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EUROCHIP-2 Belgium
Liaison between the Belgian Cancer Registry and the
PROCARE study
INTRODUCTION TO PROCARE
Definition and aim
PROCARE stands for PROject on CAncer of the REctum. It is a
multidisciplinary Belgian project with the aim to improve the
outcome of rectal cancer treatment in Belgium. The targets are an
R0-resection in >60% of the patients, an abdominoperineal resection
rate of <30%, postoperative mortality <4%, a local recurrence rate
(LRR) of <10% at two years, an overall two year survival of 80%
after R0, and an improved survival also in advanced disease i.e. in
metastastic rectal cancer. The committee is a multidisciplinary
workgroup that started its activities in 2004.
WHY?
Diagnostic and therapeutic variability and its prognostic
implications have been documented in recent years: differences in
preoperative staging and implementation of neo-adjuvant therapy,
quality of surgery, implementation of adjuvant therapy. Thus, “the
surgeon” was shown to be an independent prognostic factor, with a
correlation between LRR and survival. In order to be curative, the
tumour should be removed with tumour free margins (R0-resection)
while the autonomic nerves should be spared as much as possible.
Total mesorectal excision (TME), with control of the lateral or
circumferential margin by the pathologist, has been shown to be of
paramount importance. The LRR at two years decreased from 21% with
conventional surgery (in the Swedish rectal cancer trial) to 8% with
TME surgery in the Dutch TME project. Moreover, the survival at two
years increased from 72% to 82% and the APR rate decreased from 54%
to 26%, respectively.
Significant
improvement
of
outcome
after
rectal
cancer
treatment has been shown in several nationwide studies, projects and
audits in which TME training was a major part of the project
(Scandinavian countries, The Netherlands,…).
Neo-adjuvant radiotherapy (25 Gy) was shown to reduce the LRR
at two years (Swedish rectal cancer trial, Dutch TME project, table
1). Risk factors for local recurrence after TME surgery were
identified: tumour at ≤10 cm above the anal verge, stage II-III
tumours (larger tumours, node positive tumours). Macroscopic as well
as microscopic evaluation of the lateral margins was shown to be
clinically relevant. In the Dutch TME trial 24% of the resection
specimen in non-irradiated patients were found to be macroscopically
incomplete.
Also,
23%
of
the
circumferential
margins
were
microscopically positive in the global series. This indicates that
the quality of surgery could be improved and that a preoperative
long schedule of radiochemotherapy might be of benefit in patients
presenting a high risk for R1 (incomplete) resection and local
recurrence. This requires preoperative imaging that allows a
preoperative estimation of the lateral tumour free margin.
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Table. Preoperative 25 Gy radiotherapy, conventional and
surgery: achievements in 2 national projects (data adapted
comparison)
TME
for
Preoperative MRI staging in rectal cancer is becoming the standard
for preoperative assessment. Indeed, a significant relation between a
radiological (MRI) circumferential tumour free margin of 5 mm or less and a
microscopically positive lateral margin has been documented. Thus, a long
schedule of 45 Gy radiochemotherapy is becoming the new standard for
patients with a radiological lateral margin of 5 mm or less (tumour
extension or enlarged nodes). The aim of radiochemotherapy is to downsize
and/or downstage this type of tumours in order to obtain a higher
percentage of curative R0-surgery.
The introduction of TME surgery and preoperative radio(chemo)therapy
have resulted in a very low LRR. However, the overall survival after
‘curative’ treatment still is 80% at 2 years and about 60-70% at 5 years.
Moreover, about 20-25% of patients have metastatic disease at presentation.
Thus, metastatic disease is the remaining challenge. In this context,
several large prospective and randomised studies evaluating the benefit of
adjuvant chemotherapy are in progress.
HOW?
PROCARE will be organised in three steps: standardisation through
guidelines, implementation of guidelines, quality assurance through
registration.
The PROCARE multidisciplinary guidelines are available on the website
of the scientific societies. They describe the actual standard for
preoperative investigation, preoperative radiotherapy and chemotherapy,
elective surgery, emergency treatment, treatment of metastatic rectal
cancer, pathology, adjuvant therapy, follow-up and outcome. A typical
surgical and pathological report as well as an algorithm for resectable
rectal cancer are included.
Approximately 1500-1600 patients present with rectal carcinoma in
Belgium each year. They are treated by approximately 113 teams (hospitals).
Although a correlation between volume and outcome has been described for
several
pathologies,
including
rectal
cancer,
PROCARE
aims
to
a
decentralised training for all interested teams actually providing care for
patients with rectal cancer.
Implementation of the multidisciplinary guidelines will be based on
information of all individual physicians involved in rectal cancer
treatment, MOC chairmen and hospital leaders. Participation in PROCARE will
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be based on a voluntary basis. Documentation will be provided: manual, CD,
video, …. Informative work-sessions will be organised regionally, e.g. per
province, by the Belgian Professional Association in collaboration with the
PROCARE workgroup and the scientific societies. Decentralised surgical and
pathology instruction will be provided in 5 consecutive cases per centre.
In contrast, preoperative staging and radiotherapy will be organised
through a central scientific review committee. In view of the decentralised
(re)training/instruction, the first and second group of teams that will be
instructed/audited in 2005 will be committed to instruct all other teams in
2006-2007. All teams should have received decentralised instructions before
the end of 2006. Instruction will be based on uniform documentation and
guidelines.
Quality will be assured through centralised registration at the
Belgian Cancer Registry for continuous and prospective registration and
monitoring
(2005-2009).
Regular
feedback
will
be
provided
through
newsletters. Also, workshops will be organised per region in order to
further instruct and inform participating teams on the progress made.
Results will be compared with retrospective data on the outcome of patients
with rectal cancer treated in 1997-1998. The results of this retrospective
study will be published in 2006.
It is the aim that all teams involved in the treatment of patients with
rectal cancer in Belgium will participate in PROCARE.
EUROCHIP-2 Belgium and the Belgian Cancer Registry
The choice for the Belgian participation in the EUROCHIP-2 project was made
on the national, specific and multidisciplinary character of the PROCARE
project. A second reason was the possibility to participate in a study on
diagnostic and therapeutic settings, which enables a cancer registry to
work closely with the clinical field.
By protocol, EUROCHIP-2 works on pilot studies on “Compliance with
guidelines” for three sites: breast, colon, and rectal cancers. They are
chosen for the present feasibility studies as they are common tumours, with
high public health priority, and treated in general hospitals and in
specialized structures. Thus the study results will reflect the general
clinical practice.
The EUROCHIP-2 Pilot Studies refer for instance to the following indicator
“Proportion of patients with Dukes B or C (TNM Stage II and III) receiving
pre-operative radiotherapy” within the context of ‘compliance with
guidelines’. An important role of the Belgian Cancer Registry in the
PROCARE project is the prospective registration of the rectal cancer cases
and to provide a detailed answer on this question/EUROCHIP-2 indicator.
Additional roles for the cancer registry are the spread of the information/
newsletters and to promote contacts with the clinicians (liason function
between the Belgian Cancer Registry and PROCARE).
Conclusion
It is the aim that all teams involved in the treatment of patients
with rectal cancer in Belgium will participate in PROCARE. The Belgian
Cancer Registry plays an important role in the prospective registration and
the spread of the information to the clinical field. Within this context, a
financial support is asked within EUROCHIP-2 for a collaborator whose main
and specific tasks will be the promotion of the PROCARE study to the
clinicians and the maintenance of the contacts between PROCARE and the
Belgian Cancer Registry.