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学科主题: 临床医学
题名:
Long-term results of a randomized, double-blind, and placebo-controlled phase III trial: Endostar (rh-endostatin) versus placebo in combination with vinorelbine and cisplatin in advanced non-small cell lung cancer
作者: Sun, Yan1; Wang, Jin Wan1; Liu, Yong Yu2; Yu, Qi Tao3; Zhang, Yi Ping4; Li, Kai5; Xu, Li Yan6; Luo, Su Xia7; Qin, Feng Zhan8; Chen, Zheng Tang9; Liu, Wen Chao10; Zhou, Qing Hua11; Chen, Qiang12; Nan, Ke Jun13; Liu, Xiao Qing14; Liu, Wei15; Liang, Hou Jie16; Lu, Hui Shan17; Wang, Xiu Wen18; Wang, Jie Jun19; Song, Shu Ping20; Tu, Yuan Rong21; Zhou, Jing Min22; Li, Wei Lian23; Yao, Chen24; Endostar Phase III NSCLC Study Grp
关键词: Advanced and relapsed NSCLC ; angiogenesis inhibitor ; Endostar ; NP regimen ; recombinant human endostatin ; survival benefit
刊名: THORACIC CANCER
发表日期: 2013-11-01
DOI: 10.1111/1759-7714.12050
卷: 4, 期:4, 页:440-448
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology ; Respiratory System
研究领域[WOS]: Oncology ; Respiratory System
关键词[WOS]: RECOMBINANT HUMAN ENDOSTATIN ; ANGIOGENIC FACTORS ; COLORECTAL-CANCER ; BREAST-CANCER ; TUMOR-GROWTH ; BEVACIZUMAB ; PACLITAXEL ; THERAPY ; CHEMOTHERAPY ; ANGIOSTATIN
英文摘要:

Background:Phase II-III trials in patients with untreated and previously treated locally advanced or non-small cell lung cancer (NSCLC) suggested that Endostar was able to enhance the effect of platinum-based chemotherapy (NP regimen) with tolerable adverse effects.

MethodsFour hundred and eighty six patients were randomized into two arms: study arm A: NP plus Endostar (n = 322; vinorelbine, cisplatin, Endostar), and study arm B: NP plus placebo (n = 164; vinorelbine, cisplatin, 0.9% sodium chloride). Patients were treated every third week for two to six cycles.

Results:Overall response rates were 35.4% in arm A and 19.5% in arm B (P = 0.0003). The median time to progression was 6.3 months for arm A and 3.6 months for B, respectively (P < 0.001). The clinical benefit rates were 73.3% in arm A and 64.0% in arm B (P = 0.035). Grade 3/4 neutropenia, anemia, and nausea/vomiting were 28.5%, 3.4%, and 8.0%, respectively, in Arm A compared with 28.2%, 3.0%, and 6.6%, respectively, in Arm B (P > 0.05). There were two treatment related deaths in arm A and one in arm B (P > 0.05). The median overall survival was longer in arm A than in arm B (P < 0.0001).

Conclusion:Long-term follow-up revealed that the addition of Endostar to an NP regimen can result in a significant clinical and survival benefit in advanced NSCLC patients, compared with NP alone.

语种: 英语
项目资助者: Simcere-Medgenn Bioengineering Co.
WOS记录号: WOS:000326166200015
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/58177
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.3rd PLA Med Univ, Xinan Hosp, Chongqing, Peoples R China
2.Fujian Med Univ, Union Hosp, Fuzhou, Peoples R China
3.Liaoning Prov Canc Hosp, Shenyang, Peoples R China
4.Zhejiang Prov Canc Hosp, Hengzhou, Peoples R China
5.Tianjin Canc Hosp, Tianjin, Peoples R China
6.Thorac Tumor Hosp, Beijing, Peoples R China
7.Shandong Univ, Qilu Hosp, Jinan 250100, Peoples R China
8.Shandong Prov Canc Hosp, Jinan, Peoples R China
9.Fujian Med Univ, Hosp 1, Fuzhou, Peoples R China
10.Henan Prov Canc Hosp, Zhengzhou, Peoples R China
11.Tianjin Chest Hosp, Tianjin, Peoples R China
12.Tianjin 2nd Hosp, Tianjin, Peoples R China
13.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
14.Fujian Med Univ, Canc Hosp, Fuzhou, Peoples R China
15.Xian Commun Univ, Hosp 1, Xian, Peoples R China
16.Hebei Prov Canc Hosp, Shijiazhuang, Peoples R China
17.Anhai Prov Canc Hosp, Hefei, Peoples R China
18.3rd PLA Med Univ, Xianqiao Hosp, Chongqing, Peoples R China
19.4th PLA Med Univ, Xijing Hosp, Xian, Peoples R China
20.Sichun Univ, Huaxi Hosp, Chengdu, Peoples R China
21.Chinese Acad Med Sci, Canc Hosp, Beijing 100021, Peoples R China
22.Guangxi Med Univ, Canc Hosp, Nanning, Guangxi, Peoples R China
23.Acad Mil Med Sci, Hosp 307, Beijing, Peoples R China
24.2nd PLA Med Univ, Changzheng Hosp, Shanghai, Peoples R China

Recommended Citation:
Sun, Yan,Wang, Jin Wan,Liu, Yong Yu,et al. Long-term results of a randomized, double-blind, and placebo-controlled phase III trial: Endostar (rh-endostatin) versus placebo in combination with vinorelbine and cisplatin in advanced non-small cell lung cancer[J]. THORACIC CANCER,2013,4(4):440-448.
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