Gene assay predicts renal cell carcinoma relapse

CHICAGO – The Recurrence Score, a tool used to predict risk of relapse in renal cell carcinoma, appears effective in high-risk disease, according to an analysis of the S-TRAC trial presented at the ASCO Annual Meeting.

“Adjuvant therapy with sunitinib compared with placebo prolonged DFS in 615 patients with high-risk renal cell carcinoma (HR, 0.76; P = .03) in the S-TRAC trial,” the researchers wrote. “The 16-gene Recurrence Score was developed and validated to predict risk of recurrence of renal cell carcinoma after nephrectomy in 2 cohorts of stage 1-3 patients. We present further validation of Recurrence Score results.”

Bernard J. Escudier, MD, chairman of the renal cancer committee at Institut Gustave Roussy in Villejuif, France, and colleagues used data from the S-TRAC trial, which demonstrated that adjuvant treatment with sunitinib extended DFS compared with placebo among patients with locoregional clear-cell renal cell carcinoma at high risk for recurrence after nephrectomy. That trial included primary renal cell carcinoma tissue from 212 participants; the primary analysis by Escudier and colleagues examined patients (n = 193) with stage 3 disease. Gene expression was evaluated with reverse transcription-polymerase chain reaction. DFS and time to recurrence were determined with Cox proportional hazard regression.

Baseline characteristics were comparable between patients treated with sunitinib and patients treated with placebo, as well as among patients with and without gene expression data. The impact of sunitinib was “numerically similar” to the effect observed in the full S-TRAC trial, according to data related to DFS (HR = 0.78, 95% CI, 0.48-1.24).

The Recurrence Score projected time to recurrence and DFS in both treatment arms. The most robust findings were seen in the placebo arm, where a high Recurrence Score was indicative of significantly greater risk. No substantial interaction was observed between the Recurrence Score and treatment (time to recurrence, P = .192; DFS, P = .219), although the number of events were comparatively low.

“The prognostic value of the 16-gene assay was confirmed in S-TRAC,” the researchers wrote. “[The] Recurrence Score is now validated, with consistent results in two separate studies (level IB evidence). Recurrence Score results may help identify patients at high risk who could derive higher absolute benefit from adjuvant treatment. The predictive value of Recurrence Score to select patients for adjuvant sunitinib requires further investigation in independent adjuvant trials.” – by Julia Ernst, MS

Reference:

Escudier BJ, et al. Abstract 4508. Presented at: ASCO Annual Meeting; June 2-6, 2017; Chicago.

Disclosures: Escudier reports serving as a consultant or adviser to Bristol-Myers Squibb, Exelixis, Ipsen, Novartis, Pfizer and Roche and receiving honoraria from Acceleron Pharma, Bayer, Bristol-Myers Squibb, Exelixis, Ipsen, Novartis, Pfizer and Roche as well as research funding through his institution from Bristol-Myers Squibb and Novartis. Please see the study for all other authors’ relevant financial disclosures.