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Clinical Trial
. 2012 Oct;23(10):2619-2626.
doi: 10.1093/annonc/mds053. Epub 2012 Mar 19.

Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004)

T Ruers  1 , C Punt  2 , F Van Coevorden  3 , J P E N Pierie  4 , I Borel-Rinkes  5 , J A Ledermann  6 , G Poston  7 , W Bechstein  8 , M A Lentz  9 , M Mauer  10 , E Van Cutsem  11 , M P Lutz  12 , B Nordlinger  13 ; EORTC Gastro-Intestinal Tract Cancer Group; Arbeitsgruppe Lebermetastasen und—tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO) and the National Cancer Research Institute Colorectal Clinical Study Group (NCRI CCSG)
Affiliations
Clinical Trial

Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004)

T Ruers et al. Ann Oncol. 2012 Oct.

Abstract

Background: This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases.

Methods: This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group.

Results: The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2-73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1-70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42-0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7-22.1) and 9.9 months (95% CI 9.3-13.7), respectively.

Conclusions: This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain.

Trial registration: ClinicalTrials.gov NCT00043004.

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Figures

Figure 1.
Figure 1.
Overall survival and progression-free survival. (A) Overall survival by treatment group. (B) Progression-free survival by treatment group. RFA, radiofrequency ablation.
Figure 2.
Figure 2.
Salvage treatment of first progression by treatment group. Some patients were treated by a combination of treatment modalities. *P < 0.001. RFA, radiofrequency ablation.
See this image and copyright information in PMC

References

    1. House MG, Ito H, Gonen M, et al. Survival after hepatic resection for metastatic colorectal cancer: trends in outcomes for 1,600 patients during two decades at a single institution. J Am Coll Surg. 2010;210(5):744–745. - PubMed
    1. Kopetz S, Chang GJ, Overman MJ, et al. Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy. J Clin Oncol. 2009;27(22):3677–3683. - PMC - PubMed
    1. Mitry E, Fields AL, Bleiberg H, et al. Adjuvant chemotherapy after potentially curative resection of metastases from colorectal cancer: a pooled analysis of two randomized trials. J Clin Oncol. 2008;26(30):4906–4911. - PubMed
    1. Saltz LB, Clarke S, Diaz-Rubio E, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008;26(12):2013–2019. - PubMed
    1. Tol J, Koopman M, Cats A, et al. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med. 2009;360(6):563–572. - PubMed

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