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ACUTE LYMPHOBLASTIC LEUKEMIA STUDY GROUP OF INDIA ALL SGI

ACUTE LYMPHOBLASTIC LEUKEMIA STUDY GROUP OF INDIA ALL SGI. Dr Suresh Advani Mumbai , INDIA. ALL MAGNITUDE OF PROBLEM IN INDIA. Population : 1 Billion + Pop. < 18 yrs : 40 % New cases/ yr : ~ 8000 Per capita GNP : US $ 350 National Priority : ID & Nutritional Diseases

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ACUTE LYMPHOBLASTIC LEUKEMIA STUDY GROUP OF INDIA ALL SGI

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  1. ACUTE LYMPHOBLASTIC LEUKEMIASTUDY GROUP OF INDIAALL SGI Dr Suresh Advani Mumbai , INDIA.

  2. ALLMAGNITUDE OF PROBLEM IN INDIA Population : 1 Billion + Pop. < 18 yrs : 40 % New cases/ yr : ~ 8000 Per capita GNP : US $ 350 National Priority : ID & Nutritional Diseases 1 in 7 people in the world, Indian!

  3. ALL IN INDIA: FACTS • ~ 8000 new cases/yr;< 1000 adequately Rxed • Mostly Morphological diagnosis No National data available • Tough > 70% cured in West, in India except in major centres results still very poor. • Cost of Rx : $ 1500; affordability 70/2 5/5 Access to Rx : PCUs; infrastructure Most are HR : late presentation; biology? Females under represented

  4. ALL IN INDIA - BACKGROUND • Before 90’s : Survival rate of < 30 % • Rx not organized • Criteria for protocol entry not well defined • Diff. protocols used even in same Institution! • 1st effort to organize ALL Rx was by Dr Ian Magrath: The NCI initiative : 1985 ACI; TMH; AIIMS

  5. ACUTE LYMPHOBLASTIC LEUKEMIA (MCP 841) OAS 1990-97 1.0 .9 .8 .7 .6 Survival .5 .4 .3 .2 .1 0.0 0 2 4 6 8 10 12 YEARS OAS 65.5 % n=688

  6. All IN INDIA: NCI INITIATIVE • Helped to: • organize Rx for ALL • develop infrastructure • Rx patients uniformly- inside/outside • anticipate problems & deal with them • identify some prognostic factors • The success with MCP 841 protocol at the National level has been the impetus to form the ALLSGI !

  7. ALLSGI: FORMATION Jan 27, 2001 : Pre ISMPO; Hyderabad Why now? • More trained Onc’s: Many trained with us • PCU’s increasing • SIOP Initiative: Training of Ped’s • INCTR Initiative: expertise, training, res. • Better Communication & Transport

  8. ALL SGI : INITIAL OBJECTIVES • To get organized • To get used to data collection • Identifying participating centers • Try to develop infrastructure at participating centers (Dx; Nursing; BB;Microbiology) Chalk out short term objectives & long term goals!

  9. ALL SGI: FORMATION OF ZONES India is Big Country: Many centers, Many Pts North Zone : AIIMS, Delhi East Zone : KMC, Calcutta South Zone : ACI,Chennai West Zone : TMH, Mumbai Central data collection & Monitoring unit

  10. ALL SGIWhat Have We Achieved So Far • -Data of >2000 patients treated uniformly on a single protocol • Publications from individual centres • Publications of data as a group

  11. Event-Free Survival by Center TMH Percent Event Free Survival AIIMS CI Years since start oftherapy

  12. Risk Factors (EFS): Multivariate Analysis • WBC at AIIMS and Mumbai (p=0.0005 and 0.002 respectively), not at CI • But best risk group still < 70% EFS • No significant risk factors could be identified at Chennai – nor in Pre B or Pre-T separately • No very high or very low risk groups identifiable at all three centers • Early response not studied Extensive analysis performed by experienced NCI statisticians

  13. Temporal Changes with Identical Protocol 1995-96 1989-90 Percent Event Free Survival 1991-92, 93-94 1986-87 TMH: 2 yr intervals 101-163 patients per group Years since start oftherapy A: 1986-87 B: 1988-90 C: 1991-92 D: 1993-94 E: 1995-96 F: 1997

  14. Translocations in ALL Childhood , USA

  15. ALL SGI TO WRITE GRANTS Grant from Lady Ratan Tata Trust For : Developing the Cooperative Group To Write Grants For: Epidemological studies: Clinical & Molecular Clinical studies Lab studies: Pathogenesis, Mol. Biology Preventive Aspects

  16. ALL SGI ALL TREATMENT • Develop infrastructure • Rx data initially only from limited centers • To continue established protocol (e.g. MCP 841) at these centers • Investigational protocol(e.g. MCP 943) only at zonal centers • Highest quality of information must be assured: Diag, data collection, data analysis Once group established, only then to think about ALL National Protocol- keeping in mind simplicity & cost!

  17. ALL SGILONG TERM GOALS: RESEARCH INITIATIVES • Is ALL in India Biologically different? • Std risk factors do not show diff in outcome • many remission deaths • Delays in Rx: hepatitis, toxicity,etc • Socioeconomic risk profile • Toxicity profile: • Nutritional status • Pharmacokinetics, Pharmacogenomics Difference in Leukemic cell or Patient ??

  18. ALL : FUTURE PLANS

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