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.
abstract: OBJECTIVE
  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.
  
  
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium. JL.Vanlaethem@erasme.ulb.ac.be
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Van Laethem
authors.forename: Pascal
authors.initials: P
authors.lastname: Hammel
authors.forename: Françoise
authors.initials: F
authors.lastname: Mornex
authors.forename: David
authors.initials: D
authors.lastname: Azria
authors.forename: Geertjan
authors.initials: G
authors.lastname: Van Tienhoven
authors.forename: Philippe
authors.initials: P
authors.lastname: Vergauwe
authors.forename: Marc
authors.initials: M
authors.lastname: Peeters
authors.forename: Marc
authors.initials: M
authors.lastname: Polus
authors.forename: Michel
authors.initials: M
authors.lastname: Praet
authors.forename: Murielle
authors.initials: M
authors.lastname: Mauer
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.forename: Volker
authors.initials: V
authors.lastname: Budach
authors.forename: Manfred
authors.initials: M
authors.lastname: Lutz
authors.forename: Eric
authors.initials: E
authors.lastname: Van Cutsem
authors.forename: Karin
authors.initials: K
authors.lastname: Haustermans
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D018714:Radiotherapy, Adjuvant; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine