Cisplatin + 5-fluorouracil versus 5-fluorouracil alone in advanced colorectal cancer: a randomized study.

Sixty patients with advanced colorectal cancer were randomized between cisplatin (60 mg/mq i.v. every 3 weeks) + 5-fluorouracil (600 mg/mq i.v. bolus/weekly) and 5-fluorouracil alone (same schedule). In the 54 evaluable patients, no CR was observed. PR rate was 19.2% for the combination, and 14.5% for the monochemotherapy. Also the overall median survival time was similar for the two arms (10 and 13 months, respectively). Toxicity was acceptable, with more side-effects in the combination arm. Both treatments are of limited activity in advanced colorectal cancer and no advantage comes out from the use of this polychemotherapy.