TY  - JOUR
A1  - Ruers, Theo
A1  - Coevorden, Frits van
A1  - Punt, Cornelis J. A.
A1  - Pierie, Jean-Pierre E. N.
A1  - Borel Rinkes, Inne H. M.
A1  - Ledermann, Jonathan A.
A1  - Poston, Graeme J.
A1  - Bechstein, Wolf Otto
A1  - Lentz, Marie-Ange
A1  - Mauer, Murielle
A1  - Folprecht, Gunnar
A1  - Van Cutsem, Eric
A1  - Ducreux, Michel
A1  - Nordlinger, Bernard
T1  - Local treatment of unresectable colorectal liver metastases : results of a randomized phase II trial
T2  - Journal of the National Cancer Institute
N2  - 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.
KW  - phase 2 clinical trials
KW  - follow-up
KW  - arm
KW  - neoplasms
KW  - liver metastases
KW  - radiofrequency ablation
KW  - ablation
KW  - progressive neoplastic disease
Y1  - 2017
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/43999
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-439994
SN  - 1460-2105
SN  - 0027-8874
SN  - 0198-0157
N1  - © 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
VL  - 109
IS  - 9, djx015
SP  - 1
EP  - 10
PB  - Oxford Univ. Press
CY  - Oxford
ER  -