Survival with cetuximab/FOLFOX or cetuximab/FOLFIRI of patients with nonresectable colorectal liver metastases in the CELIM study.

Authors

null

Gunnar Folprecht

University Hospital Carl Gustav Carus, Medical Department I/University Cancer Center, Dresden, Germany

Gunnar Folprecht , Thomas Gruenberger , Wolf Bechstein , Florian Lordick , Hauke Lang , Jürgen Weitz , Thomas Suedhoff , Joerg Thomas Hartmann , Torsten Liersch , Claus-Henning Kohne

Organizations

University Hospital Carl Gustav Carus, Medical Department I/University Cancer Center, Dresden, Germany, Department of General Surgery, Medical University of Vienna, Vienna, Austria, Goethe University, Frankfurt, Germany, Klinikum Braunschweig, Braunschweig, Germany, Universitätsmedizin Mainz, Mainz, Germany, University Hospital Heidelberg, Heidelberg, Germany, Hospital Passau, Passau, Germany, Christian-Albrechts-Universitaet zu Kiel, Kiel, Germany, Department of General and Visceral Surgery, University Medical Center, Georg-August-University, Göttingen, Germany, Onkologie Klinikum Oldenburg, Oldenburg, Germany

Research Funding

Other

Background: Non-resectable liver metastases (mets) can be resected if they responded to systemic treatment. Cetuximab increases response rates in patients with k-ras wild type (wt) tumours. Methods: Patients (pts) with non-resectable liver mets (defined as technically non-resectable or ≥ 5 liver mets) were randomized to cetuximab/FOLFOX (arm A) or cetuximab/FOLFIRI (arm B). Resectability was re-evaluated after four and then every 2 months. Resection was offered to pts who became resectable during treatment. (Folprecht et al, Lancet Oncol 2010) Progression free survival (PFS) and overall survival (OS) were analysed in June 2011. Results: One hundred nine pts were randomized to cetuximab/FOLFOX or cetuximab/FOLFIRI, 106 evaluable for response. The median OS in all pts was 33.1 months [95% CI: 25.8-40.4], 35.7 [29.9-41.6] mo. in arm A and 29.0 [18.1-39.8] mo. in arm B (HR 1.09 [0.69-1.72]). The 4-year OS was 28% in all pts. The PFS was 11.2 [7.2-15.3] and 10.5 [8.9-12.2] mo. in arm A and B, respectively (HR 1.15 [0.77-1.70]). According to the k-ras mutational status, the OS and PFS was 36.1 [24.4-47.8] and 11.9 [8.25-15.6] in k-ras wt, 27.4 [15.7-39.1] and 9.9 [4.5-15.2] in k-ras mutant pts. In the k-ras wt subset, the OS was 35.8 [30.2-41.4] and 41.6 [24.8-58.5] mo. in arm A and B (HR 1.01 [0.55-1.86]), the PFS 12.1 [5.2-19.1] and 11.5 [8.8-14.1] mo. in arm A and B (HR 1.09 [0.66-1.79]). Pts with R0 resection had a significantly longer OS (median 46.7 [30.7-62.7] mo.) than pts without (median OS: 27.3 [21.2-33.3] mo, p=0.002). In R0 resected pts, the 3- and 4 year OS was 64% and 49%. The median disease free survival (DFS) was 9.9 mo after R0 resection, the 2 year DFS 19%. According to a review of CT/MRI scans which was performed by surgeons blinded to all clinical data, there was no survival difference between “resectable” pts and pts not categorized as “resectable” at baseline (HR 0.81 [0.44-1.50]), but a significantly better OS was observed for pts regarded as “resectable” after treatment vs. other categories (HR 0.47 [0.27-0.83], p=0.007). Conclusions: Pts had a favourable overall survival which was longer in R0 resected pts. Resectability after treatment seems to be important for the pts outcome.

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Abstract Details

Meeting

2012 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session C: Cancers of the Colon and Rectum

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT00153998

Citation

J Clin Oncol 30, 2012 (suppl 4; abstr 540)

DOI

10.1200/jco.2012.30.4_suppl.540

Abstract #

540

Poster Bd #

D15

Abstract Disclosures