• Brian J Druker, François Guilhot, Stephen G O'Brien, Insa Gathmann, Hagop Kantarjian, Norbert Gattermann, Michael W N Deininger, Richard T Silver, John M Goldman, Richard M Stone, Francisco Cervantes, Andreas Hochhaus, Bayard L Powell, Janice L Gabrilove, Philippe Rousselot, Josy Reiffers, Jan J Cornelissen, Timothy Hughes, Hermine Agis, Thomas Fischer, Gregor Verhoef, John Shepherd, Giuseppe Saglio, Alois Gratwohl, Johan L Nielsen, Jerald P Radich, Bengt Simonsson, Kerry Taylor, Michele Baccarani, Charlene So, Laurie Letvak, Richard A Larson, and IRIS Investigators.
• Oregon Health and Science University Cancer Institute, L592, 3181 SW Sam Jackson Park Rd., Portland, OR 97239, USA. drukerb@ohsu.edu
• N. Engl. J. Med. 2006 Dec 7; 355 (23): 2408-17.

BackgroundThe 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.MethodsWe 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.ResultsThe 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.ConclusionsAfter 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].)Copyright 2006 Massachusetts Medical Society.

34 keywords...

hide…