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