Phase 3 trial of everolimus for metastatic renal cell carcinoma : final results and analysis of prognostic factors.

Motzer, RJ; Escudier, B; Oudard, S; Hutson, TE; Porta, C; Bracarda, S; Grünwald, V; Thompson, JA; Figlin, RA; Hollaender, N; Kay, A; Ravaud, A; RECORD-1 Study Group; Davis, I; Gurney, H; Pittman, K; Goldstein, D; Mainwaring, P; Knox, J; Ades, S; Cheng, T; Hotte, S; Ko, YJ; MacKenzie, M; North, S; Escudier, B; Oudard, S; Ravaud, A; Caty, A; Rolland, F; Chevreau, C; Duclos, B; Negrier, S; Grunwald, V; Gschwend, J; Albers, P; Bergmann, L; Beck, J; Porta, C; Bracarda, S; Conte, P; Bajetta, E; Passalacqua, R; Sternberg, C; Boccardo, F; Carteni, G; Akaza, H; Uemura, H; Shinohara, N; Tsuchiya, N; Fujimoto, H; Niwakawa, M; Kanayama, H; Eto, M; Sumiyoshi, Y; Tsukamoto, T; Usami, M; Terai, A; Hamamoto, Y; Maruoka, M; Osanto, S; Van Herpen, C; Van Den Eertwegh, F; Groenewegen, G; Szczylik, C; Pikiel, J; Pluzanska, A; Zdrojowy, R; Calvo, E; del Muro, F; Climent, M; Castellano, D; Maroto, P; Motzer, R; Hutson, T; Thompson, J; Figlin, R; Gabrail, N; Appleman, L; George, D; Hamm, J; Hussain, A; Hajdenberg, J; Vogelzang, N; Logan, T; Beck, J; Rathmell, K; Lara, P; Dudek, A; Vaishampayan, U; Gordon, M; Anderson, T; Danso, M; Berry, W; Gersh, R; Guzley, G; Loesch, D; Schlossman, D; Smith, D; Alemany, C

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Document type:: journal article
Author(s):: Motzer, RJ; Escudier, B; Oudard, S; Hutson, TE; Porta, C; Bracarda, S; Grünwald, V; Thompson, JA; Figlin, RA; Hollaender, N; Kay, A; Ravaud, A; RECORD-1 Study Group; Davis, I; Gurney, H; Pittman, K; Goldstein, D; Mainwaring, P; Knox, J; Ades, S; Cheng, T; Hotte, S; Ko, YJ; MacKenzie, M; North, S; Escudier, B; Oudard, S; Ravaud, A; Caty, A; Rolland, F; Chevreau, C; Duclos, B; Negrier, S; Grunwald, V; Gschwend, J; Albers, P; Bergmann, L; Beck, J; Porta, C; Bracarda, S; Conte, P; Bajetta, E; Passalacqua, R; Sternberg, C; Boccardo, F; Carteni, G; Akaza, H; Uemura, H; Shinohara, N; Tsuchiya, N; Fujimoto, H; Niwakawa, M; Kanayama, H; Eto, M; Sumiyoshi, Y; Tsukamoto, T; Usami, M; Terai, A; Hamamoto, Y; Maruoka, M; Osanto, S; Van Herpen, C; Van Den Eertwegh, F; Groenewegen, G; Szczylik, C; Pikiel, J; Pluzanska, A; Zdrojowy, R; Calvo, E; del Muro, F; Climent, M; Castellano, D; Maroto, P; Motzer, R; Hutson, T; Thompson, J; Figlin, R; Gabrail, N; Appleman, L; George, D; Hamm, J; Hussain, A; Hajdenberg, J; Vogelzang, N; Logan, T; Beck, J; Rathmell, K; Lara, P; Dudek, A; Vaishampayan, U; Gordon, M; Anderson, T; Danso, M; Berry, W; Gersh, R; Guzley, G; Loesch, D; Schlossman, D; Smith, D; Alemany, C «
Motzer, RJ; Escudier, B; Oudard, S; Hutson, TE; Porta, C; Bracarda, S; Grünwald, V; Thompson, JA; Figlin, RA; Hollaender, N; Kay, A; Ravaud, A; RECORD-1 Study Group; Davis, I; Gurney, H; Pittman, K; Goldstein, D; Mainwaring, P; Knox, J; Ades, S; Cheng, T; Hotte, S; Ko, YJ; MacKenzie, M; North, S; Escudier, B; Oudard, S; Ravaud, A; Caty, A; Rolland, F; Chevreau, C; Duclos, B; Negrier, S; Grunwald, V; Gschwend, J; Albers, P; Bergmann, L; Beck, J; Porta, C; Bracarda, S; Conte, P; Bajetta, E; Passal... »
Title:: Phase 3 trial of everolimus for metastatic renal cell carcinoma : final results and analysis of prognostic factors.
Abstract:: A phase 3 trial demonstrated superiority at interim analysis for everolimus over placebo in patients with metastatic renal cell carcinoma (mRCC) progressing on vascular endothelial growth factor receptor-tyrosine kinase inhibitors. Final results and analysis of prognostic factors are reported.Patients with mRCC (N = 416) were randomized (2:1) to everolimus 10 mg/d (n = 277) or placebo (n = 139) plus best supportive care. Progression-free survival (PFS) and safety were assessed to the end of double-blind treatment. Mature overall survival (OS) data were analyzed, and prognostic factors for survival were investigated by multivariate analyses. A rank-preserving structural failure time model estimated the effect on OS, correcting for crossover from placebo to everolimus.The median PFS was 4.9 months (everolimus) versus 1.9 months (placebo) (hazard ratio [HR], 0.33; P< .001) by independent central review and 5.5 months (everolimus) versus 1.9 months (placebo) (HR, 0.32; P< .001) by investigators. Serious adverse events with everolimus, independent of causality, in>= 5% of patients included infections (all types, 10%), dyspnea (7%), and fatigue (5%). The median OS was 14.8 months (everolimus) versus 14.4 months (placebo) (HR, 0.87; P = .162), with 80% of patients in the placebo arm crossed over to everolimus. By the rank-preserving structural failure time model, the survival corrected for crossover was 1.9-fold longer (95% confidence interval, 0.5-8.5) with everolimus compared with placebo only. Independent prognostic factors for shorter OS in the study included low performance status, high corrected calcium, low hemoglobin, and prior sunitinib (P< .01).These results established the efficacy and safety of everolimus in patients with mRCC after progression on sunitinib and/or sorafenib.
Journal title abbreviation:: Cancer
Year:: 2010
Journal volume:: 116
Journal issue:: 18
Pages contribution:: 4256-65
Language:: eng
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/20549832
Print-ISSN:: 0008-543X
TUM Institution:: Urologische Klinik und Poliklinik
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Urologie (Prof. Gschwend)2010