PMID- 34961817 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220429 IS - 1687-8450 (Print) IS - 1687-8469 (Electronic) IS - 1687-8450 (Linking) VI - 2021 DP - 2021 TI - Efficacy and Safety of Afatinib in the Treatment of Advanced Non-Small-Cell Lung Cancer with EGFR Mutations: A Meta-Analysis of Real-World Evidence. PG - 8736288 LID - 10.1155/2021/8736288 [doi] LID - 8736288 AB - 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 I(2) 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. CI - Copyright (c) 2021 Lemeng Zhang et al. FAU - Zhang, Lemeng AU - Zhang L AUID- ORCID: 0000-0002-2239-7307 AD - Thoracic Medicine Department 1, Hunan Cancer Hospital, Changsha 410013, Hunan Province, China. FAU - Luo, Yongzhong AU - Luo Y AUID- ORCID: 0000-0003-0770-0854 AD - Thoracic Medicine Department 1, Hunan Cancer Hospital, Changsha 410013, Hunan Province, China. FAU - Chen, Jianhua AU - Chen J AD - Thoracic Medicine Department 1, Hunan Cancer Hospital, Changsha 410013, Hunan Province, China. FAU - Cheng, Tianli AU - Cheng T AD - Thoracic Medicine Department 1, Hunan Cancer Hospital, Changsha 410013, Hunan Province, China. FAU - Yang, Hua AU - Yang H AD - Thoracic Medicine Department 1, Hunan Cancer Hospital, Changsha 410013, Hunan Province, China. FAU - Pan, Changqie AU - Pan C AD - Thoracic Medicine Department 1, Hunan Cancer Hospital, Changsha 410013, Hunan Province, China. FAU - Li, Haitao AU - Li H AD - Thoracic Medicine Department 1, Hunan Cancer Hospital, Changsha 410013, Hunan Province, China. FAU - Jiang, Zhou AU - Jiang Z AD - Thoracic Medicine Department 1, Hunan Cancer Hospital, Changsha 410013, Hunan Province, China. LA - eng PT - Journal Article DEP - 20211218 PL - Egypt TA - J Oncol JT - Journal of oncology JID - 101496537 PMC - PMC8710163 COIS- The authors declare that they have no conflicts of interests. EDAT- 2021/12/29 06:00 MHDA- 2021/12/29 06:01 PMCR- 2021/12/18 CRDT- 2021/12/28 06:35 PHST- 2021/10/21 00:00 [received] PHST- 2021/11/29 00:00 [accepted] PHST- 2021/12/28 06:35 [entrez] PHST- 2021/12/29 06:00 [pubmed] PHST- 2021/12/29 06:01 [medline] PHST- 2021/12/18 00:00 [pmc-release] AID - 10.1155/2021/8736288 [doi] PST - epublish SO - J Oncol. 2021 Dec 18;2021:8736288. doi: 10.1155/2021/8736288. eCollection 2021.