spread
across Slovenia extremely quickly, which means that it almost covers the target examination
rate – table below (70 %) and that the set objectives have almost been attained. These are the
detection of cancer at an early stage of the disease, and in the form of precancerous lesions.
Response rate of invited persons by health regions and sex in the period 1.1.- 31.12.2012.
HEALTH REGION
CELJE
KOPER
KRANJ
LJUBLJANA
MARIBOR
MURSKA SOBOTA
NOVA GORICA
NOVO MESTO
RAVNE NA KOROŠKEM
SLOVENIJA
RESPONSE RATE
All
Men
61,15%
56,12%
58,23%
53,97%
65,71%
61,02%
64,53%
58,52%
59,32%
54,64%
58,03%
53,14%
65,68%
61,65%
63,46%
58,77%
62,73%
57,32%
62,32%
57,19%
2011
Leto
Umrljivost - groba stopnja
Umrljivost - SSS
Women
66,20%
62,58%
70,08%
70,28%
64,06%
62,92%
69,82%
68,41%
68,45%
67,40%
DIAGNOSTICS AND TREATMENT
Early diagnostics and appropriate treatment provide conditions for the highest possible
survival rate and quality of life. Table 1 below shows the staging of the disease at diagnosis
8
for all cancers in Slovenia in 2008. The objective is to detect as many cancers as possible in
the localised stage. To better understand the reasons that contribute to the early detection of
cancer, an agreement has been reached with the representatives of primary healthcare to
conduct a cross-cutting research of the factors that are decisive for early/late diagnosis of
cancer in Slovenia.
Table 1: Staging at diagnosis for all types of cancer (2008)
Stage
All cancers
Number of new cases
%
LOCALISED
INVASIVE
DISSEMINA
TED
UNKNOWN
5 527
3 209
48.8
28.3
2 261
19.9
339
3.0
ALL
11 336
100
Upon the request of the patients' associations and in line with the NCCP, cancer diagnostics
and treatment criteria and institutions carrying out cancer diagnostics and treatment have been
defined (oncology network). The criteria have been developed at the proposal of the extended
expert collegium for oncology and individual working groups, the members of which are
experts from different fields. On the basis of these criteria and the oncology network, the
actual number and place of interventions need to be regularly monitored in the future and data
need to be integrated in the NCCP annual reports. This will help us monitor the gradual
decentralisation of diagnostics and treatment for frequent cancers in the so-called secondary
centres, an objective which is planned within the NCCP. The report also shows the percentage
of patients who have undergone surgical treatment, systemic therapy and radiotherapy
according to cancer stage in 2008. The data reveal appropriate treatment with regard to the
recommendations for breast cancer, lung cancer and colorectal cancer (perhaps not enough
patients with colorectal cancer have undergone supplementary treatment). Data for prostate
cancer show that this type of cancer and associated cancers (urologic cancers) need to be given
more attention next year.
The precondition for quality intervention is access to radiotherapy. In the table below,
indicators of access to radiotherapy, currently only provided by Ljubljana Institute of
Oncology, are the number of pieces of radiation equipment and the trend of radiotherapy
waiting times, which have been subject to severe criticism in recent years. Due to the purchase
of new equipment, the waiting time now amounts to 22 days.
Year
2007
Number of patients Number of Average radiotherapy waiting time
undergoing
pieces
of
teleradiotherapy
radiation
equipment
4 781
6
No data
9
2008
2009
2010
2011
2012
5 009
5 050
5 888
6 016
6022
6.5
6
7
8
8
32
48
50
22
22
RESEARCH ACTIVITY
In oncology, where new treatment methods are constantly sought, it is extremely important for
Slovenia to be integrated in international research and to carry out its own research. In the
present report epidemiologic, preclinical, translational and clinical studies are listed. In 2011,
clinical research involved 480 patients, which is 4.4 % of all patients who were diagnosed with
cancer in that year (excluding non-melanoma skin cancer) and in year 2012 1995 patients,
almost 4x as in 2011. This increase is partly due to better reasearch possibilities, but also
because of better reporting.
REHABILITATION
OIL and IRIS have prepared a draft proposal for the Health Council of the Republic of
Slovenia on the comprehensive rehabilitation of patients with operable breast cancer. The
proposal was reviewed by the Society of Oncology Patients of Slovenia and the Europa Donna
association, who gave their comments thereon. Currently, the process of harmonisation of
these comments is underway, along with the inclusion of the two aforementioned associations
among the promoters of the coordinated proposal for the Health Council.
PALLIATIVE CARE
Important information on palliative care in Slovenia is available at http://paliativa.ezdrav.si.
The pages are still under formation, but the aim is that all important information regarding
palliative care for patients, their caregivers and professionals will be available on these pages.
IT SUPPORT
An agreement was reached with the State Secretary, Mrs Brigita Čokl, on the integration of IT
support of the NCCP in the e-Health project. Under this project, the cancer register would be
transformed into an e-register. The selection of data for certain cancer types would be
expanded in the form of what are called clinical registers, and the cancer register would be
linked to screening programmes (ZORA, DORA and SVIT); additional information support
for the programmes would be provided if necessary.
The deadline for implementation is the end of 2014.
10
2. Cancer burden
Monitoring of cancer burden (additional data available at: www.slora.si)
2.1.
Long-term cancer burden indicators in Slovenia: incidence,
mortality and survival
The objective of most cancer control activities is to influence long-term cancer burden
indicators, which means to reduce the incidence and mortality rates of cancer and to increase
the survival rate of cancer patients.
In this analysis, the aforementioned indicators are defined as follows:
 Incidence reflects the absolute number of all newly diagnosed cases of a disease in a
study population in one calendar year, while mortality reflects the absolute number of
all patients who died because a certain disease in a study population in one calendar
year.
 Crude incidence rate is the number of new cases of a disease calculated per 1 000 000
population, while crude mortality rate is the number of deaths, calculated per 100 000
population.
 Prevalence is the total number of patients with cancer who are alive on a given date,
irrespective of when they developed cancer.
 Age-standardised rate is a theoretical incidence (or mortality) rate assuming that the
age structure in the study population is the same as in the standard population.
 Relative survival is an approximation of the survival of patients in the case that the
observed cancer would be considered as the only cause of death. It is calculated as the
ratio between the observed survival of a study group of patients and the survival
expected with respect to gender and age in a certain period, in the whole population
from which the patients come.
Incidence and survival data are collected by the Cancer Registry of the Republic of Slovenia,
while mortality data are collected by the Institute of Public Health of the Republic of
Slovenia.
Incidence and mortality measure the cancer burden in the country and assess how they are
influenced by all cancer control measures (ranging from primary prevention, screening and
diagnostics to curative and palliative care), while survival is the criterion for health system
performance from diagnosis till treatment of cancer patients.
Basic data on incidence, mortality and prevalence in 2009 and forecasts for 2012 (Source:
Cancer in Slovenia 2009, Ljubljana Institute of Oncology, 2013)
11






In 2009, 12,226 patients in Slovenia were diagnosed with cancer (598.6 per 100,000
people), among them there were 6,602 men and 5,624 women. Of those born in 2009, one
in two men and one in three women are expected to develop cancer by the age of 75.
In 2009, 5,787 patients in Slovenia died of cancer, among them 3,260 men and 2,527
women.
There were almost 76,968 patients (32,325 men and 44,643 women) who were diagnosed
with cancer at some point in their life time (prevalence).
Although the risk of cancer is increasing moderately, it is the highest in older age groups.
Among all cancer patients diagnosed in 2009, as many as 60 % of men and 59 % of
women were aged 65 or more at diagnosis. Children and young adults (until the age of
20) diagnosed with cancer account for less than 1% of all cancer cases. As the Slovenian
population is ageing, it is expected that the number of newly diagnosed cancer patients
will further increase because of the growing numbers of elderly people. It is estimated that
the number of new cancer patients will exceed 14,000 in 2012.
In the previous decade (2000–2009), the age-standardised rate (ASR) for men increased by
1.23% per year, while the mortality rate dropped by 0,9 % per year (Figure 1).
In the same period, the age-standardised incidence rate for women increased by 1.2 % per
year, while the mortality rate dropped by 0.74% per year (Figure 1).
Figure 1: Incidence rate (crude rate and age-standardised rate (ASR)) and mortality rate
(crude rate and ASR) for all cancer sites by sex; Slovenia 1985–2009 (for the age-standardised
rate, the world standard was used)
INCIDENCE, SLOVENIA 1961-2009
700
600
500
400
300
200
100
19
61
19
63
19
65
19
67
19
69
19
71
19
73
19
75
19
77
19
79
19
81
19
83
19
85
19
87
19
89
19
91
19
93
19
95
19
97
19
99
20
01
20
03
20
05
20
07
20
09
0
Crude rate MALE
Crude rate FEMALE
Age standardized rate MALE
Age standardized rate FEMALE
12
MORTALITY, SLOVENIA 1985-2009
350
300
250
200
150
100
50
19
85
19
86
19
87
19
88
19
89
19
90
19
91
19
92
19
93
19
94
19
95
19
96
19
97
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
20
09
0
Crude rate MALE
Age standardized rate MALE
Crude rate FEMALE
Age standardized rate FEMALE

The five most common types of cancers in Slovenia – skin cancer (non-melanoma),
colorectal cancer, prostate cancer and breast cancer – comprise 58 % of all cancer cases.
Cancers of these organs are related to an unhealthy lifestyle, excessive exposure to the sun,
unhealthy food, smoking and excessive alcohol consumption; therefore, the aim of primary
prevention measures is to lower the risk associated with these factors.

Among men, prostate cancer was in the first place with 19.9 % of all cancer cases; it was
followed by colorectal cancer, non-melanoma skin cancer and lung cancer.

Among women, breast cancer ranked first, amounting to one fifth of all cancer cases
(20.1 %); it was followed by non-melanoma skin cancer, colorectal cancer and lung cancer
(Figure 2).
Figure 2: Most common cancer sites by sex – Slovenia, 2009
13
Inequalities in health associated with the socioeconomic situation in Slovenia are also
becoming evident in the cancer morbidity and mortality. Figures 3 and 4 confirm that the
trends moved from east to west in the 2005–2009 period: the cancer incidence rate is higher in
western, more developed Slovenian regions, while mortality is higher in eastern regions.
Figure 3: Age-standardised incidence rate (ASR) of all cancer sites by the 12 statistical
regions and by sex – Slovenia, 2005–2009.
Figure 4: Age-standardised mortality rate of all cancer sites (ASR) by the 12 statistical
regions and by sex – Slovenia, 2004–2008
2.2.
Survival of cancer patients
Data on the survival of all patients represent an overall assessment of cancer burden in a study
population. They reflect the outcome of all cancer control programmes, ranging from
screening and early detection of cancer to the treatment, rehabilitation and long-term followup of the patients' conditions. Since the beginning of cancer registration, the five-year relative
survival rate of Slovenian cancer patients has been constantly increasing among both, men and
women. In the 1963–1967 period, 25 % of men and 42 % of women survived five years after
14
being diagnosed. Twenty years later, i.e. in the 1983–1987 period, the survival rate increased
by approximately 5 % for both sexes; in the 1995–1999 period the five-year relative survival
of men was already 42 %, while the five-year relative survival of women increased to almost
60 %.
The five-year relative survival of male patients diagnosed with any type of cancer (except nonmelanoma skin cancer) and who had developed cancer in the 2005–2009 period, was 51.1 %,
while the five-year relative survival of female patients in the same period was 60.5 %.
The five-year relative survival of men diagnosed with cancer in the 2000–2004 period was
42.5 %, while the five-year relative survival of women in the same period was 56.9 %.
The large survival rate difference between sexes is attributed to the different proportion of
individual cancer types with regard to sex and age. Women are diagnosed more frequently
with cancers with more favourable prognostic features. Recently, the survival rate for all
cancer patients has increased primarily on account of colorectal cancer and prostate cancer in
men and breast cancer, colorectal and cervical cancer in women. The higher survival rate for
breast cancer and colon cancer probably could be attributed to an improved lifestyle, while the
higher survival rate in women with cervical cancer probably results from early diagnostics due
to the introduction of the ZORA national screening programme (recently, more female
patients have been diagnosed at lower stages of the disease). Regarding prostate cancer,
improved reporting of out-patient treatment of prostate cancers (those with more favourable
prognostic features) can be observed, as the survival rate of this type of cancer has spuriously
increased by as much as 15 %.
15
Figure 5. Five-year relative survi8val (with 95% confidence interval) of patients diagnosed
with selected cancers in periods 2000–2004 and 2005–2009.
16
2.3.
More common cancer sites in Slovenia
Basic epidemiologic data on all and more common cancer sites are available at:
http://www.slora.si/en/osnovni-podatki-o-posameznem-raku1
17
3. Basic indicators for monitoring primary prevention
(Further information available at http://www.ivz.si/ )
Primary prevention of cancer means the reduction or elimination of exposure to risk factors
affecting the incidence of cancer, and is among the key elements of the National Cancer
Control Programme. Preventive measures do not target only risk factors, but also factors
involved in protecting and promoting health. This approach has the most significant public
health potential and is the most effective long-term strategy for cancer control.
In the frame of the primary prevention activities we monitor the following indicators: smoking
habits, excessive alcohol consumption, fruit and vegetable consumption, obesity and level of
physical activity. These indicators are followed and analyzed systematically in the crosssectional epidemiological study "Risk factors for noncommunicable diseases in the adult
population of Slovenia - health-related lifestyle" conducted in the years 2001, 2004, 2008 and
2012. The study is a continuation of the European Office of the World Health Organization
study (CINDI Health Monitor Survey). The survey is conducted in four years intervals among
the adult population in Slovenia aged 25 to 74 years. Health risk factors are evaluated
according to the biological, sociological and health characteristics and the available data on
the prevalence, intensity and interconnectivity of risk factors. The fourth survey was
performed in 2012 and provided us with new information about the lifestyle and behavioral
patterns of the inhabitants of Slovenia. The trends in the population of people who are 25-65
years of age are shown in the results of this study.
3.1.
Tobacco
In 2012, 22.6% of adult population in Slovenia aged 25-64 years smoked tobacco. The
proportion of smokers among men (24.8%) was significantly higher in comparison to women
(20.3%), like in all previous surveys. In the period from 2001 to 2012, the proportion of
smokers among men significantly decreased (from 28.5% to 24.8%), while among women it
remained unchanged (20,3% in 2001 and in 2012). Between the last two surveys, from 2008 to
2012, the proportion of smokers among men did not significantly change, while it significantly
increased among women (from 17.6% to 20.3%). If we sum up the results of all available
research on prevalence of smoking among adults in Slovenia since 2000, we can conclude that
the prevalence of smoking among adults did not significantly change in the period from 2000
to 2007. Shortly after the introduction of smoking ban in all enclosed public and work places,
proportion of smokers significantly decreased. After 2008 it increased again, but probably not
to the baseline level before the introduction of the ban.
Among adolescents in Slovenia a significant proportion of 15-year olds smoke, approximately
25%. 19% of 15-years old adolescents smoke at least once a week or more frequently
(majority of them already smoke every day), while 6% smoke less then weekly. For the period
from 2002 to 2010 studies show a decreasing trend in tobacco use among adolescents in
Slovenia, but this is exclusively the result of favourable changes in the first half of this period
(from 2002 to 2006), when majority of measured indicators of smoking behaviour in
adolescents significantly decreased. This was confirmed also by other studies. But from 2006
18
to 2010 there have generally been no changes in the extent of smoking among boys, while the
proportion of smokers among girls significantly increased.
Slovenia has already introduced numerous effective tobacco control measures, the most recent
one being effectively introduced smoking ban in all enclosed public and work places. Taxation
and prices of tobacco products were continuously increasing during recent years and numerous
activities and programs were implemented. But it is worrisome that in spite of all this
prevalence of smoking among boys and men is mainly unchanged and that prevalence of
smoking among girls and women is increasing. This is attributable to different factors, the
most important are marketing activities of tobacco industry (intensive and widespread
advertising at points of sale, attractive tobacco products, high availability and affordable prices
of tobacco products, availability of cheaper tobacco products, which enable shifts to cheaper
forms of smoking, for example ‘’roll-your-own’’ etc), and intensive marketing activities
directed towards girls and women.
The following new or updated measures should be introduced in Slovenia in order to prevent
and reduce smoking among adolescents and young adults and reduce smoking among adults:
- Further increase of taxation and prices of tobacco products with simultaneous decrease
of price differences among different tobacco products,
- Total ban on tobacco advertising, including displays,
- Restrictions on price related promotions,
- Regulation of additives (especially flavours and aromas) to tobacco products,
- Introduction of more effective health warnings,
- Decreased availability of tobacco products to minors,
- Regulation of other products that are currently not treated as tobacco products
(electronic cigarettes etc).
