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学科主题: 临床医学
题名:
A Multicenter, Randomized Clinical Trial Comparing the Three-Weekly Docetaxel Regimen plus Prednisone versus Mitoxantone plus Prednisone for Chinese Patients with Metastatic Castration Refractory Prostate Cancer
作者: Zhou, Tie1; Zeng, Shu-xiong1; Ye, Ding-wei2; Wei, Qiang3; Zhang, Xu4; Huang, Yi-ran5; Ye, Zhang-qun6; Yang, Yong7; Zhang, Wei8; Tian, Ye9; Zhou, Fang-jian10; Jie, Jin11; Chen, Shi-ping12; Sun, Yan13; Xie, Li-ping14; Yao, Xing15; Na, Yan-qun16; Sun, Ying-hao1
刊名: PLOS ONE
发表日期: 2015-01-27
DOI: 10.1371/journal.pone.0117002
卷: 10, 期:1
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Multidisciplinary Sciences
研究领域[WOS]: Science & Technology - Other Topics
关键词[WOS]: CHANGING THERAPEUTIC LANDSCAPE ; PHASE-II ; WORKING GROUP ; DOUBLE-BLIND ; EFFICACY ; ANTIGEN ; RECOMMENDATIONS ; GUIDELINES ; SURVIVAL ; TAX-327
英文摘要:

Purpose

To explore the feasibility and efficacy of docetaxel plus prednisone for Chinese population with metastatic castration refractory prostate cancer (mCRPC).

Patients and methods

A total of 228 patients recruited from 15 centers were randomized to receive 10 cycles of D3P arm (docetaxel: 75 mg/m(2), intravenous infusion, every three weeks; Prednisone 10mg orally given daily) or M3P arm (mitoxantrone: 12 mg/m(2), intravenous infusion, every three weeks; Prednisone 10mg orally given daily). Primary end point was overall survival, and secondary end points were events progression-free survival (PFS), response rate, response duration. Quality of life (QoL) was also assessed in both treatment groups.

Results The median overall survival was 21.88 months in D3P arm and 13.67 months in M3P arm (P = 0.0011, hazard ratio = 0.63, 95% confidence interval, 0.46-0.86). Subgroup analysis was consistent with the results of overall analysis. Events progression-free survival (pain, PSA, tumor and disease) were significantly improved in D3P arm compared with M3P arm. PSA response rate was 35.11% for patients treated by D3P arm and 19.39% for M3P arm (P = 0.0155). Pain response rate was higher in D3P arm (61.11%, P = 0.0011) than in M3P (23.08%) arm. No statistical differences were found between D3P arm and M3P arm for QoL, tumor response rate and response duration of PSA and pain. The tolerability and overall safety of D3P arm were generally comparable to that of M3P arm.

Conclusions

Compared with M3P arm, D3P arm significantly prolonged overall survival for the Chinese patients with mCRPC and improved the response rate for PSA and pain.

语种: 英语
所属项目编号: 2012ZX09303011-002
项目资助者: Sanofi-Aventis company ; Changhai hospital GCP platform
WOS记录号: WOS:000348821400026
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/51605
Appears in Collections:北京大学临床肿瘤学院_泌尿外科_期刊论文

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作者单位: 1.Peking Univ, Hosp 1, Dept Urol, Beijing 100871, Peoples R China
2.Fujian Union Hosp, Dept Urol, Fuzhou, Peoples R China
3.Second Mil Med Univ, Changhai Hosp, Dept Urol, Shanghai 200433, Peoples R China
4.Fudan Univ, Dept Urol, Shanghai Canc Ctr, Shanghai 200433, Peoples R China
5.Sichuan Univ, Dept Urol, West China Hosp, West China Sch Med, Chengdu 610064, Peoples R China
6.Chinese PLA, Sch Med, Chinese PLA Gen Hosp, Dept Urol, Beijing, Peoples R China
7.Shanghai Jiao Tong Univ, Sch Med, Dept Urol, Renji Hosp, Shanghai 200030, Peoples R China
8.Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Urol, Wuhan 430074, Peoples R China
9.Peking Univ, Beijing Canc Hosp, Dept Urol, Beijing 100871, Peoples R China
10.Nanjing Med Univ, Jiangsu Prov Hosp, Dept Urol, Nanjing, Jiangsu, Peoples R China
11.Capital Med Univ, Beijing Friendship Hosp, Dept Urol, Beijing, Peoples R China
12.Sun Yat Sen Univ, Canc Hosp, Dept Urol, Guangzhou 510275, Guangdong, Peoples R China
13.Chinese Acad Med Sci, Canc Hosp, Dept Urol, Beijing 100730, Peoples R China
14.Zhejiang Univ, Affiliated Hosp 1, Dept Urol, Hangzhou 310003, Zhejiang, Peoples R China
15.Tianjin Med Univ, Tianjin Canc Hosp, Dept Urol, Tianjin, Peoples R China
16.Peking Univ, Dept Urol, Shougang Hosp, Beijing 100871, Peoples R China

Recommended Citation:
Zhou, Tie,Zeng, Shu-xiong,Ye, Ding-wei,et al. A Multicenter, Randomized Clinical Trial Comparing the Three-Weekly Docetaxel Regimen plus Prednisone versus Mitoxantone plus Prednisone for Chinese Patients with Metastatic Castration Refractory Prostate Cancer[J]. PLOS ONE,2015,10(1).
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