Five-Year Follow-up of Patients Receiving Imatinib for Chronic Myeloid Leukemia.
Druker, Brian J.; Guilhot, Francois; O'Brien, Stephen G.; Gathmann, Insa; Kantarjian, Hagop; Gattermann, Norbert; Deininger, Michael W.N.; Silver, Richard T.; Goldman, John M.; Stone, Richard M.; Cervantes, Francisco; Hochhaus, Andreas; Powell, Bayard L.; Gabrilove, Janice L.; Rousselot, Philippe; Reiffers, Josy; Cornelissen, Jan J.; Hughes, Timothy; Agis, Hermine; Fischer, Thomas; Verhoef, Gregor; Shepherd, John; Saglio, Giuseppe; Gratwohl, Alois; Nielsen, Johan L.; Radich, Jerald P.; Simonsson, Bengt; Taylor, Kerry; Baccarani, Michele; So, Charlene; Letvak, Laurie; Larson, Richard A.
[Article]
New England Journal of Medicine.
355(23):2408-2417, December 7, 2006.
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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.)
N Engl J Med 2006;355: 2408-17.
Copyright (C) 2006 Massachusetts Medical Society. All rights reserved.