Interventions for increasing awareness and knowledge of public and selected target groups
about this topic and interventions for strengthening protective factors are also very important.
Education and health systems are key environments to implement these interventions in order
to prevent and reduce smoking. There are ample opportunities to strengthen these activities in
both mentioned environments.
Figure 1: Smoking among adult population in Slovenia, aged 25–64 years, in total and by sex,
in 2001, 2004, 2008 and 2012 (Source: CINDI survey, National Institute of Public Health of
the Republic of Slovenia)
Population, 25-64 years of age
Never smokers Former smokers Current smokers
19
Men, 25-64 years of age
Never smokers Former smokers Current smokers
3.2.
Women, 25-64 years of age
Never smokers Former smokers Current smokers
Drinking habits (excessive drink of alcohol)
Hazardous and harmful alcohol consumption is considered to be the cause of more than sixty
different diseases and types of injuries and alcohol consumption represents the world's third
largest risk factor for burden of disease and work disability and eighth largest cause of
mortality. Alcohol remains one of the key health issues in Slovenia and Slovenia is above the
EU average in terms of its use, but even more in terms of the harm caused by alcohol.
Hazardous and harmful alcohol consumption increases the risk of cancer of the upper
respiratory and digestive tract (oral cavity, throat, pharynx, and oesophagus) by itself and in
connection with smoking. The combined effect of these two factors is the product of the two.
Alcohol consumption represents also a risk factor for cancers of the liver, colon, rectum and
breasts.
For study (CINDI) purpose the excessive drink of alcohol was defined as consume of more
than 10 g of alcohol per day in women and consume of more than 20 g of pure alcohol per day
in men. Data showed that in 2001-2004-2008-2012 among the Slovenian population, aged 2564, the prevalence of excessive drink of alcohol was about 10% (the most, 14.3%, in 2001,
and least, 9.9%, in 2008). In the surveyed period 2001-2012 the share of respondents with
excessive drink of alcohol fell significantly (not for the period 2008-2012), while the share of
abstainers increased significantly and reached the highest portion in 2012 (20.5%).
In the observed period 2001-2012 the percentage of respondents with excessive drink of
alcohol was higher among men than among women respondents, the highest was in the 55-64
years age class, among those with vocational school, in the group of lower and working class
and in Eastern Slovenia (Figure 1).
In the observed period 2001-2012 the portion of respondents with excessive drink of alcohol
significantly fell in all age groups except among those aged 30-34 years and in all educational
groups except among those with secondary school education or college. In relation to social
status the portion of excessive drinkers of alcohol significantly fell in the lowest, working and
middle classes. A trend towards fewer excessive drink of alcohol has been evident in all three
geographical regions, and in approximately half of all health regions.
20
Figure 2: Excessive drink of alcohol in terms of demographic, socio-economic and
geographical status of respondents, 2001, 2004, 2008, 2012, Slovenia (Source: CINDI, IVZ
RS)
3.3.
Diet: fruit and vegetable consumption
Indicator of fruit and vegetable consumption shows the proportion of subjects who consumed
fresh or processed fruit and fresh or processed vegetables once a day or more often, which is
defined as a healthy diet, by contrast, the consumption of these categories of fruits and
vegetables less than once a day is defined as unhealthy eating habits.
The share of those who consumed fresh vegetables once a day or more than once a day, from
2001 to 2012, declined sharply from 67.6% to 39.1%. The share of those who never eat fresh
vegetables increased (0.3% in 2001, 1.2% in 2004, 1.9% in 2008 and 4.7% in 2012). Eating
processed vegetables, according to the frequency in 2012 increased slightly, but this does not
balance the reduced consumption of fresh vegetables. In 2012, women consumed fresh
vegetables more frequently (47.4%) than men (30.9%), we observe a decreasing trend of
eating fresh vegetables once a day or more than once a day in both sexes, particularly in men
(62.5% in 2001, 54.1% in 2004, 49% in 2008 and 30.9% in 2012). Reduction of consumption
of fresh vegetables is evident in all educational and social groups, especially in 2012. We do
not observe significant differences in the consumption of vegetables in accordance with the
recommendations between groups with different educational and social status.
21
Figure 3: Percentage of respondents who consume fresh vegetables once a day or more
frequently, aged 25-64, total and by gender, in the years 2001-2004-2008-2012 (Source:
CINDI, Institute of Public Health.)
Significant differences were observed between age groups. The proportion of those who enjoy
fresh vegetables once a day or more than once a day is lowest in the age group 25-39 years
(32% in 2012), while the proportion of subjects is highest in the 55-64 age group and was 48,
9% in 2012. There are major differences in the consumption of vegetables between various
health regions. Nova Gorica and Koper region have a share of those who enjoy vegetables at
least once a day 60.2% and 49.2% in 2012, respectively, followed by Murska Sobota and
Ravne region, with around 42%, then the others, where the share is between 35.7% and 37.4%.
We are seeing a downward trend in consumption of vegetables in all regions of Slovenia from
2001 to 2012.
Trend of eating fresh fruit once a day and more than once a day since 2001 to 2012 is sloping
slightly downwards (55.6% in 2001, 56.6% in 2004, 54.3% in 2008 and 53,4% in 2012),
altough there is an increasing trend of eating fresh fruit every day, there is also a statistically
significant decreasing trend of those who enjoy it several times a day (29.0% in 2001, 27.3%
in 2004, 25.3% in 2008 and 22.3% in 2012). We are seeing an increase in the proportion of
those who do not enjoy the fruits in the recommended amounts (44.4% in 2001, 43.4% in
2004, 45.7% in 2008, 46.6% in 2012). According to the results, half of people in Slovenia
should increase consumption of fruit. Women compared with men are more likely to eat fresh
fruit, trend of those who enjoy the fruits several times a day remains decreasing for both sexes,
especially in men (65.3% of women and 41.7% of men in 2012 enjoyed fruit at least once
daily).
Figure 4: Percentage of people who consume fresh fruit once a day, or more frequently, aged
25-64, total and by gender, in the years 2001-2004-2008-2012 (Source: CINDI, Institute of
Public Health.)
22
Survey results indicate a statistically significant downward trend in the proportion of people of
all levels of education, who consume fruit more than once a day. Fruit is more frequently
consumed by people with higher education and those belonging to the higher-middle and
upper social strata. The research results indicate that fresh fruit in recommended quantities is
more frequently consumed in Koper (62.9% in 2012) and Nova Gorica region (61.7% in 2012)
and least often in Maribor (49.3% in 2012) and Novo mesto (49.6% in 2012).
In order to improve the eating habits of the population of Slovenia, with a focus on increasing
consumption of fruit and vegetables it is essential to ensure the health-favouring public
policies with systemic action at the national and regional levels, including appropriate
financial measures, reformulation of foods and bans on advertising of unhealthy foods. The
proposed measures could significantly improve the nutrition of the population of Slovenia, by
improving accessibility and supporting the choice of healthy food, especially for
disadvantaged groups of the population. In addition to the systemic, structural measures,
programs and activities to raise awareness, inform and educate the population about healthy
diet and develop healthy eating habits are important, with an emphasis on eating vegetables
and fruits.
3.4.
Obesity
The indicator shows the percentage of obesity (BMI> 30) among Slovenians: the data suggest
that the proportion of obese people is increasing (Figure 6). In 2004, the proportion of obesity
in comparison with 2001 declined slightly, but in 2008 and 2012, it increased again (15.0% in
2001, 14.6% in 2004, 16.2% in 2008 and 17.4% in 2012), mainly due to the rise of obesity in
men. The proportion of obese and the upward trend is significantly higher in men (16.2% in
2001, 18.4% in 2008, 20.7% in 2012,) in women it remains about the same in all the years of
research (13,8% in 2001, 13.9% in 2008 and 14.0% in 2012). Most obese people are observed
in the age group 55 to 64 years (26% in that age group were obese in 2012) compared with
those aged between 25 and 39 years (in 2012, 10.9%). The study showed that education and
social class affect the nutritional status. We found an increase in the proportion of obese in all
23
educational groups and social classes, but a significantly higher proportion of obese subjects is
observed in lower social classes (bottom and working social class with 22.5% in 2012, in
comparison with the higher-middle and upper social classes with 11.3% in 2012) and a
significantly higher proportion of obese subjects in the groups with lower levels of education
(primary school, 27.8% in 2012, compared with at least a higher level of education, 11.0% in
2012). The proportion of obese in all areas of Slovenia is increasing, it is higher in the eastern
part of the country.
Worrying is the fact that the proportion of obese subjects increased significantly up to year
2008 (BMI> 35: 2.4% in 2001, 2.6% in 2004, 3.5% in 2008) in 2012 remains unchanged. We
are seeing a statistically significant increase in the proportion of men with a BMI over 35 in
age groups from 25 to 34 years 35 to 44 years and from 55 to 64 years, while for women, this
trend is not observed. Especially people who perform mainly sedentary work are vulnerable to
weight gain.
Figure 5: The proportion of obesity (BMI> 30) in the adult population of Slovenia aged 25-64
overall and by gender in the years 2001-2004-2008-2012 (Source: CINDI, Institute of Public
Health.)
Ranking of Slovenian data on the proportion of obesity in the adult population among national
research data on obesity of inhabitants of some European countries shown in Figure 6, taking
into account that the survey methodology may vary slightly.
Figure 6: The proportion of obesity in the adult population of both genders in some European
countries in a national survey
24
To better manage the growing problem of obesity requires an integrated, Interministerial and
interdisciplinary approach and the creation of supportive environments to promote and provide
healthy lifestyle for the whole population, with an emphasis on healthy eating and regular
physical activity. An effective approach requires systemic measures from all sectors, health
system reorientation toward disease prevention and cooperation of nutrition-oriented and other
professionals and the media.
3.5.
Level of physical activity
The indicator to monitor the degree of physical activity is moderate-intensity physical activity,
as it is more health-enhancing than physical activity of either higher or lower intensity. This
covers a wide spectrum of activities, from sports, leisure and work activities to activities
involving transport, and represents an important share of every individual's physical activity.
25
To present the degree of physical activity, and considering the questions in the survey and the
possibility of analysis, we selected those respondents who did 30 minutes of moderateintensity activity 5 days a week, which is equivalent to at least 150 minutes per week. Data
refer to the total quantity of moderate-intensity activity and cover leisure, workplace and
housework activities, and activities on the way to work.
In the survey in 2012 different questions about physical activity than in the surveys before
were used. They are most likely to the year 2001, when questions were related to the last week
before survey. The questions 2012 are related to a typical week. A direct comparison and
estimation of trends are not entirely reliable but we are able to conclude that physical activity
levels improved from 2001 to 2012. A detailed explanation on methodology and possible
interpretation will be given in the publication on trends in CINDI surveys.
Figure 8 presents the percentage of respondents who do at least 150 minutes of moderateintensity physical activity through the week. In year 2012 the percentage of respondents who
do at least 150 minutes of moderate-intensity physical activity through the week, was 36,6%.
There are no differences between genders. That is important because in year 2001 the
percentage was significantly lower in women than in men. The results indicate, that the total
amount of moderate-intensity physical activity is significantly depended on the work of
respondents. The percentage is highest among respondents with completed vocational school
(41,6%) and lowest among respondents with at least higher education. In relation to social
status, the percentage is highest for members of the lowest classes (41,3 %) and lowest for
members of higher social classes (32,3%).
Figure 7: Share of respondents who do at least 150 minutes of moderate-intensity physical
activity through the week – total – by sex – by educational level – by social status (Source:
CINDI, IVZ)
3.6.
Cancer-related infections
Certain communicable diseases are associated with the occurrence of cancer. According to the
World Health Organization, infectious diseases cause approximately 22% of cancer deaths in
the developing countries and 6% of cancer deaths in the developed world. Viral hepatitis B
26
(HBV) and hepatitis C (HCV) are associated with the occurrence of liver cancer, while
infection with human papillomavirus (HPV) is associated with cervical, other precancerosis
and cancer and also anogenital warts. Prevention includes vaccination and other preventive
measures against infections. In Slovenia, hepatitis B and human papillomavirus vaccinations
are integrated into the National Immunisation Programme.
3.6.1. Incidence rate of hepatitis B (HBV)
Definition: Number of reported cases of hepatitis B per 100,000 population.
In Slovenia, notification of hepatitis B is mandatory under the Contagious Diseases Act
(Official Gazette of RS No 33/2006). Any medical doctor and/or the laboratory must report
the disease within three days using EU case definitions for reporting communicable diseases
to the regional institute of public health, which reports to the National Institute of Public
Health on weekly basis. Incidence rate is calculated on the basis of reported cases.
Figure 8: Incidence rate of acute and chronic hepatitis B in Slovenia 2006–2011 (Source: IVZ)
Slovenia is among the countries with low incidence rate of hepatitis B. In the period 20062011 the mean incidence rate of acute hepatitis B was 0.86 (Figure 8). Incidence rate of
hepatitis B is low and the disease is under control.
Most European countries carry out epidemiological monitoring of hepatitis B. In 2008, the
mean incidence rate of acute hepatitis B in EU countries was 1.29/100,000 population.
Comparison of data between EU countries is difficult, as monitoring and reporting systems are
largely different. The incidence of acute hepatitis B in EU countries varies considerably
27
(Figure 9). In 2012, the European Centre for Disease Prevention and Control (ECDC)
launched a long-term programme of surveillance and monitoring of hepatitis B in EU Member
States.
Figure 9: Incidence rate of hepatitis B in EU countries, Iceland and Norway, 2008 (Source:
ECDC)
Hepatitis B vaccination
In 1992 the World Health Organization recommended that all member states include hepatitis
B vaccination in their national vaccination programmes by 1997. In Slovenia, routine hepatitis
B vaccination of children started in 1998, thus the first vaccinated generation was 21 years old
in 2012.
Vaccination is provided to exposed persons at their workplace and during education, to newborns of HBsAg positive mothers, haemophiliacs and people with chronic liver disease, those
with HIV infection, and certain other categories of patients.
3.6.2. Incidence of hepatitis C (HCV)
Definition: Number of reported cases of hepatitis C per 100 000 population.
In Slovenia, notification of hepatitis C is mandatory under the Contagious Diseases Act
(Official Gazette of RS No 33/2006). Any medical doctor and/or the laboratory must report
the disease within three days using EU case definitions for reporting communicable diseases
to the regional institute of public health, which reports to the Institute of Public Health of the
Republic of Slovenia on weekly basis. Incidence is calculated on the basis of reported cases.
As underreporting may be presumed and not all infected persons seek medical help, the
burden of disease is estimated to be much higher. The mean incidence rate of acute hepatitis C
28
was 0.44/100,000 population in the period 2006-2011 (Figure 10). The most recent data for
EU countries are available in the ECDC Report 2008 (Figure 11). In 2008, the mean incidence
rate of acute hepatitis C in EU countries was 8.97/100 000 population. It should be noted that
the higher mean incidence in EU countries results from the fact that some countries report
aggregate data of acute and chronic cases.
Figure 10: Incidence rate of acute and chronic hepatitis C in Slovenia 2006–2011 (Source:
IVZ)
Comparison of the incidence of hepatitis C between EU countries is difficult, as monitoring
and reporting systems are largely different. In 2012, the European Centre for Disease
Prevention and Control (ECDC) launched a long-term programme of surveillance and
monitoring of hepatitis C in EU Member States.
Figure 11: Incidence of hepatitis C in EU countries, Iceland and Norway, 2008 (Source:
ECDC)
29
Epidemiologic, clinical and virological studies and tests on animal models showed that
chronic hepatitis B and C infections are related to hepatocellular carcinoma in humans.
Hepatocellular carcinoma typically develops 20 to 40 years after infection, and is secondary to
cirrhosis. Hepatitis C vaccine is not available; however, the treatment of the disease is
efficient. Early detection of the infection and treatment is very important. It is paramount to
prevent and control the disease by raising awareness in the population and in particular among
the groups with a risky lifestyle.
3.6.3. Human papillomavirus (HPV) vaccination
In Slovenia, human papillomavirus (HPV) vaccine is available since 2007. HPV vaccination is
routinely offered free of charge to 12-years old girls (six-grade) during systematic health
check-ups since 2009. So far, quadrivalent vaccine has been used. HPV coverage with three
doses was 48.7 % in school year 2009/2010, 55,2% in school year 2010/11 and 54,9 in school
year 2011/12 (Figure 12). In the first year the highest coverage was reached in Carinthia
(78.8%) and the lowest in Ljubljana region (38.3%). Next year vaccination coverage increased
the most in Murska Sobota (53.4% to 87.3%) and Ljubljana (38.3% to 56.8%) regions. The
lowest coverage was in Novo mesto (39.7%) and Nova Gorica (40.2%) regions. In the third
year the coverage had raised in four regions and doped in three regions. Vaccination coverage
remained above 50% since introduction.
