title: Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004).
abstract: BACKGROUND
  This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases.
  
  
  METHODS
  This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group.
  
  
  RESULTS
  The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2-73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1-70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42-0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7-22.1) and 9.9 months (95% CI 9.3-13.7), respectively.
  
  
  CONCLUSIONS
  This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain.
authors.affiliation: Department of Surgery, The Netherlands Cancer Institute-Antoni Van Leeuwenhoek ziekenhuis, Amsterdam. Electronic address: T.Ruers@NKI.nl.
authors.forename: T
authors.initials: T
authors.lastname: Ruers
authors.affiliation: Department of Medical Oncology, Academic Medical Centre, University of Amsterdam, Amsterdam.
authors.forename: C
authors.initials: C
authors.lastname: Punt
authors.affiliation: Department of Surgery, The Netherlands Cancer Institute-Antoni Van Leeuwenhoek ziekenhuis, Amsterdam.
authors.forename: F
authors.initials: F
authors.lastname: Van Coevorden
authors.affiliation: Department of Surgery, Leeuwarden Medical Center, Leeuwarden.
authors.forename: J P E N
authors.initials: JPEN
authors.lastname: Pierie
authors.affiliation: Department of Surgery, Universitair Medisch Centrum, Utrecht, The Netherlands.
authors.forename: I
authors.initials: I
authors.lastname: Borel-Rinkes
authors.affiliation: UCL and UCL Hospitals Comprehensive Biomedical Research Centre, University College London, London.
authors.forename: J A
authors.initials: JA
authors.lastname: Ledermann
authors.affiliation: Department of Surgery, Aintree University Hospital, Liverpool, UK.
authors.forename: G
authors.initials: G
authors.lastname: Poston
authors.affiliation: Department of Surgery, Klinikum Der J.W. Goethe Universitaet, Frankfurt, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Bechstein
authors.affiliation: Data Management Unit, EORTC Headquarters, Brussels.
authors.forename: M A
authors.initials: MA
authors.lastname: Lentz
authors.affiliation: Statistics Department, EORTC Headquarters, Brussels.
authors.forename: M
authors.initials: M
authors.lastname: Mauer
authors.affiliation: Department of Medical Oncology, University Hospital Gasthuisberg, Leuven, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Van Cutsem
authors.affiliation: Department of Medical Oncology, Caritasklinik St. Theresia, Saarbrücken, Germany.
authors.forename: M P
authors.initials: MP
authors.lastname: Lutz
authors.affiliation: Department of Surgery, Centre Hospitalier Universitaire Ambroise Paré, Assistance Publique Hôpitaux de Paris, Boulogne-Billancourt, France.
authors.forename: B
authors.initials: B
authors.lastname: Nordlinger
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000473:pathology*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary*; D008297:Male; D008875:Middle Aged; D015996:Survival Rate