Everolimus in Patients With Metastatic Renal Cell Carcinoma Following Progression on Prior Bevacizumab Treatment
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
An estimated 10,000 metastatic renal cell carcinoma (RCC) patients receive first-line therapy
in the Russian Federation. Bevacizumab (Avastin) in combination with interferon-alpha (IFN)
is a recommended first-line treatment for metastatic RCC according to clinical
recommendations of Russian Ministry of Health from 15.07.2010. Two randomized phase III
trials (AVOREN, CALGB) showed that 50% of patients will progress on bevacizumab plus IFN
within 8.5 - 10.2 months and will need sequential therapy.
Everolimus (Afinitor) is a single agent which was evaluated and demonstrated efficacy in
randomized phase III study (RECORD-1) in metastatic RCC patients after failure of targeted
therapy. However, in this trial everolimus was compared with placebo for the treatment of
patients whose disease had progressed on treatment with sunitinib or sorafenib (n=227). Only
9% (n=24) of patients received bevacizumab. Thus, efficacy data of everolimus in patients
with disease progression on first-line bevacizumab is limited.
Evaluating the effectiveness of everolimus in metastatic RCC patients with failure on
bevacizumab with/without interferon alpha has a scientific and practical sense, and it is
important for Russian Federation.