| General information |
| Database: | DB00469 |
| Objective: | The aim of this prospective, noninterventional, observational study was to assess efficacy and safety of everolimus after initial VEGFtargeted treatment in patients with metastatic renal cell carcinoma (mRCC) in routine clinical settings. |
| Authors: | Bergmann L, et al |
| Title: | Everolimus in metastatic renal cell carcinoma after failure of initial antiVEGF therapy: final results of a noninterventional study. |
| Journal: | BMC Cancer. |
| Year: | 2015 |
| PMID: | 25925846 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | everolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a prospective, observational study |
| Key Patients Feature: | Patients with mRCC (clear cell ornon-clear cell) were enrolled when the physicianintended to treat them with everolimus after failure ofone VEGFtargeted therapy (VEGFRTKI or bevacizumab). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Everolimus was administered per routine clinical practice. Patients with mRCC of any histology from 116 active sites in Germany were included. |
| Primary End Point: | efficacy in time to progression (TTP). progression free survival (PFS), treatment duration, tumor response, adherence to everolimus regimen, treatment after everolimus, and safety |
| Secondary End Point: | NA |
| Patients Number: | 334 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Best overall response (efficacy population, 217 patients with assessable data) was remission in 13.8% of patients, stable disease in 57.1%, and disease progression in 29.0% |
| Disease Control Rate: | NA |
| Median Time to Progression: | 7.0 months (95% CI, 6-9 months) in the safety population, 7.4 months (95% CI, 6-9 months) in the efficacy population, and 7.1 months (95% CI, 5-9 months) in the population of patients who received everolimus as secondline treatment |
| Median PFS A vs. C: | 6.9 months (95% CI, 5-9 months) in the population of patients who received everolimus as secondline treatmen |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Commonly reported adverse events (safety population, n = 318) were dyspnea (17%), anemia (15%), and fatigue (12%). |
| Conclusions: | This study reflects routine clinical use of everolimus in a large sample of patients with mRCC. Favorable efficacy and safety were seen for everolimus after previous therapy with one VEGFtargeted agent. Results of this study confirm everolimus as one of the standard options in secondline therapy for patients with mRCC. Novartis study code, CRAD001LD27 VFA registry for noninterventional studies ( httpwww.vfa.dedeforschungnisdb). |