Head-to-Head Trial Weighs Afatinib Versus Gefitinib for Treatment of NSCLC

A new study shows that Gilotrif (afatinib; Boehringer Ingelheim Pharmaceuticals, Inc) significantly improves clinical outcomes compared with Iressa (gefitinib; AstraZeneca) in treatment-naïve patients with epidermal growth factor receptor (EGFR)–mutated non-small cell lung cancer (NSCLC).

The study reported early results from LUX-Lung 7, a multicenter, open-label, randomized controlled phase 2B trial and the first international head-to-head trial to compare the safety and efficacy of these two EGFR-directed therapies in this population of patients.

Between December 2011 and August 2013, 319 patients from 64 centers in 13 countries were enrolled and randomized to afatinib 40 mg per day (n=160) or gefitinib 250 mg per day (n=159). All patients had stage IIIB or IV disease and were positive for EGFR mutation, and none had received prior treatments. The main outcome measures were progression-free survival, time to treatment failure, and overall survival based on the intention-to-treat analysis.

Compared with gefitinib, afatinib significantly improved progression-free survival (median, 10.9 months vs 11 months; hazard ratio [HR], 0.73; 95% CI, 0.57-0.95; P=.017) and had a significantly longer time to treatment failure (median, 11.5 months vs 13.7 months; HR, 0.73; 95% CI, 0.58-0.92; P=.0073).

No data on overall survival were yet available.

The most common treatment-related grade 3 or 4 adverse events were diarrhea and rash/acne (13% and 9%, respectively) with afatinib and increased liver enzyme elevations (14%) and rash/acne (3%) with gefitinib. Rates of serious adverse events related to treatment were 11% and 4% with afatinib and gefitinib, respectively. Among the fatal adverse events (occurring in 9% of patients in the afatinib group and 6% of patients in the gefitinib group), all were unrelated to treatment except for one death from drug-related hepatic and renal failure that occurred in a patient treated with gefitinib. 

“These data are potentially important for clinical decision-making in this patient population,” concluded the investigators.—FRMC Contributor

Reference

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