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舒尼替尼对中国经表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)预处理的晚期非小细胞肺癌患者的疗效和安全性评估。

The evaluation of efficacy and safety of sunitinib on EGFR-TKI pretreated advanced non-small cell lung cancer patients in China.

作者信息

Liu You-ru, Zhu Wei, Zhang Jian-liang, Huang Jia-qi, Zhao Yi-zhuo, Zhang Wei, Han Bao-hui, Yao Yi-hong, Jiang Li-yan, Li Shan-Qun

机构信息

Department of Pulmonary, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.

出版信息

Clin Respir J. 2014 Apr;8(2):206-12. doi: 10.1111/crj.12059. Epub 2013 Dec 11.

DOI:10.1111/crj.12059
PMID:24118906
Abstract

BACKGROUND

Sunitinib is an oral multitargeted tyrosine kinase inhibitor (TKI) exhibiting antiagiogenic and antitumor effects.

OBJECTIVE

To evaluate the efficacy and potential toxicity of sunitinib therapy in advanced non-small cell lung cancer (NSCLC) patients in China.

METHODS

From January 2009 to August 2011, 30 patients with stage IV NSCLC, who were pretreated with the epidermal growth factor receptor (EGFR)-TKIs and then received sunitinib, were retrospectively reviewed. Univariate and multivariate Cox proportional hazard regression analysis was performed to determine the potential prognostic risk factors influencing NSCLC survival.

RESULTS

The median progression-free survival (PFS) and median overall survival (OS) of all 30 treated patients was 1.25 months [95% confidence interval (CI): 0.90-1.9 months] and 3.40 months (95% CI: 3.00-6.80 months), respectively. Cox regression analysis suggested that Eastern Cooperative Oncology Group (ECOG) performance status (PS) is predictive of both PFS (P=0.001) and OS (P<0.001). Common adverse events (AEs) included hand-foot syndrome (53.3%), mucositis (40.0%), rash (36.7%) and diarrhea (33.3%).

CONCLUSION

No sign of overall clinical benefits of sunitinib was detected in patients with pretreated EGFR-TKIs. Most patients suffered AEs from mild to moderate severity. ECOG PS is highly associated with PFS and OS rate. Further studies in NSCLC are required to determine whether sunitinib is beneficial nor not.

摘要

背景

舒尼替尼是一种口服多靶点酪氨酸激酶抑制剂(TKI),具有抗血管生成和抗肿瘤作用。

目的

评估舒尼替尼治疗中国晚期非小细胞肺癌(NSCLC)患者的疗效和潜在毒性。

方法

回顾性分析2009年1月至2011年8月间30例IV期NSCLC患者,这些患者先接受表皮生长因子受体(EGFR)-TKIs治疗,随后接受舒尼替尼治疗。进行单因素和多因素Cox比例风险回归分析,以确定影响NSCLC生存的潜在预后危险因素。

结果

所有30例接受治疗患者的中位无进展生存期(PFS)和中位总生存期(OS)分别为1.25个月[95%置信区间(CI):0.90 - 1.9个月]和3.40个月(95%CI:3.00 - 6.80个月)。Cox回归分析表明,东部肿瘤协作组(ECOG)体能状态(PS)可预测PFS(P = 0.001)和OS(P < 0.001)。常见不良事件(AE)包括手足综合征(53.3%)、黏膜炎(40.0%)、皮疹(36.7%)和腹泻(33.3%)。

结论

在接受过EGFR-TKIs预处理的患者中,未检测到舒尼替尼具有总体临床获益的迹象。大多数患者出现轻至中度严重程度的AE。ECOG PS与PFS和OS率高度相关。需要对NSCLC进行进一步研究以确定舒尼替尼是否有益。

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