摘要
目的 ：探讨贝伐单抗联合化疗一线治疗晚期非鳞状细胞型非小细胞肺癌患者的安全性和有效性。本研究为SAiL研究中国上海市肺科医院的研究结果。方法 ：2007年7月—2008年3月招募44例晚期非鳞状细胞型非小细胞肺癌44例,临床分期为ⅢB～Ⅳ期,美国东部肿瘤协作组体能状况评分为0~1分,血液学和肝肾功能正常。贝伐单抗（每3周给药1次,每次15 mg/kg）联合紫杉醇/卡铂化疗（每3周重复1次,最多化疗6个周期）。化疗结束后获得完全缓解、部分缓解或疾病稳定的患者继续接受贝伐单抗单药维持治疗,直至疾病进展。主要研究终点为安全性,次要研究终点包括疾病进展时间和总生存时间。结果 ：44例患者中,3级以上贝伐单抗相关不良反应发生率为13.6%,其中常见的为蛋白尿（7%）、高血压（2%）和咯血（2%）,其中1例因咯血死亡。23例（52.3%）为部分缓解,20例（45.5%）为疾病稳定,1例（2.3%）为疾病进展,疾病控制率为97.7%。中位疾病进展时间为8.13个月,中位总生存时间为17.73个月。结论 ：晚期非鳞状细胞型非小细胞肺癌患者接受贝伐单抗治疗的耐受性较好,可明显延长疾病进展时间和总生存期。本研究未观察到新的贝伐单抗相关不良反应。
Objective： To assess the safety and efficacy of first-line bevacizumab combined with standard chemotherapy regimen in patients with advanced non-squamous non-small cell lung cancer. This report presents the result of a preplanned subanalysis of Shanghai Pulmonary Hospital＇s patients enrolled in SAiL study. Methods： Between July 2007 and March 2008, 44 patients with untreated locally advanced, metastatic, or recurrent non-squamous non-small cell lung cancer were recruited into this phase 4 study. Eligible patients had histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent disease （stages ⅢB-Ⅳ）; an Eastern Cooperative Oncology Group performance status score of 0-1; and adequate haematological, hepatic, and renal functions. Patients received bevacizumab （15 mg/kg every 3 weeks） plus standard chemotherapy （paclitaxeI-carboplatin） every 3 weeks for up to six cycles, followed by single-agent bevacizumab until disease progression. The primary endpoint was safety, and the secondary end points included time to disease progression and overall survival. Results： The rates of clinically significant adverse events （≥ grade 3） of special interest were relatively low in this population （13.6%）; proteinuria （7%）, hypertension （2%） and bleeding （2%） were the most common adverse events. One patient died because of hemoptysis. The partial remission and stable disease rates were 52.3% （23/44） and 45.5% （20/44）, respectively. One patient had progressive disease. The disease control rate was 97.7%. The median time to progression was 8.13 months, and the median overall survival was 1 7.73 months. Conclusion： The safety and efficacy of first-line bevacizumab- based treatment in Shanghai Pulmonary Hospital＇s patients with non-squamous non-small cell lung cancer is satisfying with benefits in time to progression and overall survival. There were no new safety signals to be reported.
出处
《肿瘤》
CAS
CSCD
北大核心
2013年第12期1081-1086,共6页
Tumor
关键词
癌
非小细胞肺
贝伐单抗
安全性
临床研究
Carcinoma, non-small cell lung
Bevacizumab
Safety
Clinical study