30
Figure 12: HPV vaccination coverage of sixth-grade girls in Slovenia 2009-2012 (Source:
IVZ)
In the United States, vaccination with quadrivalent vaccine started in June 2006, for 11 and 12
year-old girls. The catch-up programme included girls and women aged 13 through 26 years.
In Canada vaccination with the same type of vaccine started in September 2007, and in
Australia in June 2007. The vaccination rate in Australia is almost 80%, and after several
years it attains over 70% and positive effects of vaccination are already visible, as there is a
decrease of cases of condylomata acuminata (anogenital warts). In the United States the
vaccination coverage was first quite low, between 26 and 30%; however, recent data show an
increase in the vaccination coverage of girls aged 13 to 17, who received at least one dose of
vaccine (around 35%).
In 2012 the European Centre for Disease Prevention and Control updated HPV vaccination
guidelines and reported that Belgium, Denmark, France, Germany, Greece, Island, Ireland,
Italy, Latvia, Luxembourg, the Netherlands, Norway, Portugal, Romania, Slovenia, Spain,
Sweden and the UK introduced routine HPV vaccination while Malta was in the process of
introduction.
In 2010 the vaccination coverage with all three doses in those countries that provided data was
between 17 and 81%. The vaccination rate in France, Luxembourg and Norway was slightly
below 30%, in Denmark and Italy it was slightly above 50%, and the highest were in the UK
(81%) and in Portugal (80%). The funding system is different among countries but in the
majority of them there are state budget or public finances that cover the expenses. Exceptions
are Belgium and France where state budget partly covers the costs and Austria where HPV
vaccination is not covered by any means. ECDC reports also on HPV vaccination of males.
The rationale for vaccinating boys with the HPV vaccine boys would be effective in the
prevention of HPV-related conditions in men, such as condylomata, anal cancer and oral
cancer. Furthermore, universal vaccination for men would prevent cervical cancer in women
via herd immunity.
31
4. Secondary prevention – ZORA, DORA, SVIT
4.1.
Cervical cancer screening programme ZORA
Brief description of the programme
Programme name: National cervical cancer screening programme ZORA – NP ZORA.
Programme type: organised, population-based, nationwide screening programme.
Year of initiation: organised, population-based, nationwide screening programme was
launched in 2003. Before that, two pilot programmes were implemented in two Slovenian
regions in 1998 and 2001. Before the implementation of organised screening, the opportunistic
screening was available to Slovenian women since the 1960’s.
Programme founders: Ministry of Health of the Republic of Slovenia, Health Insurance
Institute of Slovenia and Institute of Oncology Ljubljana.
Responsible institution: Institute of Oncology Ljubljana.
Screening interval: three years.
Screening examination: cervical smear for cytological examination (smear, Pap test) – the
Bethesda 2001 system.
Additional diagnostics and treatment of lesions detected during screening: control smear,
revision of the smear, HPV triage, colposcopy, biopsy, abrasion of endocervical canal,
destruction, excision, conisation and hysterectomy.
Target group of population: female residents of the Republic of Slovenia aged from 20 to 64.
Women aged from 65 to 74 may attend a screening, but they are no longer invited. Exclusion
criteria for screening are the following: cervical cancer (C53) diagnosed at any time in the
past; current diagnostic or therapeutic treatment as a result of pathologic findings of cervical
smear or histopathologic diagnosis of cervical intraepithelial neoplasia (CIN), follow-up after
CIN treatment; women without a uterus (hysterectomised), but only if the cervix has also been
removed.
Invitation method:
All women from the target group of the population may request an appointment for screening
from their selected gynaecologist once every three years (+/– 3 months) without an invitation
or referral. If a woman does not attend the examination on time, she is invited by her selected
gynaecologist; if a woman does not respond, she is invited again. If her status in the central
screening registry ZORA is “eligible for invitation”, she is invited to an examination by the
registry with central invitation; if she does not respond, she is invited again. The “eligible for
invitation” status has an impact only on the central invitations from the registry – it is granted
to women who are residents of Slovenia and do not temporarily reside abroad; are aged from
20 to 64 at the time of invitation; are not finally determined as non-responsive; do not have a
registered smear in the last four years; are not registered as women without a uterus. Women
finally determined as non-responsive are those who reply in writing that they do not wish to
attend screenings for cervical cancer, and those who did not respond to two consecutive
invitations from the screening registry. A woman loses the status of non-responsiveness if a
new smear is registered, or when she expresses her wish to attend a screening.
Programme providers: gynaecological teams at the primary, secondary and tertiary levels;
cytopathology and histopathology laboratories; HPV triage test laboratories; regional institutes
32
of public health and the ZORA programme and registry department at the Institute of
Oncology Ljubljana.
Quality assurance and control: standardised and personalised screening invitation letters;
information materials for women in Slovenian, Italian and Hungarian language (ZORA
booklet); standardised reports for cytopathology and HPV triage test (forms are being prepared
also for colposcopy and histopathology); guidelines for cythopathologists, screeners and
gynaecologists who work in the ZORA programme (last updated in 2011); notification of
gynaecologists about missed follow-up exams after pathological smears by the screening
registry; guidelines for management of women with pathological smears, CIN or cervical
cancer (last updated in 2011 and 2012); regular specialised training of experts involved in
screening programme; regular revision of smears and histological preparations of women
diagnosed with cervical cancer; review of all procedures in the treatment of women diagnosed
with cervical cancer (in preparation); central information system – screening registry ZORA,
regular monitoring of quality of data in the screening registry and inquiries for missing or
incorrect data; regular monitoring of programme implementation quality and publication of
data (printed programme reports available at the website, annual presentations of
achievements at programme education and training sessions); legal basis for the programme
implementation.
Information system of the programme: central, national screening registry: ZORA registry,
Institute of Oncology Ljubljana. Links: central population register (CPR), Spatial unit register
(SUR) and Cancer Registry of the Republic of Slovenia. Data: personal data of women,
personalised data about screenings and diagnostic examinations and treatment; data on central
invitations to screenings and responses of women to these invitations.
Website of the programme: http://zora.onko-i.si/
Indicators of the ZORA national programme
According to the preliminary data from the screening registry, around 170,500 women had a
cervical smear in the year 2012, 94% of these women (about 160,000) belonging to the target
group of the program ZORA (aged 20–64 years) (Table 1). According to the Bethesda
classification almost all smears were satisfactory for the evaluation (99,8%). Most of the
smears were negative for intraepithelial lesion or malignancy (90,3% normal results and 4,6%
non-neoplastic findings), these women did not need further diagnostics within the ZORA
programme and were returned to the regular screening program in accordance with the
guidelines 2011. Epithelial cells abnormalities were found in 4,9 % of the screening smears,
these women were invited to further diagnostic evaluation to confirm or rule out precancerous
lesions (CIN grades 2 and 3) or cervical cancer. There was around 5.900 histopathological
findings (either diagnostic or therapeutic procedures) registered in the screening registry in
2012, but since pathological reports form this year are still in the process of collection and
registration, this number is not yet final.
One of the most important conditions to be fulfilled for the effective operation of screening
programmes is a good coverage of the target population by the screening test (coverage).
Coverage represents a proportion of women with at least one smear among all the women in
the target population (residents of Republic of Slovenia aged 20-64 years). The targeted three-
33
year coverage is 70 %. A low coverage may indicate a problem in the acceptance of the
screening programme by the target population group (women do not want to attend
examinations, think that they are useless etc.), but also organisational problems (inaccessibility
of screenings because of e.g. the excessive workload of gynaecologists, inappropriate
invitation system etc.).
A three-year coverage of the target population has been monitored in ZORA since the
beginning of the programme in 2003 (Figures 1 and 2). In the last three-year period (July 1st
2009 – June 30th 2012), coverage has again exceeded 70% (Table 1). Coverage is above 70 %
in women aged 20 to 49, where the number of newly diagnosed cervical cancer is high;
nevertheless, the coverage is still below 70 % in older women (50 to 64 years old) (Figure 1).
The coverage is above 70% in all health regions of Slovenia except in Koper, Maribor and
Murska Sobota (Figure 2). If we compare Slovenian results with countries with well organised
screening programmes from abroad which have a five-year screening interval, such as Finland
and the United Kingdom, the five-year coverage in Slovenia is above 80% (Table 1), which
places Slovenia among the countries with the highest coverage in Europe.
Table 1: Selected indicators of NP ZORA. (Source: Screening registry ZORA and Cancer
Registry of Slovenia.
Year
Indicator
2010
2011
2012*
priliminary data
Number of registered smears and women in the screening registry - all Slovenian women
Number of all smears
249.535
245.421
221.178
Number of all women with a smear
230.129
228.345
208.267
Number of all screening smears
190.968
190.117
173.288
Number of all women with a screening smear
187.084
186.193
170.531
Number of registered smears and women in the screening registry - target group (20–64 years old)
Number of screening smears
178.762
177.740
162.037
Number of women with a screening smear
175.124
174.083
159.489
Coverage by a screening test - target group (20–64 years old)
Three-year coverage(%)
71,4
71,5
71,3
(period)
Five-year coverage(%)
(period)
(1.7.2007–30.6.2010) (1.7.2008–30.6.2011) (1.7.2009–30.6.2012)
82,1
82,4
82,5
(1.7.2005–30.6.2010) (1.7.2006–30.6.2011) (1.7.2007–30.6.2012)
Results of the screening smears - target group (20–64 years old)
Satisfactory for evaluation (%)
94,8
Normal result (%)
88,3
Non-neoplastic changes (%)
5,6
Epithelial cell abnormalities (%)
5,9
Pathology reports - all Slovenian women
Number of histology reports (cervical pathology)
7.958
Number of newly diagnosed cervical cancers
139
96,4
89,7
5,3
4,8
99,8
90,3
4,6
4,9
7.009
138
5.896
no data yet
*Data for the year 2012 are still in the process of collection and registration, the numbers are not final yet – data
for this report were analysed on February 5th 2013.
34
Figure 1: Three-year coverage of the target population by smear within NP ZORA, by fiveyear age groups, last five three-year periods. Source: Screening registry ZORA.
20-24
25-29
30-34
Age group
35-39
40-44
45-49
50-54
55-59
60-64
Together (20–64)
0
10
20
30
40
50
60
70
80
90
100
Coverage (%)
2005–2008
2006–2009
2007–2010
2008–2011
2009–2012
Figure 2: Three-year coverage of the target population by smear within NP ZORA, by health
regions, last five three-year periods. Source: Screening registry ZORA.
RAVNE
NOVO MESTO
NOVA GORICA
Health region
MURSKA SOBOTA
MARIBOR
LJUBLJANA
KRANJ
KOPER
CELJE
Slovenija
0
10
20
30
40
50
60
70
80
90
Coverage (%)
2005–2008
2006–2009
2007–2010
2008–2011
2009–2012
35
Important achievements and programme challenges in the future
The most important achievement of the ZORA programme is undoubtedly the desired
reduction in the incidence of cervical cancer; from the introduction of the programme in 2003
until 2011, the incidence fell by almost 40%. Praise goes to the gynaecological teams who
regularly invite women to their screening exams, which certainly contributes to a good
coverage which is one of the key factors for the success. Women that do not respond to
invitations (non-responders) are mostly older (50-64 years old) and some of them don't have a
selected gynaecologist.. Although this group of women is smaller, more than half of all new
cases of cancer are diagnosed within it, and the number has even grown in recent years. Other
countries are developing different ways to include non-responders in screening programmes –
either by special invitations or by offering them self-sampling at home. Slovenia, which
follows these examples, is considering a pilot project of the ZORA programme aimed at
increasing the examination rate in this group of women.
Since 2003 a lot of work was done in NP ZORA to assure the quality within the programme.
Important progress was made in the quality of cytology. Despite the reduction of the total
number of pathological results of screening and consequently the number of control smears
and invasive diagnostic procedures, the incidence of cervical cancer in Slovenia has decreased.
Special praise goes to our cytopathologists and screeners, who had out a lot of effort to
improve the quality of cytological diagnostics. Cytology is the field of the ZORA programme
with the most evolved system for quality assurance and control. The elements of this system
are a standardised cytological referral form and a report form with uniform terminology
(Bethesda 2001 system), central registration of data in the screening registry ZORA, standards
and guidelines for work in cytopathology laboratories, annual revision of cervical smears of
women newly diagnosed with cervical cancer, and regular and systematic education of
screeners and cytopathologists. The introduction of these elements is also necessary in other
fields of ZORA programme implementation, e.g. in colposcopy and histopathology, whose
quality is becoming of key importance for the prevention of overdiagnostics and overtreatment,
especially after the introduction of a HPV triage test in the treatment of women with
precancerous changes in 2011.
While the treatment of women with cervical precancerous changes has become more and more
comprehensive and multidisciplinary, the introduction of new, standardised forms and
procedures brings further administrative burdens for healthcare and administrative personnel.
Quality in the programme can only be achieved with quality communication among different
programme providers. We need a user-friendly communication channel that allows for fast,
accurate and secure exchange of important health information among all health professionals
involved in the management of the same woman. E-ZORA will make data readily available to
all health-professionals who need these data either for a correct decision about the further
management of the woman, or for monitoring and optimisation of quality and effectiveness of
the screening programme.
Future challenges:
36
–
–
–
–
–
–
–
–
–
–
to introduce or upgrade regular, systematic education activities for professionals
involved in NP ZORA (gynaecologists, cytopathologists, histopathologists, nurses,
screeners);
to introduce or upgrade the regular, systematic activities for quality control at all levels
of the programme;
to introduce standardised reports, standards and guidelines for colposcopy and
histopathology;
to modernise the information system of the screening registry and to provide an
electronic link of the screening registry with all programme providers for faster, higher
quality and fuller transmission of data between the different experts who examine the
same woman (e-ZORA);
to upgrade of the Cancer Registry of the Republic of Slovenia with the clinical registry
of cervical cancer and CIN;
to introduce the regional multidisciplinary expert groups for counselling regional
providers in case of difficult cases;
to analyse and find solutions for the sustainability of the programme, especially
because of the lack of gynaecologists at the primary level, which is evident in the
increasingly frequent complaints of women concerning the accessibility of screening
and the determining of a selected gynaecologist in previously undetermined women;
to implement a pilot project for screening of non-responders by HPV-self-sampling;
to modernise the legal basis for the programme;
to elaborate the NP ZORA clinical path.
37
4.2.
Breast Cancer Screening Programme – DORA Programme
Brief description of the programme
Programme name: National Breast Cancer Screening Programme – NP DORA
Programme type: organised population based screening programme.
Year of initiation: first invited women were screened in this programme in April 2008.
Programme founders: Ministry of Health of the Republic of Slovenia, Health Insurance
Institute of Slovenia and Institute of Oncology Ljubljana.
Responsible institution: Institute of Oncology Ljubljana.
Screening interval: two years.
Screening examination: screening mammography.
Additional diagnostics and treatment of lesions detected during screening: additional
projections (compression, enlargement), breast ultrasound, clinical examination, core biopsy,
MRI, open biopsy, chemotherapy, radiotherapy and biological (targeted) therapy.
Target group of population: women aged from 50 to 69 with permanent residence in the
Republic of Slovenia. Exclusion criteria for screening are the following: breast cancer,
including carcinoma in situ (C50, D05), diagnosed at any time in the past.
Invitation method: all women from the target population group who do not meet the
exclusion criteria are sent a personal invitation letter with the date, hour and place of screening
examination and contact information in case they want to change the date. If a woman does
not attend the examination, she is sent another invitation. Women may also make an
appointment for the screening examination themselves, by telephone through the central
coordination centre of the programme. The DORA programme is currently implemented in
two Slovenian regions – Osrednjeslovenska and Zasavje.
Programme providers: screenings are carried out in the stationary unit of the Institute of
Oncology Ljubljana (IOL) and in two mobile units. All personnel, equipment and workflow
must meet the EU requirements for quality control as stated in the European guidelines for
quality assurance (N. Perry, M. Broeders, C. de Wolf, S. Törnberg, R. Holland, L. von Karsa
and E. Puthaar (ed.): European Guidelines for Quality Assurance in Breast Cancer Screening
and Diagnosis. Fourth Edition. European Commission. Luxembourg, Office for Official
Publications of the European Communities, 2006 (ISBN 92-79-01258-4)).
Quality assurance and control: monitoring of quality control indicators has been enabled
ever since the launch of the programme and is carried out at least twice a year, always at the
end of the current year. The resulting report is sent to the medical director of IOL. Quality
indicators are defined in the European guidelines for quality assurance (N. Perry, M. Broeders,
C. de Wolf, S. Törnberg, R. Holland, L. von Karsa and E. Puthaar (ed.): European Guidelines
for Quality Assurance in Breast Cancer Screening and Diagnosis. Fourth Edition. European
Commission. Luxembourg, Office for Official Publications of the European Communities,
2006 (ISBN 92-79-01258-4)).
