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《Chinese Journal of Lung Cancer》 2005-04
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Results of randomized, multicenter, double-blind phase Ⅲ trial of rh-endostatin (YH-16) in treatment of advanced non-small cell lung cancer patients

WANG Jinwan, SUN Yan, LIU Yongyu, YU Qitao, ZHANG Yiping, LI Kai, ZHU Yunzhong, ZHOU Qinghua, HOU Mei, GUAN Zhongzhen, LI Weilian, ZHUANG Wu, WANG Donglin, LIANG Houjie, QIN Fengzhan, LU Huishan, LIU Xiaoqing, SUN Hong, ZHANG Yanjun, WANG Jiejun, LUO Suxia, YANG Ruihe, TU Yuanrong, WANG Xiuwen, SONG Shuping, ZHOU Jingmin, YOU Lifen, WANG Jing, YAO Chen.  Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, P.R.China  
Background and objective Endostar TM (rh-endostatin, YH-16) is a new recombinant human endostatin developed by Medgenn Bioengineering Co. Ltd., Yantai, Shandong, P.R.China. Pre-clinical study indicated that YH-16 could inhibit tumor endothelial cell proliferation, angiogenesis and tumor growth. Phase Ⅰ and phase Ⅱ studies revealed that YH-16 was effective as single agent with good tolerance in clinical use.The current study was to compare the response rate , median ti me to progression (TTP) ,clinical benefit andsafety in patients with advanced non-small cell lung cancer ( NSCLC) , who were treated with YH-16 plus vi-norelbine and cisplatin (NP) or placebo plus NP.Methods Four hundred and ninety-three histologically or cy-tologically confirmed stage ⅢB and Ⅳ NSCLC patients , withlife expectancy 3 months and ECOG perform-ance status 0--2 , were enrolledin a randomized ,double-blind ,placebo-controlled , multicenter trial ,either trialgroup : NP plus YH-16 (vinorelbine 25 mg/ m2on day 1 and day 5 ,cisplatin 30 mg/ m2on days 2 to 4 , YH-167 .5 mg/ m2on days 1 to 14) or control group : NP plus placebo (vinorelbine 25 mg/ m2on day 1 and day 5 ,cis-platin 30 mg/ m2on days 2 to 4 ,0 .9 %sodium-chloride 3 .75 ml on days 1 to 14) every 3 weeks for 2--6 cycles .The trial endpoints included response rate ,clinical benefit rate ,ti me to progression,quality of life and safety .Results Of 486 assessable patients , overall response rate was 35 .4 %in trial group and 19 .5 %in controlgroup (P=0 .0003) . The median TTP was 6 .3 months and 3 .6 months for trial group and control group re-spectively (P0 .001) . The clinical benefit rate was 73 .3 %in trial group and 64 .0 %in control group (P=0 .035) .In untreated patients of trial group and control group ,the response rate was 40 .0 %and 23 .9 %(P=0 .003) ,the clinical benefit rate was 76 .5 % and 65 .0 % (P=0 .023) ,the median TTP was 6 .6 and 3 .7months (P=0 .0000) ,respectively .In pretreated patients of trial group and control group ,the response ratewas 23 .9 %and 8 .5 %(P=0 .034) ,the clinical benefit rate was 65 .2 %and 61 .7 %(P=0 .68) ,the medianTTP was 5 .7 and 3 .2 months (P=0 .0002) ,respectively . The relief rate of clinical symptoms in trial groupwas higher than that of those in control group ,but no significance existed (P0 .05) . The score of quality oflife in trial group was significantly higher than that in control group (P=0 .0155) after treat ment . There wereno significant differences in incidence of hematologic and non-hematologic toxicity , moderate and severe sideeffects betweentrial group and control group .Conclusion The addition of YH-16 to NPregi men results in sig-nificantly and clinically meaningful i mprovement in response rate , medianti me to tumor progression,and clini-cal benefit rate compared with NP alonein advanced NSCLC patients . YH-16 in combination with chemothera-py shows a synergic activity and a favorable toxic profile in advanced cancer patients .
【CateGory Index】: R734.2
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