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Blood First Edition Paper, prepublished online October 12, 2009; DOI 10.1182/blood-2009-07-232595. This Article Full Text Full Text (PDF) 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 Google Scholar Articles by Rosti, G. Articles by Baccarani, M. PubMed PubMed Citation Articles by Rosti, G. Articles by Baccarani, M. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted July 22, 2009; accepted September 13, 2009. Nilotinib for the frontline treatment of Ph+ chronic myeloid leukemia Gianantonio Rosti1,11, Francesca Palandri1, Fausto Castagnetti1, Massimo Breccia2, Luciano Levato3, Gabriele Gugliotta1, Adele Capucci4, Michele Cedrone5, Carmen Fava6, Tamara Intermesoli7, Giovanna Rege Cambrin6, Fabio Stagno8, Mario Tiribelli9, Marilina Amabile1, Simona Luatti1, Angela Poerio1, Simona Soverini1, Nicoletta Testoni1, Giovanni Martinelli1, Giuliana Alimena2, Fabrizio Pane10, Giuseppe Saglio6 and Michele Baccarani1 1 University of Bologna, S.Orsola-Malpighi Hospital, Italy; 2 "La Sapienza" University, Italy; 3 "A. Pugliese" Hospital, Italy; 4 Spedali Civili, Italy; 5 "San Giovanni - Addolorata Hospital", Italy; 6 University of Turin at Orbassano, Italy; 7 Ospedali Riuniti, Italy; 8 University of Catania, Italy; 9 University of Udine, Italy; 10 "Federico II" University, Italy * Corresponding author; email: gianantonio.rosti{at}unibo.it Abstract Nilotinib has a higher binding affinity and selectivity for BCR-ABL with respect to imatinib and is an effective treatment of chronic myeloid leukemia (CML) after imatinib failure. In a phase-2 study, 73 early chronic phase (ECP), untreated, Ph+ CML patients, received nilotinib at a dose of 400 mg BID. The primary endpoint was the complete cytogenetic response (CCgR) rate at 1 year. With a median follow-up of 15 months, the CCgR rate at 1 year was 96%, and the major molecular response (MMolR) rate 85%. Responses were rapid, with 78% CCgR and 52% MMolR at 3 months. During the first year, the treatment was interrupted at least once in 38 patients (52%). The mean daily dose ranged between 600 and 800 mg in 74% of patients, 400 and 599 mg in 18% of patients and was less than 400 mg in 8% of patients. Dose interruptions were mainly due to non-hematologic and biochemical side effects. Myelosuppression was irrelevant. One patient progressed to blastic crisis after 6 months, one went off-treatment for lipase increase grade 4 (no pancreatitis). Nilotinib is safe and very active in ECP CML. These data support a role for nilotinib for the frontline treatment of CML. (ClinicalTrials.gov - NCT00481052 [ClinicalTrials.gov] ). CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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