Immediate versus deferred cytoreductive nephrectomy (CN) in patients with synchronous metastatic renal cell carcinoma (mRCC) receiving sunitinib (EORTC 30073 SURTIME)

Abstract

Background: In clinical practice, mRCC patients with the primary tumour in situ are offered CN followed by targeted therapy. This randomized trial explored a period of targeted therapy (sunitinib) prior to CN as an alternative approach. Methods: Patients with mRCC were randomized 1:1 to immediate CN followed by sunitinib versus 3 cycles sunitinib followed by CN and sunitinib. Inclusion required histologically confirmed clear-cell subtype, resectable asymptomatic primary tumour and 0.99). The OS HR (stratified byWHOPS) of intention to treat (ITT) with deferred versus immediate CN in all patients was 0.57 (CI: 0.34 - 0.95, p=0.032) with a median OS of 32.4 (14.5-65.3) and 15.1 months (CI: 9.3, 29.5), respectively. Conclusions: The sequence of CN and sunitinib did not affect the PFR at 28 weeks. The sample size precludes definitive conclusions from other endpoints, although an OS signal was seen for deferred CN. CN after sunitinib appears safe. (Table Presented).