Stein, A, Bellmunt, J, Escudier, B, Kim, D, Stergiopoulos, SG, Mietlowski, W and Motzer, RJ (2013) Survival Prediction in Everolimus-treated Patients with Metastatic Renal Cell Carcinoma Incorporating Tumor Burden Response in the RECORD-1 Trial. EUROPEAN UROLOGY. pp. 994-1002.

Abstract

Background: The phase 3 RECORD-1 study demonstrated clinical benefit of everolimus over placebo (median progression-free survival: 4.9 mo compared with 1.9 mo, p < 0.001) in treatment-resistant patients with metastatic renal cell carcinoma(mRCC). However, the Response Evaluation Criteria in Solid Tumors (RECIST) objective response rate was low.Objective: To explore the potential role of tumor burden response to everolimus in predicting patient survival.Design, setting, and participants: RECORD-1 patients with at least two tumor assessments (baseline and weeks 2-14) were included (n = 246).Outcome measurements and statistical analysis: A multivariate Cox proportional hazard model was used to assess the impact of various prognostic factors on overall survival (OS). Components of RECIST progression were explored using univariate Cox regression.Results and limitations: The baseline sum of longest tumor diameters (SLD) and progression at weeks 2-14 were prognostic factors of OS by multivariate analysis. Univariate analysis at weeks 2-14 demonstrated that growth of nontarget lesions and appearance of new lesions were predictive of OS (p < 0.001). This retrospective analysis used data from one arm of one trial; patients in the placebo arm were excluded because of confounding effects when they crossed over to everolimus.Conclusions: This analysis identified baseline SLD as a predictive factor of OS, and the appearance of a new lesion or progression of a nontarget lesion at first assessment after baseline also affects OS in patients with mRCC treated with everolimus. (C) 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved

Item Type:	Article
Additional Information:	pubid: 208 nvp_institute: NIBR contributor_address: Novartis Inst Biomed Res, Cambridge, MA 02139 USA andrew.stein@novartis.com; Univ Hosp del Mar IMIM, Barcelona, Spain ; Inst Gustave Roussy, Villejuif, France ; Novartis Oncol Global Med Affairs, Florham Pk, NJ USA ; Novartis Oncol, Florham Pk, NJ USA ; Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA ; Novartis Inst Biomed Res, Cambridge, MA 02139 USA; Stein, A; Novartis Inst Biomed Res, 45 Sidney St, Cambridge, MA 02139 USA
Date Deposited:	13 Oct 2015 13:12
Last Modified:	13 Oct 2015 13:12
URI:	https://oak.novartis.com/id/eprint/22027