Abstract
Introduction The purpose of this study was to explore the efficacy and safety of afatinib in advanced non-small-cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations based on real-world evidence. Materials and Methods Eligible real-world studies were identified from PubMed, Cochrane Library, and Embase. Cochrane guidelines were used to assess the quality of included studies. Cochran's Q test and I2 statistics were used for the heterogeneity analysis. Results Twenty-five studies were included in this meta-analysis; nine studies were included in the qualitative descriptive analysis. The summarized disease control rate (DCR) was 87.6% (81.5%, 92.7%), and the overall response rate (ORR) was 58.9% (48.8%, 68.7%). The pooled median progression-free survival (PFS) was 12.4 (10.3, 14.5) months, mean time to failure (TTF) was 15.4 (13.6, 17.2) months, and median overall survival (OS) was 31.6 (26.7, 36.5) months. The total incidences of adverse events (AEs) for skin rashes, diarrhea, paronychia, and mucositis were 71.4% (64.4%, 77.9%), 70.4% (60.1%, 79.8%), 52.1% (41.9, 62.3%), and 36.5% (29.5%, 43.8%), respectively. The incidences of severe adverse events (SAEs, Grade ≥3) for diarrhea, skin rashes, paronychia, and mucositis were 9.7% (6.8%, 13.1%), 5.8% (4.5%, 7.2%), 3.8% (2.0%, 6.2%), and 2.1% (1.0%, 3.6%), respectively. Differences in PFS and OS between the afatinib non-full-dose (<40 mg) and full-dose (>40 mg) groups were not significant (P > 0.05). However, the ORR in the full-dose group was 78.5% (66.7%, 88.4%), which was significantly higher than that in the non-full-dose group (67.8% [56.8%, 77.9%]). Conclusion The efficacy and safety of afatinib has been confirmed by real-world evidence in advanced NSCLC with EGFR mutation, consistent with randomized controlled trial results. In real-world setting, tolerability-guided dose adjustment might not affect the afatinib efficacy.
Highlights
Lung cancer is the leading cause of cancer-related deaths and a serious threat to human health [1]
Afatinib is an irreversible second-generation ErbB family blocker [6], which has been approved as a first-line treatment for Non-small-cell lung cancer (NSCLC) patients with Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations [7]
Based on randomized controlled trials (RCTs) data, a meta-analysis has revealed that in the first-line treatment of EGFR-mutated NSCLC, there is no conclusive evidence that afatinib is more effective than gefitinib or erlotinib [15]
Summary
Lung cancer is the leading cause of cancer-related deaths and a serious threat to human health [1]. Tyrosine kinase inhibitors (TKIs), including erlotinib, gefitinib, dacomitinib, afatinib, and osimertinib, are the standard first-line treatment for advanced NSCLC patients with EGFR mutations [5]. Afatinib is an irreversible second-generation ErbB family blocker [6], which has been approved as a first-line treatment for NSCLC patients with EGFR exon 19 deletions or exon 21 L858R substitution mutations [7]. In 2013, afatinib was approved worldwide as a first-line treatment for patients with EGFR-mutant NSCLC [5, 8]. E LUX-Lung 3/6/7 trials revealed that afatinib had obvious effects in the treatment of advanced EGFR-mutant NSCLC [9,10,11,12] and might provide a better curative effect than first-generation EGFR-TKIs [13]. A meta-analysis based on randomized controlled trials (RCTs) has shown that afatinib prolonged progression-free survival (PFS), increased overall
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