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在转移性肾细胞癌患者中作为三线或四线治疗进行比较的 Tivozanib 与索拉非尼的 3 期研究的最终总生存结果。

Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma.

机构信息

Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.

Department of Oncology Medicine, Gustave Roussy Cancer Campus, Villejuif, France.

出版信息

Eur Urol. 2020 Dec;78(6):783-785. doi: 10.1016/j.eururo.2020.08.007. Epub 2020 Sep 13.

DOI:10.1016/j.eururo.2020.08.007
PMID:32938569
Abstract

Tivozanib is a potent and selective inhibitor of the VEGF receptor. In an open-label, randomized phase 3 trial, we compared tivozanib to sorafenib in patients with metastatic renal cell carcinoma (mRCC) who had received two or three prior therapies. We have previously reported that the study met its primary endpoint, demonstrating an improvement in progression-free survival with tivozanib versus sorafenib (5.6 mo vs 3.9 mo; hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.56-0.94; p=0.016). The current report reflects the final assessment of overall survival, showing no difference between treatment with tivozanib and sorafenib (HR 0.97, 95% CI 0.75-1.24). Given its activity and distinct tolerability profile, tivozanib represents a treatment option for patients with previously treated mRCC. PATIENT SUMMARY: We show that tivozanib, a targeted therapy, can delay tumor growth relative to an already approved targeted therapy (sorafenib) in patients with kidney cancer who have received two or three prior treatments. No difference in survival was observed.

摘要

替沃扎尼是一种强效且选择性的血管内皮生长因子受体抑制剂。在一项开放标签、随机 3 期临床试验中,我们比较了替沃扎尼与索拉非尼在既往接受过两种或三种治疗的转移性肾细胞癌(mRCC)患者中的疗效。我们之前报告过,该研究达到了其主要终点,与索拉非尼相比,替沃扎尼改善了无进展生存期(5.6 个月 vs 3.9 个月;风险比[HR]0.73,95%置信区间[CI]0.56-0.94;p=0.016)。本报告反映了总生存的最终评估结果,替沃扎尼与索拉非尼治疗之间无差异(HR 0.97,95%CI 0.75-1.24)。鉴于其活性和独特的耐受性特征,替沃扎尼为既往接受过治疗的 mRCC 患者提供了一种治疗选择。患者总结:我们发现,替沃扎尼(一种靶向治疗药物)可相对于已批准的靶向治疗药物(索拉非尼)延迟接受过两种或三种治疗的肾癌患者的肿瘤生长。未观察到生存差异。

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