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 Mismatchin resource-limited Countries!!

8.33

15.7

125

.63

0.52

0.17

1.14

0.3

0.98

15.3

950

7.95

506.

9814

.29

50.7

114

28.7

92.

4624

.4

2.63

18.4

13.

64

0

10

20

30

40

50

60

Ratio of no. of qualified oncologists to population in millions

0

500

1000

1500

2000

2500

3000

New cancer patients per qualified oncologist

5 %

45 % 50 %

Economic spectrum in India

‘ES’ 0/1 ‘ES’ 2 ‘ES’ 3

Approach toHigh Risk AML in

Young patients with Limited Resources

Approach toHigh 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

FINANCIA

L CONSTRAIN

S

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 datafrom India

Leukemia Lymphoma Clinic,Birla Cancer Center, SMSMC&H, Jaipur

1992 to 2010 Data N=1348

94

366

29486234

334

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 standard-

of-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

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

Prospective Single-arm Study at SMSH, JaipurN= 25

“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 lessexpensive 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 May2001

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 YOUTHANK YOU