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Retrospective Analysis of the Efficacy and Safety of Sorafenib in Chinese Patients With Metastatic Renal Cell Carcinoma and Prognostic Factors Related to Overall Survival
Yu, Xiaoteng1; Guo, Gang2; Li, Xuesong1; Zhang, Cuijian1; Huang, Lihua1; Fang, Dong1; Song, Yi1; Zhang, Xu2; Zhou, Liqun1
刊名MEDICINE
2015-08-01
DOI10.1097/MD.0000000000001361
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
引用统计
被引频次:5[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/55291
专题北京大学第一临床医学院_泌尿外科
北京大学医学部管理机构_设备与实验室管理处
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
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GB/T 7714
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.
APA Yu, Xiaoteng.,Guo, Gang.,Li, Xuesong.,Zhang, Cuijian.,Huang, Lihua.,...&Zhou, Liqun.(2015).Retrospective Analysis of the Efficacy and Safety of Sorafenib in Chinese Patients With Metastatic Renal Cell Carcinoma and Prognostic Factors Related to Overall Survival.MEDICINE,94(34),1-8.
MLA Yu, Xiaoteng,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".MEDICINE 94.34(2015):1-8.
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