T Ruers1, C Punt2, F Van Coevorden3, J P E N Pierie4, I Borel-Rinkes5, J A Ledermann6, G Poston7, W Bechstein8, M A Lentz9, M Mauer10, E Van Cutsem11, M P Lutz12, B Nordlinger13. 1. Department of Surgery, The Netherlands Cancer Institute-Antoni Van Leeuwenhoek ziekenhuis, Amsterdam. Electronic address: T.Ruers@NKI.nl. 2. Department of Medical Oncology, Academic Medical Centre, University of Amsterdam, Amsterdam. 3. Department of Surgery, The Netherlands Cancer Institute-Antoni Van Leeuwenhoek ziekenhuis, Amsterdam. 4. Department of Surgery, Leeuwarden Medical Center, Leeuwarden. 5. Department of Surgery, Universitair Medisch Centrum, Utrecht, The Netherlands. 6. UCL and UCL Hospitals Comprehensive Biomedical Research Centre, University College London, London. 7. Department of Surgery, Aintree University Hospital, Liverpool, UK. 8. Department of Surgery, Klinikum Der J.W. Goethe Universitaet, Frankfurt, Germany. 9. Data Management Unit, EORTC Headquarters, Brussels. 10. Statistics Department, EORTC Headquarters, Brussels. 11. Department of Medical Oncology, University Hospital Gasthuisberg, Leuven, Belgium. 12. Department of Medical Oncology, Caritasklinik St. Theresia, Saarbrücken, Germany. 13. Department of Surgery, Centre Hospitalier Universitaire Ambroise Paré, Assistance Publique Hôpitaux de Paris, Boulogne-Billancourt, France.
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.
RCT Entities:
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.
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