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Japanese Journal of Clinical Oncology 34:195-201 (2004)
© 2004 Foundation for Promotion of Cancer Research

A Pilot Phase II Study of Capecitabine in Advanced or Recurrent Colorectal Cancer

Yukifumi Kondo1, Masanori Terashima2, Atsushi Sato3 and Tetsuo Taguchi4,+,§

1 Department of Surgery, Sapporo-Kosei General Hospital, Sapporo, 2 The First Department of Surgery, Iwate Medical University School of Medicine, Morioka, 3 Department of Gastroenterology, Toyosu Hospital, Showa University, Tokyo and 4 Japan Society for Cancer Chemotherapy, Japan

Background: A pilot phase II study was conducted to evaluate the Japanese intermittent regimen of capecitabine in patients with advanced/recurrent colorectal cancer.

Methods: Twenty-two patients received oral capecitabine in a dose of 828 mg/m2 twice daily for 3 weeks every 4 weeks.

Results: In the 20 patients evaluable for efficacy, the overall response rate was 25.0% (95% CI, 8.7–49.1%), rising to 33.0% in the subset of patients previously untreated for metastatic disease (n = 9). A further nine patients had stable disease. The median duration of response was 7.0 months. Five patients (22.7%) experienced grade 3/4 treatment-related adverse events, the most common being a bullous rash observed in two patients (9.1%).

Conclusions: The 3 weeks out of 4 intermittent regimen of capecitabine demonstrated good antitumor activity and tolerability in patients with advanced/refractory colorectal cancer, providing a clear rationale for conducting a larger phase II study in patients with advanced disease.

+ On behalf of the Clinical Study Group of Capecitabine

§ For reprints and all correspondence: Yukifumi Kondo, Vice-director of Sapporo-Kosei General Hospital, Kita-3, Higashi-8, Chuo-ku, Sapporo, Hokkaido 060-0033, Japan. E-mail: yuki.kondou{at}ja-hokkaidoukouseiren.or.jp


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