Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis (New EPOC): Long-term results of a multicentre, randomised, controlled, phase 3 trial
The Lancet Oncology Feb 07, 2020
Bridgewater JA, Pugh SA, Maishman T, et al. - Given that treatment with cetuximab plus chemotherapy vs chemotherapy alone has been shown to significantly reduce progression-free survival in patients with resectable colorectal liver metastasis in an interim analysis of the multicentre New EPOC trial, which was a multicentre, open-label, randomised, controlled, phase 3 trial, researchers focused on the effect on overall survival in this present analysis. Using randomization (1:1), chemotherapy with or without cetuximab prior to and following liver resection was administered to adult patients (aged ≥ 18 years) with KRAS wild-type (codons 12, 13, and 61) resectable or suboptimally resectable colorectal liver metastases and a WHO performance status of 0–2. In the chemotherapy alone group and in the chemotherapy plus cetuximab group, the median progression-free survival was estimated to be 22·2 months and 15·5 months, respectively, and the median overall survival was 81·0 months and 55·4 months, respectively. Neutrophil count reduced, diarrhoea, skin rash, thromboembolic events, lethargy, oral mucositis, vomiting, peripheral neuropathy, and pain were documented as most commonly experienced grade 3–4 adverse events. Although findings revealed improved overall survival in relation to cetuximab plus chemotherapy in some studies in patients with advanced, inoperable metastatic disease, a significant disadvantage in terms of overall survival was reported when cetuximab was used in the perioperative setting in patients with operable disease. Not using cetuximab in this setting was recommended.
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