Local treatment of unresectable colorectal liver metastases : results of a randomized phase II trial

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 ben
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% (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.
show moreshow less

Metadaten
Author:Theo Ruers, Frits van Coevorden, Cornelis J. A. Punt, Jean-Pierre E. N. Pierie, Inne H. M. Borel Rinkes, Jonathan A. Ledermann, Graeme J. Poston, Wolf Otto Bechstein, Marie-Ange Lentz, Murielle Mauer, Gunnar Folprecht, Eric Van Cutsem, Michel Ducreux, Bernard Nordlinger
URN:urn:nbn:de:hebis:30:3-439994
DOI:http://dx.doi.org/10.1093/jnci/djx015
ISSN:1460-2105
ISSN:0027-8874
ISSN:0198-0157
Pubmed Id:http://www.ncbi.nlm.nih.gov/pubmed?term=28376151
Parent Title (English):Journal of the National Cancer Institute
Publisher:Oxford Univ. Press
Place of publication:Oxford
Document Type:Article
Language:English
Date of Publication (online):2017/06/08
Date of first Publication:2017/03/17
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Contributing Corporation:European Organisation for Research and Treatment of Cancer (EORTC) ; Gastro-Intestinal Tract Cancer Group, Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO) ; National Cancer Research Institute Colorectal Clinical Study Group (NCRI CCSG)
Release Date:2017/06/08
Tag:ablation; arm; follow-up; liver metastases; neoplasms; phase 2 clinical trials; progressive neoplastic disease; radiofrequency ablation
Volume:109
Issue:9, djx015
Pagenumber:10
First Page:1
Last Page:10
Note:
© The Author 2017. Published by Oxford University Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
HeBIS PPN:423733877
Institutes:Medizin
Dewey Decimal Classification:610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (English):License LogoCreative Commons - Namensnennung-Nicht kommerziell 4.0

$Rev: 11761 $