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

Research output: Contribution to journalArticle

27 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)497-503
Number of pages7
JournalBritish Journal of Haematology
Volume165
Issue number4
DOIs
StatePublished - May 2014

Keywords

  • Acute promyelocytic leukaemia
  • Leukaemia clinical
  • Leukaemia trials
  • Malignant haematology

ASJC Scopus subject areas

  • Hematology

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    Coutre, S. E., Othus, M., Powell, B., Willman, C. L., Stock, W., Paietta, E., Levitan, D., Wetzler, M., Attar, E. C., Altman, J. K., Gore, S. D., Maher, T., Kopecky, K. J., Tallman, M. S., Larson, R. A., & Appelbaum, F. R. (2014). Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy. British Journal of Haematology, 165(4), 497-503. https://doi.org/10.1111/bjh.12775