| General information |
| Database: | DB00484 |
| Objective: | To determine how TGR is modified along the treatment sequence and is associated with outcome in mRCC patients. |
| Authors: | Fert¨¦ C, et al |
| Title: | Tumor growth rate provides useful information to evaluate sorafenib and everolimus treatment in metastatic renal cell carcinoma patients: an integrated analysis of the TARGET and RECORDphase 3 trial data. |
| Journal: | Eur Urol. |
| Year: | 2014 |
| PMID: | 23993162 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | Sorafenib and everolimus
|
| Target: | NA
|
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | sorafenib and everolimus |
| Study Type: | An Integrated Analysis of the TARGET andRECORDphase III Trial Data |
| Key Patients Feature: | Metastatic Renal CellCarcinoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Renal Cancer Global Evaluation Trial (TARGET)phase 3 (sorafenib vs placebo, n = 84) and in the RECORDphase 3 trial(everolimus vs placebo, n = 43) |
| Treatment Info: | Sorafenib, everolimus, or placebo. |
| Primary End Point: | OS and PFS rates. |
| Secondary End Point: | NA |
| Patients Number: | 903 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Higher TGR (first cycle) was associated with worse PFS (hazard ratio [HR]: 3.61; 95% confidence interval [CI], 2.45-5.34) |
| Median OS A vs. C: | Higher TGR (first cycle) was associated with worse OS (HR: 4.69; 95% CI, 1.54-14.39) |
| Adverse Event(agent arm): | NA |
| Conclusions: | Computing TGR in mRCC patients is simple and provides clinically useful information for mRCC patients (1) TGR is independently associated with prognosis (PFS, OS), (2) TGR allows for a subtle and quantitative characterization of drug activity at the first evaluation, and (3) TGR reveals clear drugspecific profiles at progression. |