38
Information system of the programme: a web application that follows all steps in the
screening procedure was developed. It consists of several applications (application for the
invitation, screening, reading, consensus, assessment, pre and post- operative conference,
pathology, surgery, Dora registry, evaluation – quality control indicators). All data needed for
constant and stable workflow and statistical analysis is collected in the central data warehouse.
All screening units are using the same database (DORA registry).
Links: central population register (eCPR), spatial unit register (SUR) and Cancer Registry of
the Republic of Slovenia.
Data: personal data about women from the programme target group and findings of screening
and diagnostic examinations and treatment.
Website of the programme: http://dora.onko-i.si/
Quality Indicators of DORA NP
The DORA programme regularly controls the quality of implementation through predetermined indicators as stated in the European guidelines for quality assurance, published in
2004 (N. Perry, M. Broeders, C. de Wolf, S. Törnberg, R. Holland, L. von Karsa and E.
Puthaar (ed.): European Guidelines for Quality Assurance in Breast Cancer Screening and
Diagnosis. Fourth Edition) and states the desirable and acceptable values of quality indicators
to be followed and achieved by each breast cancer screening programme.
The Epidemiology and Cancer Registry – DORA Registry Department at the Institute of
Oncology – provides the basic statistics: it calculates the basic selection of quality indicators
and prepares more detailed statistics for the internal programme quality control (statistics by
radiographers, by radiologists…).
Participation by screening rounds, age groups and regions
Participation in the DORA programme was defined as a percentage of all invited women who
attended the screening. In order to reduce breast cancer mortality rate it is necessary to reach
at least 70 % participation rate. This percentage has been mostly reached, except in the
Zasavska region where many women reported that they don’t wish to carry out 2nd round
mammography in Ljubljana since they did the 1st round screening in the mobile unit in their
hometown.
Participation in the DORA programme by screening rounds, age groups and regions in the
period from the beginning of screening until the end of 2012 (21 April 2008 – 31 December
2012) is shown in the table below.
Participation in the DORA programme by screening rounds, age groups and regions in the period from the
beginning of screening until the end of 2012 (21 April 2008 – 31 December 2012).
39
Round number Statistical region
Age group
1
50-54
55-59
60-64
65-69
Total
50-54
55-59
60-64
65-69
Total
OSREDNJESLOVENSKA
ZASAVSKA
2
Total
OSREDNJESLOVENSKA
ZASAVSKA
3
Total
OSREDNJESLOVENSKA
Number of women
invited
Of which examined at any Participation (% of
time
women invited who
were examined at
any time)
18.278
16.099
14.015
13.152
61.544
2.255
1.607
1.283
1.108
6.253
67.797
1.695
3.015
2.907
1.972
9.589
254
372
348
293
1.267
10.856
32
223
223
216
694
79.347
50-54
55-59
60-64
65-69
Total
50-54
55-59
60-64
65-69
Total
50-54
55-59
60-64
65-69
Total
Total
75,2
74,2
74,2
71,8
74,0
58,7
62,4
67,4
68,5
63,2
73,0
92,7
93,8
96,3
95,2
94,7
46,9
57,5
61,8
61,1
57,4
90,3
87,5
95,5
98,7
97,2
96,7
75,5
13.737
11.949
10.398
9.437
45.521
1.324
1.002
865
759
3.950
49.471
1.571
2.829
2.799
1.877
9.076
119
214
215
179
727
9.803
28
213
220
210
671
59.945
Calculated on 18.03.2013.
Other quality indicators of the DORA programme
Key quality indicators of the DORA programme: 21 April 2008 – 31 December 2011
Quality control parameters of Slovene breast cancer screening program (DORA) according to
the EU guidelines recommendations (for women invited 21.4.2008-31.12.2011).
Program DORA
value
EU acceptable
level
EU desirable
level
78.6%
> 70%
> 75%
Initial round
4.7%
< 7%
< 5%
Subsequent
examinations
2.1%
< 5%
< 3%
Proportion of
women invited that
attend for screening
Proportion of
women recalled for
further assessment
40
Proportion of screen
detected cancers that
are invasive
Breast cancer
detection rate oer
1000 screened
Proportion of screen
- detected cancers
that are stage II+
81.7%
90%
80-90%
Initial round
7.8/1000
7.5/1000
> 7.5/1000
Subsequent
examinations
3.8/1000
3.7/1000
> 3.7/1000
Initial round
33,3%
--
< 30%
Subsequent
examinations
14.3%
25%
< 25%
Proportion of
invasive screen detected cancers that
are node - negative
Initial round
71.3%
--
> 70%
Subsequent
examinations
75.0%
75%
> 75%
Proportion of
invasive screen detected cancers that
are <= 10 mm in size Initial round
32.8%
--
>= 25%
Subsequent
examinations
33.3%
>= 25%
>= 30%
51.1%
50%
> 50%
5.2 days
5 days
3 days
29.2 days
15 days
10 days
Proportion of
invasive screendetected cancers that
are < 15 mm in size
Time (in working
days) between result
of screening
mammography and
offered assessment
Time (in working
days) between
decision to operate
and date offered for
surgery
41
Proportion of
women who did not
wait for the
operation more than
two weeks
Benign to malignant
open surgical biopsy
ratio in women at
initial and
subsequent
examinations
Proportion of imageguided core/vacuum
procedures with an
insufficient result
Proportion of
localisations placed
within 1 cm prior to
excision
Proportion of benign
diagnostic biopsies
weighing less than
30g
Proportion of
patients where a
repeat operation is
needed after
incomplete excision
Analyzed on 15.11.2012.
37.7%
--
> 90 %
1 : 0.5
<= 1 : 2
<= 1: 4
0.2%
< 20 %
< 10 %
100%
90%
> 90%
51.6%
90%
> 90%
11.2%
10%
< 10%
In the view of the present calculations, the DORA programme follows and meets the
acceptable levels of quality indicators according to the EU standards. The only indicators that
slightly digress from the desired values are those related to surgery, since the lack of capacities.
Important achievements and programme challenges in the future
The DORA programme has had high participation rates in the first few years and participants
are very satisfied with it. We are proud to be one of the rare European countries that strictly
follow the European guidelines in the implementation of the programme. The guidelines set
quality indicators which the DORA programme achieves almost perfectly.
In addition, the Institute of Oncology was the first in Europe to make an EU guidelines-based
web application which enables links with the electronic databases of the population register,
cancer registry, hospital information system, radiological information system and the database
for the archiving of the mammograms (PACS). The DORA web application thus enables the
invitation of women, continuous monitoring of individual women covered by the programme
and calculation of current statistical data, e.g. quality indicators – some of which have been
prepared in advance as part of e-reports.
Future challenges
42
–
–
In the future we wish to establish the programme throughout Slovenia as soon as
possible and enable high quality screening to all women in the country. This will
require agreements with centres that already have digital mammography equipment
and wish to make it available for the DORA programme. What is also necessary is
agreements about the purchase of new equipment and the parallel management of
training for new personnel (radiographers). The DORA programme has only three
mammography devices at its disposal, and even these are fully exploited.
The Act on Databases of the Republic of Slovenia is being drafted. We have tried since
2007 to give the DORA registry a legislative basis. In cooperation with the information
commissioner, we prepared the content of consent for each woman who enters the
programme and thus met the legal requirements for the acquisition of personal data; we
also obtained a positive opinion from the Medical Ethics Committee of the Republic of
Slovenia.
The DORA Programme Council was appointed and had its first meeting on 23 May 2012. The
task of the Council is to alter the DORA programme so that it spreads throughout Slovenia in
the shortest possible time, and to set the time limits for this expansion.
4.3.
Colorectal cancer screening – SVIT Programme
Short description of the programme
1 Programme name
National screening and early detection programme for colorectal cancer (Svit Programme).
2 Programme type
Organised, population based screening programme.
3 Year of programme initiation
The nationwide programme was initiated in 2009. A pilot programme was carried out in three
cities in Slovenia in 2008. Before 2009, an opportunistic colorectal cancer screening was in
place in Slovenia.
4 Programme founder
Ministry of health of the Republic of Slovenia, Health Insurance Institute of Slovenia,
Ljubljana Community Health Centre.
5 Programme operator
Institute of Public Health of the Republic of Slovenia.
6 Screening interval
2 years.
7 Screening test
Immunochemical faecal occult blood test.
8 Additional diagnostics
Colonoscopy, CT colonography, MRI of abdomen, irrigography, biopsy.
9 Treatment of changes detected by screening
Endoscopic therapy (polypectomy and similar), segmental resection of the colon or rectum,
colectomy.
43
10 Target population
Inhabitants of Slovenia, aged between 50 and 69 and covered by a compulsory health
insurance. Out of all the persons who accept the invitation, only those eligible for screening
are included in the actual screening, whilst those who meet the exclusion criteria are not
included. Persons, meeting the temporary exclusion criteria (persons who underwent
colonoscopy in the past three years with no pathologies revealed, i.e. colorectal cancer,
chronic inflammatory intestinal disease, adenoma), are invited again in the following
invitation round, whereas persons meeting the permanent exclusion criteria (adenoma
removed in colonoscopy, detected colorectal cancer, detected chronic inflammatory intestinal
disease) are permanently excluded from the programme. A part the persons who do not return
the statement of participation, the non-respondents also include those who do not wish to
participate. The latter are not participating in the screening, unless they subsequently decide
otherwise and are consequently included again in the next round of screening.
11 Invitation method
In accordance with the indent 2 of Article 23 of the Health Care and Health Insurance Act
(Official Gazette of the Republic of Slovenia, no. 9/92, and its amendments) and the Rules
amending the Rules on the provision of preventive healthcare at the primary level (Official
Gazette of the Republic of Slovenia, no 83/07), all persons aged between 50 and 69 years,
covered with the compulsory health insurance in Slovenia have the right to free participation
in the Svit programme. There are around 560.000 persons meeting these criteria who are
invited according to a pre-defined scheme in the period of two years. A test kit for two faecal
samples is sent by mail to persons who completed and returned a signed statement of
participation to the Central unit of the screening programme. All faecal samples are analysed
in one central laboratory thereby ensuring a simultaneous analysis of a large number of
samples under standard working conditions and with high quality guaranteed. The results of
the faecal samples analysis are sent by mail to the tested person and her/his general
practitioner. Persons with a positive result are then referred to colonoscopy. Colonoscopies are
performed in 23 certified colonoscopy centres. The general practitioner, whom the person
visits upon receiving a positive result, decides whether the patient is suitable for colonoscopy.
Prior to colonoscopy, the practitioner fills in a questionnaire with information on the patient
case history, his family history of colorectal cancer, medication and patient’s clinical status.
Most patients prepare for colonoscopy at home. If the practitioner assesses that the patient’s
health status requires however an inpatient preparation, an inpatient colonoscopy is organized.
The dates and the locations of the outpatient and inpatient colonoscopies are coordinated by
the Central unit of the Screening programme. The data on the course of colonoscopy, its
results and the histopathological analysis of the biological tissue samples are entered into a
uniform information system. All the data is collected by the Central unit of the screening
programme.
12 Programme providers
Programme operator Svit (Central unit), general practitioners, certified centres for
colonoscopy and histopathology. The promotion of the programme is being carried out by:
44
Svit info points at the community health centres, regional Institutes of Public Health and nongovernmental organisations.
13 Quality assurance and control
− Standardised documents: invitation to screening, information material on colorectal
cancer (booklet), instructions for taking of the faecal sample, faecal samples analysis
results, pre-colonoscopy questionnaire;
− Instructions for colonoscopists and histopathologists (last updated in 2012);
− Doctor’s referral for histopathology and colonoscopy result;
− Information to general practitioners on patients with positive and negative result of
faecal occult blood test, information to general practitioner on the patients who did not
respond to the programme or did not return faecal samples or did not respond to the
invitation to colonoscopy;
− Monitoring of the response by statistical/health regions up to the municipal level twice
a year;
− Annual professional supervision in colonoscopy centres;
− Review of all the procedures included in the treatment of patients who participated in
the screening programme and were diagnosed with colorectal cancer;
− Central information system, legal basis for programme implementation;
− Regular professional training for providers.
14 Programme information system
− Central registry of organised detection and treatment of precancerous changes and
colorectal cancer – Svit, kept by the National Institute of Public Health.
− Links: Central population register, Health Insurance Institute of Slovenia, certified
colonoscopy and histopathology centres.
− Data: target population personal data, person’s status according to the Svit programme
algorithm, targeted anamnesis, data on screening and diagnostic tests, treatment and
disease (stage according to the TNM Classification or other corresponding
clinical/pathological classification).
Website of the programme: http://www.program-svit.si/
Svit programme indicators
For the purposes of the National Cancer Control Programme, eight indicators are being
monitored for the Svit programme:
a) coverage of population by invitations
b) response to invitations
c) participation rate
d) positive faecal occult blood test rate
e) rate of colonoscopy upon referral
f) colonoscopy complication rate
45
g) advanced adenoma/cancer detection rate
h) stage of screen detected cancer
Data processing methodology: second screening round data in the period from April 2011 to
December 2012 are processed according to age groups, gender and statistical regions. The
target age of the invited population is 50 to 69 years.
Coverage of population by invitations
The indicator shows the proportion of persons invited to participate in the programme among
those in the target population who are meeting the invitation criteria; tables 1 and 2. The
indicator shows the extent to which the population meeting the invitation criteria was included
in the screening programme within a certain screening interval. From this indicator we can
deduce the share of undelivered invitations due to incomplete addresses gained from the
central population registry. In the second screening round, 502.325 persons met the invitation
criteria, out of which 99.60 % received the invitation. There were no significant differences
between statistical regions.
The Coverage of population by invitations Indicator of the Svit Programme exceeds the
internationally defined acceptable (95 %) and desirable (> 95 %) level.
Table 1: Coverage of population by invitations according to gender and age group. Source:
Svit Programme.
Table 2: Coverage of population by invitations according to gender and statistical regions.
Source: Svit Programme.
46
Report
In December 2012, the second screening round, carried out in the period from April 2011 to
December 2012, was closed. Hereinafter, we present you with the report on the course of the
programme only for the year 2012. The data on the analysis of the second screening round can
only be presented to you in 2014, regarding the fact that the last invitations to the programme
were sent only at the end of December 2012. Numerous activities (i.e. returning of the signed
statement of participation, taking of and analysis of the faecal samples, colonoscopies …) of
the participants of the second screening round are still in progress, therefore it is reasonable to
wait for the data analysis until 2014.
In the period from 1st January to 31st December 2012, 280.686 persons, covered by a
compulsory health insurance, were invited to the Svit Programme. Out of 279.592 (99.61 %)
delivered invitations, 174.241 (62.32 %) signed statements of participation were returned. Due
to temporary or permanent exclusion criteria (colonoscopy in the past three years with or
without removed polyps, colorectal cancer and chronic inflammatory intestinal disease)
12.992 (7.46 %) persons were excluded.
Test kits for the taking of two faecal samples for faecal occult blood test were sent to 162.585
persons. There were 153.881 (94.34 %) persons to return samples, appropriate for the analysis,
to the central laboratory of the Svit Programme. 144.339 (93.80 %) persons analysed came out
with a negative result and 9.542 (6.20 %) persons came out with a positive result. 154.329
persons or 57.89 % of the invited population were screened, including 448 (0.29 %) persons
who returned the faecal samples kit but were unsuitable for analysis.
9.016 colonoscopies were carried out in 8.867 persons, as well as 6.004 histopathological
analysis.
Compared to 2011, the response to the programme increased in 2012 from 58.30 % to 62.32 %.
Compared to the first screening round, the preliminary analysis of the data on the response to
the programme in 2012 shows a decrease in differences between health regions; table 3.
Table 3: Response of the invited persons according to health regions and gender in the period
from 1st January to 31st December 2012.
HEALTH REGION
CELJE
KOPER
KRANJ
LJUBLJANA
MARIBOR
MURSKA SOBOTA
NOVA GORICA
NOVO MESTO
Total
61,15%
58,23%
65,71%
64,53%
59,32%
58,03%
65,68%
63,46%
RESPONSE
Men
56,12%
53,97%
61,02%
58,52%
54,64%
53,14%
61,65%
58,77%
Women
66,20%
62,58%
70,08%
70,28%
64,06%
62,92%
69,82%
68,41%
47
RAVNE NA KOROŠKEM
SLOVENIA
62,73%
62,32%
57,32%
57,19%
68,45%
67,40%
Selected physicians play an important role in the course of the Svit Programme. The note on
patients with positive result of faecal occult blood test who need to be referred to colonoscopy
is sent to selected physicians promptly. Once a year doctors are presented with lists of defined
patients who entered the Svit Programme and had a negative result of faecal occult blood test,
and three times a year they get a list of defined patients who have not responded to the
invitation to the Svit Programme in the past four months and a list of defined patients who,
despite two reminders, have not returned the faecal samples. Selected physicians are asked to
actively include non-respondents into the programme.
