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 2combined with 5-flurorouracil (FU) bolus 400 mg/ m 2then 5-FU 2-3 g/m2/46 hours and gemcitabine1000 mg/ m 2in 30 min) in patients with locally-advanced and metastatic pancreatic adenocarcinoma appeared to be toxic ( neutropeniaand 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 2in 2 hours followed by 5-FU 1000 mg/ m 2in 22 hours, then gemcitabine800 mg/ m 2(10 mg/ m 2/min) with cycles every 14 days. Gemcitabinedose 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 neutropeniaand 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.