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)

This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases. This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic t...

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Bibliographic Details
Published in:	Annals of oncology 2012-10, Vol.23 (10), p.2619-2626
Main Authors:	Ruers, T., Punt, C., Van Coevorden, F., Pierie, J.P.E.N., Borel-Rinkes, I., Ledermann, J.A., Poston, G., Bechstein, W., Lentz, M.A., Mauer, M., Van Cutsem, E., Lutz, M.P., Nordlinger, B.
Format:	Article
Language:	eng
Subjects:	Adult Aged Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences colorectal cancer Colorectal Neoplasms - pathology Female Gastroenterology. Liver. Pancreas. Abdomen Humans liver metastases Liver Neoplasms - drug therapy Liver Neoplasms - radiotherapy Liver Neoplasms - secondary Liver. Biliary tract. Portal circulation. Exocrine pancreas Male Medical sciences Middle Aged multimodality treatment Original Pharmacology. Drug treatments radiofrequency ablation Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Survival Rate Tumors unresectable
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Summary:	This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases. 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. 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. 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.
ISSN:	0923-7534 1569-8041