| Summary: | BACKGROUND AND OBJECTIVE: The response rate and median survival with gemcitabine monotherapy, although considered the standard treatment for inoperable and metastatic pancreatic cancer, is relatively poor. We tested the efficacy and toxicity of a chemotherapy protocol consisting of gemcitabine, 5-fluorouracil (5-FU) and leucovorin in patients with inoperable or metastatic pancreatic cancer, which was shown to improve median survival in a small phase ii trial. PATIENTS AND METHODS: Patients older than 18 years of age with histologically or cytologically confirmed adenocarcinoma of the pancreas and bidimensionally measurable disease, and who were chemotherapy- and radiotherapy-naive, were treated with a chemotherapy protocol consisting of gemcitabine 1250 mg/m2 on day 1, 5-FU 450 mg/m2 and leucovorin 100 mg/m2 on days 1-3. The treatment was repeated every 2 weeks. RESULTS: In an-intention-to-treat analysis, of 37 patients with pancreatic cancer (27 males, 10 females) (67.6% stage IVb) there were 7 (18.9%) objective partial responses (95% confidence interval, 8.33% to 29), 14 (37.8%) patients had stable disease and 16 (43.2%) had progressive disease. The median response time was 3 months (range, 1.5 to 7.0 months). Median overall survival time was 6.5 months (range, 1.0 to 15.5 months). The response to chemotherapy was not different between males and females (P=.971). No grade III/IV toxicities were seen. CONCLUSION: Despite our poor survival data, the combination of gemcitabine with 5-FU and leucovorin is an active and well-tolerated regimen in patients with pancreatic cancer that merits further evaluation in prospective randomized studies. This combination may be considered a valuable alternative to gemcitabine alone.
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