International Journal of Hematology

, Volume 92, Issue 1, pp 111–117

Imatinib for newly diagnosed chronic-phase chronic myeloid leukemia: results of a prospective study in Japan

  • Tadashi Nagai
  • Jin Takeuchi
  • Nobuaki Dobashi
  • Yuzuru Kanakura
  • Shuichi Taniguchi
  • Koji Ezaki
  • Chiaki Nakaseko
  • Akira Hiraoka
  • Masaya Okada
  • Yasushi Miyazaki
  • Toshiko Motoji
  • Masaaki Higashihara
  • Norifumi Tsukamoto
  • Hitoshi Kiyoi
  • Shinji Nakao
  • Katsuji Shinagawa
  • Ryuzo Ohno
  • Tomoki Naoe
  • Kazunori Ohnishi
  • Noriko Usui
Original Article

Abstract

Although imatinib has become the current standard treatment for chronic myeloid leukemia (CML), there is limited information regarding its efficacy and safety among Japanese patients. We therefore conducted a prospective multi-center open-label study of imatinib for Japanese patients with newly diagnosed chronic-phase CML (CP-CML). A total of 107 patients were enrolled and treated with imatinib at an initial daily dose of 400 mg. Eighty-three patients completed 3 years of study treatment. The cumulative rates of major cytogenetic response and complete cytogenetic response (CCyR) were 90.9 and 90.2% at 3 years, respectively. The safety profile was not very different from that reported in the IRIS study, although grade ≥3 neutropenia occurred relatively frequently (31.8 vs. 14.3%). Only seven patients discontinued the study due to adverse events, as did four patients due to insufficient efficacy. The 3-year probabilities of overall survival and progression-free survival were 93.2 and 91.4%, respectively. Higher average daily doses (i.e., ≥350 mg) were significantly associated not only with higher rates of achieving CCyR, but also with longer duration of CCyR. These findings confirm the clinical utility of imatinib in Japanese patients with newly diagnosed CP-CML, and suggest detrimental effect of low average daily dose on treatment results.

Keywords

Chronic myeloid leukemia Chronic phase Newly diagnosed Imatinib 

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Copyright information

© The Japanese Society of Hematology 2010

Authors and Affiliations

  • Tadashi Nagai
    • 1
  • Jin Takeuchi
    • 2
  • Nobuaki Dobashi
    • 3
  • Yuzuru Kanakura
    • 4
  • Shuichi Taniguchi
    • 5
  • Koji Ezaki
    • 6
  • Chiaki Nakaseko
    • 7
  • Akira Hiraoka
    • 8
  • Masaya Okada
    • 9
  • Yasushi Miyazaki
    • 10
  • Toshiko Motoji
    • 11
  • Masaaki Higashihara
    • 12
  • Norifumi Tsukamoto
    • 13
  • Hitoshi Kiyoi
    • 14
  • Shinji Nakao
    • 15
  • Katsuji Shinagawa
    • 16
  • Ryuzo Ohno
    • 17
  • Tomoki Naoe
    • 14
  • Kazunori Ohnishi
    • 18
  • Noriko Usui
    • 3
  1. 1.Division of HematologyJichi Medical University HospitalShimotsukeJapan
  2. 2.Nihon University Itabashi HospitalTokyoJapan
  3. 3.Jikei University HospitalTokyoJapan
  4. 4.Osaka University HospitalOsakaJapan
  5. 5.Toranomon HospitalTokyoJapan
  6. 6.Fujita Health University HospitalToyoakeJapan
  7. 7.Chiba University HospitalChibaJapan
  8. 8.Osaka Medical Center for Cancer and Cardiovascular DiseasesOsakaJapan
  9. 9.The Hospital of Hyogo College of MedicineHyogoJapan
  10. 10.Nagasaki University HospitalNagasakiJapan
  11. 11.Tokyo Women’s Medical UniversityTokyoJapan
  12. 12.Kitasato University HospitalSagamiharaJapan
  13. 13.Gunma University HospitalMaebashiJapan
  14. 14.Nagoya University HospitalNagoyaJapan
  15. 15.Kanazawa University HospitalKanazawaJapan
  16. 16.Okayama University HospitalOkayamaJapan
  17. 17.Aichi Cancer CenterNagoyaJapan
  18. 18.Hamamatsu University School of MedicineHamamatsuJapan

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