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分析  

Evaluation of Safety and Efficacy of Bevacizumab Combined with Paclitaxel plus Carboplatin for Chinese Patients with Advanced Non-small Cell Lung Cancer

作　　者：唐俊舫[1] 吴羽华[1] 武玮[1] 朱允中[1] 徐丽艳[1] 史鹤玲[1] 孟弃逸[1] 刘赞[1] 郭丽丽[1] 陶虹[1] 李明智[1] 刘喆[1] 

机构地区：[1]首都医科大学附属北京胸科医院肿瘤内科,北京101149

出　　处：《结核病与胸部肿瘤》2012年第3期180-184,共5页Tuberculosis and Thoracic Tumor

摘　　要：背景与目的贝伐珠单抗是首个针对VEGF的人源化单克隆抗体，美国FDA已批准其联合紫杉醇，卡铂方案用于非鳞非小细胞肺癌（non-squamous non-small cell lung cancer，NSNSCLC）的一线治疗。SAiL（MO19390）研究是一项开放、非对照、国际多中心临床研究，旨在评价贝伐珠单抗联合化疗一线治疗晚期NSNSCLC患者的安全性与疗效。本文13例患者来自本研究中心入组SAiL研究的患者。方法贝伐珠单抗15mg/4kg，化疗d1静点，以后每3周重复；联合化疗方案为紫杉醇：175mg／m^2，d1，卡铂：AUC=6，d1，每3周重复。化疗应用4～6周期，贝伐珠单抗每3周应用一次直至病情进展。评价不良反应、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，我们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PFS7．7个月，中位OS16．1个月。6例可进行EGFR和KRAS突变检测的患者中，1例存在EGFR19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／卡铂方案一线治疗中国NSNSCLC患者耐受性良好，可延长PFS和OS。Background and objective Bevacizumab is the first recombinant humanized monoclonal antibody that selectively binds to and neutralizes the biologic activity of human vascular growth factor （VEGF） . The SAiL （MO19390） trial is an open, international multieenter, singlearm clinical study that assesses the safety and efficacy of first-line bevacizumab combined with chemotherapy in patients with advanced non-squamous non-small cell lung cancer （NSNSCLC） . The current study reported the result of 13 patients who were treated at Beijing Chest Hospital as a part of the SAiL study. Method Patients with advanced NSNSCLC were treated with bevacizumab 15 mg/kg, dl, repeated every 3 weeks until PD; Pluse paclitaxel 175 mg/m2, on dl and carboplatin AUC=6 on dl. 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. Result 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 16.1 months 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.

关 键 词：贝伐珠单抗 肺肿瘤 不良反应 治疗 

分 类 号：R734.2[医药卫生—肿瘤]