In accordance with the Svit Programme communication strategy and communication plan,
several different activities were in place. An important communication support in the
programme implementation is Svit Call centre, available every business day from 9 am to 2
pm to provide information and counselling as well as appointments for colonoscopy.
Additional support and information is provided on the websites of the Svit programme. In
2012, 25.916 persons visited the website, out of which 77.17 % visited the website for the first
time. In 2012, all regional Institutes of Public Health actively participated in the networking to
support the implementation of the Svit Programme.
In 2012, 275 cases of colorectal cancers were discovered. 2.873 persons had an advanced
adenoma, which represents a higher cancer risk; table 4.
The stated data result from a preliminary analysis carried out on the 24th January 2013.
Table 4: (The worst) findings in persons who undertook colonoscopy for the first time in 2012.
Findings
Cancer
Advanced adenoma
Nonadvanced adenoma
Other histological non-neoplastic
findings
Histology result not entered
Without samples for histology
Total
n
275
2.873
1.718
share (%)
3,11%
32,47%
19,42%
754
8,52%
4
3.224
8.848
0,05%
36,44%
100,00%
One of important objectives of the Svit Screening Programme is detecting cancer in its early
stage. According to the data of the first screening round, 71 % cancers were discovered in their
early stage, i.e. stages 1 and 2, when treatment is effective and less expensive. A similar
distribution of stages of detected cancers is expected also in 2012 and in the second screening
round.
16 Challenges for the future
48
The main challenge for the Svit programme in the year 2013 is the regulation of the legislation
in such a way that will enable the programme to integrate data required for monitoring the
quality and effectiveness of the programme implementation. Since Svit programme is yet
without appropriate legal grounds needed for its operation, it is imperative that the Ministry of
Health and the government reform the Healthcare Act.
Another important task of the Svit programme is the identification of causes and
implementation of appropriate strategies and activities to increase the responsiveness in those
individual municipalities that are significantly below the average response to the programme
in Slovenia.
49
5. Diagnosis and treatment of cancer
5.1.
Primary healthcare
Cross-sectional survey on the causes of early/late referrals from primary care level – European
research:
Prof. Poplas attended a meeting on this topic in May this year in Sweden. The delegates
decided to try to apply with the project for European funds. Should the project be adopted for
co-financing within the framework of European funds, in Slovenia it will be entrusted to the
Chair of Family Medicine (Ljubljana).
5.2.
Secondary and tertiary healthcare
In line with the NCCP and at the request of patients’ associations, the working group for
diagnosis and treatment defined criteria for cancer diagnosis and treatment, and for
implementing institutions (oncology network). The work of the group was based on the
proposal of the extended expert college for oncology and working groups composed of experts
in various topics (see the appendices below).
The extended expert college for oncology proposed also the maximal acceptable waiting time
from diagnosis to treatment – 4 weeks.
Melanoma
Liver, bile,
duct and
pancreatic
cancer
Brain and
meningeal
tumours
Testicular
cancer
Head and
neck cancers
Lung cancer
Malignant
diseases in
children
Stomach
cancer
Colorectal
cancer
Breast cancer
Adult
sarcomas
Prostate
cancer,
kidney
cancer,
bladder
cancer
According to the decision made at the 3rd session of the NCCP Supervision Council, we shall
monitor to what extent and where first treatment of frequent cancers actually takes place.
However, IT support will be required to record these data and data on complications and
quality. While such an option remains unavailable, the data on procedures performed
50
(surgeries, systemic therapy, radiation therapy) will be collected from hospital directors. These
data are shown in Table 1.
Table 1. Annual report of hospitals on first treatment of frequent cancers in 2012 (*data for
2011)
Breast cancer
Institution
Maribor University
Medical Centre
Ljubljana Institute of
Oncology
Slovenj Gradec GH
Nova Gorica GH
Celje GH
Izola GH
TOTAL
Colorectal cancer
Institution
UMC Ljubljana –
Dept. of Surgery
UMC Ljubljana –
Dept. of Internal
Medicine
UMC Maribor
Institute of Oncology
Ljubljana
Slovenj Gradec GH
Jesenice GH
Novo Mesto GH
Ptuj GH
Nova Gorica GH
Trbovlje GH
Celje GH
Izola GH
Murska Sobota GH
TOTAL
Stomach cancer
Institution
UMC Ljubljana –
Dept. of Surgery
UMC Ljubljana –
Dept. of Internal
Surgery
228
Systemic treatment
213
Radiation therapy
/
620*
750*
605*
31
109
25
47
1060
12
24
7
/
1006
/
/
/
/
605
Surgery
437
Systemic treatment
/
Radiation therapy
/
/
11
/
190
93
27
435
/
264
52
108
62
40
85
21
80
107
79
1354
/
/
/
/
1
/
5
/
/
580
/
/
/
/
/
/
/
/
/
362
Surgery
90 stomach; 40
esophagus
/
Systemic treatment
/
Radiation therapy
/
27
/
51
Medicine
UMC Maribor
Institute of Oncology
Ljubljana
Slovenj Gradec GH
Jesenice GH
Novo Mesto GH
Nova Gorica GH
Celje GH
Izola GH
Murska Sobota GH
TOTAL
Lung cancer
Institution
UMC Ljubljana –
Dept. of Surgery
UMC Maribor
Institute of Oncology
Ljubljana
Golnik Hospital for
Pulmonary and
Allergic Diseases
Slovenj Gradec GH
Jesenice GH
Novo Mesto GH
Ptuj GH
TOTAL
Prostate cancer
Institution
UMC Ljubljana –
Dept. of Surgery
UMC Maribor
Institute of Oncology
Ljubljana
Slovenj Gradec GH
Jesenice GH
Novo Mesto GH
Ptuj GH
Nova Gorica GH
Celje GH
Izola GH
Murska Sobota GH
87
/
7
100
/
73
14
13
1
10
13
26
3
297
/
/
/
/
/
/
/
179
/
/
/
/
/
/
/
73
Surgery
145
Systemic treatment
/
Radiation therapy
/
51
2
81
269*
/
550*
69
188
/
/
/
/
/
267
/
/
/
/
538
/
/
/
/
550
Radical
prostatectomy
150*
Systemic treatment
Radiation therapy
No data
/
102
/
83
128*
/
174*
263
/
18
/
51
201
18
74
18
/
44
/
/
40
/
/
/
/
/
/
/
/
/
/
52
TOTAL
Bladder cancer
Institution
UMC Ljubljana –
Dept. of Surgery
UMC Maribor
Institute of Oncology
Ljubljana
Slovenj Gradec GH
Jesenice GH
Novo Mesto GH
Ptuj GH
Nova Gorica GH
Celje GH
Izola GH
Murska Sobota GH
TOTAL
Kidney cancer
Institution
UMC Ljubljana –
Dept. of Surgery
UMC Maribor
Institute of Oncology
Ljubljana
Slovenj Gradec GH
Jesenice GH
Novo Mesto GH
Ptuj GH
Nova Gorica GH
Celje GH
Izola GH
Murska Sobota GH
TOTAL
877
203
174
Radical cystectomy
45*
Systemic treatment
/
Radiation therapy
/
18*
/
19
29
/
21
7*
/
0*
/
/
/
/
/
2*
5*
/
77
22
/
15 BCGs – as
localised
immunotherapy
/
/
/
/
/
85
Surgery
217
Systemic treatment
/
Radiation therapy
/
42
1
/
38*
/
23*
25
/
23
/
10
39
14
17
388
/
/
/
/
/
/
/
/
38
/
/
/
/
/
/
/
/
23
/
/
/
/
/
21
In order to draw up a proposal for the treatment of haematological cancers, haemato-oncology
should be included in the NCCP (a programme must be drafted and included in the NCCP) in
the same manner as the rest of the programme (proposal, discussion on the proposed text and
alignment with the NCCP).
53
5.3.
Indicators
One of the indicators of early diagnosis in Table 1 (for 2008) and in Table 2 (for 2009) shows
the different stages of all cancers, common cancers and cervical cancer; a screening
programme has been in place for the longest period of time for cervical cancer. Listed are the
following stages: localised – cancer is confined to the source organ; invasive – cancer has
spread to regional lymph nodes; disseminated – metastases were diagnosed. It is evident from
the tables that very few stages are unknown (thanks to the quality of healthcare in the field of
oncology (diagnostics) and the Cancer Registry of the Republic of Slovenia).
.
54
Table 1: Stage at diagnosis for the most common cancers and cervical cancer in 2008
ICD-10
Stage
No. of new cases
%
All cancers
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
5527
3209
2261
339
48,8
28,3
19,9
3,0
ALL
11336
100
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
ALL
196
868
350
32
1446
14
60
24
2
100
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
ALL
160
383
623
41
1207
13
32
52
3
100
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
ALL
545
496
102
5
1148
47
43
9
0,4
100
LOCALISED
74
57
Colon and rectum (C18–
C20)
Trachea, bronchus and lung
(C33–C34)
Breast (C50)
Cervix uteri (C53)
55
Prostate (C61)
INVASIVE
DISSEMINATED
NO DATA
ALL
45
11
0
130
35
8
0
100
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
ALL
785
281
75
44
1185
66
24
6
4
100
56
Table 2: Stage at diagnosis for the most common cancers and cervical cancer in 2009
ICD-10
Stage
No. of new cases
%
All cancers
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
5587
3305
2150
322
49,2
29,1
18,9
2,8
ALL
11364
100,0
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
ALL
249
920
361
35
1565
15,9
58,8
23,1
2,2
100,0
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
ALL
184
367
598
33
1182
15,6
31,0
50,6
2,8
100,0
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
ALL
552
452
98
16
1118
49,4
40,4
8,8
1,4
100,0
Colon and rectum (C18–
C20)
Trachea, bronchus and lung
(C33–C34)
Breast (C50)
57
Cervix uteri (C53)
Prostate (C61)
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
ALL
71
46
12
1
130
54,6
35,4
9,2
0,8
100,0
LOCALISED
INVASIVE
DISSEMINATED
NO DATA
ALL
837
316
91
64
1308
64,0
24,2
7,0
4,9
100,0
58
5.4.
Radiation equipment and associated waiting periods
In Slovenia, radiation therapy is provided only by the Ljubljana Institute of Oncology. We
would like to open a radiation therapy department in Maribor as soon as possible in order to
provide palliative and simple forms of radiation therapy to patients with lung, rectal and breast
cancers who live in the north-east of Slovenia. At least 50% of all cancer patients are to
receive radiation therapy.
Radiation therapy comprises teletherapy with linear accelerators (the radiation source is at a
distance from the patient’s body) and brachytherapy (the radiation source is placed inside the
patient).
TELETHERAPY
Over the years, the number of radiation treatments performed has been steadily increasing,
though depending on the number of functioning irradiation devices (irradiators and linear
accelerators) and personnel. Prior to 1996, four teletherapy devices were in operation; a fifth
device was added that year. The number of irradiation devices increased to six in 2006,
followed by an increase to seven in 2009. In 2011, we finally received the eighth linear
accelerator. The number of functioning devices has occasionally decreased due to maintenance
work.
In 2011, the waiting period, as expected, became shorter, as more devices were operational; it
then flattened out but has recently been increasing again.
Year
2007
No.
of
teleradiotherapeutic
procedures
4781
2008
2009
2010
2011
2012
5009
5050
5888
6016
6022
No.
of Average waiting period for
irradiation
radiation therapy
devices
6
NP (longer compared to
2008)
6,5
32
6
48
7
50
8
22
8
22
Modern radiation therapies have been introduced in recent years:
– in 2007, a gradual introduction of a modified technique of radiation therapy (transition from
2D- to 3D-treatment planning);
– in 2008, stereotactic radiosurgery and stereotactic radiotherapy were introduced for brain
tumours and their metastases;
– in 2010, Intensity Modulated Radiation Therapy (IMRT) was introduced;
– in 2011, Image Guided Radiation Therapy (IGRT) and volumetric modulated arc therapy
(Rapid Arc) were introduced;
– in 2012, preparing and use of radiation therapy for children under general anaesthesia were
introduced;
– in 2012, the quality control of radiation therapy was upgraded by electronic portal imaging.
In the next year, we plan to introduce extracranial stereotactic radiosurgery and extracranial
stereotactic radiotherapy.
The introduction of new techniques represents an additional burden on staff and devices, since
procedures are more demanding and time-consuming.
59
BRACHYTHERAPY
The number of brachytherapies has generally been on the increase, except for the past two
years. Since 2008, there have been two PDRs and one HDR in operation at the brachytherapy
ward, which is sufficient for Slovenia. There is no waiting period for this type of radiation
therapy, with the exception of the actual implementation of the procedure.
Year
2007
2008
2009
2010
2011
2012
No. of patients
receiving
brachytherapy
270
316
436
526
497
443
No.
of
devices
1, 3
3
3
3
3
3
Teleradiotherapy facilities in the Republic of Slovenia are insufficient, although the
radiotherapy ward has to operate every working day from 7 a.m. till 8 p.m. This has been
confirmed by daily statistics of the radiotherapy sector and by many calculations of the
required radiation therapy facilities in Slovenia. Already in 2005, the analysis performed by
the European Society for Therapeutic Radiology and Oncology (ESTRO) within the
framework of the international QUARTS project (Quantification of Radiation Therapy
Infrastructure and Staffing Needs) showed that, with respect to the cancer incidence at that
time, the structure of individual cancer types and the age structure of the population, Slovenia
would need 11.7 linear accelerators. The number of irradiation devices should be in line with
the increasing cancer incidence and the introduction of more complex irradiation techniques.
5.5.
Histological diagnosis
Precise and accurate histological diagnosis is of paramount importance for cancer treatment
planning. To this end, in the next year we shall develop standards for indispensable elements
of such diagnosis. Prior to their inclusion into the NCCP, they will be submitted for
consideration and comments to extended expert collegia/expert councils for pathology and
oncology.
60
6. Comprehensive rehabilitation of cancer patients
OIL and IRIS have prepared a draft proposal for the Health Council of the Republic of
Slovenia on the comprehensive rehabilitation of patients with operable breast cancer. The
proposal was reviewed by the Society of Oncology Patients of Slovenia and the Europa Donna
association, who gave their comments thereon. Currently, the process of harmonisation of
these comments is underway, along with the inclusion of the two aforementioned associations
among the promoters of the coordinated proposal for the Health Council.
61
7. Palliative care of cancer patients
A website for palliative care (http://paliativa.ezdrav.si) was established.
The activities of the Working Group on Monitoring and Implementation of the Action Plan,
the extended expert collegium for palliative care, the Slovenian Society of Palliative Care and
individual occupational groups of multidisciplinary palliative teams are coordinated at the
national level.
In accordance with the Action Plan, we have joined the initiative to establish an Institute of
Palliative Medicine and Care, which will take over the entire planning of comprehensive
education for specific occupational groups of multidisciplinary palliative teams. It is necessary
to develop education plans for each occupational group at both the undergraduate and
postgraduate levels. Individual groups will be formed at the conference of the Ministry of
Health and the Council for Palliative Medicine (SZPM) to be held in the autumn in Brdo, and
will start working after the beginning of the new academic year.
The Institute will be affiliated to the University of Maribor. The Senate of the University of
Maribor has already adopted a decision on its founding.
A proposal for regional coordination was drafted back in autumn 2012, but the following
negotiations failed to confirm it. Therefore a new proposal, with more precisely defined tasks,
was prepared.
An international conference on palliative care will be organised on 26 and 27 September 2013
in Brdo in cooperation with the Council for Palliative Care and the Ministry of Health. The
interesting and varied programme is intended to attract a wide range of participants.
21.5. On 21 May, the Institute of Oncology organised a conference on palliative care under the
title “Issues in Palliative Care – Can We Resolve Them?” The objective of the conference was
to lay the foundations for a primary palliative network in the Municipality of Ljubljana and
develop a model for organisation of similar conferences in other regions of Slovenia. The
attendance was high, with some 90 participants. Conferences in other regions will be
organised in cooperation with regional coordinators that have completed the relevant training
at the Ministry of Health. The next will be in the coastal region, where we plan to organise the
conference in cooperation with the Council for Palliative Care in November 2013.
Within the framework of the extended expert collegium for palliative care, we addressed the
draft programme of education to upgrade knowledge in palliative care. The extended expert
collegium agreed with the presented proposal. Further, we discussed the Advance Statement
form, which is an Annex to the Patients’ Rights Act. We will propose that the Ministry of
Health change the form, which is presently unsuitable. We note that there are several forms for
expressing patients’ will available. It is necessary to ensure that there will be only one valid
form available and that patients will be informed about its use.
Prepared by:
Mateja Lopuh, MSc, MD
National coordinator for palliative care
62
8. Research
In 2011, 479 patients were included in clinical studies, which represents – excluding nonmelanoma skin cancers – 4.4% of the estimated cancer incidence for Slovenia, while in 2012
there were 1,995 patients included, which is almost a four-fold increase on the previous year.
