Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung
Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung
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DOI：
10.2147/ott.s161506
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发表时间：
2018-01-01
影响因子：
4
通讯作者：
Zhang, Li
中科院分区：
文献类型：
--
作者：
Lu, Shun;Li, Wei;Zhang, Li
背景：全球 III 期 LUX-Lung 8 试验（ClinicalTrials.gov：NCT01523587）发现，二线阿法替尼与厄洛替尼相比，晚期肺鳞状细胞癌 (SCC) 患者的无进展生存期 (PFS)、总生存期 (OS) 和患者报告结果 (PRO) 显着改善。 材料和方法：我们对 LUX-Lung 患者的数据进行了事后分析8 名来自中国大陆 (n=67)。与厄洛替尼相比，阿法替尼使中国亚组疾病进展或死亡（PFS）风险降低30%（HR=0.70；95% CI：0.38-1.27）。结果：死亡风险降低31%（HR=0.69；95% CI：0.39-1.21）。 PRO 改善的中国患者比例也青睐阿法替尼 vs 厄洛替尼（总体健康状况/生活质量 [QoL]，52.8% vs 29.6%，P=0.072；呼吸困难，47% vs 26%，P=0.091；“呼吸困难”，44% vs 15%，P=0.017；QoL 率，53% vs 15%，P=0.017；QoL 率，53% vs 26%，P=0.091） 26%，P=0.037）。讨论：虽然该分析未能证明与总体试验人群（OTP）相比存在差异，并且基线特征（例如年龄>= 65岁的患者比例）存在一些差异，但阿法替尼治疗中国肺鳞状细胞癌患者的获益似乎至少与 LUX-Lung 8 中观察到的效果相当。与 OTP 一样，阿法替尼最常见的不良事件（AE）在中国亚组为腹泻和皮疹/痤疮，最常发生的 AE 的发生率和类型相似。结论：结果表明，阿法替尼是中国晚期肺 SCC 铂类化疗进展后患者的可行治疗选择。
Background: The global Phase III LUX-Lung 8 trial (ClinicalTrials.gov: NCT01523587) identified significant improvements in progression-free survival (PFS), overall survival (OS), and patient-reported outcomes (PROs) with second-line afatinib vs erlotinib in patients with advanced squamous cell carcinoma (SCC) of the lung.Materials and methods: We conducted a post hoc analysis of data for patients in LUX-Lung 8 from mainland China (n=67). Compared with erlotinib, afatinib reduced the risk of disease progression or death (PFS) in the Chinese subgroup by 30% (HR=0.70; 95% CI: 0.38-1.27).Results: The risk of death was reduced by 31% (HR=0.69; 95% CI: 0.39-1.21). The proportion of Chinese patients with improvements in PROs also favored afatinib vs erlotinib (global health status/quality of life [QoL], 52.8% vs 29.6%, P=0.072; dyspnea, 47% vs 26%, P=0.091; "dyspnea walked", 44% vs 15%, P=0.017; QoL rate, 53% vs 26%, P=0.037).Discussion: While this analysis was not powered to demonstrate differences compared to the overall trial population (OTP), and there were some differences in baseline characteristics (eg, the proportion of patients aged >= 65 years old), the benefits of afatinib treatment in Chinese patients with SCC of the lung appeared to be at least comparable to that observed in LUX-Lung 8. As with the OTP, the most common adverse events (AEs) with afatinib in the Chinese subgroup were diarrhea and rash/acne, and the incidence and type of the most frequently occurring AEs were similar.Conclusion: The results suggest that afatinib represents a feasible treatment option for Chinese patients with advanced SCC of the lung following progression on platinum-based chemotherapy.