Kazuhito Minami1, Masaru Morita2, Yasunori Emi3, Masahiro Okamoto4, Eiji Tanaka5, Shigeyuki Nagata6, Tetsuo Touyama7, Kippei Ohgaki8, Takaho Tanaka9, Hiroshi Okumura10, Toyokuni Suenaga11, Shoji Tokunaga12, Eiji Oki13, Yoshihiro Kakeji14, Yoshito Akagi15, Hideo Baba16, Shoji Natsugoe17, Yoshihiko Maehara13. 1. Department of Gastroenterological Surgery, National Kyushu Cancer Center, Notame 3-1-1, Minami-ku, Fukuoka, 811-1395, Japan. minami.k@nk-cc.go.jp. 2. Department of Gastroenterological Surgery, National Kyushu Cancer Center, Notame 3-1-1, Minami-ku, Fukuoka, 811-1395, Japan. 3. Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan. 4. Department of Surgery, Oita Red Cross Hospital, Oita, Japan. 5. Department of Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan. 6. Department of Surgery, Nakatsu Municipal Hospital, Oita, Japan. 7. Department of Surgery, Nakagami Hospital, Okinawa, Japan. 8. Department of Gastrointestinal Surgery, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan. 9. Department of Surgery, Social Insurance Tagawa Hospital, Fukuoka, Japan. 10. Department of Surgery, Kagoshima Kouseiren Hospital, Kagoshima, Japan. 11. Department of Surgery, Nanpuh Hospital, Kagoshima, Japan. 12. Medical Information Center, Kyushu University Hospital, Fukuoka, Japan. 13. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 14. Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, Kobe, Japan. 15. Department of Surgery, Kurume University School of Medicine, Kurume, Japan. 16. Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. 17. Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Abstract
BACKGROUND: The impact of oral capecitabine as adjuvant chemotherapy for Japanese patients with resected colon cancer was unclear. We previously planned and conducted a prospective feasibility study (KSCC0803) and reported on the safety of oral capecitabine as adjuvant chemotherapy for Japanese patients with resected stage III colon cancer. The purpose of the current study was to assess the survival results from that study. METHODS: The study subjects were Japanese patients with resected stage III colon cancer. The protocol adjuvant regimen consisted of oral capecitabine 1250 mg/m2 twice daily on days 1-14 of a 3-week cycle for a total of eight cycles. The 3- and 5-year disease free survival (DFS) rates and overall survival (OS) rates were analyzed in the eligible cohort. RESULTS: Ninety-seven patients were registered between September 2008 and August 2009 and treated with the protocol regimen. The median follow-up time was 60.7 months. The 3- and 5-year DFS rates were 71.2% [95% confidence interval (CI): 61.7-79.8%] and 69.7% (95% CI: 59.4-77.8%), respectively. The 3- and 5-year OS rates were 92.6% (95% CI: 85.2-96.4%) and 84.5% (95% CI: 75.1-90.5%), respectively. CONCLUSIONS: The survival results in this study are in line with those of previously reported, reliable, studies. The safety and tolerability of the protocol regimen have already been confirmed. Oral capecitabine is acceptable as adjuvant chemotherapy for Japanese patients with resected stage III colon cancer.
BACKGROUND: The impact of oral capecitabine as adjuvant chemotherapy for Japanese patients with resected colon cancer was unclear. We previously planned and conducted a prospective feasibility study (KSCC0803) and reported on the safety of oral capecitabine as adjuvant chemotherapy for Japanese patients with resected stage III colon cancer. The purpose of the current study was to assess the survival results from that study. METHODS: The study subjects were Japanese patients with resected stage III colon cancer. The protocol adjuvant regimen consisted of oral capecitabine 1250 mg/m2 twice daily on days 1-14 of a 3-week cycle for a total of eight cycles. The 3- and 5-year disease free survival (DFS) rates and overall survival (OS) rates were analyzed in the eligible cohort. RESULTS: Ninety-seven patients were registered between September 2008 and August 2009 and treated with the protocol regimen. The median follow-up time was 60.7 months. The 3- and 5-year DFS rates were 71.2% [95% confidence interval (CI): 61.7-79.8%] and 69.7% (95% CI: 59.4-77.8%), respectively. The 3- and 5-year OS rates were 92.6% (95% CI: 85.2-96.4%) and 84.5% (95% CI: 75.1-90.5%), respectively. CONCLUSIONS: The survival results in this study are in line with those of previously reported, reliable, studies. The safety and tolerability of the protocol regimen have already been confirmed. Oral capecitabine is acceptable as adjuvant chemotherapy for Japanese patients with resected stage III colon cancer.
Authors: M J O'Connell; J A Mailliard; M J Kahn; J S Macdonald; D G Haller; R J Mayer; H S Wieand Journal: J Clin Oncol Date: 1997-01 Impact factor: 44.544
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Authors: C G Moertel; T R Fleming; J S Macdonald; D G Haller; J A Laurie; P J Goodman; J S Ungerleider; W A Emerson; D C Tormey; J H Glick Journal: N Engl J Med Date: 1990-02-08 Impact factor: 91.245
Authors: M Yoshida; M Ishiguro; K Ikejiri; I Mochizuki; Y Nakamoto; Y Kinugasa; A Takagane; T Endo; H Shinozaki; Y Takii; H Mochizuki; K Kotake; S Kameoka; K Takahashi; T Watanabe; M Watanabe; N Boku; N Tomita; E Nakatani; K Sugihara Journal: Ann Oncol Date: 2014-06-18 Impact factor: 32.976