Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/35690
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Type: Journal article
Title: Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia
Author: Druker, B.
Guilhot, F.
O'Brien, S.
Gathmann, I.
Kantarjian, H.
Gattermann, N.
Deininger, M.
Silver, R.
Goldman, J.
Stone, R.
Cervantes, F.
Hochhaus, A.
Powell, B.
Gabrilove, J.
Rousselot, P.
Reiffers, J.
Cornelissen, J.
Hughes, T.
Agis, H.
Fischer, T.
et al.
Citation: New England Journal of Medicine, 2006; 355(23):2408-2417
Publisher: Massachusetts Medical Soc
Issue Date: 2006
ISSN: 0028-4793
1533-4406
Statement of
Responsibility: 
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 and Richard A. Larson
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.
Keywords: IRIS Investigators; Humans; Piperazines; Pyrimidines; Interferon-alpha; Fusion Proteins, bcr-abl; Cytarabine; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Survival; Treatment Outcome; Survival Rate; Survival Analysis; Follow-Up Studies; Female; Male; Protein-Tyrosine Kinases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Kaplan-Meier Estimate
Description: © 2009 Massachusetts Medical Society
RMID: 0020061911
DOI: 10.1056/NEJMoa062867
Published version: http://content.nejm.org/cgi/content/short/355/23/2408
Appears in Collections:Medicine publications

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