• Jean-Luc Van Laethem, Pascal Hammel, Françoise Mornex, David Azria, Geertjan Van Tienhoven, Philippe Vergauwe, Marc Peeters, Marc Polus, Michel Praet, Murielle Mauer, Laurence Collette, Volker Budach, Manfred Lutz, Eric Van Cutsem, and Karin Haustermans.
• Department of Gastroenterology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium. JL.Vanlaethem@erasme.ulb.ac.be
• J. Clin. Oncol. 2010 Oct 10; 28 (29): 4450-6.

PurposeThe role of adjuvant chemoradiotherapy (CRT) in resectable pancreatic cancer is still debated. This randomized phase II intergroup study explores the feasibility and tolerability of a gemcitabine-based CRT regimen after R0 resection of pancreatic head cancer.Patients And MethodsWithin 8 weeks after surgery, patients were randomly assigned to receive either four cycles of gemcitabine (control arm) or gemcitabine for two cycles followed by weekly gemcitabine with concurrent radiation (50.4 Gy; CRT arm). The primary objective was to exclude a < 60% treatment completion and a > 40% rate of grade 4 hematologic or GI toxicity in the CRT arm with type I and II errors of 10%. Secondary end points were late toxicity, disease-free survival (DFS), and overall survival (OS).ResultsBetween September 2004 and January 2007, 90 patients were randomly assigned (45:45). Patient characteristics were similar in both arms. Treatment was completed per protocol by 86.7% and 73.3% (80% CI, 63.1% to 81.9%; 95% CI, 58.1% to 85.4%) in the control and CRT arms, respectively, and grade 4 toxicity was 0% and 4.7% (two of 43; 80% CI, 1.2% to 11.9%), respectively. In the CRT arm, three patients experienced grade 3-related late toxicity. Median DFS was 12 months in the CRT arm and 11 months in the control arm. Median OS was 24 months in both arms. First local recurrence was less frequent in the CRT arm (11% v 24%).ConclusionAdjuvant gemcitabine-based CRT is feasible, well-tolerated, and not deleterious; adding this treatment to full-dose adjuvant gemcitabine after resection of pancreatic cancer should be evaluated in a phase III trial.

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