贝伐珠单抗联合TOMIRI化疗治疗晚期结直肠癌患者的临床研究

Clinical trial of bevacizumab combined with TOMIRI chemotherapy in the treatment of patients with advanced colorectal cancer

目的观察贝伐珠单抗注射液联合雷替曲塞注射剂+伊立替康注射液(TOMIRI)治疗晚期结直肠癌患者的临床疗效及安全性。方法将晚期结直肠癌患者按队列法分为对照组和试验组。对照组给予180 mg·m^(-2)伊立替康,静脉滴注30~90 min,第1天+3 mg·m^(-2)雷替曲塞,静脉滴注15 min,每3周给药1次;试验组在对照组治疗的基础上,联合给予5 mg·kg^(-1)贝伐珠单抗治疗,静脉滴注,每3周给药1次。2组患者均连续治疗4个疗程,每个疗程3周。比较2组患者的临床疗效、病灶直径、卡氏功能评分量表(KPS),以及药物不良反应的发生情况。根据随访结果,比较2组患者12个月内的无进展生存期(PFS)。结果试验组和对照组各入组53例。治疗后,试验组和对照组的总有效率分别为83.02%(44例/53例)和54.72%(29例/53例),在统计学上差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的肿瘤直径分别为(2.44±0.30)和(3.35±0.38)cm,KPS评分分别为(78.01±0.79)和(70.69±0.72)分,PFS分别为(11.26±1.43)和(8.01±0.97)个月,在统计学上差异均有统计学意义(均P<0.05)。试验组出现的药物不良反应有贫血、肝肾功能异常、恶心呕吐、白细胞减少;对照组出现的药物不良反应有消化道反应、恶心呕吐、肝肾功能异常、血液毒性、贫血、皮疹。试验组和对照组的总药物不良反应发生率分别为11.32%和28.30%,在统计学上差异无统计学意义(P>0.05)。结论贝伐珠单抗注射液联合TOMIRI有助于提高晚期结直肠癌患者的临床疗效,改善患者的生存质量,延长PFS,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of bevacizumab injection combined with raltitrexed injection and irinotecan injection(TOMIRI)in the treatment of patients with advanced colorectal cancer.Methods Patients with advanced colorectal cancer were divided into control group and treatment group according to the cohort method.The control group received 180 mg·m^(-2)irinotecan with intravenous infusion for 30 to 90 min on the first day+3 mg·m^(-2)raltitrexed with intravenous infusion for 15 min,once every three weeks.On the basis of control group,the treatment group was given 5 mg·kg^(-1)bevacizumab with intravenous infusion,once every three weeks.Two groups were treated for 4 cycles with 3 weeks per cycle.The clinical efficacy,lesion diameter,Karnofsky performance status(KPS),and adverse drug reactions were compared between two groups.Additionally,based on follow-up results,the progression-free survival(PFS)within 12 months was compared between the two groups.Results The treatment and control groups enrolled 53 patients.After treatment,the total effective rates of treatment and control groups were 83.02%(44 cases/53 cases)and 54.72%(29 cases/53 cases)with statistically significant difference(P<0.05).After treatment,the tumor diameters of treatment and control groups were(2.44±0.30)and(3.35±0.38)cm;the KPS scores were(78.01±0.79)and(70.69±0.72)points;the PFS was(11.26±1.43)and(8.01±0.97)months,there were statistically significant differences of above indexes between two groups(allP<0.05).The adverse drug reactions in the treatment group were anemia,abnormal liver and renal function,nausea and vomiting,and leukopenia,which in the control group were gastrointestinal reaction,nausea and vomiting,abnormal liver and kidney function,blood toxicity,anemia and skin rash.The total incidence of adverse drug reactions in treatment and control groups were 11.32% and 28.30%(P>0.05).Conclusion Bevacizumab injection combined with TOMIRI can helps to enhance the clinical efficacy of advanced colorectal cancer and improve patients'quality of life,improve patient quality of life,prolong PFS,and without increasing the incidence of adverse drug reactions.