Adjuvant intra-arterial 5-fluoruracil, leucovorin, epirubicin and carboplatin with or without systemic gemcitabine after curative resection for pancre

Maurizio Cantore1, 2 , Giovanni Serio3, Paolo Pederzoli4, Andrea Mambrini1, Calogero Iacono3, Coriolano Pulica5, Paola Capelli6, Mirko Lombardi7, Tito Torri1, Paola Pacetti1, Mauro Pagani1 and Giammaria Fiorentini8

(1) Department of Oncology, General City Hospital, Massa Carrara, Italy
(2) Department of Oncology, Massa Carrara City Hospital, Presidio Ospedaliero di Carrara, Località Monterosso , 54033 Massa Carrara, Italy
(3) Department of Surgery C, University of Verona, Verona, Italy
(4) Department of Surgery A, University of Verona, Verona, Italy
(5) Department of Surgery, C. Poma General Hospital, Mantova, Italy
(6) Department of Pathology, University of Verona, Verona, Italy
(7) Department of Surgery, Massa Carrara City Hospital, Massa Carrara, Italy
(8) Department of Oncology, General City Hospital, Empoli, Italy

Received: 7 November 2005 Accepted: 24 January 2006 Published online: 22 April 2006

Abstract Background: The role of adjuvant therapy in pancreatic cancer remains controversial. Gemcitabine given systemically seems to be effective; intra-arterial chemotherapy (IAC) has a deep rationale. Patients and methods: The goal was to evaluate the impact of postoperative IAC followed or not by systemic gemcitabine in patients after curative resection for pancreatic adenocarcinoma. 5-fluoruracil 750 mg sqm−1, leucovorin 75 mg sqm−1, epirubicin 45 mg sqm−1, carboplatin 225 mg sqm−1 were administered every 3 weeks into celiac axis for three cycles (FLEC regimen), then gemcitabine at the dosage of 1 g sqm−1 on days 1, 8 and 15 every 4 weeks for 3 months (FLECG regimen). Results: Forty-seven patients entered the study. The first 24 received only IAC (FLEC regimen), the other 23 received the same intra-arterial regimen followed by systemic gemcitabine (FLECG regimen). After a median follow-up of 16.9 months, 29 patients recurred (61.7%). Median disease free survival (DFS) was 18 months and median overall survival (OS) was 29.7 months. One-year DFS was 59.4% and 1-year OS was 75.5%. Main grade 3 toxicity related to IAC was only nausea/vomiting in 4%; regarding gemcitabine, grade 3 toxicities were anaemia 8%, leukopenia 8%, thrombocitopenia 17%, nausea/vomiting 4%. Conclusions: FLEC regimen with or without gemcitabine is active with a very mild toxicity and results are very encouraging in an adjuvant setting.
Keywords Adjuvant chemotherapy - Gemcitabine - Intra-arterial chemotherapy - Pancreatic cancer