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索拉非尼TARGET试验在西班牙患者中的结果。

Sorafenib TARGET trial results in Spanish patients.

作者信息

Bellmunt J, González-Larriba J L, Climent M A, López-Vivanco G, Urruticoechea L, Albanell J

机构信息

Servicio de Oncología. Hospital General Universitari Vall d'Hebrón. Barcelona, Spain.

出版信息

Clin Transl Oncol. 2007 Oct;9(10):671-3. doi: 10.1007/s12094-007-0120-6.

DOI:10.1007/s12094-007-0120-6
PMID:17974528
Abstract

INTRODUCTION

Sorafenib improves progression-free survival in advanced clear-cell renal-cell carcinoma patients progressing to first-line therapy, as has been shown in the placebo-controlled international TARGET trial. The aim of this study is to report the results of the patients included in the Spanish centres in this trial.

PATIENTS AND METHODS

The records of the patients in the database of the TARGET trial have been reviewed. Data about progression-free survival, overall survival and toxicity have been collected in order to do this subpopulation analysis.

RESULTS

A total of 15 patients have been included (sorafenib arm 7, placebo arm 8). A trend to an improved progression-free survival in the sorafenib arm has been observed period Toxicity in the sorafenib arm has been manageable.

CONCLUSION

The analysis of these 15 patients has shown efficacy and toxicity results that follow the trend observed for the overall international population.

摘要

引言

在安慰剂对照的国际 TARGET 试验中已表明,索拉非尼可改善一线治疗进展后的晚期透明细胞肾细胞癌患者的无进展生存期。本研究的目的是报告该试验中西班牙中心纳入患者的结果。

患者与方法

回顾了 TARGET 试验数据库中患者的记录。为进行该亚组分析,收集了有关无进展生存期、总生存期和毒性的数据。

结果

共纳入 15 例患者(索拉非尼组 7 例,安慰剂组 8 例)。观察到索拉非尼组无进展生存期有改善趋势。索拉非尼组的毒性是可控的。

结论

对这 15 例患者的分析显示,疗效和毒性结果与国际总体人群观察到的趋势一致。

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本文引用的文献

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When you look matters: the effect of assessment schedule on progression-free survival.评估时间的重要性:评估时间表对无进展生存期的影响。
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Vascular endothelial growth factor (VEGF) inhibition--a critical review.血管内皮生长因子(VEGF)抑制作用——一项批判性综述。
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Sorafenib in advanced clear-cell renal-cell carcinoma.索拉非尼治疗晚期透明细胞肾细胞癌
Generalised erythematous skin eruptions induced by sorafenib: cutaneous toxicity and treatment outcome.
索拉非尼诱发的全身性红斑性皮肤疹:皮肤毒性和治疗结果
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Sorafenib (BAY 43-9006) inhibits tumor growth and vascularization and induces tumor apoptosis and hypoxia in RCC xenograft models.索拉非尼(BAY 43 - 9006)在肾细胞癌异种移植模型中可抑制肿瘤生长和血管生成,并诱导肿瘤凋亡和缺氧。
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Sorafenib (BAY 43-9006, Nexavar), a dual-action inhibitor that targets RAF/MEK/ERK pathway in tumor cells and tyrosine kinases VEGFR/PDGFR in tumor vasculature.索拉非尼(BAY 43-9006,多吉美),一种双靶点抑制剂,可作用于肿瘤细胞中的RAF/MEK/ERK通路以及肿瘤血管中的酪氨酸激酶VEGFR/PDGFR。
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Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma.索拉非尼用于转移性肾细胞癌患者的II期安慰剂对照随机停药试验。
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Phase I clinical and pharmacokinetic study of the Novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors.新型Raf激酶和血管内皮生长因子受体抑制剂BAY 43 - 9006用于晚期难治性实体瘤患者的I期临床和药代动力学研究。
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BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis.BAY 43 - 9006具有广谱口服抗肿瘤活性,作用于参与肿瘤进展和血管生成的RAF/MEK/ERK信号通路及受体酪氨酸激酶。
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End points and United States Food and Drug Administration approval of oncology drugs.肿瘤药物的终点指标及美国食品药品监督管理局的批准
J Clin Oncol. 2003 Apr 1;21(7):1404-11. doi: 10.1200/JCO.2003.08.072.
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Angiogenesis in renal cell carcinoma: Evaluation of microvessel density, vascular endothelial growth factor and matrix metalloproteinases.肾细胞癌中的血管生成:微血管密度、血管内皮生长因子及基质金属蛋白酶的评估
Int J Urol. 2002 Sep;9(9):509-14. doi: 10.1046/j.1442-2042.2002.00511.x.