REACT expanded-access program in patients with metastatic renal cell carcinoma: real-world data from a European subanalysis

Bracarda, Sergio and Rottey, Sylvie and Bahl, Amit and Eichelberg, Christian and Mellado, Begona and Mangel, Laszlo and Cattaneo, Agnese and Panneerselvam, Ashok and Gruenwald, Viktor (2015) REACT expanded-access program in patients with metastatic renal cell carcinoma: real-world data from a European subanalysis. Future Oncology, 11 (21). pp. 2893-2903. ISSN 1479-6694, 1744-8301

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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).

Item Type: Article
Uncontrolled Keywords: GROWTH-FACTOR RECEPTOR; PHASE-III TRIAL; KINASE INHIBITOR THERAPY; SUBGROUP ANALYSIS; INTERFERON-ALPHA; EVEROLIMUS; EFFICACY; RECORD-1; OUTCOMES; SAFETY; European subanalysis; everolimus; expanded-access program; REACT
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Urologie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 26 Jul 2019 10:33
Last Modified: 26 Jul 2019 10:33
URI: https://pred.uni-regensburg.de/id/eprint/6170

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