Zhang Lemeng, Luo Yongzhong, Chen Jianhua, Cheng Tianli, Yang Hua, Pan Changqie, Li Haitao, Jiang Zhou
Thoracic Medicine Department 1, Hunan Cancer Hospital, Changsha 410013, Hunan Province, China.
J Oncol. 2021 Dec 18;2021:8736288. doi: 10.1155/2021/8736288. eCollection 2021.
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.
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 test and I statistics were used for the heterogeneity analysis.
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 ( > 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%]).
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.
本研究旨在基于真实世界证据探讨阿法替尼在表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌（NSCLC）患者中的疗效和安全性。
从PubMed、Cochrane图书馆和Embase中检索符合条件的真实世界研究。采用Cochrane指南评估纳入研究的质量。使用Cochran's检验和I统计量进行异质性分析。
本荟萃分析纳入了25项研究；定性描述性分析纳入了9项研究。汇总的疾病控制率（DCR）为87.6%（81.5%，92.7%），总缓解率（ORR）为58.9%（48.8%，68.7%）。汇总的无进展生存期（PFS）中位数为12.4（10.3，14.5）个月，至失败时间（TTF）均值为15.4（13.6，17.2）个月，总生存期（OS）中位数为31.6（26.7，36.5）个月。皮疹、腹泻、甲沟炎和口腔炎不良事件（AE）的总发生率分别为71.4%（64.4%，77.9%）、70.4%（60.1%，79.8%）、52.1%（41.9，62.3%）和36.5%（29.5%，43.8%）。腹泻、皮疹、甲沟炎和口腔炎严重不良事件（SAEs，≥3级）的发生率分别为9.7%（6.8%，13.1%）、5.8%（4.5%，7.2%）、3.8%（2.0%，6.2%）和2.1%（1.0%，3.6%）。阿法替尼非全剂量（<40mg）组和全剂量（>40mg）组之间的PFS和OS差异无统计学意义（>0.05）。然而，全剂量组的ORR为78.5%（66.7%，88.4%），显著高于非全剂量组（67.8%[56.8%，77.9%]）。
真实世界证据证实了阿法替尼在EGFR突变的晚期NSCLC中的疗效和安全性，与随机对照试验结果一致。在真实世界环境中，耐受性指导的剂量调整可能不会影响阿法替尼的疗效。
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