Non-Small Cell Lung Cancer Coverage from Every Angle

Can Adding Cetuximab to Afatinib Improve Outcomes in NSCLC?

By: Vanessa A. Carter, BS
Posted: Tuesday, July 27, 2021

Jacques Cadranel, MD, PhD, of the Intergroupe Francophone de Cancérologie Thoracique, Paris, and colleagues conducted a study to determine the toxicity and efficacy of first-line afatinib plus cetuximab compared with afatinib alone for the treatment of EGFR-mutant non–small cell lung cancer (NSCLC). Their results, which revealed a lack of efficacy with the combination therapy and no difference in toxicity between the combination and afatinib alone, were published in Clinical Cancer Research.

“These results suggest that addition of cetuximab to afatinib does not warrant further investigation in treatment-naive advanced EGFR-mutant NSCLC,” the authors concluded.

This phase II, open-label study enrolled 117 patients with stage III or IV, EGFR-positive NSCLC. They were randomly assigned to receive either afatinib alone (n = 59) or afatinib plus cetuximab (n = 58). Afatinib was administered at 40 mg once daily, whereas cetuximab was given intravenously at 250 mg/m² during cycle one on day 15 and then increased to 500 mg/m² every 2 weeks for 6 months; treatment continued until disease progression or dose-limiting toxicity. 

The mean patient age was 65 years, with the majority of patients being women (71.8%), and more than half were never-smokers (57.3%). In both the monotherapy and combination-therapy groups, the percentage of patients without treatment failure was fairly similar (59.3% vs. 64.9%); the median time to treatment failure was 11.1 and 12.9 months, respectively. There was no significant difference reported in progression-free survival (11.9 vs. 13.4 months), objective response rate (76.3% vs. 77.2%), disease control rate (98.3% vs. 93%), or 12-month survival rate (87.9% vs. 89.4%) with afatinib alone and with the combination of afatinib and cetuximab, respectively.

Treatment-related adverse events affected all patients on monotherapy and 56 patients on combination therapy, with grade 3 events affecting 22 and 30 individuals, respectively. Notably, the allelic frequency of EGFR mutations in circulating tumor DNA at baseline seemed to correlate with shorter progression-free survival, regardless of treatment.

Disclosure: For full disclosures of the study authors, visit

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