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 postoperat ive adjuvant chemotherapy with two drugs versus one drug could prolong survival. Patients and Methods: From 1985 to 1996, 85 patients with c ompletely 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 ever y 6 weeks. All courses were repeated four times. Results: After a medi an 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 Mante l-Cox showed survival rates significantly in favor of the MMC-FT group in the subsets of patients with node-negative disease (P = .01) and t hose whose disease was stage IB or II (P = .008). Conclusion: Signific antly better survival results were observed for MMC-FT versus MMC alon e. Subset analysis suggest a strong benefit in patients with nodenegat ive and early-stage resected gastric cancer. (C) 1998 by American Soci ety of Clinical Oncology.