贝伐珠单抗联合化疗二线及以上治疗晚期非鳞型非小细胞肺癌的临床观察  

Clinical Observation on Bevacizumab Combined with Chemotherapy as Second-or Later-line Treatment for Advanced Non-squamous Non Small Cell Lung Cancer

作　　者：胡庆庆[1] 史美祺[2] 于韶荣[2] 王丽[2] 夏国豪[2] 郭仁宏[2] 王友群[1] 

机构地区：[1]中国药科大学临床药学研究室,江苏南京210009 [2]江苏省肿瘤医院肿瘤内科,江苏南京210009

出　　处：《药学进展》2014年第11期848-854,共7页Progress in Pharmaceutical Sciences

摘　　要：目的:考察贝伐珠单抗联合化疗二线及以上治疗晚期非鳞型非小细胞肺癌的疗效和安全性。方法:28例经病理组织学或细胞学证实的晚期非鳞型非小细胞肺癌患者接受贝伐珠单抗联合化疗的二线及以上治疗,其间,贝伐珠单抗所用剂量为7.5mg·kg-1,在化疗第1d静滴给予;化疗方案包括培美曲塞加或不加铂类、白蛋白结合型紫杉醇加或不加铂类及替吉奥以及吉西他滨/紫杉醇/多西紫杉醇加或不加铂类。各治疗方案每3周为1个周期,持续4个周期,然后维持治疗,直至受试者不能耐受或疾病进展。按RECIST1.1版评价疗效,按NCI-CTC4.0版评价不良反应。结果:28例受试者中,无完全缓解病例,部分缓解11例(39.3%),稳定16例(57.1%),进展1例(3.6%);客观缓解率为39.3%(11/28),疾病控制率为96.4%(27/28);中位无进展生存期为5个月,中位总生存期为10个月。亚组数据分析可见,贝伐珠单抗联合化疗各方案亚组中,培美曲塞方案受试者的中位无进展生存期为6个月,疗效最好,较其他各方案亚组有统计学差异(P=0.028)。安全性数据分析显示,与贝伐珠单抗相关的主要不良反应有Ⅰ~Ⅲ度高血压以及Ⅰ/Ⅱ度蛋白尿/出血/发热。结论:贝伐珠单抗联合化疗用于二线及以上治疗晚期非鳞型非小细胞肺癌的疗效较单纯化疗有一定改善,且毒副反应可耐受,对经济上可以接受的患者值得推荐使用。To investigate the efficacy and safety of bevacizumab combined with chemotherapy as secondor later-line treatment tbr advanced non-squamous non small cell lung cancer（NSCLC）. A total of 28 advanced non-squamous NSCLC patients confirmed by histopathology or cytology received bevacizumab combined with chemotherapy as second- or later-line treatment. On day 1, all patients received 7.5 mg ·kg -1 bevacizumab by intravenous infusion combined with chemotherapy including pemetrexed with or without platinum, nab-paclitaxel with or without platinum or S-I and gemcitabine/paclitaxel/docetaexed with or without platinum. The treatment course was repeated every three weeks, lasting four cycles. Then the maintenance treatment was continued, until the subjects cannot tolerate the combined therapy or disease progression. The efficacy was estimated by RICIST 1.1 standard and adverse reactions were estimated by NCI CTC 4.0 standard. In the 28 patients, there was no case with complete response; 11 cases（39.3%） had partial response, 16 cases（57.1%） had stable disease and 1 case（3.6%） had progressive disease; tbe objective response rate was 39.7% （11/28） and the disease control rate was 96.4% （27/28）; the median progression-free survival （PFS） was 5 months and the median overall survival（OS） was 10 months. Further sub group analysis showed that the median PFS from the subjects receiving bevacizumab combined pemetrexed with or without platinum regimen was 6 months, which was more effective than other combined chemotherapy regimens with statistically significant difference（p=0.028）. Sat^ty analysis showed that the major bevacizumab-related adverse reactions were Ⅰ/Ⅱ degree of hypertension and Ⅰ/Ⅱ degree of proteinuria/bleeding/fever. Only one case had Ⅲ degree hypertension, the rest of patients had Ⅰ/Ⅱ degree of hypertension, proteinuria, and bleeding with good toleration from the bevacizumab-related toxicities. Conclusion： Bevacizumab combined with chemotherapy exhibits higher activ

关 键 词：非鳞型非小细胞肺癌 贝伐珠单抗 联合化疗 

分 类 号：R734.2[医药卫生—肿瘤] R979.19[医药卫生—临床医学]