Early results of a head-to-head trial comparing two prominent treatments for patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) could have a significant impact on clinical decision making for this patient population.
Investigators led by Keunchil Park, MD, Sungkyunkwan University School of Medicine, (Seoul, South Korea) conducted a clinical trial to compare the efficacy and safety of two recently approved treatments for EGFR+ NSCLC, afatinib and gefitinib. Initial results of the ongoing trial were published in The Lancet Oncology.
Between December 2011 and August 2013, 319 patients with NSCLC and a common EGFR mutation were enrolled in the trial and randomly assigned to receive either afatinib 40 mg per day (n=160) or gefitinib (n=159) 250 mg per day until disease progression or longer if it was deemed beneficial.
After a median follow-up of 27.3 months, investigators observed that patients receiving afatinib had improved outcomes compared with those of patients in the gefitinib arm. Progression-free survival and time-to-treatment failure were both longer in the afatinib group (median, 11 months and 13.7 months, respectively) than in the gefitinib group (median, 10.9 months and 11.5 months, respectively). Overall survival is also being assessed in the trial, although this data is not yet available.
Afatinib was associated with increased toxicity. Of the most common treatment-related grade 3 or 4 adverse events, more patients in the afatinib arm experienced diarrhea (20 patients [15%]) and rash or acne (15 patients [9%]) than in the gefitinib arm (2 patients [1%] and 5 patients [3%], respectively). However, no patients taking afatinib experienced liver enzyme elevations, versus 14 patients (9%) in the gefitinib arm. Additionally, the rate of serious adverse events was more than double in the afatinib arm compared with the gefitinib arm (17 patients [11%] vs 7 patients [4%]), and fatal adverse events occurred in 15 patients (9%) taking afatinib, versus 10 patients (6%) in the gefitinib arm.
Overall, researchers concluded that the toxicity profile of afatinib was manageable and that afatinib showed clear benefits over gefitinib in patients with EGFR+ NSCLC.
