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Randomized Controlled Trial
, 355 (23), 2408-17

Five-year Follow-Up of Patients Receiving Imatinib for Chronic Myeloid Leukemia

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Randomized Controlled Trial

Five-year Follow-Up of Patients Receiving Imatinib for Chronic Myeloid Leukemia

Brian J Druker et al. N Engl J Med.

Abstract

Background: The cause of chronic myeloid leukemia (CML) is a constitutively active BCR-ABL tyrosine kinase. Imatinib inhibits this kinase, and in a short-term study was superior to interferon alfa plus cytarabine for newly diagnosed CML in the chronic phase. For 5 years, we followed patients with CML who received imatinib as initial therapy.

Methods: We randomly assigned 553 patients to receive imatinib and 553 to receive interferon alfa plus cytarabine and then evaluated them for overall and event-free survival; progression to accelerated-phase CML or blast crisis; hematologic, cytogenetic, and molecular responses; and adverse events.

Results: The median follow-up was 60 months. Kaplan-Meier estimates of cumulative best rates of complete cytogenetic response among patients receiving imatinib were 69% by 12 months and 87% by 60 months. An estimated 7% of patients progressed to accelerated-phase CML or blast crisis, and the estimated overall survival of patients who received imatinib as initial therapy was 89% at 60 months. Patients who had a complete cytogenetic response or in whom levels of BCR-ABL transcripts had fallen by at least 3 log had a significantly lower risk of disease progression than did patients without a complete cytogenetic response (P<0.001). Grade 3 or 4 adverse events diminished over time, and there was no clinically significant change in the profile of adverse events.

Conclusions: After 5 years of follow-up, continuous treatment of chronic-phase CML with imatinib as initial therapy was found to induce durable responses in a high proportion of patients. (ClinicalTrials.gov number, NCT00006343 [ClinicalTrials.gov].)

Comment in

  • Imatinib in chronic myeloid leukemia.
    Krause SW, Holler E. Krause SW, et al. N Engl J Med. 2007 Apr 26;356(17):1780; author reply 1780. doi: 10.1056/NEJMc063767. N Engl J Med. 2007. PMID: 17460235 No abstract available.

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