Local Treatment of Unresectable Colorectal Liver Metastases: Results of a Randomized Phase II Trial

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • Theo Ruers - , Netherlands Cancer Institute (Autor:in)
  • Frits Van Coevorden - , Netherlands Cancer Institute (Autor:in)
  • Cornelis J A Punt - , University of Amsterdam (Autor:in)
  • Jean-Pierre E N Pierie - , Leeuwarden Medical Center (Autor:in)
  • Inne Borel-Rinkes - , Universitair Medisch Centrum (Autor:in)
  • Jonathan A Ledermann - , Cancer Research UK and UCL Cancer Trials Centre and UCL Hospitals (Autor:in)
  • Graeme Poston - , University Hospital Aintree (Autor:in)
  • Wolf Bechstein - , Universitätsklinikum Frankfurt (Autor:in)
  • Marie-Ange Lentz - , EORTC Headquarters (Autor:in)
  • Murielle Mauer - , EORTC Headquarters (Autor:in)
  • Gunnar Folprecht - , Prostatakarzinomzentrum am UniversitätsKrebsCentrum, Medizinische Klinik und Poliklinik I (Autor:in)
  • Eric Van Cutsem - , Universitair Ziekenhuis (UZ) Leuven (Autor:in)
  • Michel Ducreux - , Institut Gustave Roussy (Autor:in)
  • Bernard Nordlinger - , Assistance publique – Hôpitaux de Paris (Autor:in)
  • European Organisation for Research and Treatment of Cancer Data Center

Abstract

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.

Details

OriginalspracheEnglisch
Seitenumfang10
FachzeitschriftJournal of the National Cancer Institute
Jahrgang109
Ausgabenummer9
PublikationsstatusVeröffentlicht - 1 Sept. 2017
Peer-Review-StatusJa

Externe IDs

PubMed 28376151
PubMedCentral PMC5408999
Scopus 85017200980
ORCID /0000-0002-9321-9911/work/142252047

Schlagworte

Schlagwörter

  • Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, Catheter Ablation/methods, Chemotherapy, Adjuvant, Colorectal Neoplasms/drug therapy, Disease-Free Survival, Fluorouracil/administration & dosage, Humans, Leucovorin/administration & dosage, Liver Neoplasms/drug therapy, Middle Aged, Neoplasm Staging, Organoplatinum Compounds/administration & dosage, Oxaliplatin