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学科主题: 临床医学
题名:
Retrospective Analysis of the Efficacy and Safety of Sorafenib in Chinese Patients With Metastatic Renal Cell Carcinoma and Prognostic Factors Related to Overall Survival
作者: Yu, Xiaoteng1; Guo, Gang2; Li, Xuesong1; Zhang, Cuijian1; Huang, Lihua1; Fang, Dong1; Song, Yi1; Zhang, Xu2; Zhou, Liqun1
刊名: MEDICINE
发表日期: 2015-08-01
DOI: 10.1097/MD.0000000000001361
卷: 94, 期:34, 页:1-8
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: PHASE-II TRIAL ; FACTOR-TARGETED THERAPY ; JAPANESE PATIENTS ; ASIAN PATIENTS ; LONG-TERM ; SUNITINIB ; CANCER ; TOXICITIES ; GUIDELINES ; 1ST-LINE
英文摘要:

Sorafenib has been recommended as first- or second-line treatment for metastatic renal cell carcinoma (mRCC) by several guidelines. The objective of this study is to evaluate the efficacy of sorafenib monotherapy in Chinese patients with mRCC and determine the prognostic clinicopathologic factors associated with survival in these patients.This is a single-arm retrospective study conducted in 2 tertiary medical centers; 140 mRCC patients were enrolled between January 2007 and June 2014. Sorafenib was administered at a dose of 400mg twice daily, and continued until disease progression, at which point the dose was increased to 600 or 800mg twice daily, or the onset of an intolerable adverse drug event (ADE) that required dose reduction or temporary suspension of treatment.The primary endpoint was overall survival (OS), and the secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety.The median follow-up time was 32 months. The median OS and PFS were 24 months (range, 3-88 months) and 16 months (range, 0-88 months), respectively. Patients with clear cell carcinoma had a greater OS (P=0.001) whereas sarcomatoid differentiation (P=0.045) and disease progression (P=0.010) negatively impacted OS; time from kidney surgery or biopsy to initiation of sorafenib treatment was associated with PFS (P=0.027). Efficacy analysis revealed that 3 (2.1%) patients achieved complete responses, 28 (20.0%) patients experienced partial responses, 88 (62.9%) patients had stable disease, and 21 (15.0%) patients developed progressive disease. Moreover, the ORR was 22.1%, and the DCR was 85.0%. Most ADEs were classified as grades 1 or 2 with only 14 (10.0%) patients experiencing a severe ADE (grade 3).Sorafenib monotherapy can achieve promising OS and PFS for Chinese patients with mRCC, especially in those with clear cell carcinoma, with manageable adverse events.

语种: 英语
WOS记录号: WOS:000363547800001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/55291
Appears in Collections:北京大学第一临床医学院_泌尿外科_期刊论文

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作者单位: 1.Peking Univ, Dept Urol, Hosp 1, Inst Urol,Natl Urol Canc Ctr, Beijing 100034, Peoples R China
2.Chinese Peoples Liberat Army Gen Hosp, Dept Urol, State Key Lab Kidney Dis, Beijing, Peoples R China

Recommended Citation:
Yu, Xiaoteng,Guo, Gang,Li, Xuesong,et al. Retrospective Analysis of the Efficacy and Safety of Sorafenib in Chinese Patients With Metastatic Renal Cell Carcinoma and Prognostic Factors Related to Overall Survival[J]. MEDICINE,2015,94(34):1-8.
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