| General information |
| Database: | DB00494 |
| Objective: | Objective response as determined by Response Evaluation Criteria in Solid Tumors (RECIST) is low among patients with metastatic renal cell carcinoma (mRCC) treated with targeted agents, despite significantly improved progression free survival (PFS). A modified response threshold may be more clinically meaningful than RECIST for identifying patients who may derive a PFS benefit from targeted therapy. |
| Authors: | Oudard S, et al |
| Title: | Optimisation of the tumour response threshold in patients treated with everolimus for metastatic renal cell carcinoma: analysis of response and progression free survival in the RECORD1 study. |
| Journal: | Eur J Cancer. |
| Year: | 2012 |
| PMID: | 22342553 |
| Trial Design |
| Clinical Trial Id: | NCT00410124 |
| 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 retrospective analysis of data fromthe randomised, phase III RECORDI trial Analysisof response and progression free survival in the RECORDI study |
| Key Patients Feature: | NA |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | retrospective analysis |
| Primary End Point: | NA |
| Secondary End Point: | NA |
| Patients Number: | 288 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | In the everolimustreated group (n = 196), an objective response according to RECIST (best ¦¤SLD below 30%) was documented in seven patients (4%), whereas stable disease (best ¦¤SLD between 30% and +20%) was reported in 162 patients (83%). Twentyseven patients (14%) experienced progressive disease (best ¦¤SLD above +20%). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 8.4 months in responders and 5.0 months in nonresponders (hazard ratio [HR] 2.4, 95% confidence interval [CI] 1.6-3.7). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | In patients who have failed vascular endothelial growth factor receptortyrosine kinase inhibitor (VEGFrTKI) therapy, everolimus affords superior PFS to placebo, regardless of change in tumour burden. Hotheyver, a more than and equal to 5% reduction in SLD is a better predictor of PFS benefit than the classical more than and equal to 30% reduction used with RECIST. |