title: [Randomized controlled study on chemotherapy with 5-FD, ADM plus CDDP in advanced gastric carcinoma].
abstract: The clinical effects of combination chemotherapy with 5-FU, ADM plus CDDP for advanced carcinoma of the stomach were evaluated in a prospective randomized and controlled study. Seventy-seven patients from 18 major hospitals were randomly divided into A group and B group using the envelope method. A group was treated with protocol I (5-FU 270-300 mg/m2 iv from the 1st day to the 5th day and ADM 25 mg/m2 iv on the 5th day), and B group was treated with protocol II (5-FU, ADM plus CDDP 70 mg/m2 iv on the 1st day). These protocols were repeated every 3 weeks and repeated 3 courses in principle. Thirty-three cases from A group and 32 cases from B group were available for evaluation. The prognostic factors were compared between A and B group. No difference could be observed between the two groups. No cases from A group were interpreted as PR, while 6 cases (19%) from B group were recognized on PR after 3 courses. The response rate of the overall 19 cases from A group was 0%, while that of the overall 18 cases from B group was 33%. The statistical difference was observed between the two groups. However, no significant difference for the 50% survival time was observed between the two groups. One patient showing PR survived for 28 months. Gastrointestinal disturbances were observed in 60% and leukopenia plus thrombocytopenia in 40% of each group. Frequency and grade of the side effects were not significantly different between A and B group.
authors.affiliation: Dept. of Surgery, Sendai National Hospital.
authors.forename: K
authors.initials: K
authors.lastname: Kikuchi
authors.forename: A
authors.initials: A
authors.lastname: Wakui
authors.forename: H
authors.initials: H
authors.lastname: Shimizu
authors.forename: Y
authors.initials: Y
authors.lastname: Kunii
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D013274:Stomach Neoplasms / Q000188:drug therapy*
chemical_list: D004317:Doxorubicin; D002945:Cisplatin; D005472:Fluorouracil