| General information |
| Database: | DB00490 |
| Objective: | Everolimus is approved for treatment of antivascular endothelial growth factor (VEGF)refractory patients with metastatic renal cell carcinoma (mRCC). Clinical trials rarely mirror treatment reality. Thus, a broader evaluation of everolimus is valuable for routine use. |
| Authors: | Bergmann L, et al |
| Title: | Everolimus in metastatic renal cell carcinoma after failure of initial vascular endothelial growth factor receptortyrosine kinase inhibitor (VEGFrTKI) therapy: results of an interim analysis of a noninterventional study. |
| Journal: | Onkologie. |
| Year: | 2013 |
| PMID: | 23485996 |
| 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: | prospective multicenter, noninterventional, observational study |
| Key Patients Feature: | Patients more than and equal to 18 years old with mRCC could be documented if the treating physician had decided to prescribe everolimus in accordance with the summary of product characteristics (SmPC) [7], i.e. following failure with 1 VEGFtargeted therapy (e.g. sunitinib, sorafenib, pazopanib, or bevacizumab). Previous exposure to cytokinebased regimens such as interleukin2, interferonalpha, or bevacizumab plus interferonalpha was allowed. Pretreatment with a second VEGFrTKI for a period of less than and equal to 1 month because of intolerability was also permitted. Patients could be included if their treatment with everolimus had been ongoing for < 90 days, or less than and equal to 1 imaging followup investigation had been performed since the start of everolimus. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received oral everolimus 10 mg once daily according to usual routine practice as outlined in the SmPC. |
| Primary End Point: | effectiveness, defined as time to progression (TTP) according to investigator assessment (time from first dose to progression). |
| Secondary End Point: | NA |
| Patients Number: | 382 |
| Trial Results |
| DLT_MTD: | Most common adverse events were anemia (13%) and dyspnea (14%). Physicians assessed high tolerance and documented high adherence to everolimus therapy (approximately 97%). |
| Objective Response Rate: | na |
| Disease Control Rate: | NA |
| Median Time to Progression: | In the efficacy population (n = 165), median TTP was 7.0 months (95% confidence interval (CI) 5.1-9.0). Among patients with < or more than and equal to 6 months of previous VEGFtargeted therapy, median TTP was 6.6 months (95% CI 3.8not estimable) and 7.4 months (95% CI 4.6-9.6), respectively. |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Most common adverse events were anemia (13%) and dyspnea (14%). Physicians assessed high tolerance and documented high adherence to everolimus therapy (approximately 97%). |
| Conclusions: | In routine clinical practice, everolimus is effective, as measured by median TTP (longer than median progression free survival in RECORD1 trial), and well tolerated. Our results support everolimus use in antiVEGFrefractory patients with mRCC. |