Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/104735
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Type: Journal article
Title: Long-term outcomes of imatinib treatment for chronic myeloid leukemia
Author: Hochhaus, A.
Larson, R.
Guilhot, F.
Radich, J.
Branford, S.
Hughes, T.
Baccarani, M.
Deininger, M.
Cervantes, F.
Fujihara, S.
Ortmann, C.
Menssen, H.
Kantarjian, H.
O'Brien, S.
Druker, B.
Citation: New England Journal of Medicine, 2017; 376(10):917-927
Publisher: Massachusetts Medical Society
Issue Date: 2017
ISSN: 0028-4793
1533-4406
Statement of
Responsibility: 
Andreas Hochhaus, Richard A. Larson, François Guilhot, Jerald P. Radich, Susan Branford, Timothy P. Hughes, Michele Baccarani, Michael W. Deininger, Francisco Cervantes, Satoko Fujihara, Christine, Elke Ortmann, Hans D. Menssen, Hagop Kantarjian, Stephen G. O, Brien, and Brian J. Druker, for the IRIS Investigators
Abstract: 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. (Funded by Novartis Pharmaceuticals; IRIS ClinicalTrials.gov numbers, NCT00006343 and NCT00333840.)
Keywords: IRIS Investigators
Rights: © 2017 Massachusetts Medical Society. All rights reserved.
RMID: 0030066608
DOI: 10.1056/NEJMoa1609324
Appears in Collections:Medicine publications

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