Journal
BRITISH JOURNAL OF HAEMATOLOGY
Volume 165, Issue 4, Pages 497-503Publisher
WILEY
DOI: 10.1111/bjh.12775
Keywords
malignant haematology; leukaemia trials; acute promyelocytic leukaemia; leukaemia clinical
Categories
Funding
- PHS by National Cancer Institute [DHHS: CA32102, CA38926, CA46282, CA11083, CA41287, CA35431, CA27057, CA45807, CA20319, CA45808, CA76132, CA86780, CA58861, CA14028 (SWOG), CA31946 (CALGB), CA21115, CA17145, CA16116(ECOG)]
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Aa total of 105 patients (age >= 18years) 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 1year 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 center dot 1months, 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.
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