Outcome after induction chemotherapy for older patients with acute myeloid leukemia is not improved with mitoxantrone and etoposide compared to cytarabine and daunorubicin: a Southwest Oncology Group study
- 1 December 2002
- journal article
- clinical trial
- Published by American Society of Hematology in Blood
- Vol. 100 (12), 3869-3876
- https://doi.org/10.1182/blood-2001-12-0354
Abstract
Complete remission and long-term survival rates are low for older adults treated for acute myeloid leukemia (AML). Because of favorable phase 2 data using mitoxantrone and etoposide, we conducted a phase 3 study (SWOG-9333) in which patients over 55 years of age with previously untreated AML were randomized to receive mitoxantrone (10 mg/m2 per day × 5) and etoposide (100 mg/m2per day × 5) [ME], or cytarabine (200 mg/m2 per day × 7) and daunorubicin (45 mg/m2 per day × 3) [AD] as induction therapy. The randomization was stratified by age, onset of leukemia, and multidrug resistance phenotype. Over a 4-year period, 328 eligible patients from 66 institutions were enrolled. The complete remission rate was 34% (95% confidence interval [CI] 26%-41%) for patients in the ME and 43% (CI 35%-51%) for patients in the AD treatment arm (one-tailedP value .96). The rates of resistant disease were 43% (CI 35%-51%) and 34% (CI 27%-42%), respectively, for the 2 treatment arms (one-tailed P value .95). The estimated overall survival at 2 years was 11% (CI 6%-15%) and 19% (CI 12%-25%) for patients randomized to ME and to AD induction therapy, respectively (one-tailed P value .99). After accounting for the independent prognostic factors associated with survival (karyotype, performance status, age, white blood cell count), exploratory analysis suggested there was a worse survival for patients who received ME compared with AD induction therapy (2-tailed P value .0066). We conclude that the results of our study do not demonstrate any benefit to the use of ME induction chemotherapy instead of AD in older patients with AML.This publication has 27 references indexed in Scilit:
- Chemotherapy Compared with Autologous or Allogeneic Bone Marrow Transplantation in the Management of Acute Myeloid Leukemia in First RemissionThe New England Journal of Medicine, 1998
- Intensive Postremission Chemotherapy in Adults with Acute Myeloid LeukemiaThe New England Journal of Medicine, 1994
- Acute myelogenous leukaemia in the elderly: retrospective study of 235 consecutive patientsBritish Journal of Haematology, 1994
- Combination of Mitoxantrone and Etoposide in the Treatment of Myelodysplastic Syndromes Transformed into Acute Myeloid LeukemiaLeukemia & Lymphoma, 1994
- Prognostic factors in elderly patients with acute myeloid leukaemia: development of a model to predict survivalBritish Journal of Haematology, 1993
- ACUTE MYELOID LEUKAEMIA IN THE ELDERLY: BIOLOGY AND TREATMENTBritish Journal of Haematology, 1993
- Mitozantrone and cytosine arabinoside as first‐line therapy in elderly patients with acute myeloid leukaemiaBritish Journal of Haematology, 1991
- Proposals for the classification of the myelodysplastic syndromesBritish Journal of Haematology, 1982
- Nonparametric Estimation from Incomplete ObservationsJournal of the American Statistical Association, 1958
- Nonparametric Estimation from Incomplete ObservationsJournal of the American Statistical Association, 1958