Phase II study of leucovorin, 5-fluorouracil and gemcitabine for locally advanced and metastatic pancreatic cancer (FOLFUGEM 2).

Summary Aim FOLFUGEM 1 (leucovorin 400 mg/m 2 combined with 5-flurorouracil (FU) bolus 400 mg/m 2 then 5-FU 2-3 g/m2/46 hours and gemcitabine 1000 mg/m 2 in 30 min) in patients with locally-advanced and metastatic pancreatic adenocarcinoma appeared to be toxic (neutropenia and alopecia). The aims of this phase II multicentric study were to evaluate the response rate, clinical benefit and tolerance of a new scheme of combined leucovorin, 5-FU and gemcitabine (FOLFUGEM 2). Patients and methods FOLFUGEM 2 associated leucovorin 400 mg/m 2 in 2 hours followed by 5-FU 1000 mg/m 2 in 22 hours, then gemcitabine 800 mg/m 2 (10 mg/m 2 /min) with cycles every 14 days. Gemcitabine dose could be increased (1000 then 1250 mg/m 2 ) when NCI/CTC toxicity was ≤grade 2. Results Fifty-eight patients were included (locally-advanced tumor: N=13 and metastatic: N=45). Among the 39 patients with measurable disease, 11 had partial response (28.2%, 95% confidence interval: 14-42%) and 11 had stable disease (28.2%). On an intent-to-treat analysis, the objective response rate was 19% (95% confidence interval: 9-29%). Clinical benefit rate was 46%. Median progression-free survival and median overall survival were 3.1 and 7.2 months, respectively. There were 13% grade 3-4 neutropenia and 36% complete alopecia. Conclusion FOLFUGEM 2 schema has an antitumoral effect in advanced pancreatic cancer and has an acceptable toxicity which appears to be less than that of FOLFUGEM 1.