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甲磺酸阿帕替尼治疗驱动基因未知的晚期非小细胞肺癌的观察性研究

An observational study of apatinib mesylate in treating advanced non-small cell lung cancer with unknown driving gene(s).

作者信息

Fan Shaoshuang, Zou Yuhuan, Wang Yifeng, Fang Fang, Song Wenguang

机构信息

Graduate School of North China, University of Science and Technology, Tangshan 063000, China.

出版信息

J BUON. 2018 May-Jun;23(3):654-658.

Abstract

PURPOSE

To investigate the efficacy and safety of apatinib mesylate (AM) in treating advanced non-small cell lung cancer (aNSCLC) with wild or unknown epidermal growth factor receptor (w/nEGFR).

METHODS

A total of 34 w/nEGFR -aNSCLC patients who failed chemotherapy from August 2015 to April 2017 were administered orally AM (425 mg/d) as primary treatment and observed their progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as related adverse events.

RESULTS

Efficacy was evaluable in 30 cases, with median PFS (mPFS) 3.75 months (95% CI 0.648-6.852), ORR 20%, and DCR 73.33%. The main adverse reactions included hypertension (52.94%), hand-foot syndrome (52.94%), proteinuria (44.12%), and fatigue (41.18%); no drug-related death occurred. The efficacy correlation analysis showed that Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (p=0.008) combined with chemotherapy (p=0.009) were the factors that extended PFS, and combined chemotherapy (p=0.040, HR=3.052, 95% CI 1.052- 8.858) was an independent prognostic factor.

CONCLUSIONS

AM has good therapeutic efficacy in treating aNSCLC patients after chemotherapy failure. The side effects can be controlled and it is worth testing it in large-scale clinical studies.

摘要

目的

探讨甲磺酸阿帕替尼(AM)治疗野生型或未知表皮生长因子受体(w/nEGFR)的晚期非小细胞肺癌(aNSCLC)的疗效和安全性。

方法

选取2015年8月至2017年4月期间34例化疗失败的w/nEGFR-aNSCLC患者,口服AM(425mg/d)作为初始治疗,观察其无进展生存期(PFS)、客观缓解率(ORR)、疾病控制率(DCR)以及相关不良事件。

结果

30例患者疗效可评估,中位PFS(mPFS)为3.75个月(95%CI 0.648-6.852),ORR为20%,DCR为73.33%。主要不良反应包括高血压(52.94%)、手足综合征(52.94%)、蛋白尿(44.12%)和乏力(41.18%);未发生与药物相关的死亡。疗效相关性分析显示,东部肿瘤协作组(ECOG)体能状态(PS)0-1(p=0.008)及联合化疗(p=0.009)是延长PFS的因素,联合化疗(p=0.040,HR=3.052,95%CI 1.052-8.858)是独立预后因素。

结论

AM治疗化疗失败的aNSCLC患者具有良好的疗效,副作用可控制,值得进行大规模临床研究验证。

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