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Blood, 1 September 2006, Vol. 108, No. 5, pp. 1478-1484. Prepublished online as a Blood First Edition Paper on April 20, 2006; DOI 10.1182/blood-2006-02-001495. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2006-02-001495v1 108/5/1478    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Roy, L. Articles by Guilhot, F. Search for Related Content PubMed PubMed Citation Articles by Roy, L. Articles by Guilhot, F. Related Collections Neoplasia Oncogenes and Tumor Suppressors Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Survival advantage from imatinib compared with the combination interferon- plus cytarabine in chronic-phase chronic myelogenous leukemia: historical comparison between two phase 3 trials Lydia Roy, Joëlle Guilhot, Tillmann Krahnke, Agnès Guerci-Bresler, Brian J. Druker, Richard A. Larson, Steve O'Brien, Charlene So, Giorgio Massimini, and François Guilhot From the Department of Oncology-Hematology and Cell Therapy, EA 3805 and Clinical Research Centre, Centre Hospitalier Universitaire (CHU) La Milétrie, Poitiers, France; Novartis Pharma, Basel, Switzerland; the Department of Hematology, CHU Brabois, Vandoeuvre les Nancy, France; Oregon Health Science University Cancer Institute, Portland, OR; the University of Chicago, Chicago, IL; and the University of Newcastle, Newcastle, United Kingdom. In the multinational IRIS study comparing imatinib with interferon plus cytarabine (IFN/Ara-C) in patients with newly diagnosed chronic-phase chronic myelogenous leukemia (CP CML), imatinib demonstrated significantly higher rates of complete cytogenetic responses (CCyRs) and improved progression-free survival (PFS). However, because of a high early crossover rate to imatinib, survival benefit was not assessable. Here, we report the result of a study comparing long-term outcome of patients included in 2 prospective randomized trials: 551 patients assigned to imatinib in the IRIS trial from 2000 to 2001 and 325 patients who received the combination IFN/Ara-C in the CML91 trial between 1991 and 1996 before imatinib was available. With a follow-up of 42 months for both groups of patients, estimated CCyR, survival free of transformation, and overall survival were significantly higher with imatinib compared with IFN/Ara-C (P < .001, P = .004, and P < .001, respectively). Improved overall survival was also confirmed within different Sokal prognostic risk groups. Of interest, among all patients who achieved major cytogenetic response or CCyR at 12 months, the survival rate was similar irrespective of their treatment. In conclusion, within the limitation of this historical comparison, there is a survival advantage from first-line therapy with imatinib over IFN/Ara-C. 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