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Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma

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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; 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; METEOR Investigators.

in: NEW ENGL J MED, Jahrgang 373, Nr. 19, 05.11.2015, S. 1814-23.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Choueiri, TK, Escudier, B, Powles, T, Mainwaring, PN, Rini, BI, Donskov, F, Hammers, H, Hutson, TE, Lee, J-L, Peltola, K, Roth, BJ, Bjarnason, GA, Géczi, L, Keam, B, Maroto, P, Heng, DYC, Schmidinger, M, Kantoff, PW, Borgman-Hagey, A, Hessel, C, Scheffold, C, Schwab, GM, Tannir, NM, Motzer, RJ & METEOR Investigators 2015, 'Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma', NEW ENGL J MED, Jg. 373, Nr. 19, S. 1814-23. https://doi.org/10.1056/NEJMoa1510016

APA

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., ... METEOR Investigators (2015). Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. NEW ENGL J MED, 373(19), 1814-23. https://doi.org/10.1056/NEJMoa1510016

Vancouver

Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F et al. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. NEW ENGL J MED. 2015 Nov 5;373(19):1814-23. https://doi.org/10.1056/NEJMoa1510016

Bibtex

@article{2515a6cf06384d0282c4541a25c64664,
title = "Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma",
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<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.).",
keywords = "Adult, Aged, Aged, 80 and over, Anilides, Antineoplastic Agents, Carcinoma, Renal Cell, Disease-Free Survival, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Pyridines, Quality of Life, Sirolimus, Survival Analysis",
author = "Choueiri, {Toni K} and Bernard Escudier and Thomas Powles and Mainwaring, {Paul N} and Rini, {Brian I} and Frede Donskov and Hans Hammers and Hutson, {Thomas E} and Jae-Lyun Lee and Katriina Peltola and Roth, {Bruce J} and Bjarnason, {Georg A} and Lajos G{\'e}czi and Bhumsuk Keam and Pablo Maroto and Heng, {Daniel Y C} and Manuela Schmidinger and Kantoff, {Philip W} and Anne Borgman-Hagey and Colin Hessel and Christian Scheffold and Schwab, {Gisela M} and Tannir, {Nizar M} and Motzer, {Robert J} and {METEOR Investigators}",
year = "2015",
month = nov,
day = "5",
doi = "10.1056/NEJMoa1510016",
language = "English",
volume = "373",
pages = "1814--23",
journal = "NEW ENGL J MED",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "19",

}

RIS

TY - JOUR

T1 - Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma

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 - Géczi, 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

AU - METEOR Investigators

PY - 2015/11/5

Y1 - 2015/11/5

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<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.).

AB - 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.).

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Anilides

KW - Antineoplastic Agents

KW - Carcinoma, Renal Cell

KW - Disease-Free Survival

KW - Female

KW - Humans

KW - Kidney Neoplasms

KW - Male

KW - Middle Aged

KW - Pyridines

KW - Quality of Life

KW - Sirolimus

KW - Survival Analysis

U2 - 10.1056/NEJMoa1510016

DO - 10.1056/NEJMoa1510016

M3 - SCORING: Journal article

C2 - 26406150

VL - 373

SP - 1814

EP - 1823

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 19

ER -