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

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Abstract

Background

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.

Methods

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).

Results

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%).

Conclusions

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.

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Acknowledgments

This study was sponsored by Nippon Roche K.K. In addition to the authors, the following investigators took part in this trial: Dr. Yoshiaki Narita (Teine Keijinkai Hospital, Hokkaido, Japan); Dr. Tosei Ohmura (Sapporo Medical University, Hokkaido, Japan); Dr. Yoshiro Hayakawa (Iwate Medical University, Iwate, Japan); Dr. Masahasu Takahashi (Ota-Nishinouchi General Hospital, Fukushima, Japan); Dr. Tsuneo Imai (Nagoya University, Aichi, Japan); Dr. Takayoshi Naruse (Aichi Medical University, Aichi, Japan); Dr. Hideo Inaji (Osaka Adult Disease Center, Osaka, Japan); Dr. Ken Morimoto (Osaka City University, Osaka, Japan); Dr. Yutaka Konishi (Kobe Citizens Hospital, Hyogo, Japan); Dr. Yuichi Takatsuka (Kansai Rosai Hospital, Hyogo, Japan); Dr. Akihiko Osaki (Hiroshima University, Hiroshima, Japan); and Dr. Reiki Nishimura (Kumamoto Citizens Hospital, Kumamoto, Japan).

Author information

Author notes

  1. Mikihiro Kusama

    Present address: Sinjyuku Breast Center Kusama Clinic, Tokyo, Japan

  2. Masataka Yoshimoto

    Present address: International University of Health and Welfare, Mita Hospital, Tokyo, Japan

  3. Noboru Horikoshi

    Present address: Juntendo University School of Medicine, Tokyo, Japan

  4. Shigeto Miura

    Present address: Kamiiida Daiichi General Hospital, Nagoya, Aichi, Japan

  5. Morihiko Kimura

    Present address: Ohta General Hospital, Ohta, Gunma, Japan

  6. Kazushige Toyama

    Present address: Shizuoka Health Management Center, Shizuoka, Japan

  7. Eisei Shin

    Present address: Iseikai Hospital, Osaka, Japan

Authors and Affiliations

  1. Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan

    Mikihiro Kusama

  2. Hoshi General Hospital, Fukushima, Japan

    Tadashi Nomizu

  3. National Hospital Shikoku Cancer Center, Matsuyama, Ehime, Japan

    Kenjiro Aogi

  4. Cancer Institute Hospital, Tokyo, Japan

    Masataka Yoshimoto

  5. Japanese Foundation for Cancer Research, Tokyo, Japan

    Noboru Horikoshi

  6. Saitama Prefectural Cancer Center, Saitama, Japan

    Toshio Tabei

  7. Osaka University, Osaka, Japan

    Shinzaburo Noguchi

  8. Aichi Prefecture Cancer Center, Nagoya, Aichi, Japan

    Shigeto Miura

  9. Kyoto Prefectural University, Kyoto, Japan

    Norio Yoshimura

  10. Gunma Prefecture Cancer Center, Maebashi, Gunma, Japan

    Morihiko Kimura

  11. Shizuoka Prefecture General Hospital, Shizuoka, Japan

    Kazushige Toyama

  12. National Osaka Hospital, Osaka, Japan

    Eisei Shin

Authors
  1. Mikihiro Kusama
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  2. Tadashi Nomizu
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  3. Kenjiro Aogi
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  4. Masataka Yoshimoto
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  5. Noboru Horikoshi
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  6. Toshio Tabei
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  7. Shinzaburo Noguchi
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  8. Shigeto Miura
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  9. Norio Yoshimura
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  10. Morihiko Kimura
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  11. Kazushige Toyama
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  12. Eisei Shin
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Corresponding author

Correspondence to Mikihiro Kusama.

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Kusama, M., Nomizu, T., Aogi, K. et al. Phase II study of 4-weekly capecitabine monotherapy in advanced/metastatic breast cancer. Breast Cancer 17, 233–240 (2010). https://doi.org/10.1007/s12282-009-0137-5

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  • DOI: https://doi.org/10.1007/s12282-009-0137-5

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