安罗替尼对比多西他赛用于一线治疗失败后晚期非小细胞肺癌的疗效及安全性研究

Efficacy and safety of anlotinib versus docetaxel in advanced non-small cell lung cancer after first-line treatment failure

目的评价安罗替尼对比多西他赛用于一线治疗失败的晚期非小细胞肺癌(NSCLC)的疗效及安全性,探讨安罗替尼用于二线治疗晚期NSCLC的可行性。方法收集2018年1月至2020年3月云南省肿瘤医院干部医疗科收治的60例晚期NSCLC患者,根据临床治疗方案不同均分为3组:安罗替尼组、多西他赛组及联合组,安罗替尼组口服安罗替尼治疗,多西他赛组静脉滴注多西他赛治疗,联合组采用口服安罗替尼和静脉滴注多西他赛联合治疗,观察3组患者的临床疗效、无进展生存期(PFS)及不良反应等,用Cox比例风险回归模型分析患者PFS的影响因素。结果60例患者均达到治疗终点,未出现完全缓解病例,3组的稳定(SD)、进展(PD)及疾病控制率(DCR)差异均有统计学意义(P<0.05),安罗替尼组、联合组的SD、DCR均大于多西他赛组,PD小于多西他赛组,但3组的客观缓解率(ORR)差异无统计学意义(P>0.05)。安罗替尼组及联合组的中位PFS均优于多西他赛组(5.0、4.2个月vs.2.0个月),差异有统计学意义(P<0.05);安罗替尼组与联合组的中位PFS差异无统计学意义(P>0.05)。有吸烟史是影响患者PFS的危险因素。安罗替尼组和联合组最主要的不良反应均为乏力,分别有18例(90%)和16例(80%),多西他赛组最主要的不良反应是消化道反应(恶心呕吐)14例(70%)。结论安罗替尼比多西他赛用于一线治疗失败的晚期NSCLC显示出治疗优势和可控制的毒性。

Objective To evaluate the efficacy and safety of anlotinib versus docetaxel for advanced non-small cell lung cancer(NSCLC)that failed first-line treatment,and to explore the feasibility of anlotinib for second-line treatment of advanced non-small cell lung cancer.Methods This study collected 60 cases of patients with advanced NSCLC diagnosed and treated in the cadre medical department of Yunnan Provincial Cancer Hospital from January 2018 to March 2020,according to different clinical treatment plans,they were divided into 3 groups:the anlotinib group,the docetaxel group,the combined group;the anlotinib group received oral anlotinib treatment,and the docetaxel group received intravenous infusion of docetaxel treatment;the combination group was treated with oral anlotinib and intravenous infusion of docetaxel treatment.The clinical efficacy,progression-free survival(PFS)and adverse reactions of the three groups were observed,and the Cox proportional hazard regression model was used to analyze the influencing factors of PFS in patients.Results All 60 patients reached the end point of treatment,none of the patients in the three groups had complete remission.The differences in stability(SD),progression(PD),and disease control rates(DCR)of the three groups were statistically significant(P<0.05).The SD and DCR of the anlotinib group and the combined group were higher than those of the docetaxel group,and the PD was less than docetaxel group,but the objective response rate(ORR)difference of the 3 groups was not statistically significant(P>0.05).the median PFS of the anlotinib group and the combination group was better than that of the docetaxel group(5.0,4.2 months vs.2.0 months),the difference was statistical significance(P<0.05);the median PFS difference between the anlotinib group and the combination group was not statistically significant(P>0.05).Smoking history is a risk factor of affecting patients with PFS.The most important adverse reactions in the anlotinib group and the combined group were fatigue,with 18 cases(90%)and 16 cases(80%)respectively.The main adverse reaction in the docetaxel group was the digestive tract reaction(nausea and vomiting)14 cases(70%).Conclusions Anlotinib shows therapeutic advantages and controllable toxicity compared with docetaxel for advanced NSCLC that failed first-line treatment.