Afatinib significantly prolonged progression-free survival (PFS) compared with gefitinib as first-line treatment for patients with epidermal growth factor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC), a study presented at the European Lung Cancer Conference (ELCC) 2016 has shown.1

Afatinib is an irreversible ErbB family inhibitor indicated for the first-line treatment of patients with advanced EGFR-mutant NSCLC. Researchers sought to compare the efficacy and safety of first-line afatinib to that of gefitinib, a reversible EGFR kinase inhibitor.

For the international, open-label, phase 2b LUX-Lung 7 trial, researchers enrolled 319 patients with stage IIIb or stage IV NSCLC who harbor an EGFR mutation. Participants were randomly assigned 1:1 to receive afatinib 40 mg orally daily or gefitinib 250 mg orally daily until radiological disease progression or beyond if determined to be beneficial by the investigator.

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Results showed afatinib significantly improved PFS compared with gefitinib (hazard ratio [HR], 0.73; 95% CI, 0.57-0.95; P = .017). Researchers also found that time to treatment failure was significantly longer with afatinib (HR, 0.73; 95% CI, 0.58-0.92; P = .007).

Objective response rate was 70% and 56% with afatinib and gefitinib, respectively (P = .008). Overall survival data were not yet mature and will be presented at a later date.

In terms of safety, the most frequently reported grade 3 or worse adverse events with afatinib were diarrhea (12.5%) and rash/acne (9.4%). The most common grade 3 or worse gefitinib-related adverse event was elevated alanine aminotransferase (8.2%).

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Four patients in the gefitinib arm experienced drug-related interstitial disease compared with no patients in the afatinib arm. Approximately 6% of patients in each group discontinued therapy due to drug-induced toxicities.


  1. Park K, Tan E, Zhang L, et al. LUX-Lung 7: A phase IIb, global, randomised, open-label trial of afatinib vs gefitinib as first-line treatment for patients (pts) with advanced non-small cell lung cancer (NSCLC) harbouring activating EGFR mutations. Poster presentation at: European Lung Cancer Conference 2016; April 13-16, 2016; Geneva, Switzerland.