Breast Cancer

, Volume 17, Issue 4, pp 233–240

Phase II study of 4-weekly capecitabine monotherapy in advanced/metastatic breast cancer

  • Mikihiro Kusama
  • Tadashi Nomizu
  • Kenjiro Aogi
  • Masataka Yoshimoto
  • Noboru Horikoshi
  • Toshio Tabei
  • Shinzaburo Noguchi
  • Shigeto Miura
  • Norio Yoshimura
  • Morihiko Kimura
  • Kazushige Toyama
  • Eisei Shin
Original Article



A multicenter, phase II study was conducted to evaluate the efficacy and safety of the Japanese intermittent 4-week regimen of capecitabine in patients with advanced/metastatic breast cancer.


Fifty patients who had received no more than one prior chemotherapy regimen for advanced/metastatic disease were enrolled from 23 centers and received at least two 4-weekly cycles of capecitabine (828 mg/m2 orally twice daily for 3 weeks followed by a 1-week rest period).


The overall response rate assessed by the Independent Review Committee (standard population, n = 46) was 28.3% (95% confidence interval 16.0–43.5%), including complete responses in 6.5%. Stable disease was observed in 20 patients and maintained for more than 6 months in 10 patients. The median duration of response in 13 evaluable responders was 5.3 months. Among evaluable patients (n = 47), median time to disease progression was 5.1 months. Median overall survival was 20.2 months. The most common treatment-related adverse events (all grades) were hand–foot syndrome (66%), nausea (26%), stomatitis (22%) and diarrhea (20%). Grade 3/4 treatment-related adverse events were seen in 23 patients (46%). The most common grade 3/4 adverse events were lymphocytopenia (22%), hand–foot syndrome (18%) and hyperbilirubinemia (10%).


Although the target overall response rate was not reached, the Japanese intermittent 4-week regimen of capecitabine was shown to be an effective and well-tolerated first- or second-line therapy for advanced/metastatic breast cancer.


Capecitabine Breast cancer Advanced Metastatic Efficacy Safety Four-week (Japanese) regimen 


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Copyright information

© The Japanese Breast Cancer Society 2009

Authors and Affiliations

  • Mikihiro Kusama
    • 1
    • 13
  • Tadashi Nomizu
    • 2
  • Kenjiro Aogi
    • 3
  • Masataka Yoshimoto
    • 4
    • 14
  • Noboru Horikoshi
    • 5
    • 15
  • Toshio Tabei
    • 6
  • Shinzaburo Noguchi
    • 7
  • Shigeto Miura
    • 8
    • 16
  • Norio Yoshimura
    • 9
  • Morihiko Kimura
    • 10
    • 17
  • Kazushige Toyama
    • 11
    • 18
  • Eisei Shin
    • 12
    • 19
  1. 1.Tokyo Medical UniversityTokyoJapan
  2. 2.Hoshi General HospitalFukushimaJapan
  3. 3.National Hospital Shikoku Cancer CenterMatsuyamaJapan
  4. 4.Cancer Institute HospitalTokyoJapan
  5. 5.Japanese Foundation for Cancer ResearchTokyoJapan
  6. 6.Saitama Prefectural Cancer CenterSaitamaJapan
  7. 7.Osaka UniversityOsakaJapan
  8. 8.Aichi Prefecture Cancer CenterNagoyaJapan
  9. 9.Kyoto Prefectural UniversityKyotoJapan
  10. 10.Gunma Prefecture Cancer CenterMaebashiJapan
  11. 11.Shizuoka Prefecture General HospitalShizuokaJapan
  12. 12.National Osaka HospitalOsakaJapan
  13. 13.Sinjyuku Breast Center Kusama ClinicTokyoJapan
  14. 14.International University of Health and Welfare, Mita HospitalTokyoJapan
  15. 15.Juntendo University School of MedicineTokyoJapan
  16. 16.Kamiiida Daiichi General HospitalNagoyaJapan
  17. 17.Ohta General HospitalOhtaJapan
  18. 18.Shizuoka Health Management CenterShizuokaJapan
  19. 19.Iseikai HospitalOsakaJapan

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