Long-term outcomes of imatinib treatment for chronic myeloid leukemia

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, Brian J. Druker

Research output: Contribution to journalArticle

335 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)917-927
Number of pages11
JournalNew England Journal of Medicine
Volume376
Issue number10
DOIs
StatePublished - Mar 9 2017

ASJC Scopus subject areas

  • Medicine(all)

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    Hochhaus, A., Larson, R. A., Guilhot, F., Radich, J. P., Branford, S., Hughes, T. P., Baccarani, M., Deininger, M. W., Cervantes, F., Fujihara, S., Ortmann, C. E., Menssen, H. D., Kantarjian, H., O'Brien, S. G., & Druker, B. J. (2017). Long-term outcomes of imatinib treatment for chronic myeloid leukemia. New England Journal of Medicine, 376(10), 917-927. https://doi.org/10.1056/NEJMoa1609324