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 RECORD phase 3 trial data

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Ferté C., Koscielny S., Albiges L., Rocher L., Soria J.-C., Iacovelli R., Loriot Y., Fizazi K., Escudier B.

European Urology 2014 65:4 (713-720)

Background Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be sufficient to evaluate the response of targeted therapies in metastatic renal cell carcinoma (mRCC). The tumor growth rate (TGR) incorporates the time between evaluations and may be adequate. Objective To determine how TGR is modified along the treatment sequence and is associated with outcome in mRCC patients. Design, setting, and participants Medical records from all patients prospectively treated at Gustave Roussy (IGR) in the Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGET) (sorafenib vs placebo, n = 84) and the RECORD (everolimus vs placebo, n = 43) phase 3 trials were analyzed. TGR was computed across clinically relevant periods: BEFORE treatment introduction (wash-out), UNDER (first cycle), at PROGRESSION (last cycle) and AFTER treatment discontinuation (washout). The association between TGR and outcome (overall survival [OS] and progression-free survival [PFS]) was computed in the entire TARGET cohort (n = 903). Intervention Sorafenib, everolimus, or placebo… (ver más)


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