Apart from higher inclusion of patients in clinical studies, such an increase may be also
attributed to more consistent reporting on the patients included.
8.1.
Public funds earmarked for cancer research
Share of public funds earmarked for research in oncology (Slovenian Research Agency) in
2010, 2011 and 2012
For 2010:
Total
Medicine
Oncology
8.2.
EUR 176
million
EUR
11.5
million
EUR
1.86
million
100%
For 2011:
Total
6.5%
Medicine
1.1%
Oncology
EUR 176
million
EUR 13
million
EUR 1.96
million
100%
7,4%
1.1%
Cancer research
63
Raziskave s področja raka - PREDKLINIČNE RAZISKAVE
Šifra /Akronim
Naziv raziskave
Priprava in validacija terapevtskih plazmidov brez
selekcije gena za antibiotično rezistenco za gensko
terapijo raka z inducibilnimi in tkivno specifičnimi
promotorji
Priprava in validacija terapevtskih plazmidov brez
selekcijskega gena za antibiotično rezistenco
Vpliv rekombinantnega humanega eritropoetina
na izražanje genov in prenos signala pri raku na
dojkah
Patologija in molekularna genetika
Diferenciacija urotelijskih celic
Farmacevtska kemija: načrtovanje, sinteza in
vrednotenje učinkovin
Apoptotično delovanje alkilpiridinijevih spojin na
celice pljučnega adenokarcinoma
Glavni raziskovalec
Ustanova
Maja Čemažar, Metka Filipič
UP FVZ, UL BF, OIL
Maja Čemažar
UP FVZ, OIL
Nataša Debeljak
Nina Gale
Rok Romih
UL MF
UL MF
UL MF
Danijel Kikelj
Tom Turk, Metka Filipič, Maja
Čemažar
UL FFA
Primerjalna genomika in genomska biodiverziteta
Ginekologija in reprodukcija: Genomika in matične
celice
Razvoj in ovrednotenje radiooznačenih bioloških
molekul za ciljano radionuklidno terapijo
Development and evaluation of radiolabelled biomolecules for targeted radionuclide therapy
Razvoj in ovrednotenje novih terapij za zdravljenje
malignih tumorjev
Imunomodulacija s tumorskimi vakcinami
pripravljenimi iz celih tumosrkih celic
Uporaba antiangiogene sirna za zdravljenje
malignih melanomov
Uporaba magnetne nanotehnologije za
transfekcijo normalnih in tumorskih celic
Kombinacija elektrogenske imunske terapije z
interlevkinom-12 in obsevanjem za zdravljenje
Antiangiogena genska terapija raka: tarčno
zdravljenje z uporabo elektroporacije in magnetnih
nanodelcev kot dostavnih sistemov
Metoda za večmodalno primerjalno analizo 3d
volumnov na osnovi ct/mr slijk
PROGRAM BIOMEDICINSKA TEHNIKA (Projekt
PhysiCoDerm)
Aplikacije pulzirajočih električnih polj v biologiji in
medicin- LEA
Razvoj programa za numerično modeliranje
elektroporacije in vivo ter njegova validacija? in
Peter Dovč
UKC MB, UL BF
Borut Peterlin
UKC LJ, UL MF
Jurij Fettich
UKC LJ
Jurij Fettich
UKC LJ
Gregor Serša
OIL, UP FVZ
Srdjan Novaković
OIL
Maja Čemažar
OIL
Gregor Serša
OIL
Maja Čemažar
OIL
Gregor Serša
OIL
Robert Hudej
OIL
Gregor Serša
OIL
Gregor Serša
OIL
Gregor Serša
OIL
Gregor Serša
OIL
Srdjan Novaković
OIL
Maja Čemažar
OIL
Gregor Serša
OIL
Gregor Serša
OIL
Gregor Serša
OIL
Gregor Serša
Tamara Lah Turnšek
OIL
NIB, IJS, UL FKKT, UKC LJ,
BIA
Tamara Lah Turnšek
NIB
Funkcijska genomika in biotehnologija za zdravje
Raziskave vlog inhibitorjev cisteinskih proteaz v
mehanizmu razvoja in metastaziranja tumorjev
J3-4267-0106
mlečnih žlez
P1-140
Proteoliza in njena regulacija
Light-based functional in vivo monitoring of
FP7 projekt LIVIMODE Diseases related enzymes
Strupene kovine in organokovinske spojine v
J1-4140
kopenskem okolju
J3-0386
Vloga sekretornih fosfolipaz a2 pri raku dojke
Raziskave vlog inhibitorjev cisteinskih proteaz v
mehanizmu razvoja in metastaziranja tumorjev
J3-4267
mlečnih žlez
RS-EPTA
1000-11-340007
EP4 receptor: potencialna tarča
Farmakogenetski pristop k raziskavam, diagnostiki
J3―3615
in terapiji levkemij
Vpliv aktivnega transporta imatiniba in različnih
genotipov pacientov na uspešnost terapije
J3-4313-0787
kronične mieloične levkemije
TUMimm
Imunoterapija tumorjev
Določanje novih biomarkerjev možganskih
tumorjev – gliomov za diagnozo in kot nove tarče
zdravljenja = Identification of new glioma
biomarkers as potential diagnostic and therapeutic
GLIOMA
targets
Razvoj orodij sistemske biologije za celično
SYSTHER
zdravljenje in razvoj zdravil
Ostanki zdravilnih učinkovin in sredstev za osebno
nego v okolju: prisotnost, viri, čiščenje in učinki /
Pharmaceutical and personal care product
residues in the environment: Occurence, sources,
L1-5457
treatment and effects
Radovan Komel
KI, UL MF
Olga Vasiljeva
Boris Turk
Institut 'Jožef Stefan'
Institut 'Jožef Stefan'
Boris Turk
Institut 'Jožef Stefan'
Radmila Milačič, Metka Filipič
Jože Pungerčar
IJS, NIB
IJS
Olga Vasiljeva
IJS
Irena Mlinarič-Raščan
Fakulteta za farmacijo
Irena Mlinarič-Raščan
Fakulteta za farmacijo
Albin Kristl
Tamara Lah Turnšek
Fakulteta za farmacijo
ESSR-INTERREG
Tamara Lah Turnšek
ESSR-INTERREG
ERA-NET
(PathoGenoMics)
Urban Bren, Metka Filipič
ARRS, KI, NIB
J1-5448
Ester Heath, Metka Filipič
ARRS, IJS, NIB
J3-4259
J3-4259
J3-0124
P3-0054
P3-0108
P1-0208
J1-4044
P4-0220
P3-0326
J3-4285
J3-4285-0312
P3-0003
J3-0465
J3-0485
J3-2069
J3-2277
J3-4211
L3-0494
PhysiCoDerm
LEA EBAM
L2-4105
J3-4211
J3-4195
J3-2277-0302
J3-2069-0302
J2- 3639
J1-4131
BI-US/11-12-011
J1-4247
P1-0245
Antiangiogena genska terapija raka: tarčno
zdravljenje z uporabo elektroporacije in magnetnih
Ustvarjanje linije multipotentnih/pluripotentnih
matičnih celic iz odraslega humanega tkiva
Kombinacija elektrogenske imunske terapije z
interlevkinom-12 in obsevanjem za zdravljenje
eksperimentalnih tumorjev
Uporaba magnetne nanotehnologije za
transfekcijo normalnih in tumorskih celic
Novi lipidni modelni sistemi za določitev
mehanizmov elektroporacije
Sinteza, karakterizacija in uporaba novih
rutenijevih spojin v elektrokemoterapiji tumorjev
Uporaba elektrogenske terpije pri zdravljenju raka,
predklinični in klinični aspekti
Dvojna narava matičnih celic v raku in njihova
uporaba v zdravljenju
Program: Ekotoksikologija, toksikogenomika in
karcinogeneza
P1-0104
Mikrovalovna kataliza in kemijska karcinogeneza
Tamara Lah Turnšek
UL BF, NIB, UL VF, IJS, OIL
64
J1-4247
Raziskave s področja raka - TRANSLACIJSKE RAZISKAVE
Naziv raziskave
Ustanova
Spremembe v izražanja genov in mi-RNA pri ploščatoceličnem karcinomu pljuč,
glave in vratu.
UL MF
UKC Ljubljana,
UL,Fak.za kemijo in
kemijsko
Dvojna narava matičnih celic v raku in njihova uporaba v zdravljenju
tehnologijo, IJS, BIA
J3-4135
Molekularne osnove ednometrioze in raka endomestrija - študije metaboloma
Šifra
Z3-2210
J3-4220
L3-0427
J3-4285-0312
L3-0427
J3-4285-0312
P3-0321
P3-0321
P3-0307
Glavni raziskovalec
Mojca Stražišar
dr.Tamara Turnšek
Lah, Nacionalni
inštitut za bilologijo
dr.Tea Lanišnik
Rižner, UL MF
UKC Ljubljana
UKC LJ Pediatrična
Vloga genetskih polimorfizmov na izid zdravljenja in pojav zapletov pri otrocih z klinika, UL Fakulteta
rakom
za farmamcijo,
Janez Jazbec
Razoporeditev genotipov in podtipskih različic humanih virusov papiloma pri
bolnicah z rakom materničnega vratu
UKC LJ
Eda Vrtačnik-Bokal
Razvoj in ovrednotenje radiooznačenih bioloških molekul za ciljano
UKC LJ
Jurij Fettich
radionuklidno terapijo nevroendokrinih tumorjev in spremljajočo diagnostiko
Razoporeditev genotipov in podtipskih različic humanih virusov papiloma pri
bolnicah z rakom materničnega vratu
UKC LJ
Eda Vrtačnik-Bokal
Razvoj in ovrednotenje radiooznačenih bioloških molekul za ciljano
radionuklidno terapijo nevroendokrinih tumorjev in spremljajočo diagnostiko
UKC LJ
Jurij Fettich
Barbara Jezeršek
Napovedni dejavniki poteka bolezni in odgovora na zdravljenje pri raku dojk in OIL, UKC MB in UKC Novaković, Iztok
drugih rakih
LJ
Takač
Barbara Jezeršek
Napovedni dejavniki poteka bolezni in odgovora na zdravljenje pri raku dojk in
Novaković, Iztok
drugih rakih
OIL, UKC LJ, UKC MB Takač
Rak glave in vratu – analiza bioloških značilnosti in poskus izboljšanja zdravljenja OIL, UKC LJ
Značilnosti malignih neoplazem, pomembne za diagnozo, napoved poteka
bolezni in izida zdravljenja
OIL, UKC LJ
Napovedni dejavniki poteka bolezni in odgovora na zdravljenje pri raku dojk in
drugih rakih
OIL, UKC LJ
Primož Strojan
OIL, UKC LJ
Primož Strojan
OIL, UKC LJ
OIL
Nikola Bešić
Nikola Bešić
OIL
Matjaž Zwitter
OIL
Marko Hočevar
OIL
Martina Reberšek
OIL
Erik Škof
OIL
Milena Kerin Povšič
OIL
Gregor Serša
OIL
Primož Petrič
OIL
Gregor Serša
SMILEON
Rak glave in vratu – analiza bioloških značilnosti in poskus izboljšanja zdravljenja
Značilnosti malignih neoplazem, pomembne za diagnozo, napoved poteka
bolezni in izida zdravljenja
Genetske in radioizotopne metode v diagnostiki in terapiji raka ščitnice
Genetska in terapevtska raznolikost bolnikov pri načrtovanju individualizirane
terapije pljučnega raka
Spremljanje somatskih mutacij genov odgovornih za nastanek melanoma in
klinična prognoza bolezni
Vpliv mutacij v BRAF in KRAS genu in histoloških parametrov na klinični potek
bolezni pri bolnikih z adenokarcinomom debelega črevesa in danke
Novi prognostični in/ali napovedni biološki dejavniki pri neoadjuvantnem
zdravljenju bolnikov z jetrnimi zasevki raka debelega črevesa in danke
Primerjava C reaktivnega proteina, prokalcitonina, razmerja nevtrofilci/limfociti
in levkocitne površinske molekule CD64 kot zgodnjih napovedovalcev okužbe po
operacijah karcinoma debelega črevesa in danke
Varnost in učinkovitost intratumorskega elektrotransferja plazmida AMEP pri
bolnikih z napredovalim in metastatskim melanomom: odprto preizkušanje 1.
faze
Vnaprejšnje načrtovanje 3D brahiterapije lokalno napredovalega raka
materničnega vratu na podlagi vstavitve aplikatorja v regionalnem
paracervikalnem bloku in magnetno resonančnega slikanja
European Standard Operating Procedures of Electrochemotherapy and
Electrogenetherapy
Podpora inovativnim pristopom učenja z integracijo mobilne tehnologije na
delovnem mestu - Onkološka zdravstvena nega
Katarina Lokar
CytoThreat
Usoda in učinki citostatskih zdravil v okolju in identifikacija biomarkerjev za
izboljšavo ocen tveganja za okoljsko izpostavitev
OIL
NIB (koordinator),
OIL, MF UL (UKC LJ,
Inštitut za
patologijo,
Medicinski center za
molekularno
biologijo).
NIB (koordinator),
OIL, MF UL (UKC LJ,
Inštitut za
patologijo,
Medicinski center za
molekularno
biologijo).
Klinika Golnik
Klinika Golnik
Mitja Košnik
Tanja Čufer
Klinika Golnik
Tanja Čufer
IJS
Fakulteta za
farmacijo
Fakulteta za
farmacijo
BUTINAR,
veterinarske
storitve d.o.o.
Zdenka Šlejkovec
Irena MlinaričRaščan
P3-0289
P3-0321
P3-0307
P3-0289
J3-0570
J3-2359
J3-4118
Usoda in učinki citostatskih zdravil v okolju in identifikacija biomarkerjev za
izboljšavo ocen tveganja za okoljsko izpostavitev
Genetska in terapevtska raznolikost bolnikov pri načrtovanju individualizirane
J3-2359
terapije
J3-4076-1613 Molekularni in drugi označevalci raka pljuč in mezotelioma
Kardiovaskularne bolezni, metabolizem in ledvična funkcija pri bolnikih z rakom
J3―2394-1613 pljuč
Vpliv metabolitov arzenovega trioksida na zdravljenje akutne promielocitne
J3-0161
levkemije in multiplega mieloma
CytoThreat
J3―3615
J3―4313
Farmakogenetski pristop k raziskavam, diagnostiki in terapiji levkemij
Vpliv aktivnega transporta imatiniba in različnih genotipov pacientov na
uspešnost terapije kronične mieloične levkemije
L3-4171
Kronične vnetne in rakaste spremembe ustne sluznice
Nikola Bešić
Barbara Jezeršek
Novaković
Metka Filipič, Maja
Čemažar
Metka Filipič, Maja
Čemažar
65
Irena Albin Kristl
dr.Nataša Hren
Ihan, UKC ljubljana
Šifra
Naziv raziskave
Raziskave s področja raka - EPIDEMIOLOŠKE RAZISKAVE
Ustanova
UKC MB in
P3-0036
Bio-psiho-socialni model kvalitete življenja
Družine s povišano ali visoko ogroženostjo za raka: svetovanje, odkrivanje
P3-0352
mutacij in preprečevanje raka
J3-0480
Genetika dednega melanoma
Študija celostnega sklapljanja zdravstvenih in okoljskih podatkov v Zasavju
kot model študije za podporo pri oblikovanju in izvajanju medsektorskih
V3- 1049
politik s področja okolja in zdravja (CRP)
Izdelava strokovnih podlag za zbiranje in spremljanje izbranih kazalnikov
V3- 1048
učinkovitosti Državnega programa obvladovanja raka (CRP)
Doživljensko spremljanje preživelih od raka v otroštvu in mladosti in
IP-0302
translacijske raziskave
BI-CY/12-13-002 Gensko testiranje družin z dednim melanomom v Sloveniji
Identifikacija moških z dedno ogroženostjo za raka prostate: Usmerjeno
presejanje pri nosilcih mutacij BRCA1/2 in kontrolnih osebah- Raziskava
IMPACT
Prehranska vizita (v slovenskih bolnišnicah)
RARECARENet
Informacijsko mrežje za redke vrste raka
EPAAC
Evropsko partnerstvo v boju proti raku
Onkološko genetsko svetovanje pri ženskah z večjo ogroženostjo z rakom
dojk in jajčnikov: znanje, pričakovanja in odnos
INSIGHT - Implementation of Personalized Medicine in
NSCLC: EGFR Testing, Histopatological and Clinical Features lastnosti /
Izvajanje posamezniku prilagojenega zdravljenja nedrobnoceličnega
pljučnega raka: EGFR testiranje, histopatološke in klinične lastnosti.
