Randomized trial of adjuvant chemotherapy with mitomycin plus ftorafur versus mitomycin alone in resected locally advanced gastric cancer

Purpose: We performed a clinical trial to determine whether postoperative adjuvant chemotherapy with two drugs versus one drug could prolong survival. Patients and Methods: From 1985 to 1996, 85 patients with completely resected cancer were enrolled. The subjects were randomized into two treatment groups, as follows: mitomycin (MMC) 10 to 20 mg/m(2) intravenously (IV) on day 1 every 6 weeks plus ftorafur (FT) 500 mg/m(2)/d for 36 consecutive days; or MMC alone, 10 to 20 mg/m(2) IV every 6 weeks. All courses were repeated four times. Results: After a median follow-vp duration of 62 months, the overall 5-year survival rates were 67% for the MMC-FT group versus 44% for the MMC group (P = .04). Subgroup analysis to compare survival curves using the method of Mantel-Cox showed survival rates significantly in favor of the MMC-FT group in the subsets of patients with node-negative disease (P = .01) and those whose disease was stage IB or II (P = .008). Conclusion: Significantly better survival results were observed for MMC-FT versus MMC alone. Subset analysis suggest a strong benefit in patients with nodenegative and early-stage resected gastric cancer. (C) 1998 by American Society of Clinical Oncology.