Gemcitabine/5-flourouracil/leucovorin for the treatment of advanced pancreatic carcinoma

Abstract

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 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-naïve, 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. 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. 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.