1. Imatinib and pegylated human recombinant interferon-alpha2b in early chronic-phase chronic myeloid leukemia
- Author
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Baccarani, Michele, Martinelli, Giovanni, Rosti, Gianantonio, Trabacchi, Elena, Testoni, Nicoletta, Bassi, Simona, Amabile, Marilina, Soverini, Simona, Castagnetti, Fausto, Cilloni, Daniela, Izzo, Barbara, De Vivo, Antonio, Messa, Emanuela, Bonifazi, Francesca, Poerio, Angela, Luatti, Simona, Giugliano, Emilia, Alberti, Daniele, Fincato, Gianluca, Russo, Domenico, Pane, Fabrizio, Saglio, Giuseppe, GIMEMA CML Working Party, Bocchia, Monica, Baccarani, M, Martinelli, G, Rosti, G, Trabacchi, E, Testoni, N, Bassi, S, Amabile, M, Soverini, S, Castagnetti, F, Cilloni, D, Izzo, Barbara, DE VIVO, A, Messa, E, Bonifazi, F, Poerio, A, Luatti, S, Giugliano, E, Alberti, D, Fincato, G, Russo, D, Pane, Fabrizio, Saglio, G, GIMEMA WORKING PARTY ON CHRONIC MYELOID, L. E. U. K. E. M. I. A., BACCARANI M., MARTINELLI G., ROSTI G., TRABACCHI E., TESTONI N., BASSI S., AMABILE M., SOVERINI S., CASTAGNETTI F., CILLONI D., IZZO B., DE VIVO A., MESSA E., BONIFAZI F., POERIO A., LUATTI S., GIUGLIANO E., ALBERTI D., FINCATO G., RUSSO D., PANE F., SAGLIO G., and GIMEMA WORKING PARTY ON CHRONIC MYELOID LEUKEMIA
- Subjects
Male ,PHILADELPHIA-CHROMOSOME ,Biochemistry ,Gastroenterology ,Piperazines ,hemic and lymphatic diseases ,Antineoplastic Combined Chemotherapy Protocols ,Chronic ,BCR-ABL ,Leukemia ,CLINICAL RESISTANCE ,CHRONIC MYELOGENOUS LEUKEMIA ,Myeloid leukemia ,TYROSINE KINASE INHIBITOR ,ABL-POSITIVE CELLS ,SEQUENCE BINDING-PROTEIN ,FUSION GENE TRANSCRIPTS ,CYTOGENETIC RESPONSES ,ANTILEUKEMIC AGENTS ,Hematology ,Middle Aged ,Recombinant Proteins ,Toxicity ,Benzamides ,Imatinib Mesylate ,Female ,Drug ,medicine.drug ,Adult ,medicine.medical_specialty ,Immunology ,Alpha interferon ,Interferon alpha-2 ,Dose-Response Relationship ,chronic myeloid leukemia ,Aged ,Dose-Response Relationship, Drug ,Humans ,Interferon-alpha ,Leukemia, Myelogenous, Chronic, BCR-ABL Positive ,Pyrimidines ,Internal medicine ,medicine ,Adverse effect ,business.industry ,Imatinib ,Cell Biology ,medicine.disease ,Imatinib mesylate ,imatinib ,BCR-ABL Positive ,recombinant alpha2b interferon ,business ,Chronic myelogenous leukemia ,Myelogenous - Abstract
Since interferon-α and imatinib (IM; STI571, Glivec, Gleevec) 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/d) and a variable pegylated interferon-α (PegIFN) dose (50 μg/wk, 100 μg/wk, and 150 μg/wk). The criteria for dose adjustment were designed so as to ensure the delivery of the IM dose and to protect life quality. There were 76 patients with previously untreated Philadelphia (Ph)–positive CML enrolled in the study. There were 3 patients who discontinued IM and 45 patients who 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 μg/wk or 100 μg/wk PegIFN but not to those who were assigned to receive 150 μg/wk. The median administered dose of PegIFN ranged between 32 μg/wk and 36 μg/wk. The cytogenetic response was 70% complete (Ph-neg 100%) and 83% major (Ph-neg > 65%). The BCR/ABL transcript was reduced by 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.
- Published
- 2004