Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer

Patients with measurable or evaluable locally advanced or metastatic squamous cell carcinoma of the oesophagus were treated with cisplatin (CDDP), 100 mg/m 2, combined with 5-fluorouracil (5-FU) at a dose of 1000 mg/m 2 as a continuous infusion from days 1–5 (Arm A) or with CDDP alone (Arm B). Cycle...

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Bibliographic Details
Published in:European journal of cancer (1990) Vol. 33; no. 8; pp. 1216 - 1220
Main Authors: Bleiberg, H, Conroy, T, Paillot, B, Lacave, A.J, Blijham, G, Jacob, J.H, Bedenne, L, Namer, M, De Besi, P, Gay, F, Collette, L, Sahmoud, T
Format: Journal Article
Language:English
Published: Oxford Elsevier Ltd 01.07.1997
Elsevier
Subjects:
5-FU
Adult
advanced
Aged
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
cancer
Carcinoma, Squamous Cell - drug therapy
Carcinoma, Squamous Cell - pathology
Chemotherapy
cisplatin
Cisplatin - administration & dosage
Cisplatin - adverse effects
Disease Progression
Esophageal Neoplasms - drug therapy
Esophageal Neoplasms - pathology
Female
Fluorouracil - administration & dosage
Fluorouracil - adverse effects
Humans
Male
Medical sciences
Middle Aged
oesophageal
Pharmacology. Drug treatments
squamous cell carcinoma
Survival Rate
toxicity
toxicity
advanced
cancer
oesophageal
cisplatin
chemotherapy
squamous cell carcinoma
5-FU
Antineoplastic agent
Human
Drug
Drug combination
Squamous cell carcinoma
Toxicity
Treatment efficiency
Esophageal disease
Malignant tumor
Cisplatin
Esophagus
Chemotherapy
Digestive diseases
Complication
Advanced stage
Fluorouracil
ISSN:0959-8049, 1879-0852
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Summary:Patients with measurable or evaluable locally advanced or metastatic squamous cell carcinoma of the oesophagus were treated with cisplatin (CDDP), 100 mg/m 2, combined with 5-fluorouracil (5-FU) at a dose of 1000 mg/m 2 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.
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ISSN:0959-8049
1879-0852
DOI:10.1016/S0959-8049(97)00088-9