Impact of post-remission therapy in patients aged 65-70 years with de novoacute myeloid leukemia: A comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria

Abstract

BackgroundThere is no standard post-remission therapy in older patients with acute myeloid leukemia.Design and MethodsFrom 1999 to 2006, the Acute Leukemia French Association group ran two concurrent randomizedtrials with overlapping inclusion criteria for patients aged 65 to 70 with acute myeloidleukemia, with different post-remission strategies: two intensive courses in the 9801 trial, oneintensive course or six outpatient courses in the 9803 trial. We analyzed the outcome of thesepatients per protocol and per post-remission therapy.ResultsTwo hundred and eleven patients aged 65 to 70 years with de novo acute myeloid leukemiawere enrolled in trial 9801 (n=76) or 9803 (n=135). The patients in the two trials had comparablewhite blood cell counts (P=0.3), cytogenetics (P=0.49), and complete remission rates (70%and 57%, respectively; P=0.17). Overall survival was identical in both trials (32% and 34% at2 years, respectively; P=0.71). Overall survival after complete remission was identical in the 103of 130 patients who received the planned post-remission courses (n=44 with two intensivecourses, n=28 with one intensive course, n=31 with six outpatient courses; 41%, 55%, and58% at 2 years, respectively; P=0.34). Even in patients with favorable or normal karyotype(n=97), overall survival from complete remission was not improved by more intensive postremissiontherapy.ConclusionsIn patients aged 65 to 70 years with de novo acute myeloid leukemia in complete remission afterstandard intensive induction chemotherapy, there is no apparent benefit from intensive postremissiontherapy. (ClinicalTrials.gov Identifiers: NCT00931138 and NCT00363025). ©2011 Ferrata Storti Foundation.