贝伐珠单抗联合白蛋白紫杉醇和卡铂治疗晚期非小细胞肺癌患者的临床研究

Clinical trial of bevacizumab combined with albumin paclitaxel and carboplatin in the treatment of patients with advanced non-small cell lung cancer

目的观察贝伐珠单抗联合注射用紫杉醇(白蛋白结合型)和卡铂注射液治疗晚期非小细胞肺癌(NSCLC)患者的临床疗效及安全性。方法将晚期NSCLC患者随机分为对照组和试验组。对照组给予130 mg·kg^(-1)·m^(-2)紫杉醇,静脉滴注40 min,第1和8天+300 mg·m^(-2)卡铂,静脉滴注,第1天;试验组在对照组治疗的基础上,联合7.5 mg·kg^(-1)·m^(-2)贝伐珠单抗,静脉滴注,第1天。2组患者均治疗4个周期,每个周期3周。比较2组患者的临床疗效,癌胚抗原(CEA)、糖类抗原125(CA125)、CA199、血管内皮生长因子(VEGF)和结缔组织生长因子(CTGF)水平,1年累积生存率,以及药物不良反应的发生情况。结果试验组入组45例,脱落4例,最终有41例纳入统计分析;对照组入组47例,脱落6例,最终有41例纳入统计分析。治疗后,试验组和对照组的客观缓解率分别为34.15%(14例/41例)和14.63%(6例/41例),疾病控制率分别为87.80%(36例/41例)和65.83%(27例/41例),差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的CEA分别为(18.51±3.52)和(24.31±3.89)ng·mL^(-1),CA125分别为(17.68±3.62)和(25.62±4.21)ng·mL^(-1),CA199分别为(30.24±5.99)和(45.23±7.25)ng·mL^(-1),VEGF分别为(126.34±14.21)和(170.25±18.69)ng·L^(-1),CTGF分别为(1400.14±199.21)和(1542.31±210.35)ng·L^(-1),差异均有统计学意义(均P<0.05)。试验组和对照组的1年累积生存率分别为70.73%(29例/41例)和48.78%(20例/41例),差异有统计学意义(P<0.05)。2组患者的药物不良反应均以食欲缺乏、胃肠道反应、骨髓抑制、肝肾功能损害和蛋白尿为主。试验组和对照组的总药物不良反应发生率分别为39.02%和34.15%,差异无统计学意义(P>0.05)。结论贝伐珠单抗联合注射用紫杉醇(白蛋白结合型)和卡铂注射液治疗晚期NSCLC患者的临床疗效确切,其能显著提高患者的生存率,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of bevacizumab combined with paclitaxel for injection(albumin bound)and carboplatin injection in the treatment of patients with advanced nonsmall cell lung cancer(NSCLC).Methods The patients with advanced NSCLC were divided into control and treatment groups.The control group was given 130 mg·kg^(-1)·m^(-2)paclitaxel,intravenous infusion for 40min,on the day 1 and 8+300 mg·m^(-2)carboplatin,intravenous infusion on the day 1.On the basis of the control group,the treatment group was combined with 7.5 mg·kg^(-1)·m^(-2)bevacizumab,intravenous infusion,on the day 1.Two groups were treated for 4 cycles with 3 weeks per cycle.The clinical efficacy,levels of carcinoembryonic antigen(CEA),carbohydrate antigen 125(CA125),CA199,vascular endothelial growth factor(VEGF)and connective tissue growth factor(CTGF),1-year cumulative survival rate and adverse drug reactions were compared between two groups.Results In the treatment group,45 cases were enrolled,4 cases dropped out,and 41 cases were included in the analysis.In the control group,47 cases were enrolled,6 cases were dropped out,and 41 cases were finally included in the analysis.After treatment,the CEA levels of treatment and control groups were(18.51±3.52)and(24.31±3.89)ng·mL^(-1);the CA125 levels were(17.68±3.62)and(25.62±4.21)ng·mL^(-1);the CA199 levels were(30.24±5.99)and(45.23±7.25)ng·mL^(-1);the VEGF levels were(126.34±14.21)and(170.25±18.69)ng·L^(-1);the CTGF levels were(1400.14±199.21)and(1542.31±210.35)ng·L^(-1),and the differences were statistically significant(all P<0.05).The 1-year cumulative survival rates of treatment and control groups were70.73%(29 cases/41 cases)and 48.78%(20 cases/41 cases)with significant difference(P<0.05).The adverse drug reactions of two groups were anorexia,gastrointestinal reaction,bone marrow suppression,liver and kidney function impairment and proteinuria.The total incidences of adverse drug reactions in the treatment and control groups were 39.02%and 34.15%without significant difference(P>0.05).Conclusion Bevacizumab combined with paclitaxel(albumin bound)injection and carboplatin injection has a definite clinical efficacy in the treatment of patients with advanced NSCLC,which can significantly improve the survival rate,and without increasing the incidence of adverse drug reactions.