Objective: To evaluate the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer (NSCLC). Methods: Patients with stage ⅢB/Ⅳ NSCLC who progressed after two lines or more regimens were randomized into anlotinib group (12 mg daily from day 1 to 14 of a 21-day cycle) or placebo group with ratio of 2∶1. Study drugs or placebo were given until disease progression or intolerable toxicity. The primary endpoint was overall survival (OS), and the second endpoints were progression free survival (PFS), objective response rate, and disease control rate. Results: Between April 2015 and December 2015, twenty-four patients were assigned at Peking Union Medical College Hospital. The baseline characteristics of the anlotinib group (n=16) and placebo group (n=8) were fairly comparable. The median OS was 12.7 months in anlotinib group and 11.1 months in placebo group (P=0.460).The median PFS was 4.0 months in anlotinib group and 1.4 months in placebo group (P=0.065).The common adverse events were manageable such as hypertension, hand-foot syndrome, thyroiddy sfunction. No drug-related mortality occurred. Conclusions: Anlotinib had a trend of improvement in OS and PFS as third-line treatment or beyond in advanced NSCLC compared with placebo with manageable toxicity. ClinicalTrials:: NCT02388919.
目的： 观察安罗替尼治疗晚期非小细胞肺癌的疗效与安全性。 方法： 入选病理确诊的ⅢB/Ⅳ期、既往接受过至少一线、二线全身化疗的晚期非小细胞肺癌患者，随机（2∶1）分至安罗替尼组和安慰剂组,分别服用安罗替尼（12 mg）和安慰剂（0 mg），1次/d，连续口服14 d，21 d为1个周期。记录患者总生存期、无进展生存期、客观反应率、疾病控制率及不良反应。 结果： 2015年4—12月共纳入本研究24例患者，安罗替尼组16例，男性9例，女性7例，中位年龄57.5岁，腺癌11例，鳞癌5例；安慰剂组8例，男性4例，女性4例，中位年龄62.5岁，腺癌8例。安罗替尼组部分缓解3例，疾病稳定10例，疾病进展3例；安慰剂组疾病稳定3例，疾病进展5例。安罗替尼组和安慰剂组患者中位无进展生存期分别为4.00个月和1.41个月（P=0.065），中位总生存期分别为12.8个月和11.1个月（P=0.460）。常见不良反应为高血压、手足综合征、甲状腺功能异常，对症处理及安罗替尼暂停、减量后均可控制，未出现药物相关的死亡。 结论： 安罗替尼在晚期非小细胞肺癌三线及三线以上治疗中，中位无进展生存期及中位总生存期均较安慰剂有延长趋势。不良反应可控。 美国临床研究注册号：： NCT02388919.
Keywords: Anlotinib; Carcinoma, non-small cell lung; Targeted therapy.