Sergio Bracarda1, Sylvie Rottey2, Amit Bahl3, Christian Eichelberg4,5, Begoña Mellado6, László Mangel7, Agnese Cattaneo8, Ashok Panneerselvam9, Viktor Grünwald10. 1. Department of Oncology, Ospedale San Donato USL8, Istituto Toscano Tumori, Arezzo, Italy. 2. Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium. 3. Department of Oncology, British Haematology & Oncology Centre, Bristol, UK. 4. Department of Urology, Caritas-St. Josef Medical Center, University of Regensburg, Germany. 5. Department of Urology, University Medical Center Hamburg-Eppendorf, Germany. 6. Medical Oncology Department, Hospital Clinic l Provincial de Barcelona, Barcelona, Spain. 7. Department of Oncotherapy, Medical School, University of Pécs, Pécs, Hungary. 8. Oncology, Novartis Farma S.p.A., Origgio, Italy. 9. Biostatistics, Novartis Pharmaceuticals Corporation, Florham Park, NJ, USA. 10. Clinic for Hematology, Hemostasis, Oncology, & Stem Cell Transplantation, Medical School Hannover, Hannover, Germany.
Abstract
AIM: RAD001 Expanded Access Clinical Trial (REACT) provided everolimus to patients with metastatic RCC before its commercial availability. This retrospective subgroup analysis evaluated eventual differences, mainly in safety, between the large European population (n = 906; 66.3%) and the overall population (n = 1367). PATIENTS & METHODS: REACT enrolled patients from 34 countries who received everolimus 10 mg/day until progression/discontinuation or commercial availability. RESULTS: Baseline characteristics, except race/ethnicity, were similar. Incidences of grade 3/4 adverse events were 50.7/11.3% in the European population and 48.8/12.8% in the overall population. A similar percentage of the European and overall populations achieved stable disease (∼ 51%) and completed treatment (20.6 and 19.7%). CONCLUSION: These results do not suggest differences for the European population and support everolimus as a worldwide standard of care for VEGFR-refractory metastatic RCC (NCT00655252).
AIM: RAD001 Expanded Access Clinical Trial (REACT) provided everolimus to patients with metastatic RCC before its commercial availability. This retrospective subgroup analysis evaluated eventual differences, mainly in safety, between the large European population (n = 906; 66.3%) and the overall population (n = 1367). PATIENTS & METHODS: REACT enrolled patients from 34 countries who received everolimus 10 mg/day until progression/discontinuation or commercial availability. RESULTS: Baseline characteristics, except race/ethnicity, were similar. Incidences of grade 3/4 adverse events were 50.7/11.3% in the European population and 48.8/12.8% in the overall population. A similar percentage of the European and overall populations achieved stable disease (∼ 51%) and completed treatment (20.6 and 19.7%). CONCLUSION: These results do not suggest differences for the European population and support everolimus as a worldwide standard of care for VEGFR-refractory metastatic RCC (NCT00655252).
Entities:
Keywords:
European subanalysis; REACT; everolimus; expanded-access program
Authors: Tobias B Polak; David G J Cucchi; Joost van Rosmalen; Carin A Uyl-de Groot; Jonathan J Darrow Journal: Front Pharmacol Date: 2022-05-23 Impact factor: 5.988
Authors: Petri Bono; Stephane Oudard; Istvan Bodrogi; Thomas E Hutson; Bernard Escudier; Jean-Pascal Machiels; John A Thompson; Robert A Figlin; Alain Ravaud; Mert Basaran; Camillo Porta; Sergio Bracarda; Thomas Brechenmacher; Chinjune Lin; Maurizio Voi; Viktor Grunwald; Robert J Motzer Journal: Clin Genitourin Cancer Date: 2016-04-27 Impact factor: 2.872