British Journal of Haematology 2014-05-01

Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy.

Steven E Coutre, Megan Othus, Bayard Powell, Cheryl L Willman, Wendy Stock, Elisabeth Paietta, Denise Levitan, Meir Wetzler, Eyal C Attar, Jessica K Altman, Steven D Gore, Tracy Maher, Kenneth J Kopecky, Martin S Tallman, Richard A Larson, Frederick R Appelbaum

Index: Br. J. Haematol. 165(4) , 497-503, (2014)

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Abstract

Aa total of 105 patients (age ≥18 years) with newly diagnosed low or intermediate risk acute promyelocytic leukaemia (APL) were treated with a standard induction and consolidation regimen including arsenic trioxide (ATO). Sixty-eight patients who were polymerase chain reaction (PCR) negative for PML-RARA post-consolidation were randomized to either 1 year of maintenance with tretinoin, mercaptopurine and methotrexate, or observation. Enrollment in this non-inferiority trial was stopped prematurely due to slow accrual. With a median follow up of 36·1 months, the overall survival of the 105 patients was 93%, and there have been no relapses in the patients randomized to maintenance or observation. These results demonstrate that cures can be expected in >90% of patients with low and intermediate risk APL and suggest that maintenance therapy may not be needed if patients are treated with an intensive post-remission regimen including ATO. This trial was registered at clinicaltrials.gov as #NCT00492856. © 2014 John Wiley & Sons Ltd.