A phase III randomised controlled trial of erlotinib vs gefitinib in advanced non-small cell lung cancer with EGFR mutations

Abstract

Background:A phase III trial was conducted to compare the safety and efficacy of erlotinib with that of gefitinib in advanced non-small cell lung cancer harbouring epidermal growth factor receptor mutations in exon 19 or 21.Methods:Eligible patients were randomised to receive erlotinib (150 mg per day) or gefitinib (250 mg per day) orally until disease progression or unacceptable toxicity. We aimed to determine whether erlotinib is superior to gefitinib in efficacy. The primary end point was progression-free survival.Results:A total of 256 patients were randomised to receive erlotinib (N=128) or gefitinib (N=128). Median progression-free survival was not better with erlotinib than with gefitinib (13.0 vs 10.4 months, 95% confidence interval (CI) 0.62–1.05, P=0.108). The corresponding response rates and median overall survival were 56.3% vs 52.3% (P=0.530) and 22.9 vs 20.1 months (95% CI 0.63–1.13, P=0.250), respectively. There were no significant differences in grade 3/4 toxicities between the two arms (P=0.172).Conclusions:The primary end point was not met. Erlotinib was not significantly superior to gefitinib in terms of efficacy in advanced non-small cell lung cancer with epidermal growth factor receptor mutations in exon 19 or 21, and the two treatments had similar toxicities.

Clinical outcomes and secondary epidermal growth factor receptor (EGFR) T790M mutation among first‐line gefitinib, erlotinib and afatinib‐treated non‐small cell lung cancer patients with activating EGFR mutations

“…Its side effects are modest and most patients tolerate it well . Erlotinib is another EGFR TKI proven to be effective against EGFR‐mutant NSCLC in randomized controlled trials, with adverse effects similar to gefitinib . The concentration and penetration rate of erlotinib in cerebrospinal fluid are significantly higher than that of gefitinib .…”

“…Two randomized controlled trials comparing EGFR TKIs were published recently. CTONG 0901, comparing first‐line erlotinib to gefitinib in advanced EGFR 19 or 21‐mutated NSCLC, found similar PFS, response rates and overall survival (OS) . The toxicity profiles were also very similar between erlotinib‐treated or gefitinib‐treated patients.…”

Treatment choice in epidermal growth factor receptor mutation-positive non-small cell lung carcinoma: latest evidence and clinical implications

“…There have been two studies conducted in Asian patients which directly compared erlotinib and gefitinib, but were based on previously treated patients [Yang et al 2015c;Urata et al 2016]. Neither of these studies showed differences in PFS and OS between TKIs.…”

EGFR inhibition in NSCLC: New findings…. and opened questions?

“…ARCHER-1050, NCT01774721, is another ongoing study compar-ing first vs second-generation EGFR-TKI (gefitinib vs dacomitinib), but results are not available yet. CTONG 0901 is a phase II study of erlotinib vs gefitinib which didn't show any significant survival differences between the two treatment arms (Yang et al, 2015b). Finally the impressive efficacy results observed with the thirdgeneration EGFR-TKI osimertinib in the first-line cohort of AURA study (RR: 77%, PFS: 19.7 months) (Ramalingam et al, 2016) have led to the design of the randomized phase III FLAURA trial.…”