SEARCH:   Advanced

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 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 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 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. Related Collections Free Research Articles Myeloid Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia: a European LeukemiaNet Study Michele Baccarani1, Gianantonio Rosti1, Fausto Castagnetti1, Ibrahim Haznedaroglu2, Kimmo Porkka3, Elisabetta Abruzzese4, Giuliana Alimena5, Hans Ehrencrona6, Henrik Hjorth-Hansen7, Veli Kairisto8, Luciano Levato9, Giovanni Martinelli1, Arnon Nagler10, Johan Lanng Nielsen11, Ugur Ozbek12, Francesca Palandri1, Fausto Palmieri13, Fabrizio Pane14, Giovanna Rege-Cambrin15, Domenico Russo16, Giorgina Specchia17, Nicoletta Testoni1, Ole Weiss-Bjerrum18, Giuseppe Saglio15, and Bengt Simonsson6 1 Department of Hematology-Oncology "L. and A. Seràgnoli," S Orsola-Malpighi University Hospital, Bologna, Italy; 2 Hematology Unit, Hacettepe University, Ankara, Turkey; 3 Hematology Research Unit, Biomedicum Helsinki, University Central Hospital Helsinki, Helsinki, Finland; 4 Department of Hematology, S Eugenio, Tor Vergata University Hospital, Rome, Italy; 5 Department of Hematology, La Sapienza University Hospital, Rome, Italy; 6 Akademiska University Hospital, Uppsala, Sweden; 7 St Olavs Hospital-Trondheim University Hospital, Trondheim, Norway; 8 University Central Hospital, Turku, Finland; 9 Regional Hospital, Catanzaro, Italy; 10 Chaim Sheba Medical Center, Tel-Hashomer, Israel; 11 University Hospital, Aarhus, Denmark; 12 Molecular Laboratory DTAE, Istanbul University, Istanbul, Turkey; 13 Division of Haematology, General Hospital, Avellino, Italy; 14 Division of Hematology, University Federico II, Naples, Italy; 15 Department of Clinical and Biological Science, University of Torino at Orbassano, Turin, Italy; 16 Division of Hematology, University of Brescia, Brescia, Italy; 17 Division of Hematology, University of Bari, Bari, Italy; and 18 Rigshospitalet, Copenhagen, Denmark Imatinib mesylate (IM), 400 mg daily, is the standard treatment of Philadelphia-positive (Ph+) chronic myeloid leukemia (CML). Preclinical data and results of single-arm studies raised the suggestion that better results could be achieved with a higher dose. To investigate whether the systematic use of a higher dose of IM could lead to better results, 216 patients with Ph+ CML at high risk (HR) according to the Sokal index were randomly assigned to receive IM 800 mg or 400 mg daily, as front-line therapy, for at least 1 year. The CCgR rate at 1 year was 64% and 58% for the high-dose arm and for the standard-dose arm, respectively (P = .435). No differences were detectable in the CgR at 3 and 6 months, in the molecular response rate at any time, as well as in the rate of other events. Twenty-four (94%) of 25 patients who could tolerate the full 800-mg dose achieved a CCgR, and only 4 (23%) of 17 patients who could tolerate 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. This trial was registered at www.clinicaltrials.gov as #NCT00514488 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

	Copyright © 2009 by American Society of Hematology         Online ISSN: 1528-0020