This study was prospectively designed with prespecified genes and analysis plan using primary RCC tissues from 193 stage III evaluable patients from S-TRAC. Gene expression was quantitated using RT-PCR, and time to recurrence (TTR) and DFS were analyzed using Cox proportional hazards modelling. Baseline characteristics were similar in sunitinib and placebo arms and in patients with and without gene expression data. The Recurrence Score predicted TTR (HR 2.5-4.2) and DFS (HR 2.3-3.8) in both the treatment and placebo arms, with stronger results noted in the placebo arm. The authors also note that the interaction of Recurrence Score with treatment was not significant (TTR p=0.19; DFS p=0.22); however, the number of events was relatively low.
In conclusion, the prognostic value of the Recurrence Score gene assay was confirmed in the high-risk stage III S-TRAC patients, with the strongest association observed in the placebo arm. Since the Recurrence Score has now been validated in multiple studies, these results may help identify patients at high-risk who may derive added benefit from adjuvant therapy. Given the side effect incidence and severity in the previous RCTs with adjuvant treatment, having additional predictors selecting patients that may benefit from adjuvant therapy is significant.
Presented By: Bernard J. Escudier, Gustave Roussy Cancer Campus, Paris, France
Co-Authors: Brian I. Rini, Jean-Francois Martini, Wayne Yen-Hwa Chang, Jan Breza, Ahmed Magheli, Christer Svedman, Margarita Lopatin, Dejan Knezevic, Audrey D. Goddard, Patricia A English, Rachel Li, Xun Lin, Olga Valota, Giacomo Cartenì, Michael D. Staehler, Robert J. Motzer, Alain Ravaud
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre
at the 2017 ASCO Annual Meeting - June 2 - 6, 2017 – Chicago, Illinois, USA
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