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Lookup NU author(s): Professor Stephen O'Brien
This is the final published version of an article that has been published in its final definitive form by Massachussetts Medical Society , 2017.
For re-use rights please refer to the publisher's terms and conditions.
Copyright © 2017 Massachusetts Medical Society. BACKGROUND: Imatinib, a selective BCR-ABL1 kinase inhibitor, improved the prognosis for patients with chronic myeloid leukemia (CML). We conducted efficacy and safety analyses on the basis of more than 10 years of follow-up in patients with CML who were treated with imatinib as initial therapy. METHODS: In this open-label, multicenter trial with crossover design, we randomly assigned patients with newly diagnosed CML in the chronic phase to receive either imatinib or interferon alfa plus cytarabine. Long-term analyses included overall survival, response to treatment, and serious adverse events. RESULTS: The median follow-up was 10.9 years. Given the high rate of crossover among patients who had been randomly assigned to receive interferon alfa plus cytarabine (65.6%) and the short duration of therapy before crossover in these patients (median, 0.8 years), the current analyses focused on patients who had been randomly assigned to receive imatinib. Among the patients in the imatinib group, the estimated overall survival rate at 10 years was 83.3%. Approximately half the patients (48.3%) who had been randomly assigned to imatinib completed study treatment with imatinib, and 82.8% had a complete cytogenetic response. Serious adverse events that were considered by the investigators to be related to imatinib were uncommon and most frequently occurred during the first year of treatment. CONCLUSIONS: Almost 11 years of follow-up showed that the efficacy of imatinib persisted over time and that long-term administration of imatinib was not associated with unacceptable cumulative or late toxic effects.
Author(s): Hochhaus A, Larson RA, Guilhot F, Radich JP, Branford S, Hughes TP, Baccarani M, Deininger MW, Cervantes F, Fujihara S, Ortmann CE, Menssen HD, Kantarjian H, O'Brien SG, Druker BJ
Publication type: Article
Publication status: Published
Journal: New England Journal of Medicine
Year: 2017
Volume: 376
Issue: 10
Pages: 917-927
Online publication date: 09/03/2017
Acceptance date: 02/04/2016
Date deposited: 06/06/2017
ISSN (print): 0028-4793
ISSN (electronic): 1533-4406
Publisher: Massachussetts Medical Society
URL: https://doi.org/10.1056/NEJMoa1609324
DOI: 10.1056/NEJMoa1609324
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