Japanese Journal of Clinical Oncology Advance Access published online on July 6, 2006
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyl058
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1 University of Tsukuba, Tsukuba, Ibaraki, Japan
* To whom correspondence should be addressed. 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.
Received March 1, 2006
Accepted April 6, 2006
Original Article
A Phase II Study of the Global Dose and Schedule of Capecitabine in Japanese Patients with Metastatic Colorectal Cancer
Ichinosuke Hyodo 1 *,
Kuniaki Shirao 2,
Toshihiko Doi 3,
Kiyohiko Hatake 4,
Yasuaki Arai 2,
Kensei Yamaguchi 5,
Takao Tamura 6,
Shoji Takemiya 7,
Hiroya Takiuchi 8,
Kazuhiko Nakagawa 9,
and
Hideyuki Mishima 10
2 National Cancer Center Hospital, Tokyo, Japan
3 National Cancer Center Hospital East, Kashiwa, Chiba, Japan
4 Cancer Institute Hospital, Tokyo, Japan
5 Saitama Cancer Center, Saitama, Japan
6 Kobe University GraduateSchool of Medicine, Kobe, Japan
7 Kanagawa Cancer Center, Yokohama, Japan
8 Osaka Medical College, Takatsuki, Osaka, Japan
9 Kinki University, Osakasayama, Osaka, Japan
10 National Hospital Organization Osaka National Hospital, Osaka, Japan
Ichinosuke Hyodo, E-mail: ihyodo{at}md.tsukuba.ac.jp
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