For this study, patients will receive pazopanib 800 mg orally daily or sunitinib 50 mg daily, 4 weeks on and 2 weeks off; choice of TKI will be according to investigator’s clinical practice. The primary objective is to assess overall survival (OS). Secondary objectives include (i) progression-free survival (PFS), (ii) response rate (RR), (iii) safety, and (iv) evaluation of the predictive role of circulating tumor cells count and circulating tumor DNA at baseline, before and after surgery (in pts undergoing CN), 24 weeks after randomization and at the time of disease progression. Inclusion criteria include (i) favorable or intermediate MSKCC or Heng prognostic risk group, (ii) histological diagnosis of clear cell RCC, (iii) resectable asymptomatic mRCC with primary tumor in situ, (iv) up to three different metastatic sites, and (v) ≥ 3 metastatic lesions. The sample size (n=270) was calculated in order to compare 5-year OS between subjects randomized to receive CN followed by TKIs and those randomized to receive upfront TKIs. A total of 191 deaths will yield 80% power to detect a hazard ratio of 1.5 of upfront TKIs vs CN followed by TKIs with an overall type 1 error of 0.05. Such a HR corresponds to an increase in the 5-year OS, from an anticipated value of 10% for TKIs to 21.5% for CN followed by TKIs. The study is open at 16 centers and currently enrolling, with 10 patients enrolled to date.
Clinical trial: NCT02535351
Presented By: Paolo Grassi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
Co-Authors: Elena Verzoni, Alessandra Bearz, Sergio Bracarda, Marco Bregni, Sebastiano Buti, Saverio Cinieri, Ugo De Giorgi, Giuseppe Fornarini, Luca Galli, Michele Milella, Franco Morelli, Franco Nole, Rodolfo Passalacqua, Roberto Sabbatini, Daniele Santini, Roberto Salvioni, Vera Cappelletti, Raffaele Ratta, Giuseppe Procopio
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
1. Flanigan RC, Mickisch G, Sylvester R, et al. Cytoreductive nephrectomy in patients with metastatic renal cancer: a combined analysis. J Urol 2004 Mar;171(3):1071-1076.