J3-2394
Glavni raziskovalec
Medicinska
fakulteta Univerze
OIL, UKC LJ in UKC
MB
OIL
Dušanka Mičetić-Turk, Borut
Gorišek, Dejan Dinevski
Janez Žgajnar, Bogdan
Ćizmarević
Marko Hočevar
OIL
Vesna Zadnik
OIL
Maja Primic Žakelj
OIL
OIL
Lorna Zadravec Zaletel
Srdjan Novaković
OIL
OIL
OIL
OIL
OIL
Janez Žgajnar
Nada Rotovnik Kozjek
Maja Primic Žakelj
Maja Primic Žakelj
Mateja Krajc
Klinika Golnik
Tanja Čufer
EuLuCA - European Lung cancer Audit; An observational, non-intervention,
study for the feasibility of prospectively collecting demographic
and clinical data on lung cancer patients in a Pan-European setting /
Opazovalna, neintervencijska prospektivna študija izvedljivosti zbiranja
demografskih
in kliničnih podatkov o bolnikih z rakom pljuč v vseevropskem okolju.
Klinika Golnik
Tanja Čufer
DIEPP - A prospective Dose Intensity and Neutropenia Prophylaxis
Evaluation Program in patients receiving myelosuppressive chemotherapy
with moderate or high risk of febrile neutropenia for different cancer types
/ Prospektivni program za oceno intenzivnosti preprečevanja nevtropenije pri
bolnikih, ki prejemajo mielosupresivno kemoterapijo z zmernim do visokim
tveganjem za febrilno nevtropenijo pri različnih vrstah raka.
Klinika Golnik
Tanja Čufer
SCOT - Treatment and outcome in SCLC / Zdravljenje in izidi zdravljenja
drobnoceličnega pljučnega raka.
Kardiovaskularne bolezni, metabolizem in ledvična funkcija pri bolnikih z
rakom pljuč
Klinika Golnik
Tanja Čufer
Klinika Golnik
Tanja Čufer
66
Raziskave s področja raka-KLINIČNE RAZISKAVE
Šifra
UNIVERZA
MAGDEBU
RG 012306/11
UNIVERZA
HEIDELBER
G
NOVARTIS
01-24/11
Naziv raziskave
Ocena zdravila Sorafenib v kombinaciji z lokalno mikroterapijo, kontrolirano s pomočjo
magnetno resonančnega slikanja s kontrastnim sredstvom Gd-EOB-DTPA pri bolnikih z
inoperabilnim hepatoceličnim karcinomom” (SORAMIC) s številko EudraCT 2009-01257627.
Evropska raziskava zdravljenja in izidov kronične mieloične levkemije (EUTUS za CML) za
dobo treh let
Multicentrična, odprta študija faze lllb nilotiniba pri odraslih bolnikih z na novo
Randomizirana, dvojno slepa (priprava zdravila za zadostitev kriterijev dvojno slepe bo
potekala na raziskovalnem mestu) klinična raziskava Faze III s primerjalno skupino, z
MSD 01- namenom ocene učinkovitosti in varnosti Aprepitanta pri preprečevanju s kemoterapijo
313/12
povzročene slabosti in bruhanja pri pediatričnih bolnikih
Globalna raziskava o terapevtskem odločanju pri karcinomu jetrnih celic in njegovem
BAYER
zdravljenju
ARS
Vpliv prehranskega dopolnila Kapsule spor Ganoderma lucidum na potek napredovalega
PHARMAE raka prostate.
AMGEN 01- Prospektivna neintervencijska študija o uporabi zdravila VECTIBIX pri bolnikih s
1856/11
ponavljajočim kolorektalnim rakom.
Multicentrično, randomizirano, dvojno slepo, s placebom kontrolirano preskušanje tretje
AMGEN 01- faze zdravila AMG 479 ali placeba v kombinaciji z gemcitabinom kot zdravljenje prve linije
1831/11
za metastatski adenokarcinom trebušne slinavke.
ADAX 012982/11
Opazovalna študija zdravljenja multiplega mieloma v rutinski klinični praksi
Ustanova
Glavni nosilec
št. vključenih
bolnikov 2012
UKC LJ
Peter Popovič
/
UKC LJ
Irena Preložnik
Zupan
/
UKC LJ
Zupan
/
UKC LJ
Kitanovski
/
UKC LJ
Rado Janša
/
UKC LJ
Andrej Kmetec
/
UKC LJ
Borut Štabuc
/
UKC LJ
Borut Štabuc
/
UKC LJ
/
Prehranska vizita (v slovenskih bolnišnicah)
OIL
Zdravljenje jetrnih zasevkov z elektrokemoterapijo (ECTJ)
Napoved estetskega izgleda bolnic po zdravljenju raka dojke z ohranitvijo dojke
Primerjava dveh shem zdravljenja napredovalega ne-drobnoceličnega raka pljuč za bolnike
v stanju zmogljivosti who 2 - STOG 10
Agili - zdravljenje bolnikov z malignim mezoteliomom plevre: Primerjava zdravljenja s
cisplatinom in pemetrexetom vs cisplatinom in gemcitabinom v počasni infuziji,
randomizirana raziskava, faza II.
Identifikacija moških z dedno ogroženostjo za raka prostate: Usmerjeno presejanje pri
nosilcih mutacij BRCA1/2 in kontrolnih osebah- Raziskava IMPACT
Evropska raziskava brahiterapije raka materničnega vratu na podlagi magnetnoresonančnega slikanja-EMBRACE
Kasne posledice pooperativne radioterapije pri bolnikih s karcinomom želodca
Temozolomid kot dodatek k obsevanju v zdravljenju bolnikov s pljučnim rakom z zasevki v
možganih
Izmenično zdravljenje z inhibitorjem tirozin kinaze in citostatsko terapijo pri bolnikih z
napredovalim pljučnim rakom (Študija ITAC 2)
Evidenca zdravljenja z bevacizumabom na področju raka debelega črevesa in danke,
"eVA".
Onkološko genetsko svetovanje pri ženskah z večjo ogroženostjo z rakom dojk in jajčnikov:
znanje, pričakovanja in odnos
Ugotavljanje okvare srčne mišice pri bolnicah z rakom dojke na zdravljenju s kemoterapijo
in trastuzumabom
Spremljanje zdravljenja z erlotinibom pri bolnikih z nedrobnoceličnim rakom pljuč stadija
IIIb/IV
LUX-Breast 1: Odprta, randomizirana raziskava faze III zdravljenja s kombinacijo
preskušanega zdravila BIBW 2992 in vinorelbina v primerjavi s kombinacijo
trastuzumabain vinorelbina pri bolnicah z metastatskim rakom dojke s prekomerno
izraženim HER2, pri katerih eno predhodno zdravljenje s trastuzumabom ni bilo uspešno
Raziskava faze I-II: lapatinib in docetaksel za neoadjuvantno zdravljenje HER2 pozitivnega
raka dojk Klinična raziskava faze I-II z lapatinibom in docetaxelom za neoadjuvantno
zdravljenje lokalno napredovalega/vnetnega ali velikega operabilnega raka dojk (10054)
LAPATAX
OIL
OIL
Černelč Peter
Nada Rotovnik
Kozjek
Gregor Serša
Janez Žgajnar
OIL
Matjaž Zwitter
44
OIL
Viljem Kovač
11
OIL
Janez Žgajnar
4
OIL
Primož Petrič
11
OIL
Irena Oblak
100
OIL
Uroš Smrdel
10
OIL
Matjaž Zwitter
15
OIL
Janja Ocvirk
235
OIL
Mateja Krajc
173
OIL
Erika Matos
31
OIL
Matjaž Zwitter
13
OIL
Cvetka Grašič Kuhar 2
OIL
Erika Matos
4
Dvojno slepa, s placebom kontrolirana randomizirana študija faze II, ki ima namen oceniti
učinkovitost in varnost profilaktične uporabe doksiciklina z/ali brez kreme z vitaminom K OIL
pri bolnikih z mCRC, ki se v prvi liniji zdravijo z Erbituxom in FOLFIRIjem (E-VITA študija)
Janja Ocvirk
5
Vpliv mutacij v BRAF in KRAS genu in histoloških parametrov na klinični potek bolezni pri
bolnikih z adenokarcinomom debelega črevesa in danke
Martina Reberšek
63
OIL
106
7
0
67
Uvodna kemoterapija, predoperativna radiokemoterapija, dopolnilna kemoterapija,
operacija in pooperativna kemoterapija lokalno in/ali področno napredovalega raka danke OIL
– OIGIT 5-01 raziskava faze II
Kožna reakcija na Cetuksimab kot kriterij za izbor zdravljenja pri bolnikih z lokalno
OIL
napredovalim ploščatoceličnim karcinomom glave in vratu. ORL-01-11
Randomizirana raziskava faze IIIb za primerjavo vzdrževalnega zdravljenja s subkutanim
rituksimabom do napredovanja, zgolj z opazovanjem pri bolnikih z recidivnim ali
refraktarnim indolentnim ne-Hodkinovim limfomom, ki so dokončali in so se odzvali na
OIL
indukcijsko imunokemoterapijo na podlagi rituksimaba ter uvodno 2-letno vzdrževalno
zdravljenje s subkutanim rituksimabom (št. protokola: MO25455) EudraCT št: 2010-02340795
Sprejemljivost dodatnega obsevanja medeničnih bezgavk prikazanih s PET CT pri
OIL
karcinomu prostate (raziskava faze 1-2)
Novi prognostični in/ali napovedni biološki dejavniki pri neoadjuvantnem zdravljenju
OIL
bolnikov z jetrnimi zasevki raka debelega črevesa in danke
Primerjava C reaktivnega proteina, prokalcitonina, razmerja nevtrofilci/limfociti in
levkocitne površinske molekule CD64 kot zgodnjih napovedovalcev okužbe po operacijah OIL
karcinoma debelega črevesa in danke
Randomizirana, multicentrična,dvojno slepa, s placebom kontrolirana primerjava
kemoterapije v kombinaciji s trastuzumabom in placebom ter kemoterapije v kombinaciji s
OIL
trastuzumabom in pertuzumabom kot adjuvantnega zdravljenja pri bolnikih z operabilnim,
HER 2 pozitivnim primarnim rakom dojk – APHINITY (BIG 4-11/BO25126/TOC4939G)
Mednarodna klinična študija CONVERT: Klinična študija 3. faze z naključnim izborom med
dvakrat dnevnim ali enkrat dnevnim obsevanjem, oboje s sočasno kemoterapijo s
cisplatinom in etoposidom pri bolnikih z omejeno razširjenostjo drobnoceličnega
pljučnega raka
Testing of HER2 Positivity In Adenocarcinoma of stomach or gastroesophageal junction
"THEIA
Randomizirana multicentrična raziskava pospešene frakcionirane radioterapije z ali brez
hipoksičnega radiosenzibilizatorja nimorazola v zdravljenju ploščatoceličnega karcinoma
glave in vratu« (z oznako IAEA HypoX CRP E.3.30.30).
Genetski označevalci raka Huerthlejevih celic ščitnice
Retrospektivna analiza rezultatov zdravljenja pri bolnikih s ponovljenim ali metastatskim
rakom glave in vratu – analiza zdravljenja s tedensko kemoterapijo po shemi docetaxel,
cisplatin, 5-fluorouracil (TCF)
REO-018: randomizirana, dvojno slepa, multicentrična, dvostopenjska, adaptivna raziskava
faze III z intravenoznim zdravljenjem z zdravilom REOLYSIN® (reovirus tipa 3 Dearing) v
kombinaciji s paklitakselom in karboplatinom v primerjavi z zdravljenjem samo s
kemoterapijo pri bolnikih z metastatskim ali ponovljenim ploščatoceličnim karcinomom
glave in vratu, napredovalim med kemoterapijo na osnovi platine ali po njej
Multicentrična odprta raziskava (z eno skupino) pertuzumaba v kombinaciji s
trastuzumabom in taksanom za prvo linijo zdravljenja bolnic s HER2-pozitivnim
napredovalim (metastatskim ali ob lokalni ponovitvi) rakom dojke, številka protokola:
MO28047-PERUSE
Odprta multicentrična raziskava faze II z enim krakom za oceno varnosti vismodegiba
(GDC-0449) pri bolnikih z lokalno napredovalim ali metastatskim bazalnoceličnim
karcinomom-STIVIE
Randomizirana multicentrična faza III študija o predoperativnem obsevanju po kratkem
protokolu, podaljšani predoperativni kemoterapiji in nato operaciji pri bolnikih z rakom
danke z visokim tveganjem za lokalno in/ali oddaljeno ponovitev v primerjavi s standardno
radio-kemoterapijo, operacijo in eventuelnim sistemskim zdravljenjem
Vpliv telesne sestave, stanja prehranjenosti in kaheksije na bioelektrični impedančni fazni
kot pri bolnikih z rakom glave in vratu
Retrospektivna študija vpliva obsevanja vratu in zdravljenja s citostatiki na potek bolezni
pri bolnikih s T3 in T4 diferenciranim rakom ščitnice
Imunocitokemično in imunohistokemično barvanje folikularne neoplazme ščitnice s
protitelesi za arginazo II (ARG2)
Sprejemljivost dodatnega obsevanja medeničnih bezgavk prikazanih s PET CT pri
karcinomu prostate (raziskava faza 1-2)
Imunohistokemični in genetski markerji pri glioblastomu multiforme
Dvojno slepa, randomizirana študija faze III vzdrževalne terapije s Pazopanibom v
primerjavi s placebom pri NSCLC pacinetih, pri katerih ni prišlo do progresa po prvi liniji
kemoterapije MAPPING
Genetsko svetovanje, BRCA 1/2 status in kliničnopatološke značilnosti pri bolnicah mlajših
od 45 let z epitelnim rakom jajčnikov
A European study on MRI-guided brachytherapy in locally advanced cervical cancer EMBRACE
Vaneja Velenik
33
Branko Zakotnik,
Primož Strojan
28
Barbara Jezeršek
Novaković
1
Borut Kragelj
9
Erik Škof
87
Milena Kerin Povšič 113
Simona Borštnar
6
OIL
Matjaž Zwitter
4
OIL
Barbara Gazić
107
OIL
Primož Strojan
1
OIL
Nikola Bešić
65
OIL
Cvetka Grašič Kuhar 0
OIL
Cvetka Grašič Kuhar 2
OIL
Erika Matos
2
OIL
Janja Ocvirk
2
OIL
Ibrahim Edhemović 2
OIL
Primož Strojan
37
OIL
Nikola Bešić
45
OIL
Nikola Bešić
0
OIL
Borut Kragelj
9
OIL
Uroš Smrdel
0
OIL
Mirjana Rajer
0
OIL
Marko Hočevar
21
OIL
Barbara Šegedin
0
Janja Ocvirk
0
Randomizirana, dvojno slepa, multicentrična raziskava 3. faze z irinotekanom, folno kislino
in 5-fluorouracilom (FOLFIRI) v kombinaciji z ramucirumabom ali placebom pri bolnikih z
OIL
metastatskim rakom debelega črevesa in danke, ki je napredoval med kombiniranim
zdravljenjem prve linije z bevacizumabom, oksaliplatinom in fluoropirimidinom ali po njem
68
Anamorelin HCL za zdravljenje nedrobnoceličnega pljučnega raka-kaheksije podaljšanja
raziskava - ROMANA 3 (Številka protokola: HT-ANAM-303, EudraCT številka: 2010-023650- OIL
36)
Anamorelin HCL za zdravljenje nedrobnoceličnega pljučnega raka-kaheksije - ROMANA 1
OIL
(Številka protokola: HT-ANAM-301, EudraCT številka: 2010-023648-301
Ugotavljanje stanja podhranjenosti in kaheksije v Republiki Sloveniji
Register vzorcev zdravljenja bolnikov z metastatskim, proti kastraciji odpornim rakom
prostate (mKORP), ki jim je bolezen napredovala med zdravljenjem s shemo na podlagi
docetaksela ali po takšnem zdravljenju - PROXIMA
Mednarodna prospektivna opazovalna multicentrična kohortna raziskava LAS VEGAS
(Local Assessment of Ventilatory Management during General Anesthesia for Surgery and
effects on Postoperative Pulmonary Complications)
Program NARA – obvladovanje stresa in depresije skozi čuječnost
Zbiranje izvidov preiskav določanja mutacij v genu KRAS in načinov prve linije zdravljenja
pri bolnikih z metastaskim rakom debelega črevesa in danke z divjim tipom gena KRAS v
dnevni klinični praksi
Klinična raziskava faze II za raziskovanje krizotiniba (PF-02341066) pri bolnikih z
napredovalimi tumorji s spremembami ALK in/ali MET (»CREATE«), EORTC protocol 90101
(EudraCT number 2011-001988-52) (NCT01524926)
Nerandomizirana multicentricna raziskava trastuzumabemtanzina (T-DM1) pri bolnicah s
HER2-pozitivnim, lokalno napredovalim ali metastatskim rakom dojke, ki so predhodno
prejemale zdravljenje anti-HER2 in kemoterapijo
VINKRISTIN ALI CIS-PLATIN, oba v kombinaciji z gemcitabinom ali pemetrexedom za
zdravljenje napredovalega ne-drobnoceličnega raka pljuč – VIP študija
Vpliv vitamina K1 na ponovno vzpostavitev delovanja receptorja za epidermalni rastni faktor v
koži pri bolnikih z metastatskim kolorektalnim rakom, ki se zdravijo z zaviralcem receptorja za
epidermalni rastni dejavnik
Randomizirana, dvojno slepa, s placebom kontrolirana, multicentrična študija faze 3 z
denosumabom kot adjuvantnim zdravljenjem za ženske z zgodnjim stadijem raka dojke in
s povečanim tveganjem za ponovitev bolezni (D-CARE)
Mednarodna III. faza multicentričnega randomiziranega preizkušanja pomožne terapije za
bolnice s HER-2 pozitivnim rakom dojke v bezgavke-pozitivni ali visoko rizični, bezgavkenegativni obliki, v kateri se kemoterapija z dodanim trastuzumabom primerja s
kemoterapijo z dodanim trastuzumabom in bevacizumabom. (Protokol CIRG (TRIO) 011,
raziskava BETH
Mednarodna, randomizirana, dvojno-slepa, s placebom kontrolirana raziskava ocene
učinkovitosti in varnosti AVE5026 pri preprečevanju venske trombembolije (VTE) pri
karcinomskih bolnikih, zdravljenih s kemoterapijo in visokim tveganjem za VTE (ICON
Clinical Research Limited, EFC 6521)
"ARTIST: Ocena trenutnega obvladovanja ravni hemoglobina pri bolnikih z rakom
(opredeljenimi trdimi tumorji) s simptomatsko anemijo zaradi kemoterapije, zdravljenih z
zdravilom Aranesp (darbopoetin alfa): neintervencijsko klinično preskušanje pri trdih
tumorjih" protokol številka 20101341 verzija protokola 1.0 z dne 17. okt. 2011
>PROSPEKTIVNA, NERANDOMIZIRANA, MULTICENTRIČNA, MEDNARODNA, ODPRTA
RAZISKAVA FAZE III Z DVEMA KOHORTAMA ZA OCENO VARNOSTI ASISTIRANEGA
INJICIRANJA IN SAMOINJICIRANJA SUBKUTANEGA TRASTUZUMABA KOT ADJUVANTNEGA
ZDRAVLJENJA PRI BOLNICAH Z OPERABILNIM ZGODNJIM HER2-POZITIVNIM RAKOM DOJKE
"Globalna raziskava za oceno dodatka bevacizumaba karboplatinu in paklitakselu pri
prvem zdravljenju epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega
peritonealnega karcinoma", ROSIA, številka protokola MO22923"
Program zgodnjega dostopa do zdravila abirateronacetat skladno z dokumentom
"Information for physician treating patients with metastatic advanced prostate cancer
with abirateron acetat"
Mednarodna multicentrična raziskava Odprta raziskava razširjene dostopnosti zdravljenja
z lapatinibom in kapecitabinom pri osebah s preveliko ekspresijo gena ErbB2 in lokalno
napredovalim ali metastatskim rakom dojke (EGF 103659)
Mirjana Rajer
0
Mirjana Rajer
0
OIL
Nada Rotovnik
Kozjek
209
OIL
Boštjan Šeruga
0
OIL
Barbka Novak Supe 0
OIL
Katja Zupančič
18
OIL
Janja Ocvirk
0
OIL
Branko Zakotnik
0
OIL
Simona Borštnar
0
OIL
Matjaž Zwitter
0
OIL
Janja Ocvirk
0
UKC MB
Iztok Takač
4
UKC MB
Iztok Takač
3
UKC MB
Iztok Takač
3
UKC MB
Iztok Takač
0
UKC MB
Iztok Takač
4
UKC MB
Iztok Takač
1
UKC MB
Dejan Bratuš
0
UKC MB
Iztok Takač
10
Boris Sedmak
/
Dvojno slepa, s placebom nadzorovana študija za ocenitev nove motnjave ali slabšanja
motnjave očesne leče pri osebah z nemetastatskim rakom prostate, ki dobivajo zdravilo
denosumab za zdravljenje izgube kostne mase zaradi zdravljenja z deprivacijo androgenov UKC LJ
69
Dvojno slepa randomizirana raziskava faze III vzdrževalnega zdravljenja z zdravilom
pazopanib v primerjavi s placebom pri bolnikih z nedrobnoceličnim rakom pljuč, brez
napredovanja po prvi liniji kemoterapije - MAPPING
Klinika Golnik Tanja Čufer
Učinkovitost in varnost XM 02 v primerjavi s filgrastimom pri bolnikih z drobnoceličnim ali
nedrobnoceličnim pljučnim rakom, ki prejemajo kemoterapijo v kombinaciji s platinolom.
