Efficacy and Safety of Imatinib Mesylate for Patients in the First Chronic Phase of Chronic Myeloid Leukemia: Results of a Japanese Phase II Clinical Study

  • Yasuo Morishima
  • Michinori Ogura
  • Miki Nishimura
  • Fumiharu Yazaki
  • Masami Bessho
  • Hideaki Mizoguchi
  • Shigeru Chiba
  • Hisamaru Hirai
  • Tetsuzo Tauchi
  • Akio Urabe
  • Masatomo Takahashi
  • Kazunori Ohnishi
  • Toshiya Yokozawa
  • Nobuhiko Emi
  • Masami Hirano
  • Chihiro Shimazaki
  • Shinji Nakao
  • Yasukazu Kawai
  • Masahiro Fujimoto
  • Hirokuni Taguchi
  • Itsuro Jinnai
  • Ryuzo Ohno
Article

DOI: 10.1532/IJH97.04074

Cite this article as:
Morishima, Y., Ogura, M., Nishimura, M. et al. Int J Hematol (2004) 80: 261. doi:10.1532/IJH97.04074

Abstract

Imatinib mesylate is a relatively new drug that targets the BCR-ABL chimeric protein, the molecular basis of chronic myeloid leukemia (CML). A phase II clinical trial in 39 Japanese patients in the first chronic phase of CML was conducted with imatinib mesylate at a dose of 400 mg/day. Hematologic complete response was obtained in 92.3% of the patients, complete cytogenetic response (CR) was obtained in 43.6%, and major partial CR was obtained in 20.5% of the patients. Although 29 of 39 patients required an adjustment of dosing because of grade 3 or 4 adverse events, most of the events were reversible, and 25 of the 29 patients were able to resume therapy. Between day 15 and day 35, grade 3 or 4 neutropenia and/or leukocytopenia occurred in 13 patients, and grade 3 thrombocytopenia occurred in 5 patients. Overall, nonhematologic grade 3 adverse events occurred in 28.2% of the patients.These data support the use of imatinib mesylate as the treatment of choice for chronic-phase CML patients.

Key words

Imatinib mesylate Chronic myeloid leukemia Phase II clinical study 

Copyright information

© The Japanese Society of Hematology 2004

Authors and Affiliations

  • Yasuo Morishima
    • 1
  • Michinori Ogura
    • 1
  • Miki Nishimura
    • 2
  • Fumiharu Yazaki
    • 3
  • Masami Bessho
    • 3
  • Hideaki Mizoguchi
    • 4
  • Shigeru Chiba
    • 5
  • Hisamaru Hirai
    • 5
  • Tetsuzo Tauchi
    • 6
  • Akio Urabe
    • 7
  • Masatomo Takahashi
    • 8
  • Kazunori Ohnishi
    • 9
  • Toshiya Yokozawa
    • 10
  • Nobuhiko Emi
    • 10
  • Masami Hirano
    • 11
  • Chihiro Shimazaki
    • 12
  • Shinji Nakao
    • 13
  • Yasukazu Kawai
    • 14
  • Masahiro Fujimoto
    • 15
  • Hirokuni Taguchi
    • 16
  • Itsuro Jinnai
    • 17
  • Ryuzo Ohno
    • 18
  1. 1.Department of Hematology and Cell TherapyAichi Cancer Center HospitalNagoyaJapan
  2. 2.Second Department of Internal MedicineChiba University School of MedicineChibaJapan
  3. 3.Department of HematologySaitama Medical SchoolSaitamaJapan
  4. 4.Department of HematologyTokyo Women’s Medical University School of MedicineTokyoJapan
  5. 5.Department of Hematology/Oncology and Cell Therapy/Transplantation MedicineUniversity of Tokyo HospitalTokyoJapan
  6. 6.First Department of Internal MedicineTokyo Medical UniversityTokyoJapan
  7. 7.Department of HematologyNTT Kanto Medical CenterTokyoJapan
  8. 8.Division of Hematology and OncologySt. Marianna University School of MedicineKawasakiJapan
  9. 9.Third Department of Internal MedicineHamamatsu University School of MedicineHamamatsuJapan
  10. 10.Department of HematologyNagoya University Graduate School of MedicineNagoyaJapan
  11. 11.Department of MedicineFujita Health University School of MedicineToyoakeJapan
  12. 12.Second Department of MedicineKyoto Prefectural University of MedicineKyotoJapan
  13. 13.Cellular Transplantation BiologyKanazawa University Graduate School of Medical ScienceKanazawaJapan
  14. 14.First Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
  15. 15.First Department of Internal MedicineKansai Medical UniversityOsakaJapan
  16. 16.Department of Hematology and Respiratory Medicine Kochi Medical SchoolKochi UniversityKochiJapan
  17. 17.Department of Hematology Atomic Bomb Disease InstituteNagasaki University Graduate School of BiosciencesNagasakiJapan
  18. 18.Aichi Cancer CenterNagoyaJapan

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