阿法替尼对比吉非替尼治疗非小细胞肺癌的真实世界疗效：一项捷克多中心研究。
Real-life Effectiveness of Afatinib Gefitinib in Patients With Non-small-cell Lung Cancer: A Czech Multicentre Study.
机构信息
Department of Pneumology and Phthisiology, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czech Republic;
Department of Respiratory Diseases, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
出版信息
Anticancer Res. 2021 Apr;41(4):2059-2065. doi: 10.21873/anticanres.14975.
BACKGROUND/AIM: We investigated efficacy differences for afatinib versus gefitinib in non-small-cell lung cancer (NSCLC) according to epidermal growth factor receptor (EGFR) mutations.
PATIENTS AND METHODS
We retrospectively analysed data for 343 patients with NSCLC with performance status 1 having EGFR mutations treated with gefitinib or afatinib. Overall response rate (ORR) was tested by Fisher's exact test. Overall (OS) and progression-free (PFS) survival were estimated by Kaplan-Meier method.
RESULTS
ORR did not differ in any group or subgroup. Among all patients, we observed significantly longer PFS for those treated with afatinib vs. gefitinib (median 13.4 vs. 9.5 months, p=0.026), but only a nonsignificant trend was observed for OS. We showed nonsignificant trends of better PFS and OS using afatinib for exon 19 deletion and L858R subgroups. We observed no significant PFS differences for other EGFR mutations but a nonsignificant trend towards better OS for those treated with afatinib.
CONCLUSION
Afatinib led to longer PFS for patients with common EGFR mutations but not for those with rare mutations.
背景/目的：我们研究了表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者中阿法替尼与吉非替尼的疗效差异。
患者和方法
我们回顾性分析了 343 例 EGFR 突变的 NSCLC 患者的临床数据，这些患者体力状况为 1 分，接受了吉非替尼或阿法替尼治疗。采用 Fisher 确切检验检测总缓解率（ORR）。采用 Kaplan-Meier 方法估计总生存期（OS）和无进展生存期（PFS）。
结果
在任何组或亚组中，ORR 均无差异。在所有患者中，与吉非替尼相比，阿法替尼治疗的患者 PFS 显著延长（中位 PFS 为 13.4 个月 vs. 9.5 个月，p=0.026），但 OS 仅显示出非显著趋势。对于外显子 19 缺失和 L858R 亚组，我们观察到使用阿法替尼的 PFS 和 OS 有更好的非显著趋势。对于其他 EGFR 突变，我们没有观察到 PFS 的显著差异，但阿法替尼治疗的患者 OS 有更好的非显著趋势。
结论
对于常见 EGFR 突变的患者，阿法替尼可延长 PFS，但对罕见突变的患者则没有影响。
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