Background: Afatinib is a second-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) that has been approved by the Food and Drug Administration for the treatment of advanced non-small cell lung cancer (NSCLC) harboring EGFR mutations. We performed a meta-analysis to assess the efficacy and safety of afatinib in advanced NSCLC. Methods: We searched PubMed, PMC database, EMBASE, Cochrane Library and Web of Science to obtain the relevant literature. The efficacy and safety of afatinib was assessed based on progression-free survival (PFS), overall survival (OS), overall response rate (ORR), primary grade 3/4 adverse events and fatal adverse events (FAEs). A subgroup analysis was performed according to control type for all end-points. Results: Seven randomized controlled trials were included, with a total of 3093 patients. The meta-analysis showed that afatinib treatment significantly prolonged PFS in patients compared with control groups (HR = 0.57, 95% CI: 0.42-0.76; P = 0.00), increased OS (HR = 0.91, 95% CI: 0.83-0.99; P = 0.04) and ORR (RR = 1.82, 95% CI: 1.13-2.93; P = 0.01). In terms of safety, afatinib significantly increased the incidence of diarrhea (RR = 8.9, 95% CI: 5.33-14.93; P = 0.00), rash (RR = 7.31, 95% CI: 1.56-34.12; P = 0.01) and stomatitis (RR = 6.45, 95% CI: 1.27-32.78; P = 0.03), compared with the control group. However, there was no significant difference in FAEs (RR = 0.75, 95% CI: 0.38-1.49; P = 0.41). Conclusions: This meta-analysis confirmed that afatinib extended survival, improved response rates and did not increase the risk of treatment-related mortality in advanced NSCLC. As a novel EGFR-TKI, afitinib has significant potential for clinical application.
Keywords: Immunotherapy; Meta-analysis; Non-small cell lung cancer; Response rate; Survival.