Phase II evaluation of 5-fluorouracil, folinic acid and cisplatin in advanced-stage colorectal adenocarcinoma.

Twenty-seven patients with advanced measurable colorectal carcinoma were treated with a combination protocol consisting of folinic acid (FA) 200 mg/m2 i.v. bolus followed by 5-fluorouracil (5-FU) 550 mg/m2, and cisplatin (CIS) 20 mg/m2 each administered as a 2-hour i.v. infusion. Treatment was given on 4 consecutive days at 3- to 4-weekly intervals. Of 25 evaluable patients, 1 achieved complete remission and 5 partial remission for an overall response rate of 24%, while 9 patients (36%) had stable disease. Two out of 6 responders had previously progressed on 5-FU-containing regimens. The 95% confidence interval for response is 7-41%. Median survival time for all 27 patients enrolled in the study is 27+ weeks. Tolerance was remarkable and consisted primarily of mild and reversible gastrointestinal symptoms and myelosuppression. This 3-drug-regimen had significant palliative activity in our patient population. Its definitive role in the treatment of metastatic colorectal cancer as well as the potential improvement of the therapeutic index of 5-FU/FA by addition of CIS, require further evaluation in a randomized phase III trial.