重组人血管内皮抑素联合同步放化疗治疗局部晚期非小细胞肺癌的随机对照临床研究  

A randomized clinical trail of endostar combined with concurrent chemoradiotherapy in treatment of local advanced non-small cell lung cancer

作　　者：马家宝[1] 杨家林[1] 李志琳[1] 李日方[1] 黄丹丹[1] 颜高姝[1] 王冀川[1] 郎锦义[1] 

机构地区：[1]四川省肿瘤医院放疗科,四川成都610041

出　　处：《实用临床医药杂志》2009年第11期20-24,共5页Journal of Clinical Medicine in Practice

摘　　要：目的探索恩度联合同步放化疗治疗局部晚期非小细胞肺癌（NSCLC）的临床疗效、毒副反应及耐受性。方法经过病理组织学或细胞学检查确诊的局部晚期（ⅢA、ⅢB）非小细胞肺癌患者46例，随机分成同步放化疗联合恩度治疗组（试验组23例）和同步放化疗组（对照组23例）。采用调强放疗技术对肿瘤区域以及累及淋巴结区域进行放疗，总剂量DT60～76Gy／30-38次，共6-8周。同步化疗长春瑞滨20mg／m^2第1、8d，顺铂30mg／m^2第1～3天，21-28d为1个周期，共3～4个周期。重组人血管内皮抑素15mg／d，第1～14天连续给药，与化疗同步进行。按照RECIST标准评价近期疗效，参照Kamofsky评分（KPS）变化评价生活质量（QoL），按照NCICUL；3．0版标准评价毒性反应。结果试验组和对照组总有效率（CR＋PR）分别为78．3％（18／23）和69．6％（16／23）（P〉0．05），QoL改善稳定率为86．9％（20／23）和82．6％（19／23）（P〉0．05）。1年的生存率分别为74．1％（17／23）和65．5％（15／23），1年无进展生存率为56．7％（13／23）和52．3％（12／23），1年的局部控制率为78．3％（18／23）和65，4％（15／23）（P〉0．05）。主要毒副反应是骨髓抑制和消化道反应，试验组中4例患者出现暂时性的心电图改变，经过对症处理后均能够恢复正常。结论恩度联合同步放化疗组具有良好的近期疗效，能够改善或稳定生活质量，毒性较低，安全性和耐受性比较好，其1年生存率、1年无进展生存率以及1年局控率较单纯同步放化疗均有所提高，但是差异无统计学意义。Objective Endostar（endostar, Endostatin, and plays a key role in antiangiogenesis YH-16） is a new type of recombinant human through the inhibition of migration of neovascularization endothelial cells. The aim of this study is to evaluate the effects, toxicities and tolerance of concurrent chemoradiotherapy combined with or without Endostar for local advanced non-small cell lung cancer （NSCLC）. Methods A total of 46 patients were randomly divided into experimental group（ n = 23） and control group（ n = 23）. The patients were given intensity-modulated radiotherapy（ IMRT）, the dose of primary tumors and involved lymph nodes was 60-76 Gy/30-38 f/6- 8 w. Concurrently they were administrated chemotherapy with or without endostar. Vinorelbine 20 mg/m^2 on day 1 and 8, DDP 30 mg/m^2 on day 1-3, the chemotherapy was repeated every 21-28 days as a cycle. The endostar was given 15 mg/d from day 1 to day 14 simultaneously. The efficacy was evaluated according to RECIST criteria , quality of life （ QOL ） was evaluated by karnofsky safety was evaluated according to NCI CTC 3 . 0 version criteria . Results The overall response rate was 78.3 % in the experimental group and 69.6% in the control group respectively （P〉0.05）. The rates of improved and stabled QoL were 86.9% and 82.6% （P〉0.05） respectively. The 1-year overall survival rate was 74.1% and 65.5 %, 1-year local progression-free survival rate was 56.7% and 52.3%, 1-year local control rate was 78.3% and 65.4% （P 〉0.05）. The main toxicities were marrow suppression and gastrointestinal symptoms. Transient electrocardiogram changes occurred in 4 cases of the experimental group. The symptoms could be well controlled by clinical intervention. Conclusion Endostar combined with concurrent chemoradiotherapy is effective for local advanced NSCLC and can improve the quality of life. Also it is lowtoxic and tolerable. The 1-year survival rate, 1-year progression-free survival rate and 1-year local control rate of the experimental group is high

关 键 词：肺肿瘤 内皮抑素 放射治疗 抗肿瘤血管形成 

分 类 号：R734.2[医药卫生—肿瘤] R730.53[医药卫生—临床医学]