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Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up

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Abstract

Dasatinib is a highly potent BCR-ABL kinase inhibitor with established efficacy and safety in imatinib-resistant or -intolerant patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia. In the global phase III DASISION trial in patients with newly diagnosed chronic phase CML (CML-CP), dasatinib was found to have an acceptable safety profile and demonstrated significantly faster and higher rates of complete cytogenetic response (CCyR) and major molecular response (MMR) compared with imatinib. Here, we report the results of a subset analysis of Japanese patients enrolled in the DASISION trial, showing safety and efficacy profiles generally consistent with patients enrolled worldwide, including higher response rates (CCyR, MMR) with dasatinib compared with imatinib and similar high rates of progression-free and overall survival with both therapies. However, the small sample size of the present study limits the strength of these conclusions, and further exploration is needed to confirm any differences observed in Japanese patients compared with the total treated population. These findings support the use of dasatinib 100 mg QD as a first-line treatment in Japanese patients with newly diagnosed CML-CP.

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Acknowledgments

The authors would like to thank all participating study sites for this Bristol-Myers Squibb-sponsored study. The authors would like to particularly thank the patients who participated in this study and acknowledge the efforts of study staff at the study centers in Japan: Osaka City University Hospital, Nagoya Daini Red Cross Hospital, Yokohama City University Medical Center, Tohoku University Hospital, University Hospital, Kyoto Prefectural University of Medicine, Imamura Bun-in Hospital, Kameda Clinic of Medical Corporation Tesshokai, Fukuoka University Hospital, Kanto Medical Center NTT EC, Okayama University Hospital, Iwate Medical University Hospital, and Tokyo Metropolitan Komagome Hospital. StemScientific, funded by Bristol-Myers Squibb, provided writing and editorial support. The authors did not receive financial compensation for authoring the manuscript.

Conflict of interest

Shin Fujisawa has no conflict of interest to disclose. Hirohisa Nakamae has served as a consultant and lecturer for Novartis and Bristol-Myers Squibb and received from both: grants and payment for travel/accommodations/meeting expenses unrelated to activities listed. Michinori Ogura has received research funding from Bristol-Myers Squibb, Eisai, Kyowa Hakko Kirin Co., Ltd, Chugai, Pfizer, Novartis, Solasia, Celgene, SymBio, GlaxoSmithKline, Otsuka, Dainippon Sumitomo, MSD, and Janssen Pharma. Ken-ichi Ishizawa has no conflict of interest to disclose. Masafumi Taniwaki has no conflict of interest to disclose. Atae Utsunomiya has received consulting fees or honorarium from Bristol-Myers K.K. and Kyowa Hakko Kirin Co., Ltd. Kosei Matsue has no conflict of interest to disclose. Yasushi Takamatsu has no conflict of interest to disclose. Kensuke Usuki has no conflict of interest to disclose. Mitsune Tanimoto has no conflict of interest to disclose. Yoji Ishida has no conflict of interest to disclose. Hideki Akiyama has no conflict of interest to disclose. Shintaro Onishi is employed by Otsuka, and was formerly employed by Bristol-Myers Squibb throughout the manuscript development.

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Authors and Affiliations

  1. Department of Hematology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan

    Shin Fujisawa

  2. Department of Hematology and Stem Cell Transplantation, Osaka City University Hospital, Osaka, Japan

    Hirohisa Nakamae

  3. Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Aichi, Japan

    Michinori Ogura

  4. Division of Hematopathology, Tohoku University Hospital, Sendai, Miyagi, Japan

    Ken-ichi Ishizawa

  5. Department of Hematology, University Hospital, Kyoto Prefectural University of Medicine, Kamigyo, Kyoto, Japan

    Masafumi Taniwaki

  6. Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan

    Atae Utsunomiya

  7. Department of Hematology, Oncology, Kameda Clinic of Medical Corporation Tesshokai, Kamogawa, Chiba, Japan

    Kosei Matsue

  8. Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Fukuoka, Japan

    Yasushi Takamatsu

  9. Division of Hematology, Kanto Medical Center NTT EC, Shinagawa, Tokyo, Japan

    Kensuke Usuki

  10. Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan

    Mitsune Tanimoto

  11. Department of Hematology and Oncology, Internal Medicine, Iwate Medical University School of Medicine, Morioka, Japan

    Yoji Ishida

  12. Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo-Ku, Tokyo, Japan

    Hideki Akiyama

  13. Bristol-Myers K.K. and Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan

    Shintaro Onishi

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  1. Shin Fujisawa
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  2. Hirohisa Nakamae
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  3. Michinori Ogura
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  4. Ken-ichi Ishizawa
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  5. Masafumi Taniwaki
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  6. Atae Utsunomiya
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  7. Kosei Matsue
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  8. Yasushi Takamatsu
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  9. Kensuke Usuki
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  10. Mitsune Tanimoto
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  11. Yoji Ishida
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  12. Hideki Akiyama
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  13. Shintaro Onishi
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Corresponding author

Correspondence to Shin Fujisawa.

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Fujisawa, S., Nakamae, H., Ogura, M. et al. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol 99, 141–153 (2014). https://doi.org/10.1007/s12185-013-1470-1

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  • DOI: https://doi.org/10.1007/s12185-013-1470-1

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