Japanese Journal of Clinical Oncology Advance Access originally published online on July 6, 2006
Japanese Journal of Clinical Oncology 2006 36(7):410-417; doi:10.1093/jjco/hyl058
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© 2006 Foundation for Promotion of Cancer Research
A Phase II Study of the Global Dose and Schedule of Capecitabine in Japanese Patients with Metastatic Colorectal Cancer
1 University of Tsukuba, Tsukuba, Ibaraki, 2 National Cancer Center Hospital, Tokyo, 3 National Cancer Center Hospital East, Kashiwa, Chiba, 4 Cancer Institute Hospital, Tokyo, 5 Saitama Cancer Center, Saitama, 6 Kobe University Graduate School of Medicine, Kobe, 7 Kanagawa Cancer Center, Yokohama, 8 Osaka Medical College, Takatsuki, Osaka, 9 Kinki University, Osakasayama, Osaka and 10 National Hospital Organization Osaka National Hospital, Osaka, Japan
For reprints and all correspondence: Ichinosuke Hyodo, Division of Gastroenterology, Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba, 1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8575, Japan. E-mail: ihyodo{at}md.tsukuba.ac.jp
Received March 1, 2006; accepted April 6, 2006
Background: Although the standard 3-week capecitabine regimen (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest) has shown superior activity and improved safety over bolus 5-fluorouracil/leucovorin in two large randomized phase III trials in Europe and in the United States, only a 4-week regimen of capecitabine (828 mg/m2 twice daily for 3 weeks) has been studied in Japan. Therefore, we performed a phase II study to investigate the 3-week regimen of capecitabine in Japanese patients with metastatic colorectal cancer (MCRC).
Methods: Previously untreated patients with MCRC received oral capecitabine 1250 mg/m2 twice daily for 2 weeks. Treatment was repeated every 3 weeks. Blood and urine samples were collected for pharmacokinetic analysis.
Results: Sixty patients were enrolled. The overall response rate was 35% [95% confidence interval (CI), 23–48%], and 52% of patients had stable disease. The median time to progression was 5.5 months (95% CI, 4.2–6.7 months). The median overall survival was 20.2 months (95% CI, 16.6–27.8 months). The most frequently occurring adverse drug reaction was hand-foot syndrome (all-grade 73%; grade 3 13%). Diarrhea, anorexia, nausea and stomatitis were each seen in 37% of patients. The pharmacokinetic profiles of capecitabine and its metabolites were similar to those reported in Caucasian patients.
Conclusions: The 3-week regimen of capecitabine was effective and well tolerated in Japanese patients with MCRC as well, and could be used as the basic regimen for future combination therapies.
Key Words: capecitabine • colorectal cancer • phase II study