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Blood, 9 April 2009, Vol. 113, No. 15, pp. 3428-3434. Prepublished online as a Blood First Edition Paper on February 11, 2009; DOI 10.1182/blood-2007-08-103499. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2007-08-103499v1 113/15/3428    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 Castagnetti, F. Articles by Rosti, G. Search for Related Content PubMed PubMed Citation Articles by Castagnetti, F. Articles by Rosti, G. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted August 3, 2007 Accepted January 28, 2009 Results of high-dose imatinib mesylate in intermediate SOKAL risk chronic myeloid leukemia patients in early chronic phase: A phase II trial of the GIMEMA CML WP Fausto Castagnetti*, Francesca Palandri, Marilina Amabile, Nicoletta Testoni, Simona Luatti, Simona Soverini, Ilaria Iacobucci, Massimo Breccia, Giovanna Rege Cambrin, Fabio Stagno, Giorgina Specchia, Piero Galieni, Franco Iuliano, Fabrizio Pane, Giuseppe Saglio, Giuliana Alimena, Giovanni Martinelli, Michele Baccarani, and Gianantonio Rosti Institute of Hematology “L. & A. Seragnoli", University of Bologna, Bologna, Italy Chair of Hematology, University "La Sapienza", Roma, Italy Chair of Internal Medicine, S Luigi Gonzaga Hospital, Orbassano, Torino, Italy Chair of Hematology, University of Catania, Catania, Italy Chair of Hematology, University of Bari, Bari, Italy Division of Hematology, Ascoli Piceno, Italy Hematology Unit, Rossano Calabro, Italy CEINGE, "Federico II" University, Napoli, Italy * Corresponding author; email: faucast{at}inwind.it. Imatinib mesylate has become the treatment of choice for Chronic Myeloid Leukemia (CML): the standard dose for chronic phase (CP) CML is 400 mg daily. Response rates are different according to Sokal score, being significantly lower in intermediate and high Sokal risk patients. Phase I-II trials have shown a dose-response effect and high-dose imatinib trials in early CP CML showed better results compared to standard dose. Our study is the first prospective trial planned to evaluate the efficacy and tolerability of high-dose imatinib in a selected risk category, namely the intermediate Sokal risk one, of previously untreated CML patients. Seventy-eight patients were treated with 400 mg imatinib twice daily: complete cytogenetic response (CCgR) rates at 12 and 24 months were 88% and 91%; moreover, at 12 and 24 months 56% and 73% of CCgR patients achieved a major molecular response. The incidence of adverse events was slightly higher than reported by the most important standard-dose trials. With a median follow-up of 24 months, 3 patients progressed to advanced phase. In intermediate Sokal risk newly diagnosed CML patients, high-dose imatinib induced rapid and high response rates, apparently faster than those documented in the IRIS study for the same risk category. These clinical trials are registered at www.clinicaltrials.gov under NCT00510926. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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