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Real-world assessment of afatinib for patients with EGFR-positive non-small cell lung cancer.
Investigational New Drugs ( IF 3.4 ) Pub Date : 2020-05-15 , DOI: 10.1007/s10637-020-00948-9
Satoshi Igawa 1 , Taihei Ono 1 , Masashi Kasajima 1 , Seiichiro Kusuhara 1 , Sakiko Otani 1 , Tomoya Fukui 1 , Masanori Yokoba 2 , Masaru Kubota 2 , Masato Katagiri 2 , Hisashi Mitsufuji 3 , Jiichiro Sasaki 4 , Katsuhiko Naoki 1
Affiliation  

Introduction Afatinib is used to treat patients with advanced non-small cell lung cancer (NSCLC) harboring common EGFR mutations; however, the clinicopathological factors that predict this drug’s effectiveness in real-world settings remain unclear. We therefore evaluated the effectiveness of afatinib in such patients and assessed potential prognostic factors. Methods We retrospectively investigated patients with NSCLC who received first-line afatinib between July 2014 and August 2018. Variables (including sex, age, performance status, neutrophil-to-lymphocyte ratio, EGFR genotype, smoking status, clinical stage prior to treatment [stage IV vs.. postoperative recurrence], presence or absence of brain metastases, body surface area, any afatinib dose reductions, and afatinib starting dose [40 vs.. 20 or 30 mg]) were subjected to a Cox proportional hazards regression model to estimate progression-free survival (PFS). Results Forty-eight patients with a median age of 67 years were included; the objective response rate was 62.5% (30 patients). The median PFS was 14.1 months; the PFS periods were 11.8 and 15.9 months for patients receiving 40 mg versus 20–30 mg of afatinib (P = 0.41), respectively, and were 14.5 and 13.8 months for patients who required afatinib dose reduction and those who did not, respectively (P = 0.80). The PFS tended to be longer in patients without brain metastases (albeit not significantly). Ultimately, no significant predictive values for PFS were identified. Conclusions Afatinib is effective for patients with NSCLC harboring common EGFR mutations irrespective of their clinicopathological backgrounds. A direct comparison of afatinib and osimertinib in treatment-naïve patients is warranted to determine the optimal standard of care.



中文翻译:

阿法替尼对 EGFR 阳性非小细胞肺癌患者的真实世界评估。

简介阿法替尼用于治疗携带常见EGFR突变的晚期非小细胞肺癌 (NSCLC) 患者;然而,预测该药物在现实环境中有效性的临床病理学因素仍不清楚。因此,我们评估了阿法替尼在此类患者中的有效性,并评估了潜在的预后因素。方法我们回顾性调查了 2014 年 7 月至 2018 年 8 月期间接受一线阿法替尼治疗的 NSCLC 患者。变量(包括性别、年龄、体能状态、中性粒细胞与淋巴细胞比率、EGFR基因型、吸烟状况、治疗前的临床分期 [IV 期与术后复发]、是否存在脑转移、体表面积、任何阿法替尼剂量减少和阿法替尼起始剂量 [40 vs.. 20 或 30 mg] ) 进行 Cox 比例风险回归模型以估计无进展生存期 (PFS)。结果48 名中位年龄为 67 岁的患者被纳入;客观缓解率为 62.5%(30 名患者)。中位 PFS 为 14.1 个月;接受 40 mg 和 20-30 mg 阿法替尼治疗的患者的 PFS 期分别为 11.8 和 15.9 个月 ( P  = 0.41),需要减少阿法替尼剂量和不需要减少阿法替尼剂量的患者分别为 14.5 和 13.8 个月 ( P = 0.80)。没有脑转移的患者的 PFS 往往更长(尽管不显着)。最终,没有发现 PFS 的显着预测值。结论无论临床病理学背景如何,阿法替尼对携带常见EGFR突变的 NSCLC 患者均有效。有必要在初治患者中直接比较阿法替尼和奥希替尼,以确定最佳护理标准。

更新日期:2020-05-15
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