Afatinib significantly improved outcomes compared with gefitinib in treatment-naïve patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC), a study published in the journal The Lancet Oncology has shown.1

Afatinib is an irreversible ErbB family blocker while gefitinib is a reversible EGFR kinase inhibitor. Both are indicated for the first-line treatment of EGFR mutation-positive NSCLC. Therefore, researchers sought to compare the efficacy and safety of afatinib with that of gefitinib in this patient population.

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

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Results showed that at a median follow-up of 27.3 months, median progression-free survival was 11.0 months (95% CI, 10.6-12.9) with afatinib vs 10.9 months (95% CI, 9.1-11.5) with gefitinib (HR, 0.73; 95% CI, 0.57-0.95; P=.017).

Median time to treatment failure was 13.7 months (95% CI, 11.9-15.0) and 11.5 months (95% CI, 10.1-13.1), respectively (HR, 0.73; 95% CI, 0.58-0.92; P=.0073). Overall survival data are not yet mature.

In terms of safety, the most common treatment-related grade 3 or 4 adverse events with afatinib were diarrhea and rash/acne, while the most frequently reported with gefitinib included liver enzyme elevation. Serious treatment-related adverse events occurred in 11% of afatinib-treated patients and 4% of patients in the gefitinib group.

In each treatment arm, 6% of patients discontinued treatment due to drug-related toxicities. One patient in the gefitinib arm died as a result of treatment-related hepatic and renal failure.

The findings demonstrate that afatinib significantly improved progression-free survival and time to treatment failure as compared with gefitinib, with a manageable tolerability profile. These results may ultimately influence clinical decision making in this population of treatment-naïve patients harboring an EGFR mutation.


1. Park K, Tan E-H, O’Byrne K, et al. Afatinib versus gefitinib as first-line treatment of patients withEGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial [published online ahead of print April 12, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)30033-X.