There was no significant difference in overall survival between afatinib and gefitinib among patients treated for EGFR mutation-positive non-small cell lung cancer (NSCLC), according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1

Both afatinib and gefitinib are approved by the U.S. Food and Drug Administration for the frontline treatment of patients with advanced EGFR mutation-positive NSCLC. The phase 2 LUX-Lung 7 trial ( Identifier: NCT01466660) previously demonstrated that treatment with afatinib significantly prolonged progression-free survival, improved overall response rate, and delayed time to treatment failure compared with gefitinib in this treatment setting.

After a median follow-up of 42.6 months, investigators conducted the primary analysis of mature overall survival data. Median overall survival was 27.9 months with afatinib versus 24.5 months with gefitinib (hazard ratio [HR], 0.86; 95% CI, 0.66-1.12; P = .258).

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In addition, 24-month and 30-month overall survival rates for afatinib and gefitinib were 61% versus 51% and 48% versus 40%, respectively.

Subgroup analyses demonstrated similar overall survival results in patients with exon 19 deletions (HR, 0.83; 95% CI, 0.58-1.17) and L858R mutations (HR, 0.92; 95% CI, 0.62-1.36).

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Researchers also found no significant differences in overall survival with respect to age. Updated analyses reaffirmed that afatinib was associated with improved progression-free survival, overall response rate, and time to treatment failure compared with gefitinib.

No new safety signals were observed.                                     


  1. Paz-Ares L, Tan E, Zhang L, et al. Afatinib (A) vs gefitinib (G) in patients (pts) with EGFR mutation-positive (EGFRm+) non-small-cell lung cancer (NSCLC): overall survival (OS) data from the phase IIb trial LUX-Lung 7 (LL7). Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.