安罗替尼联合替吉奥治疗三线及以上晚期非小细胞肺癌的安全性和有效性

Safety and efficacy of combination therapy with anlotinib and S-1 in thirdly-line or later-line treatment of advanced non-small cell lung cancer

目的:前瞻性应用安罗替尼联合替吉奥治疗三线及以上晚期非小细胞肺癌,观察临床疗效和药物的安全性。方法:均经组织病理或细胞学明确诊断晚期非小细胞肺癌,且二线化疗治疗后疾病进展。口服安罗替尼胶囊8 mg/d,d1~14联合替吉奥胶囊60 mg/m2 bid d1~14,21天为一个周期。治疗终止时间为疾病进展或出现不可接受的毒副反应。结果:本研究结果显示,总体客观缓解率(ORR)可达到26.8%,总体疾病控制率(DCR)可达到80.5%,中位无进展生存期(mPFS)达到5.2个月(95%CI:3.9~6.6个月)。单因素分析,脑转移组患者mPFS(4.8个月)对比无脑转移组患者mPFS(5.9个月),两组差异具有统计学意义(P=0.039)。多变量回归分析显示,ECOG评分(P=0.002)、治疗线数(P=0.015)和疗效(P=0.014)是PFS的独立影响因素。最常见毒副反应为高血压、蛋白尿、骨髓抑制、胃肠道反应、疲乏和口腔黏膜炎。结论:安罗替尼联合替吉奥胶囊在晚期非小细胞肺癌三线及以上治疗中,其总体的疗效确切且药物毒副反应可控。

Objective:To investigate the efficacy and safety of anlotinib plus S-1 as thirdly-line or later-line treatment in patients with advanced non-small cell lung cancer.Methods:In this study,eligible patients had histologically orcytologically confimed NSCLC and documented disease progression after second-line chemotherapy treatment.Patients were treated anlotinib(8 mg daily)and S-1(60 mg/m 2 bid d 1~14),repeated every 3 weeks.Treatment was continued until disease progression or unacceptable toxicity occured.Results:The total objective response rate was 26.8%,and the disease control rate was 80.5%.The median progression-free survival was 5.2 months(95%CI:3.9~6.6 months).In univariate analysis,there was significant difference in mPFS between patients with brain metastases and those without brain metastases(4.8 months vs 5.9 months,P=0.039).ECOG performance status(P=0.002),lines of therapy(P=0.015)and therapeutic evaluation(P=0.014)were independent influencing factor of PFS.The most common adverse events were hypertension,proteinuria,myelosuppression,gastrointestinal reactions,fatigue,and mucositis.Conclusion:Anlotinib plus S-1 is an effective and safe regimen for NSCLC in thirdly-line or later-line treatment.