J Cancer 2019; 10(4):885-892. doi:10.7150/jca.27528 This issue
1. Central Laboratory of Medical Research Centre, Anhui Provincial Hospital, Anhui Medical University, Hefei, 230001, China
2. Department of Thoracic Surgery, Anhui Provincial Hospital, Anhui Medical University, Hefei, 230001, China
3. Department of Respiration, Anhui Provincial Hospital, Anhui Medical University, Hefei, 230001, China
4. Department of Oncology, Anhui Provincial Hospital, Anhui Medical University, Hefei, 230001, China
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, Survival, Non-small cell lung cancer, Response rate, Meta-analysis