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


Gruenwald V., Karakiewicz P. I., Bavbek S. E., Miller K., Machiels J., Lee S., ...More

EUROPEAN JOURNAL OF CANCER, vol.48, no.3, pp.324-332, 2012 (SCI-Expanded, Scopus)

  • Publication Type: Article / Article
  • Volume: 48 Issue: 3
  • Publication Date: 2012
  • Doi Number: 10.1016/j.ejca.2011.06.054
  • Journal Name: EUROPEAN JOURNAL OF CANCER
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.324-332
  • Istanbul University Affiliated: Yes

Abstract

Background and objectives: 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.