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Title: Adjuvant Gemcitabine Alone Versus Gemcitabine-Based Chemoradiotherapy After Curative Resection for Pancreatic Cancer: A Randomized EORTC-40013-22012/FFCD-9203/GERCOR Phase II Study
Authors: Van Laethem, Jean-Luc ×
Hammel, Pascal
Mornex, Françoise
Azria, David
Van Tienhoven, Geertjan
Vergauwe, Philippe
Peeters, Marc
Polus, Marc
Praet, Michel
Mauer, Murielle
Collette, Laurence
Budach, Volker
Lutz, Manfred
Van Cutsem, Eric
Haustermans, Karin #
Issue Date: 10-Oct-2010
Publisher: Grune & Stratton
Series Title: Journal of Clinical Oncology vol:28 pages:4450-4456
Abstract: PURPOSE The 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 METHODS Within 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). Results Between 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%). CONCLUSION Adjuvant 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.
URI: 
ISSN: 0732-183X
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Experimental Radiotherapy
Interdepartmental Platform Hospital Care
Translational Research in GastroIntestinal Disorders
Clinical Digestive Oncology (+)
× corresponding author
# (joint) last author

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