The international phase III DASISION trial demonstrated improved efficacy of dasatinib versus imatinib in treatment-naive patients with chronic myeloid leukemia in the chronic phase (CML-CP). We report efficacy and safety outcomes in a Japanese population from the final, 5-year follow-up of DASISION. At the end of the study, 77% (20/26) of dasatinib-treated and 61% (14/23) of imatinib-treated patients remained on initial therapy. Improved responses were observed in Japanese patients who received dasatinib versus imatinib (complete cytogenetic response: 96 vs 87%; major molecular response: 88 vs 74%; BCR-ABL1 ≤0.0032% International Scale [MR4.5]: 58 vs 52%). In patients who achieved BCR-ABL1 ≤10% at 3 months, 5-year progression-free survival and overall survival rates were high with dasatinib (96 and 96%) and imatinib (88 and 100%). The majority of adverse events were grade 1/2 in Japanese patients. Pleural effusion occurred more frequently in dasatinib-treated Japanese patients versus all patients (42 vs 28%), with no treatment discontinuations. Overall, in Japanese patients, dasatinib maintained its safety profile and had higher or comparable response and survival outcomes compared with imatinib or with all patients in DASISION. These findings demonstrate the long-term efficacy and tolerability of dasatinib and support frontline treatment of Japanese patients with CML-CP with dasatinib.
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The authors would like to thank all participating study sites for this Bristol-Myers Squibb (BMS)-sponsored analysis. Professional medical writing and editorial assistance was provided by Kelly M. Fahrbach, PhD, of StemScientific, an Ashfield Company, part of UDG Healthcare plc, funded by BMS. The authors did not receive financial compensation from BMS for authoring this manuscript.
All authors provided feedback and guidance on the analysis and interpretation of the results, critically reviewed and provided revisions to the manuscript, and approved the final draft for submission.
Conflict of interest
Hirohisa Nakamae has worked as a consultant for, received honoraria from, received research funding and travel expense reimbursement from, and served on speakers’ bureaus for Bristol-Myers Squibb and Novartis. Shin Fujisawa received research funding from Pfizer. Michinori Ogura has received research funding from Celltrion and SymBio Pharmaceuticals, has received honoraria from AstraZeneca, Janssen, and Takeda, and acted as a consultant for AstraZeneca, Celltrion, Meiji-Seika Pharma, and Mundipharma. Toshiki Uchida has received honoraria from Janssen Pharmaceuticals. Yasushi Onishi has received research funding from Bristol-Myers Squibb KK, and Novartis. Masafumi Taniwaki has received research funding from Chugai Pharmaceutical, Eisai, Kyowa Hakko Kirin, Pfizer, and Toyama Chemical. Atae Utsunomiya has served as a consultant to and received honoraria from Bristol-Myers Squibb KK and Kyowa Kakko Kirin Co., Ltd. Kosei Matsue has received honoraria from Celgene. Yasushi Takamatsu has received honoraria from Celgene, Kyowa Hakko Kirin, and Taisho Toyama Pharmaceutical. Kensuke Usuki has received research funding from Astellas Pharma, Fujimoto Pharmaceutical, Otsuka Pharmaceutical, Sumitomo Dainippon Pharma. Mitsune Tanimoto has received research funding from Astellas Pharma, Chugai Pharmaceutical, Kyowa Hakko Kirin, Nippon Shinyaku, Novartis, Otsuka Pharmaceutical, and Pfizer. Yoji Ishida declares no conflict of interest. Kazuteru Ohashi declares no conflict of interest. Li Li is an employee of Bristol-Myers Squibb. Masafumi Miyoshi is an employee of Bristol-Myers Squibb KK.
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Nakamae, H., Fujisawa, S., Ogura, M. et al. Dasatinib versus imatinib in Japanese patients with newly diagnosed chronic phase chronic myeloid leukemia: a subanalysis of the DASISION 5-year final report. Int J Hematol 105, 792–804 (2017). https://doi.org/10.1007/s12185-017-2208-2
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