Final results of a prospective trial of a PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) regimen followed by radiotherapy after curative surgery for pancreatic adenocarcinoma

Background. Postoperative management of patients with pancreatic adenocarcinoma (PA) is controversial. Methods: The aim of this pilot study was to assess the feasibility of postoperative combination chemotherapy followed by radiotherapy in patients aged 18-70 years with a histological diagnosis of PA, and Karnofsky performance status (KPS) >= 70. Cisplatin and epirubicin 40 mg/m(2) on day 1, gemcitabine 600 mg/m(2) on day 1 and 8, and 5-fluorouracil 200 mg/m(2)/day as protracted infusion (PEFG regimen) were delivered every 28 days for 4 cycles. Assuming a minimum one-year disease-free survival (DFS) of interest of 65% and a maximum of low interest of 45% (alpha 0.05; beta 0.10), the target enrollment was 51 patients, and the strategy would be considered to deserve further analysis if more than 29 patients were DF at one-year from surgery. Results: Fifty-one patients, KPS >80:29, median tumor size 3.5 cm, stage II/III/IVA: 2/34/13, grade 3-4: 22, positive resection margins: 26, node positive: 46, received 179 cycles of chemotherapy. Main grade 3/4 toxicity consisted of neutropenia (51%), thrombocytopenia (18%), and anemia (4%). One-year DFS was 67 +/- 7%. Two-year overall survival was 53 7%. Conclusion: Postoperative management of PA with this multimodality strategy was well tolerated and yielded a promising outcome. Copyright (C) 2005 S. Karger AG, Basel.