title: REACT expanded-access program in patients with metastatic renal cell carcinoma: real-world data from a European subanalysis.
abstract: OBJECTIVE
  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).
  
  
  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%).
  
  
  CONCLUSIONS
  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).
authors.affiliation: Department of Oncology, Ospedale San Donato USL8, Istituto Toscano Tumori, Arezzo, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Bracarda
authors.affiliation: Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Rottey
authors.affiliation: Department of Oncology, British Haematology & Oncology Centre, Bristol, UK.
authors.forename: Amit
authors.initials: A
authors.lastname: Bahl
authors.affiliation: Department of Urology, Caritas-St. Josef Medical Center, University of Regensburg, Germany.|Department of Urology, University Medical Center Hamburg-Eppendorf, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Eichelberg
authors.affiliation: Medical Oncology Department, Hospital Clinic l Provincial de Barcelona, Barcelona, Spain.
authors.forename: Begoña
authors.initials: B
authors.lastname: Mellado
authors.affiliation: Department of Oncotherapy, Medical School, University of Pécs, Pécs, Hungary.
authors.forename: László
authors.initials: L
authors.lastname: Mangel
authors.affiliation: Oncology, Novartis Farma S.p.A., Origgio, Italy.
authors.forename: Agnese
authors.initials: A
authors.lastname: Cattaneo
authors.affiliation: Biostatistics, Novartis Pharmaceuticals Corporation, Florham Park, NJ, USA.
authors.forename: Ashok
authors.initials: A
authors.lastname: Panneerselvam
authors.affiliation: Clinic for Hematology, Hemostasis, Oncology, & Stem Cell Transplantation, Medical School Hannover, Hannover, Germany.
authors.forename: Viktor
authors.initials: V
authors.lastname: Grünwald
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology*; D018450:Disease Progression; D000068338:Everolimus / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D000068338:Everolimus
keywords: European subanalysis; REACT; everolimus; expanded-access program