Reference : Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative res...
Scientific journals : Article
Human health sciences : Oncology
http://hdl.handle.net/2268/85358
Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study.
English
Van Laethem, Jean*-Luc [> > > >]
Hammel, Pascal [> > > >]
Mornex, Francoise [> > > >]
Azria, David [> > > >]
Van Tienhoven, Geertjan [> > > >]
Vergauwe, Philippe [> > > >]
Peeters, Marc [> > > >]
Polus, Marc mailto [Centre Hospitalier Universitaire de Liège - CHU > > Gastro-Entérologie-Hépatologie >]
Praet, Michel [> > > >]
Mauer, Murielle [> > > >]
Collette, Laurence [> > > >]
Budach, Volker [> > > >]
Lutz, Manfred [> > > >]
Van Cutsem, Eric [> > > >]
Haustermans, Karin [> > > >]
2010
Journal of Clinical Oncology
American Society of Clinical Oncology
28
29
4450-6
Yes (verified by ORBi)
0732-183X
1527-7755
Alexandria
VA
[en] Adult ; Aged ; Antimetabolites, Antineoplastic/adverse effects/therapeutic use ; Chemotherapy, Adjuvant ; Combined Modality Therapy ; Deoxycytidine/adverse effects/analogs & derivatives/therapeutic use ; Diarrhea/chemically induced ; Drug Administration Schedule ; Fatigue/chemically induced ; Feasibility Studies ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Nausea/chemically induced ; Pancreatic Neoplasms/drug therapy/radiotherapy/surgery ; Radiotherapy, Adjuvant ; Treatment Outcome
[en] 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.
http://hdl.handle.net/2268/85358
10.1200/JCO.2010.30.3446

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