Approach to Young,
High Risk AML patients
with Limited Resources
Dr. Hemant Malhotra,
MD, FRCP (London), MNAMS, FUICC, FICP, FIMSA
Professor of Medicine &
Head, Division of Medical Oncologist
SMS Medical College & Hospital, Jaipur.
Email: drmalhotrahemant@gmail.com
Sawai Man Singh [SMS]
Medical College
Hospital
Welcome to Jaipur –
The ‘pink’ city of the world !!
Disclaimer
• No significant conflict of interest to
declare related to this presentation
• Views expressed by me in this
presentation are essentially mine
and my perspective of the problem
WARNING !!!!
• The following presentation may contain
contents and/or issues which may be
upsetting and/or disturbing to a section
of the audience!!
• Viewer discretion is advised while
attending this session!!
Talk Outline
•
•
•
•
•
Some India-specific Issues
AML - Overview
AML in India
AML in resource limited setting
The Future
India - Population & Problems
•
•
•
•
•
•
1.20 billion people (estimated 2011)
15% of the world’s population
2nd most populous country after China
Increasing at the rate of 1.7% annually
Likely to overtake China in the middle of this century
Rapidly aging population – presently 40% younger that
15 yrs.
• Senior citizens expected to increase by 274% by year
2040. India will have 20% of the world’s senior citizens
by 2040.
• No social system of medicine
• 10 to 15 % have access to medical insurance – 85 to
90% ‘out-of-pocket’ payment
The Cancer problem
in India
On the threshold of an ‘Epidemic’!!
“Cancer Sunami”
Cancer in India
• 1 million new cases detected every year
• 3-3,50,000 die each year due to cancer
• 500 % increase in cancer in India by 2025
(280% due to ageing & 220% due to
tobacco use)
Oncology Care in India:
Best to the non-existent
• Oncology setups in Metros - Matching
best international standards
• Good hospitals with trained oncologists
in category A & most category B cities
• Radiotherapy dept in most medical
college hospitals
• No/minimal presence at district/village
level hospitals
The Economic Mismatch
in resource-limited Countries!!
40
30
20
10
0
50
50
60
50.71
50
Egyp
t
Leba
8.33
non
Phi lli
15.71
pines
25.63
Nepa
Myan l 0.52
ma r
0.17
Iran
1.14
Indo
nesia
0.3
Indi a
0.98
Chi n
a
15.39
Arme
nia
Bosn
ia
7.95
Mol d
ova
Geor
gia
6.98
Serb
ia
14.29
Bel a
rus
Ukra
ine
14
Urag
uay
28.79
Ecua
dor
Vene
2.46
zuela
24.4
Peru
Arge
ntina 2.63
18.41
Braz
il
3.64
Ratio of no. of qualified oncologists
to population in millions
Eg
y
Leb pt
ano
n
Ph
illip
ine
s
Ne
M y pal
anm
ar
I
I nd ran
one
sia
I nd
ia
Ch
in
Arm a
eni
a
Bo
s ni
Mo a
ldo
va
Ge
org
ia
Se
rbia
Be
laru
Uk s
rain
U ra e
gua
y
Ec
uad
o
Ve
nez r
uel
a
Pe
ru
Arg
ent
ina
Bra
z il
New cancer patients per qualified oncologist
3000
0
18
3
5
1500
500
9
45
80 94
78
8
2
2500
2000
29
3
1
1000
5
63
5
83
8
39
0
11 65
6
38 320
45
1
53
2
20 3
3
61 1
0
65
51
2
47
5
16
Economic spectrum in India
45 %
50 %
5%
‘ES’ 0/1
‘ES’ 2
‘ES’ 3
Approach to
High Risk AML in
Young patients with
Limited Resources
Approach to
High Risk AML in
Young patients with
Limited Resources
Approach to
High Risk AML in
Young patients with
Limited Resources
Approach to
High Risk AML in
Young patients with
Limited Resources
Aggressive Rx of AML in
Limited Resource setting!!
AML
PATIENT
AML –
Prognosis
& Rx:
Published
Data !!
High Risk AML in
Young patients with
Limited Resources
Standard aggressive induction
chemotherapy followed by 3/4
cycles of Consolidation
chemotherapy with HD Ara-C or
Allogenic HSCT in 1st remission
Prognostic Factor in AML
Prognostic Factor in AML
Prognostic Factor in AML:
In developing Countries
AML in INDIA
AML in India
• Remission rates: 60 to 70%
• 2 year DFS: 10 to 30% (more in children)
• Total cost of Standard 3+7 Induction CT
followed by 3 to 4 HD Ara-C (including
supportive care): INR 3,00,000/- to
5,00,000/- (USD: 6,000/- to10,000/-)
• Approximate cost of Allogenic HSCT: INR
7,00,000/- to 10,00,000/- (USD: 14,000 to
20,000)
AML published data
from India
Leukemia Lymphoma Clinic,
Birla Cancer Center, SMSMC&H, Jaipur
1992 to 2010 Data
N=1348
94
334
366
234
294
86
AML
ALL
CML
CLL
HD
NHL
Jaipur AML Data
•
•
•
•
N= 94
Median age: 48 years
22 patients less that 20 years of age
Only 16 out of 94 received standard-of-care
chemotherapy
• Majority not eligible for standard-of-care
chemotherapy b/o:
– Financial constrains
– Lack of supportive care (no blood and/or platelet
donors)
– Logistic issues
– Co-morbidities
AML in India
• Less than 30% of patients eligible for standardof-care treatment aggressive treatment
• Less than 5% of patients receive allogenic SCT
• Majority not eligible for standard-of-care
chemotherapy b/o:
– Financial constrains
– Lack of supportive care (no blood and/or platelet
donors)
– Logistic issues
– Co-morbidities
AML in India
• Options for the patient who are not
eligible for standard aggressive CT:
– Best Supportive Care
– Low-dose, metronomic chemotherapy
– Innovative approaches (e.g. arsenic for
APML)
– Other novel combinations: e.g. targeted
agents (FLT3 I) with chemotherapy standard/metronomic, other combinations
– Clinical trials
Low-dose, oral metronomic
Treatment for patients with
AML who are not candidates
for standard-Rx
Low-dose Metronomic
Rx in AML
Low-dose Metronomic
Rx in AML
To study the efficacy and toxicity of low
dose, metronomic chemotherapy in
patients of AML who are not candidates
for standard-aggressive chemotherapy
Prospective Single-arm Study at SMSH, Jaipur
N= 25
THE METRONOMIC CHEMOTHERAPY OF AML: (PEM)
Prednisolone
40 mg/m2/day,
Etoposide
50 mg/m2/day and
6-MP
75 mg/m2/day
Given orally on out-patient basis continuously for 21 days every month
“When administered, as in the schedule published here, it is associated with minimal
toxicity and is well tolerated. After remission induction, it can be administered on an
outpatient basis; this, in combination with the absence of conventional toxicities of
chemotherapy such as grade 3/4 neutropenia and mucositis, makes it significantly less
expensive to administer. In our setting, administration of an ATRA plus chemotherapy
regimen is associated with expenses of approximately $15 000 to $20 000, while this
single-agent As2O3-based regimen is associated with expenses of approximately $3000
to $5000.”
28 May
2001
Conclusions:
• AML Rx in a resource-constrained setting is a
major challenge
• No easy answers
• All out efforts to increase infra-structure and
provide medical insurance/other funding for
diagnosis & Rx (including supportive care &
HSCT) at least for the young patient with AML
• Role of metronomic Rx
• Role of targeted agents
• Region-specific clinical trials needed to
address local issues
THANK YOU