Phase 3 trial of everolimus for metastatic renal cell carcinoma : Final results and analysis of prognostic factors (pages 4256–4265)
Robert J. Motzer, Bernard Escudier, Stephane Oudard, Thomas E. Hutson, Camillo Porta, Sergio Bracarda, Viktor Grünwald, John A. Thompson, Robert A. Figlin, Norbert Hollaender, Andrea Kay and Alain Ravaud, for the RECORD-1 Study Group
Article first published online: 19 AUG 2010 | DOI: 10.1002/cncr.25219
Final results and prognostic factor analysis of a phase 3 trial assessing everolimus in patients with metastatic renal cell cancer who progressed on sorafenib and/or sunitinib are reported. Median progression-free survival was 4.9 months with everolimus versus 1.9 months with placebo by independent central review. Survival was 1.9-fold longer with everolimus compared with placebo after correcting for 80% of patients in the placebo arm who crossed over to everolimus, using a rank-preserving structural failure time model. Independent prognostic factors for shorter overall survival included low performance status, high corrected calcium, low hemoglobin, and prior sunitinib.