title: Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer.
abstract: Patients with measurable or evaluable locally advanced or metastatic squamous cell carcinoma of the oesophagus were treated with cisplatin (CDDP), 100 mg/m2, combined with 5-fluorouracil (5-FU) at a dose of 1000 mg/m2 as a continuous infusion from days 1-5 (Arm A) or with CDDP alone (Arm B). Cycles were repeated every 3 weeks. 92 patients were randomised centrally, 88 were eligible. The response rate was 35% (95% CI (confidence interval), 20-54%) in Arm A and 19% (95% CI, 8-35%) in Arm B. One complete response was observed in each arm. The median duration of survival was 33 weeks and 28 weeks for Arm A and Arm B, respectively. Haematological and non-haematological toxicities were more frequent and more severe in Arm A. The most prominent toxicities were grade 4 aplasia and septicaemia (2), meningeal haemorrhage (1), cerebrovascular accident (3) and ischaemia of the lower limbs (1) all occurring in Arm A. Overall, seven treatment-related deaths (16%) were observed in Arm A, none in Arm B. The severe side-effects induced by the combination suggest that, currently, no standard chemotherapy can be recommended for patients with advanced squamous cell oesophageal cancer.
authors.affiliation: Institut J. Bordet, Brussels, Belgium.
authors.forename: H
authors.initials: H
authors.lastname: Bleiberg
authors.forename: T
authors.initials: T
authors.lastname: Conroy
authors.forename: B
authors.initials: B
authors.lastname: Paillot
authors.forename: A J
authors.initials: AJ
authors.lastname: Lacave
authors.forename: G
authors.initials: G
authors.lastname: Blijham
authors.forename: J H
authors.initials: JH
authors.lastname: Jacob
authors.forename: L
authors.initials: L
authors.lastname: Bedenne
authors.forename: M
authors.initials: M
authors.lastname: Namer
authors.forename: P
authors.initials: P
authors.lastname: De Besi
authors.forename: F
authors.initials: F
authors.lastname: Gay
authors.forename: L
authors.initials: L
authors.lastname: Collette
authors.forename: T
authors.initials: T
authors.lastname: Sahmoud
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D015996:Survival Rate
chemical_list: D002945:Cisplatin; D005472:Fluorouracil