摘要
目的:探讨贝伐珠单抗联合紫杉醇/卡铂方案治疗晚期非小细胞肺癌的临床疗效和安全性。方法:选择本研究中心入组SAiL(MO19390)研究的13例患者为研究对象,给予贝伐珠单抗15mg/kg,化疗d1静点,以后每3周重复;联合化疗方案为175mg/m2紫杉醇,d1,卡铂AUC=6,d1,每3周重复。化疗4-6周期,贝伐珠单抗每3周应用一次直至病情进展。评价患者的不良反应、客观有效率(objective response rate,ORR)、中位无进展生存期(progression free survival,PFS)和总生存期(overall survival,OS)。同时,对可取得肿瘤组织标本的患者进行回顾性EGFR和KRAS突变检测。结果:13例患者中,发生5级肺动脉栓塞1例,4级脑梗塞1例,4级蛋白尿2例,3级鼻出血1例,最常见的不良反应为鼻出血(69.2%)、蛋白尿(46.2%)、高血压(38.5%)、咯血(30.8%)、流涕(30.8%)、头晕(23.1%),大多程度较轻可以耐受。部分缓解(partial response,PR)7例(53.8%),疾病稳定(stable disease,SD)6例(46.2),总有效率53.8%,疾病控制率100%,中位PFS 7.7个月,中位OS 16.1个月。6例可进行EGFR和KRAS突变检测的患者中,1例存在EGFR 19外显子缺失突变,1例存在21外显子L858R点突变,4例未检测到EGFR敏感突变,6例患者KRAS突变均为阴性。结论:贝伐珠单抗联合紫杉醇/卡铂方案治疗中国晚期非小细胞肺癌可延长PFS和OS,患者的耐受性良好。
Objective： To evaluate the efficacy and safety of bevacizumab combined with paclitaxel plus carboplatin for Chinese patients with advanced non-small cell lung cancer.Methods： Thirteen patients with advanced NSNSCLC who enrolled in the SAiL study in our hospital were treated with bevacizumab 15mg/kg,d1,repeated every 3 weeks until PD;Plus paclitaxel 175mg/m2,on d1 and carboplatin AUC=6 on d1.The cycle was repeated every 3 weeks.Adverse effects（AEs）,objective response rate（ORR）,median progression free survial（PFS）and overall survival（OS）were measured.EGFR and K-RAS gene mutations were analysed retrospectively in patients who had enough tumor samples.Results： In the 13 patients,Grade 5 pulmonary embolism was observed in one patient,grade 4 cerebrovascular event was observed in one patient,grade 4 proteinuria was observed in two patients,and grade 3 epistaxis was observed in one patient.The most frequent AEs were epistaxis（69.2%）,proteinuria（46.2%）,hypertension（38.5%）,hemoptysis（30.8%）,nasal discharge（30.8%）,dizzy（23.1%）.AEs were generally mild and could be well tolerated.The partial response and stable disease rate were 53.8% and 46.2% respectively,disease control rate was 100%.The median PFS and OS were 7.7 and 16.1months respectively.Six patients had enough tumor sample,one was detected a deletion mutation in exon 19,one was detected the mutation in exon 21 of EGFR gene,and none was detected mutation of K-RAS.Conclusion： Bevacizumab combined with paclitaxel plus carboplatin may be well tolerated and benefical for Chinese patients with advanced NSNSCLC.
出处
《现代生物医学进展》
CAS
2013年第12期2305-2309,共5页
Progress in Modern Biomedicine
关键词
贝伐珠单抗
晚期非小细胞肺癌
紫杉醇
卡铂方案
临床疗效
Bvacizumab
Advanced non-small cell lung cancer
Paclitaxel plus Carboplatin
Clinical efficacy
