摘要
目的:观察西妥昔单抗或贝伐单抗联合FOLFOX4方案治疗晚期直肠癌患者的临床疗效。方法:将114例晚期直肠癌患者按随机数字表法分为西妥昔单抗组和贝伐单抗组,各57例,其中贝伐单抗组脱落1例。两组患者均接受FOLFOX4方案治疗:奥沙利铂85 mg/m^2+亚叶酸钙200 mg/m^2,ivgtt,2 h,然后5-氟尿嘧啶(5-FU)400 mg/m^2,ivgtt,再以5-FU 600 mg/m^2,ivgtt,22 h。西妥昔单抗组患者在FOLFOX4方案基础上给予西妥昔单抗500 mg/m^2,贝伐单抗组患者在FOLFOX4方案基础上给予贝伐单抗5mg/kg,ivgtt。2周为1个疗程,两组患者均治疗4个疗程后评估其临床疗效、无进展生存期(PFS)及毒副反应。结果:西妥昔单抗组患者客观缓解率(RR)为45.61%、疾病控制率(DCR)为92.98%,中位PFS为10.0个月;贝伐单抗组患者RR为48.21%、DCR为87.50%,中位PFS为11.0个月,两组比较差异无统计学意义(P>0.05)。两组患者感觉神经毒性、白细胞减少、血小板减少、恶心呕吐、腹泻、皮疹等不良反应发生率比较,差异亦无统计学意义(P>0.05)。结论:西妥昔单抗或贝伐单抗联合FOLFOX4方案治疗晚期直肠癌患者的疗效相当,毒副反应发生率均较低。
OBJECTIVE：To observe clinical efficacy of bevacizumab or cetuxizumab combined with FOLFOX4 regimen in the treatment of advanced rectal cancer. METHODS：114 patients with rectal cancer were randomly assigned to cetuxizumab group and bevacizumab group,with 57 cases in each group,among which one patient of bevacizumab group withdrew from therapy. Both groups received FOLFOX4 regimen：oxaliplatin 85 mg/m^2＋ calcium folinate 200 mg/m^2,ivgtt,2 h,and 5-FU 400 mg/m^2,ivgtt,last,5-FU 600 mg/m^2,ivgtt,22 h. Cetuxizumab group was additional given cetuxizumab 500 mg/m^2;bevacizumab group was additionally given bevacizumab 5 mg/kg,ivgtt. A treatment course lasted for 2 weeks. Both groups received 4 courses of treatment,and then clinical efficacy,toxic reaction and progression-free survival（PFS） were evaluated. RESULTS：Objective remission rate（RR）,disease control rate（DCR）and median PFS of cetuxizumab group was 45.61%,92.98% and 10.0 months,those of bevacizumab group were 48.21%,87.50% and 11.0 months;there was no statistical significance between 2 groups（P〉0.05）. No significant differences were found in the incidence of ADR such as sensory neurotoxicity,aleucocytosis,thrombopenia,nausea and vomiting,diarrhea and erythra between 2 groups（P〉0.05）. CONCLUSIONS：Both bevacizumab or cetuxizumab combined with FOLFOX4 regimen have a similar effect on patients with advanced cancer,with low incidence of toxic reaction.
出处
《中国药房》
CAS
北大核心
2016年第8期1078-1081,共4页
China Pharmacy
基金
重庆市卫生计生委医学科研项目(No.20142058)
