Postoperative adjuvant 5-fluorouracil plus methyl-CCNU therapy for gastric cancer patients. Eastern Cooperative Oncology Group study (EST 3275).

After en bloc resection of gastric adenocarcinoma, 180 patients were randomized to 2 years of 5-fluorouracil (5-FU) + semustine (MeCCNU) chemotherapy or to observation only. After a median follow-up time of 64 months, 48 of 89 control patients and 51/91 treated patients recurred (P < 0.71). The sites of recurrent cancer were similar for both groups: liver, 32%; local esophagus or stomach, 51%; abdominal nodes and peritoneum, 38%; and extra-abdominal nodes, 14%. The survival curves overlap; 51/89 controls and 57/91 treated patients died with a median survival of 32.7 and 36.6 months, respectively (P < 0.73). Treated patients experienced clinically important hematologic toxicity and two treated patients died of marrow failure with leukemia. Because of the toxicity and the lack of effectiveness, adjuvant 5-FU + MeCCNU is not recommended for patients with resectable gastric cancer.