Author(s): Ruers T.; Van Coevorden F.; Verwaal V.J.; Punt C.J.A.; Pierie J.-P.E.N.; Borel-Rinkes I.; Ledermann J.A.; Gillams A.; Poston G.; Bechstein W.; Lentz M.-A.; Mauer M.; Folprecht G.; Van Cutsem E.; Ducreux M.; Nordlinger B.; Pare A.; Gruenberger T.; Klaase J.; Falk S.; Wals J.; Jansen R.L.; Lindner P.; Mulier S.; Bosscha K.; Jaeck D.; Arnaud J.P.; Smith D.; Sherlock D.; Ammori B.; El-Serafi M.; Glimelius B.; Hellman P.
Source: Journal of the National Cancer Institute; Sep 2017; vol. 109 (no. 9)
Publication Date: Sep 2017
Publication Type(s): Article
Abstract: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 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% (95% CI = 3.3% to 18.1%), respectively, in the systemic treatment arm. Median OS was 45.6 months (95% CI = 30.3 to 67.8 months) in the combined modality arm vs 40.5 months (95% CI = 27.5 to 47.7 months) in the systemic treatment arm. Conclusions: This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases.
Copyright © 2017 The Author 2017. Published by Oxford University Press.