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)
(2012) In Annals of Oncology 23(10). p.2619-2626- 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... (More)
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.
(Less)
- author
- publishing date
- 2012-10
- type
- Contribution to journal
- publication status
- published
- keywords
- Colorectal cancer, Liver metastases, Multimodality treatment, Radiofrequency ablation, Unresectable
- in
- Annals of Oncology
- volume
- 23
- issue
- 10
- pages
- 2619 - 2626
- publisher
- Oxford University Press
- external identifiers
-
- scopus:84864129583
- pmid:22431703
- ISSN
- 0923-7534
- DOI
- 10.1093/annonc/mds053
- language
- English
- LU publication?
- no
- id
- 8259a67f-e540-4a26-acb5-5c60bb1a4888
- date added to LUP
- 2022-04-12 11:05:11
- date last changed
- 2024-06-17 00:43:27
@article{8259a67f-e540-4a26-acb5-5c60bb1a4888,
abstract = {{<p>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.</p>}},
author = {{Ruers, T. and Punt, C. and Van coevorden, F. and Pierie, J. P.E.N. and Borel-Rinkes, I. and Ledermann, J. A. and Poston, G. and Bechstein, W. and Lentz, M. A. and Mauer, M. and Van Cutsem, E. and Lutz, M. P. and Nordlinger, B. and Verwaal, V. J. and Gruenberger, T. and Klaase, J. and Falk, S. and Wals, J. and Jansen, R. L. and P Lindnér, Lindnér and Mulier, S. and Bosscha, K. and Jaeck, D. and Arnaud, J. P. and Smith, D. and Sherlock, D. and Ammori, B. and Gillams, A. and El-Serafi, M. and Glimelius, B. and Hellman, P.}},
issn = {{0923-7534}},
keywords = {{Colorectal cancer; Liver metastases; Multimodality treatment; Radiofrequency ablation; Unresectable}},
language = {{eng}},
number = {{10}},
pages = {{2619--2626}},
publisher = {{Oxford University Press}},
series = {{Annals of Oncology}},
title = {{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)}},
url = {{http://dx.doi.org/10.1093/annonc/mds053}},
doi = {{10.1093/annonc/mds053}},
volume = {{23}},
year = {{2012}},
}