Despite significant improvements in progression-free survival and overall response rate with afatinib, there was no significant difference in overall survival between afatinib and gefitinib among patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC), according to a study published in Annals of Oncology.1

The open-label, phase 2b LUX-Lung 7 ( Identifier: NCT01466660) enrolled 319 treatment-naïve patients with EGFR mutation-positive stage IIIB or IV adenocarcinoma of the lung. Participants were randomly assigned 1:1 to receive first-line afatinib or gefitinib orally once daily until disease progression or unacceptable toxicity.

Previously reported results showed that afatinib significantly prolonged progression-free survival, time-to-treatment failure, and objective response rate compared with gefitinib. Investigators confirmed these results with longer follow-up.

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Median follow-up was 42.6 months. There was no significant difference in overall survival between the 2 treatment arms (hazard ratio [HR], 0.86; 95% CI, 0.66-1.12; P = .2580). Median overall survival was 27.9 months with afatinib and 24.5 months with gefitinib.

Subgroup analyses revealed similar overall survival trends in patients with exon 19 deletion (HR, 0.83; 95% CI, 0.58-1.17; P = .2841) and those with L858R mutations (HR, 0.91; 95% CI, 0.62-1.36; P = .6585).

About three-quarters of patients in both groups had at least 1 subsequent systemic therapy for NSCLC after discontinuation of afatinib or gefitinib, including approximately 14% to 15% who received a third-generation EGFR kinase inhibitor such as osimertinib.

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Although there was no significant difference in overall survival between afatinib and gefitinib, the LUX-Lung 7 trial continued to demonstrate significant improvements in other clinical outcomes with afatinib. Clinicians may use these data to inform clinical decision-making in this patient population.


  1. Paz-Ares L, Tan EH, O’Byrne K, et al. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. 2017 Feb 7. doi: 10.1093/annonc/mdw611 [Epub ahead of print]