دورية أكاديمية

Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma

التفاصيل البيبلوغرافية
العنوان: Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma
المؤلفون: Choueiri, Toni K, Escudier, Bernard, Powles, Thomas, Mainwaring, Paul N, Rini, Brian I, Donskov, Frede, Hammers, Hans, Hutson, Thomas E, Lee, Jae-Lyun, Peltola, Katriina, Roth, Bruce J, Bjarnason, Georg A, Géczi, Lajos, Keam, Bhumsuk, Maroto, Pablo, Heng, Daniel Y C, Schmidinger, Manuela, Kantoff, Philip W, Borgman-Hagey, Anne, Hessel, Colin, Scheffold, Christian, Schwab, Gisela M, Tannir, Nizar M, Motzer, Robert J
المصدر: Choueiri , T K , Escudier , B , Powles , T , Mainwaring , P N , Rini , B I , Donskov , F , Hammers , H , Hutson , T E , Lee , J-L , Peltola , K , Roth , B J , Bjarnason , G A , Géczi , L , Keam , B , Maroto , P , Heng , D Y C , Schmidinger , M , Kantoff , P W , Borgman-Hagey , A , Hessel , C , Scheffold , C , Schwab , G M , Tannir ....
سنة النشر: 2015
المجموعة: Aarhus University: Research
مصطلحات موضوعية: Adult, Aged, 80 and over, Anilides, Antineoplastic Agents, Carcinoma, Renal Cell, Disease-Free Survival, Everolimus, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Pyridines, Quality of Life, Sirolimus, Survival Analysis
الوصف: BACKGROUND: Cabozantinib is an oral, small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR) as well as MET and AXL, each of which has been implicated in the pathobiology of metastatic renal-cell carcinoma or in the development of resistance to antiangiogenic drugs. This randomized, open-label, phase 3 trial evaluated the efficacy of cabozantinib, as compared with everolimus, in patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy. METHODS: We randomly assigned 658 patients to receive cabozantinib at a dose of 60 mg daily or everolimus at a dose of 10 mg daily. The primary end point was progression-free survival. Secondary efficacy end points were overall survival and objective response rate. RESULTS: Median progression-free survival was 7.4 months with cabozantinib and 3.8 months with everolimus. The rate of progression or death was 42% lower with cabozantinib than with everolimus (hazard ratio, 0.58; 95% confidence interval [CI] 0.45 to 0.75; P<0.001). The objective response rate was 21% with cabozantinib and 5% with everolimus (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.).
نوع الوثيقة: article in journal/newspaper
اللغة: English
DOI: 10.1056/NEJMoa1510016
الإتاحة: https://doi.org/10.1056/NEJMoa1510016Test
https://pure.au.dk/portal/da/publications/cabozantinib-versus-everolimus-in-advanced-renalcell-carcinomaTest(9df00135-0dbb-4d69-8804-43d5232e7abc).html
حقوق: info:eu-repo/semantics/restrictedAccess
رقم الانضمام: edsbas.1A9CF9E4
قاعدة البيانات: BASE