Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION)
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- Hagop M. Kantarjian
- The University of Texas M. D. Anderson Cancer Center, Houston, TX;
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- Neil P. Shah
- University of California–San Francisco School of Medicine, San Francisco, CA;
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- Jorge E. Cortes
- The University of Texas M. D. Anderson Cancer Center, Houston, TX;
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- Michele Baccarani
- Department of Hematology-Oncology “L. and A. Seràgnoli,” University of Bologna, Bologna, Italy;
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- Mohan B. Agarwal
- Institute of Medical Sciences, Bombay Hospital, Mumbai, India;
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- María Soledad Undurraga
- Department of Hematology, Hospital del Salvador, Santiago, Chile;
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- Jianxiang Wang
- Department of Clinical Hematology, Institute of Hematology and Blood Diseases Hospital, Tianjin, China;
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- Juan Julio Kassack Ipiña
- Hospital General de Mexico, Mexico City, Mexico;
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- Dong-Wook Kim
- Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea;
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- Michinori Ogura
- Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan;
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- Carolina Pavlovsky
- FUNDALEU, Angélica Ocampo Hospitalization and Clinical Research Center, Buenos Aires, Argentina;
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- Christian Junghanss
- Department of Hematology/Oncology, University of Rostock, Rostock, Germany;
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- Jorge H. Milone
- Department of Hematology, Hospital Italiano de La Plata, Buenos Aires, Argentina;
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- Franck E. Nicolini
- Hematology Department, Edouard Herriot Hospital, Lyon, France;
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- Tadeusz Robak
- Department of Hematology, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland;
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- Jan Van Droogenbroeck
- Department of Haematology, AZ St Jan Hospital, Brugge, Belgium;
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- Edo Vellenga
- Department of Hematology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands;
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- M. Brigid Bradley-Garelik
- Bristol-Myers Squibb, Wallingford, CT; and
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- Chao Zhu
- Bristol-Myers Squibb, Wallingford, CT; and
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- Andreas Hochhaus
- Abteilung Hämatologie/Onkologie, Universitätsklinikum Jena, Jena, Germany
抄録
<jats:title>Abstract</jats:title> <jats:p>Dasatinib is a highly potent BCR-ABL inhibitor with established efficacy and safety in imatinib-resistant/-intolerant patients with chronic myeloid leukemia (CML). In the phase 3 DASISION trial, patients with newly diagnosed chronic-phase (CP) CML were randomized to receive dasatinib 100 mg (n = 259) or imatinib 400 mg (n = 260) once daily. Primary data showed superior efficacy for dasatinib compared with imatinib after 12 months, including significantly higher rates of complete cytogenetic response (CCyR), confirmed CCyR (primary end point), and major molecular response (MMR). Here, 24-month data are presented. Cumulative response rates by 24 months in dasatinib and imatinib arms were: CCyR in 86% versus 82%, MMR in 64% versus 46%, and BCR-ABL reduction to ≤ 0.0032% (4.5-log reduction) in 17% versus 8%. Transformation to accelerated-/ blast-phase CML on study occurred in 2.3% with dasatinib versus 5.0% with imatinib. BCR-ABL mutations, assessed after discontinuation, were detected in 10 patients in each arm. In safety analyses, fluid retention, superficial edema, myalgia, vomiting, and rash were less frequent with dasatinib compared with imatinib, whereas pleural effusion and grade 3/4 thrombocytopenia were more frequent with dasatinib. Overall, dasatinib continues to show faster and deeper responses compared with imatinib, supporting first-line use of dasatinib in patients with newly diagnosed CML-CP. This study was registered at ClinicalTrials.gov: NCT00481247.</jats:p>
収録刊行物
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- Blood
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Blood 119 (5), 1123-1129, 2012-02-02
American Society of Hematology