ASCO 2015: Second-Line Afatinib Improves Overall Survival vs Erlotinib in Advanced Squamous Cell Carcinoma of the Lung
In a phase III head-to-head trial comparing the safety and efficacy of two EGFR-directed treatments, afatinib (Gilotrif) treatment resulted in a significant improvement in overall survival over erlotinib (Tarceva) in patients with previously treated advanced squamous cell carcinoma of the lung. Updated results from the LUX-Lung 8 trial were reported on May 31 at the 2015 ASCO Annual Meeting in Chicago (Abstract 8002).
Updated Analysis
LUX-Lung 8 was conducted across 23 countries and is the first prospective trial to compare two different tyrosine kinase inhibitors in patients with advanced squamous cell carcinoma of the lung. Overall survival was the key secondary endpoint of this randomized phase III head-to-head trial and was analyzed following positive results for the primary endpoint of progression-free survival presented in 2014.
Afatinib treatment resulted in a 19% reduction in risk of death compared with erlotinib, a significant improvement in overall survival (median, 7.9 vs 6.8 months; hazard ratio [HR] = 0.81, 95% confidence interval [CI] = 0.69–0.95, P = .008). Significant differences in overall survival were seen at 6 (63.6% vs 54.6%; P = .010), 12 (36.4 vs 28.2%; P = .016), and 18 (22.0% vs 14.4%; P = .013) months.
The updated analysis of progression-free survival confirmed a significant 19% reduction in the risk of cancer progression among patients treated with afatinib compared with erlotinib (median, 2.6 vs 1.9 months; HR = 0.81, 95% CI = 0.69–0.96, P = .010).
Improved Cancer-Related Symptoms
The delay in cancer progression seen with afatinib treatment was accompanied by improved control of cancer-related symptoms; a higher proportion of patients treated with afatinib reported improvement in cough (43.4% vs 35.2%), shortness of breath (51.3 vs 44.1%), and overall well-being and quality of life (35.7 vs 28.3%) compared with erlotinib.
The rate of severe adverse events was similar between afatinib and erlotinib treatment arms (57.1 vs 57.5%). A higher incidence of severe diarrhea and stomatitis was observed with afatinib compared to erlotinib (grade 3/4 diarrhea: 9.9%/0.5% vs 2.3%/0.3%, grade 3 stomatitis: 4.1% vs 0.0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10.4% vs 5.9%).
Squamous cell carcinoma represents approximately 30% of non–small cell lung cancer cases. Treatment options are limited, and squamous cell carcinoma of the lung is associated with a poor prognosis, with less than 5% of patients with advanced disease surviving for 5 years or longer.
The complete results from this study will be the basis for global regulatory submissions later this year, according to Boehringer Ingelheim. Afatinib is not approved for use in patients with squamous cell carcinoma of the lung.
The study was sponsored by Boehringer Ingelheim. For full disclosures of the study authors, view the study abstract at abstract.asco.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
