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 Druker

Research output: Contribution to journalArticle

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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

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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Cytarabine
Interferon-alpha
Imatinib Mesylate
Leukemia, Myeloid, Chronic Phase
Therapeutics
Poisons
Cytogenetics
Cross-Over Studies
Multicenter Studies
Phosphotransferases
Survival Rate
Research Personnel
Safety
Survival

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Hochhaus, A., Larson, R. A., Guilhot, F., Radich, J. P., Branford, S., Hughes, T. P., ... Druker, B. (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

Long-term outcomes of imatinib treatment for chronic myeloid leukemia. / Hochhaus, Andreas; Larson, Richard A.; Guilhot, François; Radich, Jerald P.; Branford, Susan; Hughes, Timothy P.; Baccarani, Michele; Deininger, Michael W.; Cervantes, Francisco; Fujihara, Satoko; Ortmann, Christine Elke; Menssen, Hans D.; Kantarjian, Hagop; O'Brien, Stephen G.; Druker, Brian.

In: New England Journal of Medicine, Vol. 376, No. 10, 09.03.2017, p. 917-927.

Research output: Contribution to journalArticle

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, B 2017, 'Long-term outcomes of imatinib treatment for chronic myeloid leukemia', New England Journal of Medicine, vol. 376, no. 10, pp. 917-927. https://doi.org/10.1056/NEJMoa1609324
Hochhaus A, Larson RA, Guilhot F, Radich JP, Branford S, Hughes TP et al. Long-term outcomes of imatinib treatment for chronic myeloid leukemia. New England Journal of Medicine. 2017 Mar 9;376(10):917-927. https://doi.org/10.1056/NEJMoa1609324
Hochhaus, Andreas ; Larson, Richard A. ; Guilhot, François ; Radich, Jerald P. ; Branford, Susan ; Hughes, Timothy P. ; Baccarani, Michele ; Deininger, Michael W. ; Cervantes, Francisco ; Fujihara, Satoko ; Ortmann, Christine Elke ; Menssen, Hans D. ; Kantarjian, Hagop ; O'Brien, Stephen G. ; Druker, Brian. / Long-term outcomes of imatinib treatment for chronic myeloid leukemia. In: New England Journal of Medicine. 2017 ; Vol. 376, No. 10. pp. 917-927.
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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.",
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AU - Hughes, Timothy P.

AU - Baccarani, Michele

AU - Deininger, Michael W.

AU - Cervantes, Francisco

AU - Fujihara, Satoko

AU - Ortmann, Christine Elke

AU - Menssen, Hans D.

AU - Kantarjian, Hagop

AU - O'Brien, Stephen G.

AU - Druker, Brian

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N2 - 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.

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