lung cancer

Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non–Small-Cell Lung Cancer: Final Results From SWOG S1403

In the October 6, 2020 edition of Journal of Clinical Oncology, Sarah B. Goldberg  and colleague report on the results of the SWOG S1403 trial.

PURPOSE

The combination of afatinib plus cetuximab has been shown to overcome resistance to EGFR TKIs, hence investigators developed a clinical trial, assessing this combination and newly diagnosed patients with EGFR mutated untreated non-small cell lung cancer.

METHODS

Patients with EGFR-mutant non-small cell lung cancer with no prior treatment of advanced disease were entered in this phase II, trial, which is multicenter, and randomized to afatinib 40 mg daily plus cetuximab 500 mg/m2 intravenously every 2 weeks or afatinib alone. The primary end point was progression free survival.

RESULTS

174 patients were randomized, and 168 (83 on afatinib + cetuximab and 85 on afatinib) were found to be eligible. There was no improvement in progression free survival in the afatinib plus cetuximab treatment arm compared with afatinib alone ([HR], 1.01; 95% CI, 0.72 – 1.43; P = .94; median, 11.9 months v 13.4 months).  The investigators also reported no difference in response rate (67% v 74%; P = .38) or OS (HR, 0.82; 95% CI, 0.50 to 1.36; P = .44).  It was important to note that toxicity was higher with the combination: grade ≥ 3 AE related to treatment were seen in 72% of patients treated with afatinib plus cetuximab compared with 40% of those receiving afatinib alone, the most common being rash and diarrhea. Dose reductions were more common in patients receiving the combination, and 30% of patients in this arm discontinued cetuximab as a result of toxicity.

The authors concluded “ The addition of cetuximab to afatinib did not improve outcomes in previously untreated EGFR-mutant NSCLC, despite recognized activity in the acquired resistance setting.”

Reference:

Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non–Small-Cell Lung Cancer: Final Results From SWOG S1403

https://ascopubs.org/doi/full/10.1200/JCO.20.01149

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