Phase 3 Trial of Everolimus for Metastatic Renal Cell Carcinoma Final Results and Analysis of Prognostic Factors
Journal Title: OncoReview - Year 2011, Vol 1, Issue 1
Abstract
A phase 3 trial demonstrated superiority at interim analysis for everolimus over placebo in patients with metastatic renal cell carcinoma (mRCC) progressing on vascular endothelial growth factor receptor tyrosine kinase inhibitors. Final results and analysis of prognostic factors are reported.METHODS: Patients with mRCC (N=416) were randomized (2:1) to everolimus 10 mg/d (n=277) or placebo (n=139) plus best supportive care. Progression-free survival (PFS) and safety were assessed to the end of double-blind treatment. Mature overall survival (OS) data were analyzed, and prognostic factors for survival were investigated by multivariate analyses. A rank-preserving structural failure time model estimated the effect on OS, correcting for crossover from placebo to everolimus.RESULTS: The median PFS was 4.9 months (everolimus) versus 1.9 months (placebo) (hazard ratio [HR], 0.33; P <0.001) by independent central review and 5.5 months (everolimus) versus 1.9 months (placebo) (HR, 0.32; P <0.001) by investigators. Serious adverse events with everolimus, independent of causality, in ≥5% of patients included infections (all types, 10%), dyspnea (7%), and fatigue (5%). The median OS was 14.8 months (everolimus) versus 14.4 months (placebo) (HR 0.87; P=0.162), with 80% of patients in the placebo arm crossed over to everolimus. By the rank-preserving structural failure time model, the survival corrected for crossover was 1.9-fold longer (95% confidence interval, 0.5–8.5) with everolimus compared with placebo only. Independent prognostic factors for shorter OS in the study included low performance status, high corrected calcium, low hemoglobin, and prior sunitinib (P <0.01).CONCLUSIONS: These results established the efficacy and safety of everolimus in patients with mRCC after progression on sunitinib and/or sorafenib.
Authors and Affiliations
Robert J. Motzer
Keywords
Related Articles
- EP ID EP53095
- DOI -
- Views 264
- Downloads 0
IgM multiple myeloma: diagnostic difficulties and results of bortezomib treatment – case report
The IgM paraprotein secretion is most frequently associated with Waldenström’s macroglobulinemia. In very rare cases it may also occur in multiple myeloma. The diagnostic and therapeutic process of a 84 year old male suf...
Patient with metastatic renal cell carcinoma treated successfully with pazopanib for four years.
We present a case of a patient with metastatic renal cell carcinoma who was treated with pazopanib in the first-line treatment. Although nephrectomy was not performed, there was a positive reaction to the therapy with mu...
Zastosowanie filtrów żylnych w profilaktyce przeciwzakrzepowej przed zabiegami onkologicznymi
Jedną z najczęstszych przyczyn powikłań i zgonów pacjentów onkologicznych jest żylna choroba zakrzepowo-zatorowa. Postępowanie lecznicze w tej grupie chorych sprowadza się przede wszystkim do odpowiedniej farmakoterapii....
Interstitial pneumonia during treatment with rituximab
Rituximab (RTX) is a chimeric anti-CD20 antibody. It plays an important role in the treatment of B cell lymphomas and diseases of autoaggression. RTX-induced lung disease is a rare entity, which should be considered in t...
Spotkanie z człowiekiem. Co ja mogę z tego mieć?
Coraz częściej na konferencjach onkologicznych pojawiają się osoby reprezentujące głos pacjentów. Pragną one zwrócić naszą uwagę na inne niż medyczne aspekty choroby nowotworowej. Powinniśmy pamiętać, jak ważne jest w na...