Treatment of patients with advanced colorectal cancer with cisplatin, 5-fluorouracil, and leucovorin

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Abstract
Based on in vitro studies that have demonstrated synergy between 5‐fluorouracil (5‐FU), leucovorin (LV), and cisplatin (CDDP) against human colon cancer cell lines, a clinical trial was initiated to determine the effects of this combination in patients with advanced unresectable colorectal carcinoma. Fifty‐nine patients were enrolled in the study and 12 of them had received prior conventional 5‐FU chemotherapy. Treatment consisted of 4 weekly courses of high‐dose LV (200 mg/m2) administered by intravenous (IV) bolus, followed by 5‐FU (550 mg/m2) and CDDP (20 mg/m2) each administered as a 2‐hour infusion on 4 consecutive days. After a median of 5.5 treatment cycles, objective tumor response was seen in 20 of 59 patients (34%) (this included 3 complete remissions). The response rate in the 47 previously untreated patients was 38% (95% confidence limits, 26% to 53%). Stable disease occurred in 16 (27%) patients, whereas the tumor progressed in 23 (39%) patients. The median survival time was 11.5 months, with 15% of the patients alive at 2 years. The regimen was well tolerated and the primary side effects were mild and reversible gastrointestinal symptoms and myelosuppression. There was no episode of life‐threatening toxicity. Eastern Cooperative Oncology Group (ECOG) Grade III adverse reactions that required 25% dose reductions occurred in only 14% of the patients. The results of this trial suggest that 5‐FU, LV, and CDDP is an active, safe, and well‐tolerated combination regimen in patients with advanced colorectal cancer.

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