TY - JOUR
T1 - Final report of KSCC0803
T2 - feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japan
AU - KYUSHU STUDY GROUP OF CLINICAL CANCER (KSCC)
AU - Minami, Kazuhito
AU - Morita, Masaru
AU - Emi, Yasunori
AU - Okamoto, Masahiro
AU - Tanaka, Eiji
AU - Nagata, Shigeyuki
AU - Touyama, Tetsuo
AU - Ohgaki, Kippei
AU - Tanaka, Takaho
AU - Okumura, Hiroshi
AU - Suenaga, Toyokuni
AU - Tokunaga, Shoji
AU - Oki, Eiji
AU - Kakeji, Yoshihiro
AU - Akagi, Yoshito
AU - Baba, Hideo
AU - Natsugoe, Shoji
AU - Maehara, Yoshihiko
N1 - Funding Information:
Yoshihiko Maehara has received research funding from Chugai Pharmaceutical. All other authors declare no conflicts of interest.
Publisher Copyright:
© 2017, Japan Society of Clinical Oncology.
PY - 2017/6/1
Y1 - 2017/6/1
N2 - 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.
AB - 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.
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U2 - 10.1007/s10147-017-1088-z
DO - 10.1007/s10147-017-1088-z
M3 - Article
C2 - 28101757
AN - SCOPUS:85009812145
SN - 1341-9625
VL - 22
SP - 505
EP - 510
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 3
ER -
