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阿帕替尼(YN968D1)二线化疗后治疗Ⅲ/Ⅳ期非小细胞肺癌的疗效和毒性的临床研究:一项回顾性研究。

Clinical investigation of the efficacy and toxicity of apatinib (YN968D1) in stage III/IV non-small cell lung cancer after second-line chemotherapy treatment: A retrospective study.

机构信息

Department of Oncology, Shandong Cancer Hospital Affiliated to Shandong University, Shandong University, Jinan, China.

Department of Oncology, Shandong Cancer Hospital Affiliated to Shandong University, Shandong Academy of Medical Sciences, Shandong Cancer Hospital and Institute, Jinan, China.

出版信息

Thorac Cancer. 2018 Dec;9(12):1754-1762. doi: 10.1111/1759-7714.12898. Epub 2018 Oct 19.

Abstract

BACKGROUND

This study was designed to assess the clinical efficacy and toxicity of apatinib (YN968D1) as third or subsequent-line treatment for stage III/IV non-small cell lung cancer (NSCLC).

METHODS

A total of 100 patients with advanced NSCLC who were treated with apatinib at a daily dose of 250/425/500 mg at Shandong Cancer Hospital from January 2016 to June 2018 were enrolled in our study. The objective response, disease control, and median progression-free survival rates were reviewed and evaluated. Univariate and multivariate analyses were performed to determine the prognostic factors. The main adverse events were evaluated per the Common Terminology Criteria for Adverse Events version 4.0.

RESULTS

All patients were assessable for response. No complete responses were observed, 11 patients achieved a partial response, and 56 showed stable disease. The objective response rate was 11.0%, the disease control rate was 67.0%, and the median progression-free survival was 2.93 months (95% confidence interval 2.07-3.87). In Cox regression analysis, the Eastern Cooperative Oncology Group performance status score (hazard ratio 1.799; P < 0.05) and smoking history (hazard ratio 1.958; P < 0.05) were predictive indicators for apatinib treatment efficacy. Treatment-related adverse events were tolerated, predictable, reversible, and controllable.

CONCLUSION

Apatinib was found to be both effective and safe in advanced NSCLC patients without a genetic driver mutation who experienced progression after two or more lines of chemotherapy treatment.

摘要

背景

本研究旨在评估阿帕替尼(YN968D1)作为三线或后线治疗 III/IV 期非小细胞肺癌(NSCLC)的临床疗效和毒性。

方法

2016 年 1 月至 2018 年 6 月,山东肿瘤医院共收治 100 例接受阿帕替尼治疗的晚期 NSCLC 患者,每日剂量为 250/425/500mg。我们回顾并评估了客观缓解率、疾病控制率和中位无进展生存期。进行单因素和多因素分析以确定预后因素。主要不良事件按不良事件通用术语标准 4.0 进行评估。

结果

所有患者均可评估疗效。未观察到完全缓解,11 例患者部分缓解,56 例患者疾病稳定。客观缓解率为 11.0%,疾病控制率为 67.0%,中位无进展生存期为 2.93 个月(95%置信区间 2.07-3.87)。在 Cox 回归分析中,东部肿瘤协作组体能状态评分(危险比 1.799;P<0.05)和吸烟史(危险比 1.958;P<0.05)是阿帕替尼治疗疗效的预测指标。治疗相关不良事件可耐受、可预测、可逆且可控制。

结论

在二线或二线以上化疗进展后无遗传驱动突变的晚期 NSCLC 患者中,阿帕替尼治疗有效且安全。

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