Local Treatment of Unresectable Colorectal Liver Metastases: Results of a Randomized Phase II Trial

作者：Theo J. M. Ruers, Frits van Coevorden, Cornelis J.A. Punt, Jean-Pierre E. N. Pierie, Inne Borel-Rinkes, Jonathan A. Ledermann, Graeme J. Poston, Wolf O. Bechstein, M.A. Lentz, Murielle E.L. Mauer, Gunnar Folprecht, Eric Van Cutsem, Michel Pierre Ducreux, Bernard Nordlinger · 发表于：JNCI Journal of the National Cancer Institute · 年份：2017 · DOI：10.1093/jnci/djx015 · 被引用次数：691 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cholangiocarcinoma and Gallbladder Cancer Studies、Intraperitoneal and Appendiceal Malignancies

Background: Tumor ablation is often employed for unresectable colorectal liver metastases. However, no survival benefit has ever been demonstrated in prospective randomized studies. Here, we investigate the long-term benefits of such an aggressive approach. Methods: In this randomized phase II trial, 119 patients with unresectable colorectal liver metastases (n < 10 and no extrahepatic disease) received systemic treatment alone or systemic treatment plus aggressive local treatment by radiofrequency ablation ± resection. Previously, we reported that the primary end point (30-month overall survival [OS] > 38%) was met. We now report on long-term OS results. All statistical tests were two-sided. The analyses were according to intention to treat. Results: At a median follow up of 9.7 years, 92 of 119 (77.3%) patients had died: 39 of 60 (65.0%) in the combined modality arm and 53 of 59 (89.8%) in the systemic treatment arm. Almost all patients died of progressive disease (35 patients in the combined modality arm, 49 patients in the systemic treatment arm). There was a statistically significant difference in OS in favor of the combined modality arm (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.38 to 0.88, P = .01). Three-, five-, and eight-year OS were 56.9% (95% CI = 43.3% to 68.5%), 43.1% (95% CI = 30.3% to 55.3%), 35.9% (95% CI = 23.8% to 48.2%), respectively, in the combined modality arm and 55.2% (95% CI = 41.6% to 66.9%), 30.3% (95% CI = 19.0% to 42.4%), 8.9% (9...