Phase II trial of 5-fluorouracil and the natural l isomer of folinic acid in the treatment of advanced colorectal carcinoma

摘要: Between February 1991 and July 1992, 79 previously untreated patients with metastatic colorectal carcinoma were enrolled in a phase II study of combined 5-fluorouracil (5-FU) l-folinic acid (FA). 5-FU 370 mg/m2/day was administered for 5 consecutive days as an intravenous (i.v.) bolus injection preceded by l-FA 100 the same administration modality. Treatment given every 4 weeks until progression. evaluable toxicity 64 response. 2 (3%) achieved complete remission 8 (12.5%) partial remission, 33 (52%) had stable disease 21 (33%) progressive disease. Median duration 32.5 median survival all 64.5 weeks. Substantial to severe side-effects occurred 39% patients. Dose-limiting (grade 3-4) mainly diarrhoea (18%) mucositis (15%). Nausea/vomiting, cutaneous toxicity, leucopenia, alopecia conjunctivitis grade 3-4 respectively 6, 4, 2.5, 1 1% cases. Toxicity appeared be substantially similar that characteristic chiral mixture d,l-FA. Efficacy within range observed 5-FU/d,l-FA combination, although at lower level.