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Abstract
Adjuvant oxaliplatin plus capecitabine (XELOX) therapy is recommended for patients with curatively resected colon cancer. However, prospective data on its practical application in Japanese patients are limited. Therefore, we aimed to conduct a long-term clinical evaluation of the efficacy and safety of adjuvant XELOX in patients with curatively resected stage III colon cancer (MCSCO-1024). This prospective, multi-center, open-label, single-arm, phase II study enrolled patients with curatively resected stage III colon cancer. The treatment protocol consisted of a 120-minute intravenous infusion of oxaliplatin (130 mg/m2) on day 1 and two divided doses oral capecitabine (2000 mg/m2/day) for 14 days in a 3-week cycle, totaling eight cycles (24 weeks). The primary endpoint was 3-year disease-free survival (DFS), and the secondary endpoints were 5-year overall survival and long-term prognosis of peripheral sensory neuropathy. A total of 196 patients were enrolled between November 2011 and August 2014 (34 months). The 3-year DFS rate was 73%, and the 5-year overall survival rate was 87%. The overall incidence of peripheral sensory neuropathy was 17%, with a 1% rate of grade 3 neuropathy after 5 years. Adjuvant XELOX demonstrated utility and safety in the clinical management of Japanese patients with stage III colon cancer.
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1 Kansai Rosai Hospital, Department of Surgery, Japan Organization of Occupational Health and Safety, Amagasaki, Japan (GRID:grid.414976.9) (ISNI:0000 0004 0546 3696)
2 Osaka University, Department of Gastroenterological Surgery, Graduate School of Medicine, Suita, Japan (GRID:grid.136593.b) (ISNI:0000 0004 0373 3971)
3 Minoh City Hospital, Department of Surgery, Mino, Japan (GRID:grid.415904.d)
4 Yao Municipal Hospital, Department of Surgery, Osaka, Japan (GRID:grid.517853.d)
5 Osaka Police Hospital, Department of Surgery, Osaka, Japan (GRID:grid.416980.2) (ISNI:0000 0004 1774 8373)
6 Osaka General Medical Center, Department of Surgery, Osaka, Japan (GRID:grid.416985.7) (ISNI:0000 0004 0378 3952)
7 Saiseikai Senri Hospital, Department of Surgery, Suita, Japan (GRID:grid.416985.7)
8 Toyonaka Municipal Hospital, Department of Surgery, Toyonaka, Japan (GRID:grid.417245.1) (ISNI:0000 0004 1774 8664)
9 Osaka Rosai Hospital, Department of Surgery, Sakai, Japan (GRID:grid.417001.3) (ISNI:0000 0004 0378 5245)
10 Higashiosaka City Medical Center, Department of Surgery, Higashiosaka , Japan (GRID:grid.416707.3) (ISNI:0000 0001 0368 1380)
11 Hyogo Prefectural Nishinomiya Hospital, Department of Surgery, Nishinomiya, Japan (GRID:grid.413719.9)
12 Suita Municipal Hospital, Department of Gastroenterological Surgery, Suita, Japan (GRID:grid.416694.8) (ISNI:0000 0004 1772 1154)
13 Ikeda City Hospital, Department of Surgery, Ikeda, Japan (GRID:grid.414568.a) (ISNI:0000 0004 0604 707X)
14 Kinki Central Hospital of the Mutual Aid Association of Public School Teachers, Department of Surgery, Itami, Japan (GRID:grid.415371.5) (ISNI:0000 0004 0642 2562)