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Blood, 7 May 2009, Vol. 113, No. 19, pp. 4497-4504. Prepublished online as a Blood First Edition Paper on March 4, 2009; DOI 10.1182/blood-2008-12-191254. This Article Full Text (PDF) Supplemental Tables All Versions of this Article: blood-2008-12-191254v1 113/19/4497    most recent Alert me when this article is cited Alert me if a correction is posted 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 CrossRef Citing Articles via Google Scholar Google Scholar Articles by Baccarani, M. Articles by Simonsson, B. Search for Related Content PubMed PubMed Citation Articles by Baccarani, M. Articles by Simonsson, B. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted December 2, 2008 Accepted February 2, 2009 A comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of patients with high risk, Philadelphia-positive, chronic myeloid leukaemia: a European LeukemiaNet study Michele Baccarani*, Gianantonio Rosti, Fausto Castagnetti, Ibrahim Haznedaroglu, Kimmo Porkka, Elisabetta Abruzzese, Giuliana Alimena, Hans Ehrencrona, Henrik Hjorth-Hansen, Veli Kairisto, Luciano Levato, Giovanni Martinelli, Arnon Nagler, Johan Lanng Nielsen, Ugur Ozbek, Francesca Palandri, Fausto Palmieri, Fabrizio Pane, Giovanna Rege-Cambrin, Domenico Russo, Giorgina Specchia, Nicoletta Testoni, Ole Weiss-Bjerrum, Giuseppe Saglio, and Bengt Simonsson Department of Hematology-Oncology "L. and A. Seragnoli", S.Orsola-Malpighi University Hospital, Bologna, Italy Hematology Unit, Hacettepe University, Ankara, Turkey Hematology Research Unit, Biomedicum Helsinki, University Central Hospital Helsinki, Helsinki, Finland Department of Hematology, S. Eugenio Tor Vergata University Hospital, Rome, Italy Department of Hematology, La Sapienza University Hospital, Rome, Italy Akademiska University Hospital, Uppsala, Sweden St. Olavs Hospital-Trondheim University Hospital, Trondheim, Norway University Central Hospital, Turku, Finland Regional Hospital, Catanzaro, Italy Chaim Sheba Medical Center, Tel-Hashomer, Israel University Hospital, Aarhus, Denmark Molecular Laboratory DTAE, Istanbul University, Istanbul, Turkey General Hospital, Avellino, Italy Division of Hematology, University Federico II, Naples, Italy Department of Clinical and Biological Science, University of Torino at Orbassano, Turin, Italy Division of Hematology, University of Brescia, Brescia, Italy Division of Hematology, University of Bari, Bari, Italy Rigshospitalet, Copenhagen, Denmark * Corresponding author; email: michele.baccarani{at}unibo.it. Imatinib mesylate (IM) is the standard front-line treatment of Philadelphia positive (Ph+), chronic myeloid leukemia (CML). The dose was set at 400 mg daily, but preclinical data together with results of single-arm studies, raised the suggestion that better results could be achieved with a higher dose. To investigate if the systematic use of a higher dose of IM could lead to better results, 216 Ph+ CML patients, high risk (HR) according to Sokal index, were randomized to receive IM 800 mg or 400 mg daily, front-line, for at least 1 year. The primary endpoint was the complete cytogenetic response (CCgR) rate at 1 year. The CCgR rate at 1 year was 69/108 (64%) in the high dose arm vs 63/108 (58%) in the standard dose arm (P = 0.435). No differences were detectable also in the cytogenetic response rate at 3 and 6 months, in the molecular response rate at any time point, as well as in the rate of other events, including failures and treatment discontinuation for toxicity or other reasons. 24/25 patients (94%) who could tolerate the full 800 mg dose achieved a CCgR, and only 4/17 patients (23%) who could tolerate only less than 350 mg achieved a CCgR. This study does not support the extensive use of high dose IM (800 mg daily) front-line in all CML HR patients (ClinicalTrials.gov. no. NCT00514488). CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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