Survival of patients with initially unresectable colorectal liver metastases treated with FOLFOX/cetuximab or FOLFIRI/cetuximab in a multidisciplinary concept (CELIM study)

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • G. Folprecht - , Department of Internal Medicine I, University Cancer Centre Dresden, University Hospital Carl Gustav Carus Dresden (Author)
  • T. Gruenberger - , Medical University of Vienna (Author)
  • W. Bechstein - , Goethe University Frankfurt a.M. (Author)
  • H. R. Raab - , Klinikum Oldenburg (Author)
  • J. Weitz - , University Cancer Centre Dresden, University Hospital Carl Gustav Carus Dresden (Author)
  • F. Lordick - , Leipzig University (Author)
  • J. T. Hartmann - , University Hospital Schleswig-Holstein Campus Kiel (Author)
  • J. Stoehlmacher-Williams - , University Hospital Carl Gustav Carus Dresden (Author)
  • H. Lang - , University Medical Center Mainz (Author)
  • T. Trarbach - , University of Duisburg-Essen (Author)
  • T. Liersch - , University of Göttingen (Author)
  • D. Ockert - , Hospital of the Brothers of Mercy Trier (Author)
  • D. Jaeger - , Heidelberg University  (Author)
  • U. Steger - , University of Würzburg (Author)
  • T. Suedhoff - , Hospital Passau (Author)
  • A. Rentsch - , University Cancer Centre Dresden, University Hospital Carl Gustav Carus Dresden (Author)
  • C. H. Köhne - , Klinikum Oldenburg (Author)

Abstract

Background: Initially, unresectable colorectal liver metastases can be resected after response to chemotherapy. While cetuximab has been shown to increase response and resection rates, the survival outcome for this conversion strategy needs further evaluation. Patients and methods: Patients with technically unresectable and/or ≥5 liver metastases were treated with FOLFOX/cetuximab (arm A) or FOLFIRI/cetuximab (arm B) and evaluated with regard to resectability every 2 months. Tumour response and secondary resection data have been reported previously. A final analysis of overall survival (OS) and progression-free survival (PFS) was carried out in December 2012. Results: Between December 2004 and March 2008, 56 patients were randomised to arm A, 55 to arm B. The median OS was 35.7 [95% confidence interval (CI) 27.2–44.2] months [arm A: 35.8 (95% CI 28.1–43.6), arm B: 29.0 (95% CI 16.0–41.9) months, HR 1.03 (95% CI 0.66–1.61), P = 0.9]. The median PFS was 10.8 (95% CI 9.3–12.2) months [arm A: 11.2 (95% CI 7.2–15.3), arm B: 10.5 (95% CI 8.9–12.2) months, HR 1.18 (95% CI 0.79–1.74), P = 0.4]. Patients who underwent R0 resection (n = 36) achieved a better median OS [53.9 (95% CI 35.9–71.9) months] than those who did not [21.9 (95% CI 17.1–26.7) months, P < 0.001]. The median disease-free survival for R0 resected patients was 9.9 (95% CI 5.8–14.0) months, and the 5-year OS rate was 46.2% (95% CI 29.5% to 62.9%). Conclusions: This study confirms a favourable long-term survival for patients with initially sub-optimal or unresectable colorectal liver metastases who respond to conversion therapy and undergo secondary resection. Both FOLFOX/FOLFIRI plus cetuximab, appear to be appropriate regimens for ‘conversion’ treatment in patients with K-RAS codon 12/13/61 wild-type tumours. Thus, liver surgery can be considered curative or alternatively as an additional ‘line of therapy’ in those patients who are not cured. Clinical Trial Number: NCT00153998, www.clinicaltrials.gov.

Details

Original languageEnglish
Pages (from-to)1018-1025
Number of pages8
JournalAnnals of oncology
Volume25
Issue number5
Publication statusPublished - May 2014
Peer-reviewedYes

External IDs

PubMed 24585720
ORCID /0000-0002-9321-9911/work/162348655

Keywords

Sustainable Development Goals

ASJC Scopus subject areas

Keywords

  • cetuximab, chemotherapy, colorectal cancer, liver metastases, multidisciplinary treatment, resection