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FDA ODAC AML in Older Individuals

FDA ODAC AML in Older Individuals. Frederick R. Appelbaum, MD May 5, 2005. Age-related Incidence of AML and ALL. Performance Status and Age in AML N = 437. Age, Performance Status and Early Death in AML N = 437. Age, Performance Status and Early Death in AML N = 437. Age.

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FDA ODAC AML in Older Individuals

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  1. FDA ODACAML in Older Individuals Frederick R. Appelbaum, MD May 5, 2005

  2. Age-related Incidence of AML and ALL

  3. Performance Status and Age in AMLN = 437

  4. Age, Performance Status and Early Death in AMLN = 437

  5. Age, Performance Status and Early Death in AMLN = 437 Age Death within 30 days Performance Status

  6. Age, Performance Status and Complete Response Rate in AMLN = 437

  7. AML in Older Patients • More often preceded by myelodysplasia • Less proliferative • More frequently associated with unfavorable cytogenetics • Expresses multidrug resistance more often

  8. Hematologic Values at Diagnosis

  9. Southwest Oncology Group Leukemia CommitteePercentage of Patients in Cytogenetic Risk Groupsby Age Category

  10. Cytogenetics by Age

  11. MRK Staining

  12. Complete Response in Older AML Patients1 1Leith et al. Blood, 89:3323-3329, 1997

  13. Factors Associated with Lower CR Rates in Older AML Patients (multivariate)1N =211 Patients with all three factors had a CR rate of 11% versus a CR rate of 81% in patients without all three. 1Leith et al., Blood 89: 3323-3329, 1997

  14. MCR AML 111 Induction – DAT vs. ADE vs. MAC ± G-CSF Consolidation – 2 cycles vs. 6 cycles 1Goldstone et al., Blood 98: 1302, 2001

  15. MRC AML 11

  16. MRC AML 11Outcome

  17. Survival on MRC AML 11 by Induction Treatment

  18. Factors Predictive of Outcome in Multivariate Analysis from MRC AML 11

  19. Summary Using conventional chemotherapy, complete response rates of 50% and a median survival of 9 months can be expected in patients over age 55 with AML. However, patient and disease-related factors vary greatly and heavily influence treatment outcome. Particularly important are: Age Performance status 1° vs. 2° presentation Cytogenetics MDR status

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