The addition of cetuximab to chemotherapy in the neoadjuvant setting lead to significantly worse clinical outcomes for patients who had resectable liver metastases caused by colorectal cancer, showed an updated analysis of the randomized phase 3 New EPOC trial (ClinicalTrials.gov Identifier: NCT00482222). The findings were recently published in Lancet Oncology.
The New EPOC trial randomly assigned 257 patients with KRAS wild-type resectable or suboptimally resectable liver metastases caused by colorectal cancer to receive chemotherapy alone (128 patients) or chemotherapy plus cetuximab (129 patients).
A previous interim analysis showed that at a median follow-up of 21 months, the progression-free survival (PFS) was more than 6 months shorter for patients who received chemotherapy plus cetuximab than patients who received chemotherapy alone (14.1 vs 20.5 months, respectively; hazard ratio (HR), 1.48; 95% CI, 1.04–2.12; P =.030).
Having a median follow-up of 66.7 months, the current analysis showed that patients who received chemotherapy plus cetuximab continued to have a significantly shorter PFS compared with patients who received chemotherapy alone (15.5 vs 22.2 months, respectively; HR, 1.17; 95% CI, 0.87–1.56; P =.304).
Patients who received chemotherapy plus cetuximab also had a more than 2-year shorter overall survival compared with patients who received chemotherapy alone (55.4 vs 81.0 months, respectively; HR, 1.45; 95% CI, 1.02–2.05; P =.036).
A total of 4 patients died from treatment with chemotherapy plus cetuximab; 1 patient died from treatment with chemotherapy alone.
The addition of cetuximab to chemotherapy in the perioperative setting in patients with operable disease confers a “significant disadvantage” in terms of overall survival, the study authors wrote. “Cetuximab should not be used as neoadjuvant therapy in patients with operable colorectal liver metastases.”
Disclosure: Some of the authors disclosed financial relationships with pharmaceutical and medical device companies. For a full list of disclosures, please refer to the original study.
Bridgewater JA, Pugh SA, Maishman T, et al. 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 [published online January 21, 2020]. Lancet Oncol. doi: 10.1016/S1470-2045(19)30798-3