重组人血管内皮抑素联合TP方案治疗晚期非小细胞肺癌的临床研究  

Clinical Study of the rh-endostatin combined with TP regimen for advanced non-small cell lung cancer

作　　者：杨润祥[1] 任宏轩[1] 庄莉[1] 高春林[1] 杨冠勤[1] 董超[1] 

机构地区：[1]云南省肿瘤医院内二科,昆明650118

出　　处：《临床肿瘤学杂志》2010年第5期453-456,共4页Chinese Clinical Oncology

摘　　要：目的观察重组人血管内皮抑素注射液(恩度)联合TP方案治疗晚期非小细胞肺癌(NSCLC)的近期疗效和安全性。方法经病理组织学或细胞学检查确诊的ⅢB～Ⅳ期NSCLC患者39例,其中鳞癌14例,腺癌20例,腺鳞癌5例;ⅢB期14例,Ⅳ期25例;有脑转移10例,肝转移10例,均接受恩度联合TP方案治疗。恩度15mg加入生理盐水500ml静滴3～4小时,第1～14天连续给药,间歇7天重复,同时联合紫杉醇(PTX)150mg/m2d1,顺铂(DDP)75mg/m2d2～d4,分3次给药,21天重复。参照WHO标准观察和评价近期客观疗效;参考KPS评分以及患者临床症状缓解情况评价患者的生活质量;根据NCICTC3.0版标准评价药物毒副反应。治疗1周期评价毒性,2周期评价疗效。结果 39例患者均可评价客观疗效和药物毒副反应。获得CR2例,PR10例,MR10例,SD11例,PD6例,即客观有效率(RR)30.8%(12/39),疾病控制率(DCR)84.6%(33/39);其中肝转移病灶CR4例,PR5例,MR1例,RR90.0%,脑转移病灶PR3例,MR3例,SD4例,RR30.0%。3～4级毒性主要与化疗药物有关,包括白细胞减少17.64%、粒细胞减少21.56%和恶心呕吐3.92%。轻度感觉异常和肌肉酸痛发生率较高,主要与紫杉醇有关。疲乏和腹痛发生率分别为41.10%、35.29%,均为轻度。心电图上T波和ST-T改变为33.33%,窦性心动过速27.45%。少见毒副反应包括发热1.96%、过敏反应3.92%和色素沉着7.84%。结论恩度与TP方案联合治疗晚期NSCLC具有良好疗效,可改善患者的生活质量,毒性低,安全性和耐受性好,尤其在治疗肝、脑转移灶中显示出较好的疗效,但病例数少,值得临床上进一步试用。Objective To study the safety and the short term effects of rh-endostatin combined with the TP regimen in advanced non-small cell lung cancer.Methods Thirty-nine cases with ⅢB-Ⅳ stage non-small cell lung cancer confirmed by histopathology or cytopathology were enrolled in the study and were given intravenous drip of endostar combined with the TP regimen.Fourteen patients were squamous cell arcinoma,20 were adenocarcinoma,and 5 were adenosquamous carcinoma;and 14 of them were of the ⅢB stage while the other 25 were of the Ⅳ stage.In addition,10 of them were diagnosed as brain metastasis and other 10 as liver metastasis.In this study,15mg of endostar dissolved in 500ml of normal saline was slowly intravenously dropped three to four hours from day 1 to day 14,repeated after 7 days.Meanwhile paclitaxel and cisplatin were also applied,and their dosages and usages were specified as follows：150mg/m2of paclitaxel was given on the first day;for the next three days 75mg/m2 d2-4 of cisplatin were applied;the combined regimen was repeated every 21 days.During the treatment,the efficacy was evaluated strictly after 2 cycles according to WHO criteria,safety was evaluated after 1 cycle according to NCI CTC3.0 version criteria.Otherwise the quality of life（QOL）was evaluated according to karnofsky scores and the alleviation and the well-being of the patients.Total 102 cycles have been completed.Results Assessable effects of the treatment and the toxic effect obtained in each of the 39 cases were detailed as 2 cases of CR,10 cases of PR,10 cases of MR,11 cases of SD and 6 cases of PD,with an objective response rate（RR） of 30.8%（12/39） and disease control rate（DCR） of 84.6%（33/39）.Specifically,for the 4 cases of CR with foci of liver metastasis,5 cases of PR,1 case of MR,the RR was 90.0%;for the 3 cases of PR with foci of brain metastasis,3 cases of MR,and the 4 cases of SD,the RR was 30.0%.The toxic effects of G3/4 were mainly connection with the chemotherapy agents,especially the paclitaxel,include a

关 键 词：重组人血管内皮抑制素/恩度 非小细胞肺癌 联合治疗 疗效 

分 类 号：R734.2[医药卫生—肿瘤]