Cabozantinib与依维莫司在晚期肾细胞癌中的比较。
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Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F, Hammers H, Hutson TE, Lee JL, Peltola K, Roth BJ, Bjarnason GA, Geczi L, Keam B, Maroto P, Heng DY, Schmidinger M, Kantoff PW, Borgman-Hagey A, Hessel C, Scheffold C, Schwab GM, Tannir NM, Motzer RJ
Cabozantinib与依维莫司在晚期肾细胞癌中的比较。
中华外科杂志2015年11月5日;373(19):1814-23。doi: 10.1056 / NEJMoa1510016。Epub 2015 9月25日。
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26406150 (PubMed视图］
- 摘要
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背景:Cabozantinib是一种口服小分子酪氨酸激酶抑制剂，靶向血管内皮生长因子受体(VEGFR)以及MET和AXL，其中每一种都与转移性肾细胞癌的病理生物学或抗血管生成药物的发展有关。这项随机、开放标签的3期临床试验评估了cabozantinib与依维莫司在vegfr靶向治疗后进展的肾细胞癌患者中的疗效。方法:我们随机分配658例患者接受cabozantinib剂量60mg / d或依维莫司剂量10mg / d。主要终点为无进展生存期。次要疗效终点为总生存期和客观缓解率。结果:cabozantinib组中位无进展生存期为7.4个月，依维莫司组为3.8个月。与依维莫司相比，cabozantinib组的进展率或死亡率降低42%(危险比，0.58;95%置信区间[CI] 0.45至0.75;P < 0.001)。cabozantinib和everolimus的客观有效率分别为21%和5% (P<0.001)。 A planned interim analysis showed that overall survival was longer with cabozantinib than with everolimus (hazard ratio for death, 0.67; 95% CI, 0.51 to 0.89; P=0.005) but did not cross the significance boundary for the interim analysis. Adverse events were managed with dose reductions; doses were reduced in 60% of the patients who received cabozantinib and in 25% of those who received everolimus. Discontinuation of study treatment owing to adverse events occurred in 9% of the patients who received cabozantinib and in 10% of those who received everolimus. CONCLUSIONS: Progression-free survival was longer with cabozantinib than with everolimus among patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy. (Funded by Exelixis; METEOR ClinicalTrials.gov number, NCT01865747.).
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