Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer
| Autor: | H Bleiberg, T Conroy, B Paillot, A.J Lacave, G Blijham, J.H Jacob, L Bedenne, M Namer, P De Besi, F Gay, L Collette, T Sahmoud |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Esophageal Neoplasms medicine.medical_treatment Phases of clinical research Gastroenterology Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Carcinoma Humans Esophagus Survival rate Aged Cisplatin Chemotherapy business.industry Middle Aged medicine.disease Surgery Survival Rate medicine.anatomical_structure Oncology Epidermoid carcinoma Fluorouracil Carcinoma Squamous Cell Disease Progression Female business medicine.drug |
| Zdroj: | European journal of cancer (Oxford, England : 1990). 33(8) |
| ISSN: | 0959-8049 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect