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安罗替尼用于标准治疗方案后进展的晚期非小细胞肺癌患者的疗效和安全性及疗效预测指标的初步分析

Efficacy and Safety of Anlotinib for Patients with Advanced NSCLC Who Progressed After Standard Regimens and the Preliminary Analysis of an Efficacy Predictor.

作者信息

Cheng Jian-De, Chai Li-Xun, Zhao Zhi-Ping, Hao Yan-Yan, Li Shuo

机构信息

Department of Respiratory and Critical Care Medicine, The Shanxi Bethune Hospital, Taiyuan 030032, Shanxi, People's Republic of China.

Department of Thoracic Surgery, The Shanxi Bethune Hospital, Taiyuan 030032, Shanxi, People's Republic of China.

出版信息

Cancer Manag Res. 2020 Jul 12;12:5641-5650. doi: 10.2147/CMAR.S253366. eCollection 2020.

Abstract

BACKGROUND

The aim of this study was to investigate the efficacy and safety of anlotinib for patients with advanced non-small cell lung cancer (NSCLC) who progressed after standard regimens in real world situations and the preliminary analysis of an efficacy predictor.

METHODS

A total of 118 patients with advanced NSCLC who progressed after standard regimens were included in this retrospective study. Efficacy was evaluated and toxicity profile was recorded. Progression-free survival (PFS) and overall survival (OS) were assessed using Kaplan-Meier survival curve and multivariate analysis was adjusted using Cox regression analysis.

RESULTS

All of the 118 patients with NSCLC were available for evaluation of efficacy. Complete response (CR, 0 case), partial response (PR, 10 cases), stable disease (SD, 79 cases) and progressive disease (PD, 29 cases) were evaluated according to RECIST version 1.1. In consequence, objective response rate (ORR) was 8.47% and disease control rate (DCR) was 75.42%. The median PFS of the 118 patients with NSCLC was 4.3 months and the median OS was 10.3 months. The results of Cox regression analysis suggested that ECOG score was an independent factor for PFS. The toxicity profile indicated that hypertension and hand-foot syndrome were the most common adverse reactions. Additionally, the preliminary analysis of an efficacy predictor suggested that the PFS of patients with hypertension was superior to those without hypertension.

CONCLUSION

Anlotinib is effective and safe for patients with advanced NSCLC who progressed after standard regimens in real world situations. Hypertension may be a biomarker for efficacy prediction.

摘要

背景

本研究旨在探讨在现实世界中,安罗替尼对经标准治疗方案后病情进展的晚期非小细胞肺癌(NSCLC)患者的疗效和安全性,以及对疗效预测指标进行初步分析。

方法

本回顾性研究纳入了118例经标准治疗方案后病情进展的晚期NSCLC患者。评估疗效并记录毒性反应情况。采用Kaplan-Meier生存曲线评估无进展生存期(PFS)和总生存期(OS),并使用Cox回归分析进行多因素分析。

结果

118例NSCLC患者均可供疗效评估。根据实体瘤疗效评价标准(RECIST)1.1版评估,完全缓解(CR,0例)、部分缓解(PR,10例)、疾病稳定(SD,79例)和疾病进展(PD,29例)。结果显示,客观缓解率(ORR)为8.47%,疾病控制率(DCR)为75.42%。118例NSCLC患者的中位PFS为4.3个月,中位OS为10.3个月。Cox回归分析结果表明,美国东部肿瘤协作组(ECOG)评分是PFS的独立影响因素。毒性反应情况表明,高血压和手足综合征是最常见的不良反应。此外,疗效预测指标的初步分析表明,高血压患者的PFS优于无高血压患者。

结论

在现实世界中,安罗替尼对经标准治疗方案后病情进展的晚期NSCLC患者有效且安全。高血压可能是疗效预测的生物标志物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/62d5/7367729/846fc30f3bfb/CMAR-12-5641-g0001.jpg

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