Adjuvant treatments following curative resection for gastric cancer. The Italian Gastrointestinal Tumor Study Group.
The results of a prospective randomized trial of adjuvant treatment after curative resection for gastric cancer are reported. The study consisted of three arms: (1) surgery only; (2) chemotherapy (5-fluorouracil (FU) and 1-(2-chloroethyl)-3-(4-methylcyclohexil)-1-nitrosourea (Me-CCNU] after surgery; (3) chemo-immunotherapy (FU, Me-CCNU and levamisole) after surgery. Between March 1977 and June 1981, 235 patients were included in the study by 18 co-operating institutions. Thirteen per cent of patients in arm 2 and thirteen per cent in arm 3 suffered major toxicity, necessitating interruption of treatment. Two of these patients died of marrow aplasia. Statistical analysis of survival showed that prognosis was influenced by the well-known prognostic variables, invasion of the wall, nodal status and site of tumour. The different treatments in the three arms, however, did not show any impact on prognosis, even when adjustments were made for the most relevant prognostic variables. Given the lack of effect on survival and the presence of clinically important toxicity, FU and Me-CCNU +/- levamisole cannot be recommended as adjuvant therapy for resected gastric cancer.
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007167:Immunotherapy; D007978:Levamisole / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D011379:Prognosis; D011446:Prospective Studies; D011897:Random Allocation; D012673:Semustine / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000401:mortality / Q000601:surgery / Q000628:therapy*
D012673:Semustine; D007978:Levamisole; D005472:Fluorouracil