O-018 - Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): Long-term survival results of a rand...

Date 04 July 2015
Event WorldGI 2015
Session Oral and LBA abstracts
Topics Anticancer agents
Supportive measures
Colon and Rectal Cancer
Surgical oncology
Therapy
Biological therapy
Radiation oncology
Presenter T. Ruers
Citation Annals of Oncology (2015) 26 (suppl_4): 108-116. 10.1093/annonc/mdv235
Authors T. Ruers1, B. Nordlinger2, E. Van Cutsem3, G. Poston4, C.J.A. Punt5, F. van Coevorden1, J.-. Pierie6, I. Borel Rinkes7, J. Ledermann8, W. Bechstein9, M.-. Lentz1, M. Mauer1, M. Lutz10
  • 1The Netherlands Cancer Institute - Antoni Van Leeuwenhoek ziekenhuis, Amsterdam/NL
  • 2Assistance Publique Hôpitaux de Paris, Boulogne-Billancourt/FR
  • 3University Hospitals Leuven, Leuven/BE
  • 4University Hospital Aintree, Liverpool/UK
  • 5University of Amsterdam, Amsterdam/NL
  • 6Leeuwarden Medical Center, Leeuwarden/NL
  • 7University Medical Centre Utrecht, Utrecht/NL
  • 8UCL Cancer Institute, London/UK
  • 9University Hospital Frankfurt/Main, Frankfurt/Main/DE
  • 10Caritasklinik St. Theresa, Saarbruecken/DE

Abstract

Introduction

This study evaluates the benefit of combining systemic chemotherapy (CT) with local tumour destruction by RFA in patients with unresectable CRC LM up to 9 lesions and without extrahepatic disease. Overall survival (OS) at 30 months and progression free survival (PFS) results were reported (Ann Oncol. 23(10): 2619-26, 2012). We now report on OS results, after a long-term median follow-up of 9.7 years.

Methods

Between 2002 and 2007, 119 pts were randomised between CT alone (59) or RFA + CT (60). In both arms, CT consisted of 6 months FOLFOX (oxaliplatin 85mg/m2 and LV5FU2) plus, since October 2005, bevacizumab. In the CT arm resection was allowed when unresectable disease was converted by CT to resectable disease. Primary objective was a 30-months OS rate > 38% for the combined treatment group. OS and PFS were secondary endpoints.

Results

In the RFA + CT arm, 56 pts (93.3%) received RFA which was combined with resection in 27 pts (45%), 1 pt had all metastases resected (ineligible), 2 pts were not treated at all, in 1 pt no local treatment data were available. 51 patients (85%) in the RFA + CT arm received CT compared to all 59 in the CT arm. 6 pts in the CT arm eventually underwent hepatic resection. The primary endpoint was met; 30-months OS rate was 61.7% (95% CI: 48.2-73.9) for combined treatment. However, 30-month OS for systemic treatment only was 57.6% (95% CI: 44.1-70.4), higher than anticipated.

At a median follow-up of 9.7 years, 92 deaths were reported, 53 in the CT arm and 39 in the RFA + CT arm. Causes of death in the CT arm were progressive disease (49 pts), and unknown for 4 pts, and in the RFA + CT arm, progressive disease (35 pts), other causes (2 pts) and unknown (2 pts). There was a significant difference in OS in favor of the RFA + CT arm (HR = 0.58, 95% CI: 0.38-0.88, p = 0.01). Observed median OS was 45.6 months (95% CI: 30.3–67.8) in the RFA + CT arm vs. 40.5 months (95% CI: 27.5 - 47.7) in the CT arm.

Conclusion

This is the first study that prospectively investigated the efficacy of RFA +CT in pts with unresectable CRC LM. In this phase II trial, RFA + CT was associated with improved long-term OS compared to CT alone.