Cabozantinib versus everolimus in advanced renal-cell carcinoma

Toni K. Choueiri, Bernard Escudier, Thomas Powles, Paul N. Mainwaring, Brian I. Rini, Frede Donskov, Hans Hammers, Thomas E. Hutson, Jae Lyun Lee, Katriina Peltola, Bruce J. Roth, Georg A. Bjarnason, Lajos Geczi, Bhumsuk Keam, Pablo Maroto, Daniel Y C Heng, Manuela Schmidinger, Philip W. Kantoff, Anne Borgman-Hagey, Colin Hessel & 4 others Christian Scheffold, Gisela M. Schwab, Nizar M. Tannir, Robert J. Motzer

Research output: Contribution to journalArticle

Abstract

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

Original languageEnglish (US)
Pages (from-to)1814-1823
Number of pages10
JournalNew England Journal of Medicine
Volume373
Issue number19
DOIs
StatePublished - Nov 5 2015

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Renal Cell Carcinoma
Vascular Endothelial Growth Factor Receptor
Disease-Free Survival
Protein-Tyrosine Kinases
Everolimus
cabozantinib
Confidence Intervals
Survival
Pharmaceutical Preparations
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

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Choueiri, T. K., Escudier, B., Powles, T., Mainwaring, P. N., Rini, B. I., Donskov, F., ... Motzer, R. J. (2015). Cabozantinib versus everolimus in advanced renal-cell carcinoma. New England Journal of Medicine, 373(19), 1814-1823. https://doi.org/10.1056/NEJMoa1510016

Cabozantinib versus everolimus in advanced renal-cell carcinoma. / 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.; Geczi, 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.

In: New England Journal of Medicine, Vol. 373, No. 19, 05.11.2015, p. 1814-1823.

Research output: Contribution to journalArticle

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, DYC, Schmidinger, M, Kantoff, PW, Borgman-Hagey, A, Hessel, C, Scheffold, C, Schwab, GM, Tannir, NM & Motzer, RJ 2015, 'Cabozantinib versus everolimus in advanced renal-cell carcinoma', New England Journal of Medicine, vol. 373, no. 19, pp. 1814-1823. https://doi.org/10.1056/NEJMoa1510016
Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F et al. Cabozantinib versus everolimus in advanced renal-cell carcinoma. New England Journal of Medicine. 2015 Nov 5;373(19):1814-1823. https://doi.org/10.1056/NEJMoa1510016
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. ; Geczi, 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. / Cabozantinib versus everolimus in advanced renal-cell carcinoma. In: New England Journal of Medicine. 2015 ; Vol. 373, No. 19. pp. 1814-1823.
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AU - Choueiri, Toni K.

AU - Escudier, Bernard

AU - Powles, Thomas

AU - Mainwaring, Paul N.

AU - Rini, Brian I.

AU - Donskov, Frede

AU - Hammers, Hans

AU - Hutson, Thomas E.

AU - Lee, Jae Lyun

AU - Peltola, Katriina

AU - Roth, Bruce J.

AU - Bjarnason, Georg A.

AU - Geczi, Lajos

AU - Keam, Bhumsuk

AU - Maroto, Pablo

AU - Heng, Daniel Y C

AU - Schmidinger, Manuela

AU - Kantoff, Philip W.

AU - Borgman-Hagey, Anne

AU - Hessel, Colin

AU - Scheffold, Christian

AU - Schwab, Gisela M.

AU - Tannir, Nizar M.

AU - Motzer, Robert J.

PY - 2015/11/5

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N2 - 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

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