盐酸安罗替尼胶囊治疗晚期非小细胞肺癌的临床研究

Anlotinib hydrochloride capsules in the treatment of advanced non-small cell lung cancer patients: a clinical study

目的探讨盐酸安罗替尼胶囊治疗晚期非小细胞肺癌(NSCLC)的临床疗效和安全性。方法根据入组标准和排除标准选取2015年4月到2015年11月在空军军医大学(第四军医大学)唐都医院呼吸与重症医学科就诊的NSCLC患者10例,采用盐酸安罗替尼胶囊与安慰剂对照治疗,并在标准治疗后晚期NSCLC患者中采用随机双盲、安慰剂对照的多中心Ⅲ期临床试验设计,各研究中心竞争入组。结果入组结束后揭盲,提示纳入进展后生存期(post-progression survival,PPS)集7例,2例剔除(1例伴有乙肝、1例无可测量病灶); 1例脱落。安罗替尼组5例,安慰剂组2例。主要疗效指标:安罗替尼组总生存期(overall survival,OS)平均长达11.19个月;安慰剂组OS平均延长达14.09个月;次要疗效指标:安罗替尼组无进展生存率(progression free survival,PFS)平均长达3.4个月,安慰剂组PFS平均长达2.33个月。本研究中发生严重不良事件(serious adverse event,SAE) 6次,其中呼吸困难4级3例,咳嗽、咯血、视力模糊和肺感染均为3级,各1例,均发生在对照组;而实验组中血栓栓塞事件(肺栓塞) 4级。结论安罗替尼与安慰剂组相比,其疗效及安全性均有一定的优势,可为多线化疗失败及EGFR-TKI耐药后的难治性NSCLC患者提供新的治疗手段。

Objective To evaluate the efficacy and safety of Anlotinib hydrochloride capsules inpatients with advanced non-small cell lung cancer compared with placebo. Methods From April 2015 toNovember 2015, 10 patients were enrolled in non-small cell lung cancer from the Department of Respiratory andCritical Care Medicine in Tangdu Hospital of the Military Medical University of the United States. Anlotinibhydrochloride capsules were compared with placebo. The treatment was designed in a randomized, double-blind, placebo-controlled, multicenter, phase Ⅲ clinical trial in patients with advanced non-small cell lungcancer after standard treatment, and each study center competed for entry into the group. Result After thegroup was enrolled, it was revealed that 7 cases were included in the PPS set, 2 cases were excluded （1 casewas associated with hepatitis B, 1 case had no measurable lesions）; 1 case was detached. Five patients in theanlotinib group and two in the placebo group. Main outcome measures： The overall survival （ OS） of theanaerotinib group averaged 11.19 months; the OS of the placebo group averaged 14.09 months; the secondaryefficacy indicators： the progression free survival （PFS） of the anlotinib group averaged 3.4 months, the placebogroup PFS The average is up to 2.33 months. In this study the serious adverse event （SAE） 6 times, includingdyspnea grade 4 in 3 patients, cough, hemoptysis, blurred vision, and pulmonary infection were level 3, each one, had occurred in the control group; Thromboembolic events in the experimental group （ pulmonaryembolism） grade 4. Conclusion Ann for compared with the placebo group, its efficacy and safety all havecertain advantages, can be multiple line after chemotherapy failure and EGFR-TKI resistance of refractory fornew treatment approaches for patients with non-small cell lung cancer.