Multinacionalna, multicentrična, randomizirana in kontrolirana raziskava
Klinika Golnik Nadja Triller
Randomizirana, dvojno slepa, s placebom kontrolirana študija za oceno varnosti in
učinkovitosti darbepoetina alfa v odmerkih 500 µg enkrat na 3 tedne pri bolnikih z anemijo
in napredovalim nedrobnoceličnim rakom pljuč, ki prejemajo kemoterapijo v več ciklusih
Randomizirana, placebo-kontrolirana, dvojno-slepa raziskava faze 1b/2 U3-1287 (AMG
888) v kombinaciji z Erlotinibom pri bolnikih, ki še niso imeli terapije ciljane na EGFR, z
napredovanim nedrobnoceličnim rakom pljuč (NSCLC), ki je napredoval po vsaj eni
predhodni kemoterapiji
Randomizirana, dvojno slepa, s placebom nadzorovana multicentrična študija tretje faze,
ki vrednosti varnost in učinkovitost Anamorelina HCI pri bolnikih z NSCLC - C - ROMANA 1
(osnovna raziskava) po protokolu številka HT-ANAM-301 (Anamorelin HCI) za zdravljenje
nedrobnoceličnega pljučnega raka - kaheksije (NSCLC - C) in dvojna slepa podaljšana
raziskava - ROMANA 3 po protokolu HT-ANAM-303
Razvoj orodij za optimizacijo peroralnega odmerka etopozida pri zdravljenju bolnikov z
drobnoceličnim pljučnim rakom (ETO)
Pomen COX-2 inhibicije v prvi liniji zdravljenja razširjenega drobnoceličnega raka pljuč
(COX-2)
/
/
Klinika Golnik Nadja Triller
/
Klinika Golnik Nadja Triller
/
Klinika Golnik Tanja Čufer
/
Klinika Golnik Tanja Čufer
/
Klinika Golnik Tanja Čufer
/
1660
70
Klinične raziskave, kjer je vključevanje bolnikov že zaključeno
Šifra
Naziv raziskave
Predoperativno obsevanje s kapecitabinom in bevacizumabom pri lokalno napredovalnem
raku danke-CRAB raziskava faze II" št. Protokola ML21901
Učinkovitost dopolnilnega zdravljenja raka dojk z docetakselom in doksorubicinom
istočasno ali zaporedoma, kateremu sledi kemoterapevtska kombinacija CMF, v primerjavi
z učinkovitostjo zdravljenja samo doksorubicinom ali kombinacijo doksorubicina in
ciklofosfamida, katerima ponovno sledi kemoterapevtska kombinacija CMF – večcentrična
raziskava III.Faze (B.I.G. 2 – 2098)
Učinkovitost dopolnilnega zdravljenja raka dojke z letrozolom pri pomenopavznih bolnicah
s hormonsko odvisnimi tumorji (pozitivni estrogenski in/ali progesteronski receptorji) –
večcentrična raziskava III. Faze IBCSG 18-98 (BIG 1-98)
Varovalna bezgavka / AMAROS, EORTC, št. 10981
Prva, prospektivna, večcentrična raziskava o napovedni vrednosti p53, določenega s
funkcionalnim testom na glivah za odgovor na kemoterapijo z ali brez taksanov pri
bolnicah z lokalno napredovalim/vnetnim rakom dojke ali pa večjim, operabilnim rakom
dojke (EORTC 10994-BIG 00-01)
TAX GMA 301(BCIRG 005) Multicentrična randomizirana raziskava faze III, za ugotavljanje
učinkovitosti docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom (TAC) v
primerjavi z učinkovitostjo doksorubicina in ciklofosfamida, ki jima sledi docetaksel (AC›T),
v dopolnilnem zdravljenju operabilnega raka dojk HER2NEU negativnih bolnic s pozitivnimi
pazdušnimi bezgavkami
BCIRG 006 (TAX GMA 302) Multicentrična randomizirana raziskava III. faze, za primerjavo
doksorubicina in ciklofosfamida, ki jima sledi docetaksel (AC→ T) z doksorubicinom in
ciklofosfamidom, ki jima sledita docetaksel in trastuzumab (AC›TH), ter z docetakselom,
platinovo soljo in trastuzumabom (TCH) v adjuvantnem zdravljenju bolnic s pozitivnimi
bezgavkami in visoko ogroženih bolnic z negativnimi bezgavkami z operabilnim rakom
dojk, ki ima izražen HER2NEU
Klinična raziskava III. faze: zdravljenje s PEG-Intronom A v primerjavi z opazovanjem pri
bolnikih z melanomom s stadijem III po operativni odstranitvi področnih bezgavk (EORTC
18991 - Final ver. 8.2.2000)
Gemcitabin v podaljšani infuziji v kombinaciji s cisplatinom za bolnike z napredovalim
rakom pljuč in mezoteliomom
Cetuximab (Erbitux®), Capecitabine (Xeloda®) in obsevanje v preoperativnem zdravljenju
bolnikov z lokalno napredovalim resektabilnim rakom danke
Multicentrična mednarodna raziskava kapecitabina ą bevacizumaba v adjuvantnem
zdravljenju raka na debelem črevesu in danki (QUASAR2 MO17092)
Druga faza odprte randomizirane študije o učinkovitosti in varnosti kemoterapije po
shemi FOLFOX4 + Cetuximab 1x tedensko v primerjavi s FOLFOX4+ Cetuximab 2x tedensko,
ki se v zdravljenju bolnikov z metastaksim rakom danke in črevesa uporablja kot
prednostna terapija (Protokol CECOG/CORE.1.2.002) EudraCT,štev. 2006-006941-15
Randomizirano, odprto klinično preskušanje faze III za oceno učinkovitosti in varnosti
bevacizumaba v kombinaciji s kapecitabinom v prvi liniji zdravljenja starejših bolnikov z
metastatskim rakom debelega črevesa in danke (AVEX MO19286)
ALTTO – študija optimizacije adjuvantnega zdravljenja z lapatinibom in/ali
trastuzumabom; Randomizirana, multicentrična, odprta faza III klinična raziskava
dopolnilnega zdravljenja z lapatinibom, trastuzumabom, njunega zaporedja in kombinacije
pri bolnikih s HER2/ErbB2 pozitivnim primarnim rakom dojke
MINDACT - Z mikromrežno analizo se pri bolezni z negativnimi bezgavkami (po novem z 13 pozitivnimi) lahko izognemo kemoterapiji
Randomizirana, multicentrična, odprta študija faze III učinkovitosti in varnosti zdravila
trastuzumab MCC-DM1 v primerjavi s kombinacijo kapecitabina in lapatiniba pri bolnicah
in bolnikih s HER2 pozitivnim, lokalno napredovalim ali metastatskim rakom dojk, ki so
predhodno dobivali terapijo na podlagi trastuzumaba Protokol št. TDM4370g/Bo21977
(EMILIA)
Faza III, klinična raziskava, ki preučuje vlogo eksemestana in GnRH analoga kot
dopolnilnega zdravljenja za predmenopavzne ženske s hormonsko odvisnim rakom dojke
(IBCSG 25-02: TEXT)
Vpliv farmakokinetičnih in farmakodinamičnih lastnosti Rituksimaba na njegovov klinično
učinkovitost pri bolnikih z difuznim velikoceličnim B-limfomom
Program kohortne sočutne uporabe pri bolnikih z metastatskim, proti hormonom
odpornim rakom prostate, predhodno zdravljenim s shemo, ki je vključevala docetaksel
Glavni nosilec
št. vključenih
bolnikov 2012
Vaneja Velenik
0
Simona Borštnar
0
Simona Borštnar
0
Marko Snoj
0
Erika Matos
0
Erika Matos
0
Erika Matos
0
Janja Ocvirk
0
Matjaž Zwitter
0
Vaneja Velenik
0
Janja Ocvirk
0
Janja Ocvirk
0
Janja Ocvirk
0
Erika Matos
0
Erika Matos
0
Simona Borštnar
0
Erik Škof
0
Barbara Jezeršek
Novaković
0
Boštjan Šeruga
11
71
SOLE- Raziskava podaljšanja zdravljenjaz letrozolom - Raziskava faze III ocenitve vloge
stalnega prejemanja letrozola v primerjavi s prejemanjem letrozola v presledkih, ki sledi
predhodni 4- do 6-letni adjuvantni endokrini terapiji pomenopavznih žensk z zgodnjim
hormonsko odvisnim rakom dojk s pozitivnimi bezgavkami
Randomizirana, dvojno slepa, s placebom kontrolirana, multicentrična študija faze 3 z
denosumabom kot adjuvantno zdravljenje za ženske z rakom dojke v zgodnjem stadiju z
velikim tveganjem za ponovitevbolezni (D-CARE).
Simona Borštnar
2
Simona Borštnar
3
Faza 3 randomizirana, dvojno- slepa študija s tedenskim odmerkom zdravila Paclitaxel plus
AMG 386 ali placebo pri ženskah z epitelnimi jajčniki, ki so ponovljivo delno občutljivi ali
odporni na platino, s primarnim peritonalnim rakom ali z rakom na jajcevodih
Olga Cerar
Multicentrično, randomizirano, dvojno slepo, s palcebom kontrolirano preskušanje tretje
faze zdravila AMG 479 ali placeba v kombinaciji z gemcitabinomkot zdravljenje prve linije
za metastatski adenokarcinom trebušne slinavke (številka protokola (AMG 479) 20060540)
Janja Ocvirk
Globalna raziskava za oceno dodatka bevacizumaba karboplatinu in paklitakselu pri prvem
zdravljenju epiteljiskega raka jajčnikov, karcinoma jajcevodov ali primarnega
peritonealnega karcinoma (MO22923)-ROSIA
Vpliv sočasnega obsevanja in zdravljenja s trastuzumabom na kardiotoksičnost pri
bolnicah z zgodnjim rakom dojke
PREDICT - Patient characteristics in REnal cell carcinoma and Daily practICe Treatment with
Nexavar
Kakovost življenja bolnikov z lokalno napredovalim resektabilnim rakom danke
Opredelitev nodalnih drobnoceličnih limfomov B v citopatologiji
Odprta, multicentrična raziskava razširjenega dostopa do zdravila RO5185426 pri bolnikih
z metastatskim melanomom (BRAF)
REO-018: randomizirana, dvojno slepa, multicentrična, dvostopenjska, adaptivna raziskava
faze III z intravenoznim zdravljenjem z zdravilom REOLYSIN® (reovirus tipa 3 Dearing) v
kombinaciji s paklitakselom in karboplatinom v primerjavi z zdravljenjem samo s
kemoterapijo pri bolnikih z metastatskim ali ponovljenim ploščatoceličnim karcinomom
glave in vratu, napredovalim med kemoterapijo na osnovi platine ali po njej
Klinična raziskava faze II učinkovine bortezomid (VELCADE) s cisplatinom v prvi liniji
zdravljenja malignega mezotelioma
Klinika Golnik
Mednarodna, randomizirana, dvojno-slepa, s placebom kontrolirana raziskava ocene
učinkovitosti in varnosti AVE5026 pri preprečevanju venske trombembolije (VTE) pri
karcinomskih bolnikih, zdravljenih s kemoterapijo in visokim tveganjem za VTE
Klinika Golnik
1
2
Olga Cerar
1
Tanja
Breda Škrbinc
Vaneja Velenik
Ulrika Klopčič
Janja Ocvirk
157
0
0
0
11
Cvetka Grašič Kuhar
2
Tanja Čufer
/
Nadja Triller
/
190
72
9. IT support
An agreement was reached with the State Secretary, Mrs Brigita Čokl, on the integration of IT
support of the NCCP in the e-Health project. Under this project, the cancer register would be
transformed into an e-register. The selection of data for certain cancer types would be
expanded in the form of what are called clinical registers, and the cancer register would be
linked to screening programmes (ZORA, DORA and SVIT); additional information support
for the programmes would be provided if necessary.
The deadline for implementation is the end of 2014.
.
73