An international expanded-access programme of everolimus: addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy

Grünwald, V; Karakiewicz, P; Bavbek, S; Miller, K; Machiels, J; Lee, S; Larkin, J; Bono, P; Rha, S; Castellano, D; Blank, C; Knox, J; Hawkins, R; Anak, O; Rosamilia, M; Booth, J; Pirotta, N; Bodrogi, I; Romedi, M; Ferrandini, S; Rondinon, M; Pittman, K; Goldstein, D; Shapiro, J; Troon, S; Yip, D; Mainwaring, P; Zigeuner, R; Loidl, W; Greil, R; Schmidinger, M; De Grève, J; Rottey, S; Vermorken, J; Machiels, J; Gil, T; Gennigens, C; Roumeguere, T; Barrios, C; Mathias, C; Assi, H; Hotte, S; Karakiewicz, P; Knox, J; Spadafora, S; Wood, L; Zalewski, P; Mackensie, M; Bjarnason, G; Lalancette, A; Chan, A; Higgins, B; North, S; Soulieres, D; Asselah, J; Sperlich, C; Miller, W; Yadav, S; El Maraghi, R; Godoy, J; Prausová, J; Katolicka, J; Petruzelka, L; Kiss, I; Bono, P; Lapela, M; Miller, K; Grünwald, V; Bergmann, L; Beck, J; Jäger, E; Kindler, M; Overkamp, F; Wirth, M; Hölzer, W; Gschwend, J; Stenzl, A; Gauler, T; Niederwieser, D; Marschner, N; Lück, A; Tessen, H; Eichelberg, C; Steiner, T; Goebell, P; Kettner, E; Bakhshandeh Bath, A; Wilhelm, M; Schmitz, S; Jacob, A; Bierer, S; Kube, U; Staehler, M; Engel, E; Frambach, M; Schellenberger, U; Albers, P; Simon, J; Gleissler, M; Klotz, T; Repp, R; Kröning, H; Westermann, J; Rebmann, U; Brehmer, B; Niederle, N; Grund, C; Verpoort, K; Fonara, P; Rassweiler, J; Bamias, A; Fountzilas, G; Razis, E; Mouratidou, D; Georgoulias, V; Samantas, E; Bodrogi, I; Mangel, L; Szanto, J; Berger, R; Pe'Er, A; Sella, A; Ben Yosef, R; Nechushtan, H; Crinò, L; Bracarda, S; Ciuffreda, L; Graiff, C; Falcone, A; Roselli, M; Sternberg, C; Santoro, A; Ruggeri, E; Bearz, A; Venturini, M; Aglietta, M; Amadori, D; Di Costanzo, F; Bari, M; Gebbia, N; Conte, P; Bonetti, A; Bordonaro, R; Cascinu, S; Contu, A; Cruciani, G; Gasparro, D; Nardi, M; Lelli, G; Lo Re, G; Boccardo, F; Lorusso, V; Maiello, E; Manente, P; Passalacqua, R; Piantedosi, F; Porta, C; Sacco, C; Tondini, C; De Placido, S; Carteni, G; Dogliotto, L; Rosti, G; Milella, M; Roila, F; Amoroso, D; Farina, G; Al Khatib, H; Lee, S; Kim, T; Ahn, J; Lim, H; Rha, S; Chung, I; Kim, J; Chung, J; Ghosn, M; Shameseddine, A; Lugo, R; Cabrera, P; Osanto, S; Groenewegen, G; Blank, C; van den Eertwegh, F; van Herpen, C; Oosting, S; Soetekouw, P; Lilleby, W; Klepp, O; Guren, T; Alcedo, J; Karlov, P; Nosov, D; Roman, L; Rusakov, I; Bazarbashi, S; Toh, C; Mardiak, J; del Muro Solans, F; Ray, J; Mollins, J; Castellano, D; Martinez, I; Gonzalez, B; Santasusana, M; Piqueras, M; Fuentes, J; Larriba, J; Caro, R; Garcia, A; Aparicio, L; Lopez, N; Aragon, V; Morales, C; Figueiras, M; Ibanez, J; Billalabeitia, G; Estrada, E; Arranz, J; Sorrosal, J; Lozano, A; de Villena, M; Espinosa, E; Lopez, R; Perez, J; Laurell, A; Stierner, U; Cwikiel, M; Borner, M; Dietrich, P; Rothermundt, C; Pu, Y; Chang, Y; Ou, Y; Chuang, C; Liao, Y; Srimuninnimit, V; Sriuranpong, V; Bavbek, S; Buyukberber, S; Yalcin, B; Goker, E; Yalcin, S; Geldart, T; Wagstaff, J; Nicholson, S; Chowdhury, S; Bahl, A; Jones, R; Azzabi, A; Chao, D; Fife, K; Hawkins, R; Larkin, J; Mead, G; Nathan, P; Pandha, H; Hajdenberg, J; Gabrail, N; Nimeh, N; Logan, T; Flaig, T; Schraeder, R; Rini, B; O'Rourke, M; Alemany, C; Beck, J; Kessinger, A; Amin, A; Arriaga, M; Rodriguez, J

doi:10.1016/j.ejca.2011.06.054

The RECORD-1 trial established the clinical benefit of everolimus in patients with metastatic renal cell carcinoma (mRCC) after failure of initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy. The REACT (RAD001 Expanded Access Clinical Trial in RCC) study was initiated to address an unmet medical need by providing everolimus prior to commercial availability, and also to further assess the safety and efficacy of everolimus in patients with VEGFr-TKI-refractory mRCC.

Grünwald, V., Karakiewicz, P., Bavbek, S., Miller, K., Machiels, J., Lee, S., et al. (2012). An international expanded-access programme of everolimus: addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy. EUROPEAN JOURNAL OF CANCER, 48(3), 324-332 [10.1016/j.ejca.2011.06.054].