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

作者: F Gay , L Collette , T Sahmoud , H Bleiberg , T Conroy

DOI: 10.1016/S0959-8049(97)00088-9

关键词:

摘要: Patients with measurable or evaluable locally advanced metastatic squamous cell carcinoma of the oesophagus were treated cisplatin (CDDP), 100 mg/m2, combined 5-fluorouracil (5-FU) at a dose 1000 mg/m2 as continuous infusion from days 1-5 (Arm A) CDDP alone B). Cycles repeated every 3 weeks. 92 patients randomised centrally, 88 eligible. The response rate was 35% (95% CI (confidence interval), 20-54%) in Arm A and 19% CI, 8-35%) B. One complete observed each arm. median duration survival 33 weeks 28 for B, respectively. Haematological non-haematological toxicities more frequent severe A. most prominent grade 4 aplasia septicaemia (2), meningeal haemorrhage (1), cerebrovascular accident (3) ischaemia lower limbs (1) all occurring Overall, seven treatment-related deaths (16%) A, none side-effects induced by combination suggest that, currently, no standard chemotherapy can be recommended oesophageal cancer.

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