安罗替尼联合伊立替康二线治疗小细胞肺癌的临床疗效及安全性

The clinical efficacy and safety of anlotinib combined with irinotecan as the second-line therapy in patients with small cell lung cancer

目的观察安罗替尼联合伊立替康二线治疗小细胞肺癌的临床疗效及安全性。方法选取一线治疗失败的82例小细胞肺癌患者作为研究对象,按照随机数字表法分为对照组(41例)和研究组(41例),对照组采用伊立替康治疗,研究组在对照组的基础上给与安罗替尼治疗,计划治疗6个周期。观察2组疾病控制率(DCR)、客观缓解率(ORR)、总生存时间(OS)、无进展生存时间(PFS)和Ⅲ级以上不良反应;治疗前后采用酶联免疫吸附法(ELISA)检测血清血管内皮生长因子(VEGF)、多效生长因子(PTN)和可溶性死亡受体5(sDR5)水平变化情况。结果治疗后研究组ORR(53.66%vs.31.71%,χ^(2)=4.038)和DCR(87.80%vs.68.29%,χ^(2)=4.556)均高于对照组(均P<0.05)。研究组中位PFS长于对照组(5个月vs.3个月,Log-rankχ^(2)=7.752,P<0.01),中位OS差异无统计学意义(9个月vs.7个月,Log-rankχ^(2)=3.701,P>0.05)。治疗后,2组血清VEGF、PTN和sDR5水平较治疗前均降低(P<0.05),且研究组血清VEGF、PTN和sDR5水平低于对照组(P<0.05)。治疗期间,2组Ⅲ级及以上不良反应发生率差异均无统计学意义(P>0.05)。结论安罗替尼联合伊立替康二线治疗小细胞肺癌具有较好的疗效,可有效降低血清VEGF、PTN和sDR5水平表达,安全性较好。

Objective To observe the clinical efficacy and safety of anlotinib combined with irinotecan in the secondline treatment of small cell lung cancer(SCLC).Methods A total of 82 SCLC patients who failed at the first-line treatment were selected as the research objects,and they were randomly divided into control group(41 cases)and study group(41 cases)according to the random number table method.The control group was treated with irinotecan,and the study group was treated with anlotinib on the basis of the control group for six courses.The disease control rate(DCR),objective remission rate(ORR),overall survival time(OS),progression free survival time(PFS)and adverse reactions were observed.The serum vascular endothelial growth factor(VEGF),pleiotropic protein(PTN)and soluble death receptor 5(sDR5)levels were detected by enzyme-linked immunosorbent assay(ELISA)before and after treatment.Results The ORR(53.66%vs.31.71%,χ^(2)=4.038)and DCR(87.80%vs.68.29%,χ^(2)=4.556)were significantly higher in the study group than those of the control group(P<0.05).The median PFS in the study group was longer than that in the control group(5 months vs.3 months,Log-rankχ^(2)=7.752,P<0.01),and the median OS difference was not statistically significant(9 months vs.7 months,Logrankχ^(2)=3.701,P>0.05).After treatment,the serum levels of VEGF,PTN and sDR5 were significantly lower than those of before treatment in the two groups(P<0.05),and the levels of VEGF,PTN and sDR5 were significantly lower in the study group than those of in the control group(P<0.05).During the treatment,there were no significant differences in the incidence of blood system,digestive system and fatigue of gradeⅢand above adverse reactions between the two groups(P>0.05).Conclusion Anlotinib combined with irinotecan as the second-line treatment for SCLC has good curative effect,can effectively reduce the serum expressions of VEGF,PTN and sDR5,and has good safety.