On the value of intensive remission-induction chemotherapy in elderly patients of 65+ years with acute myeloid leukemia: a randomized phase III study of the European Organization for Research and Treatment of Cancer Leukemia Group.

TLDR

The study aimed to compare survival outcomes between intensive induction chemotherapy and a wait‑and‑see supportive care strategy in patients aged 65 and older with AML. Arm A patients received intensive induction with daunorubicin, vincristine, and cytarabine followed by consolidation if complete remission, whereas Arm B patients received only supportive care and mild cytoreductive chemotherapy (hydroxyurea or cytarabine) initiated about nine days after diagnosis. Patients receiving intensive induction had a significantly longer median survival (21 weeks vs 11 weeks) and a 58 % complete‑remission rate versus 0 % in the wait‑and‑see group, with a 2‑year projected disease‑free survival of 17 %, while hospital‑stay percentages were comparable.

Abstract

We report the results of a prospective study in patients more than 65 years of age in whom two different therapeutic strategies were compared: immediate intensive-induction chemotherapy (arm A) versus "wait and see" and supportive care and mild cytoreductive chemotherapy only for relief of progressive acute myeloid leukemia (AML)-related symptoms (arm B). The major objective of the study was to compare survival outcome of both regimens. Thirty-one patients on arm A received one or two courses of daunorubicin, vincristine, and cytarabine for remission induction followed by one additional cycle for consolidation in case of complete remission (CR). Among 29 patients on arm B, cytoreductive chemotherapy (hydroxyurea, cytarabine) had to be initiated for palliation of leukemia-associated complications in 21 patients at a median of 9 days after diagnosis. Overall survival duration for patients treated on arm A was significantly (P = .015) longer than the survival in arm B (median survival, 21 weeks v 11 weeks; projected survival at 2.5 years, 13% v 0%). Eighteen (58%) of arm A patients and none (0%) of arm B patients entered CR. Of the first group, projected disease-free survival at 2 years is 17%. The median percentages of days spent in the hospital by arm A and B patients were 55% and 50%, respectively. This study shows that a strategy based on modern supportive care and a wait and see approach yields extremely poor results. It is not superior in regard to the frequency of hospital admission and is inferior regarding survival outcome.