阿帕替尼在晚期非鳞状非小细胞肺癌多线治疗后的疗效、安全性及预测指标：阿帕替尼治疗非鳞状非小细胞肺癌
Efficacy, safety and predictive indicators of apatinib after multilines treatment in advanced nonsquamous nonsmall cell lung cancer: Apatinib treatment in nonsquamous NSCLC.
作者信息
Wu Di, Liang Li, Nie Ligong, Nie Jun, Dai Ling, Hu Weiheng, Zhang Jie, Chen Xiaoling, Han Jindi, Ma Xiangjuan, Tian Guangming, Han Sen, Long Jieran, Wang Yang, Zhang Ziran, Xin Tao, Fang Jian
机构信息
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital and Institute, Beijing, China.
Department of Tumor Chemotherapy and Radiation Sickness, Third Hospital, Peking University, Beijing, China.
出版信息
Asia Pac J Clin Oncol. 2018 Dec;14(6):446-452. doi: 10.1111/ajco.12870. Epub 2018 Mar 24.
AIM
Patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC) who experienced progression with two or more lines chemotherapy have no treatment options that clearly confer a survival benefit. As a novel vascular endothelial growth factor receptor-2 tyrosine kinase inhibitor, apatinib has a certain antitumor effect for various solid tumors. The present study evaluated the efficacy and safety of apatinib in advanced nonsquamous NSCLC as salvage treatment in Chinese real-world practice.
METHODS
Twenty-eight patients were enrolled in this observational study from October 2015 to May 2017. Progression-free survival (PFS) and overall survival (OS) were graphed by Kaplan-Meier curve and intergroup comparisons were carried out by log-rank test. Objective response rate (ORR), disease control rate (DCR) and adverse effects (AEs) were also evaluated.
RESULTS
Seven patients obtained partial response, and 18 obtained stable disease, representing an ORR of 26% and a DCR of 93%. Median PFS and OS were 3 (95% confidence interval [CI] 2.6-3.4) and 7.4 (95% CI 1.3-13.5) months, respectively. The efficacy analysis showed that Eastern Cooperative Oncology Group (ECOG) performance status 0-1 was correlated with prolonged OS and PFS (P < 0.05), and hypertension during apatinib treatment was correlated with prolonged OS (P < 0.05). Cox regression showed that ECOG performance status (P < 0.01) (RR = 0.231) (95% CI 0.083-0.642) and hypertension during apatinib treatment (P = 0.05) were predictive indicators for apatinib treatment. Grade 3-4 AEs with incidences of 10% or greater were hypertension (21%), hand-foot syndrome (14%) and proteinuria (11%) which could be relieved by dose reduction.
CONCLUSION
In conclusion, apatinib has a certain therapeutic effect in patients with advanced nonsquamous NSCLC. ECOG performance status and hypertension during apatinib might be predictive indicators for treatment efficacy.
目的
接受过两种或更多线化疗后病情进展的晚期非鳞状非小细胞肺癌（NSCLC）患者没有明确能带来生存获益的治疗选择。作为一种新型血管内皮生长因子受体-2酪氨酸激酶抑制剂，阿帕替尼对多种实体瘤具有一定的抗肿瘤作用。本研究评估了阿帕替尼在中国真实世界实践中作为挽救治疗用于晚期非鳞状NSCLC的疗效和安全性。
方法
2015年10月至2017年5月，28例患者纳入本观察性研究。采用Kaplan-Meier曲线绘制无进展生存期（PFS）和总生存期（OS），并通过对数秩检验进行组间比较。还评估了客观缓解率（ORR）、疾病控制率（DCR）和不良反应（AE）。
结果
7例患者获得部分缓解，18例病情稳定，ORR为26%，DCR为93%。中位PFS和OS分别为3（95%置信区间[CI] 2.6 - 3.4）个月和7.4（95% CI 1.3 - 13.5）个月。疗效分析显示，东部肿瘤协作组（ECOG）体能状态0 - 1与OS和PFS延长相关（P < 0.05），阿帕替尼治疗期间的高血压与OS延长相关（P < 0.05）。Cox回归显示，ECOG体能状态（P < 0.01）（RR = 0.231）（95% CI 0.083 - 0.642）和阿帕替尼治疗期间的高血压（P = 0.05）是阿帕替尼治疗的预测指标。发生率为10%或更高的3 - 4级AE为高血压（21%）、手足综合征（14%）和蛋白尿（11%），可通过减量缓解。
结论
总之，阿帕替尼对晚期非鳞状NSCLC患者有一定治疗效果。ECOG体能状态和阿帕替尼治疗期间的高血压可能是治疗疗效的预测指标。
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