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Blood, 15 December 2004, Vol. 104, No. 13, pp. 4245-4251.
Prepublished online as a Blood First Edition Paper on August 19, 2004; DOI 10.1182/blood-2004-03-0826.
 Previous Article | Next Article 
Submitted March 8, 2004
Accepted August 3, 2004
Imatinib and pegylated human recombinant interferon- 2b in early chronic phase chronic myeloid leukemia
Michele Baccarani*, Giovanni Martinelli, Gianantonio Rosti, Elena Trabacchi, Nicoletta Testoni, Simona Bassi, Marilina Amabile, Simona Soverini, Fausto Castagnetti, Daniela Cilloni, Barbara Izzo, Antonio de Vivo, Emanuela Messa, Francesca Bonifazi, Angela Poerio, Simona Luatti, Emilia Giugliano, Daniele Alberti, Gianluca Fincato, Domenico Russo, Fabrizio Pane, and Giuseppe Saglio
Institute of Hematology and Medical Oncology, University of Bologna, Bologna, Italy
University of Turin, University of Turin Division of Hematology and Internal Medicine, Department of Clinical and Biological Sciences, Turin, Italy
CEINGE Biotecnologie Avanzate and Department of Biochemistry and Medical Biotechnology, University of Naples Federico II, Naples, Italy
Novartis Pharma, Origgio (VA), Italy
Schering-Plough, Milan, Italy
Department of Hematology, University of Brescia, Brescia, Italy
* Corresponding author; email: mbaccarani{at}med.unibo.it.
Since Interferon- and Imatinib (IM) are effective for the treatment of chronic myeloid leukemia (CML) and their mechanisms of action are different, we designed an exploratory study investigating the effects of a standard IM dose (400 mg/day) and a variable pegylated Interferon- (PegIFN) dose (50, 100 and 150 µg/week). The criteria for dose adjustment were designed so as to ensure the delivery of the IM dose and to protect life quality. Seventy-six patients with previously untreated Philadelphia (Ph) positive CML were enrolled. Three patients discontinued IM and 45 patients discontinued PegIFN. The severity of adverse events increased with increasing PegIFN dose. The IM dose could be administered to the patients who were assigned to receive 50 or 100 µg/w PegIFN but not 150 µg/w. The median administered dose of PegIFN ranged between 32 and 36 µg/w. The cytogenetic response was 70% complete (Ph-neg 100%) and 83% major (Ph-neg >65%). The BCR/ABL transcript was reduced of at least 3 logs in 68% of complete cytogenetic responders. These data of toxicity, compliance and efficacy may assist in the design and preparation of prospective studies.
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