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EAU 2018

EAU 2018: Systematic Review and Meta-Analysis of Adjuvant Therapy after Nephrectomy for High-Risk, Non-Metastatic Renal Cell Carcinoma

Copenhagen, Denmark (UroToday.com) Renal cell carcinoma (RCC) has traditionally been surgically managed. Extirpative surgery, either radical nephrectomy (RN) or partial nephrectomy (PNx), remains the standard of care for localized disease. Targeted therapies (TT), including tyrosine kinase inhibitors (TKIs) and mTOR inhibitors, have become a cornerstone of RCC therapy, specifically for metastatic RCC, demonstrating extended progression-free survival. While the efficacy of targeted therapies is well established for metastatic RCC, its role as an adjuvant therapy is less clear. Two randomized controlled trials (RCTs) demonstrated conflicting cancer-specific survival outcomes with sunitinib and sorafenib in the adjuvant setting for high-risk localized RCC. In ASSURE, there was no significant difference in disease-free survival (DFS) between high-risk patients treated with sunitinib, sorafenib or placebo, while in S-TRAC, sunitinib-treated patients had a 1.2 year improved DFS. 

In this study, the authors completed a systematic review and meta-analysis of the three published adjuvant trials to-date: S-TRAC, ASSURE, and the most recent, PROTECT. PROTECT compared pazopanib 600mg OR 800 mg to placebo, and found that pazopanib 600 mg also showed no DFS or OS benefit, while pazopanib 800 mg demonstrated improved DFS, but not OS benefit. 

Summary of trials below:


Bandini 2

Following their systematic review of these three trials, they completed a meta-analysis. The pooled DFS and OS estimates from these three trials resulted in DFS and OS hazard ratios of 0.92 (95%CI: 0.82-1.03) and 0.99 (95%CI: 0.85-1.17), specifically using pazopanib 600mg. When pazopanib 800 mg was used instead, the pooled DFS and OS hazard ratios were 0.87 (95%CI: 0.73-1.04) and 1.04 (95%CI: 0.89-1.22). 

As such, in line with general consensus and current guidelines, adjuvant therapy for RCC showed no OS benefit and equivocal DFS benefits.


Presented by: M. Bandini 

Co-Authors: Bandini M.1, Capitanio U.1, Tian Z.2 , Smith A.2 , Marchioni M.2, Nazzani S.2, Preisser F.2, Bondarenko H.2, Larcher A.1, Fossati N.1, Gandaglia G.1, Shariat S.3, Montorsi F.1 , Briganti A.1, Kapoor A.4, Karakiewicz P.2

Author Information:
1. IRCCS Ospedale San Raffaele, Division of Oncology,Unit of Urology, URI, Milan, Italy
2. University of Montreal Health Center, Montreal, Cancer Prognostics and Health Outcomes Unit, Division of Urology, Montreal, Canada
3. Medical University of Vienna, Dept. of Urology, Vienna, Austria 
4. McMaster University, Division of Urology, Hamilton, Canada

Written by: Thenappan Chandrasekar, MD Clinical Fellow, University of Toronto, twitter: @tchandra_uromd at the 2018 European Association of Urology Meeting EAU18, 16-20 March, 2018 Copenhagen, Denmark


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The ProtecT Trial

Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial

S-TRAC trial: Sensitivity Analyses of Disease-Free Survival