Table 1.

Phase 3 randomized trials investigating the role of CN in patients with mRCC in the targeted therapy era

Trial	Patient population	Intervention arm	Control arm	Outcomes	Sample size	Median followup	Results for primary outcome
CARMENA3	Clear-cell mRCC, ECOG 0–1, no prior systemic or surgical treatment for RCC	CN followed by sunitinib	Sunitinib alone	– Primary: OS, – Secondary: objective response, PFS, treatment compliance, safety and adverse events	n=452	50.2 months	HR for OS: 0.89 (95% CI 0.7–1.10)
SURTIME4	Clear-cell mRCC, ECOG 0–1, no prior systemic or surgical treatment for RCC	Sunitinib followed by CN followed by sunitinib	CN followed by sunitinib	– Primary: disease progression at 28 weeks – Secondary: OS, objective response, safety and adverse events	n=99*	30.9 months	Progression at 28 weeks**: – Upfront CN: 42.0%, – Upfront sunitinib: 42.9% (p>0.99)
TARIBO48	Clear-cell mRCC, ECOG 0–1, good- or intermediate-risk disease, no prior systemic or surgical treatment for RCC	CN followed by sunitinib or pazopanib	Sunitinib or pazopanib alone	– Primary: OS – Secondary: objective response, PFS, safety and adverse events, biomarker analysis	n=270 (estimated)	***	***

^*Initial accrual target was 458 patients.

^**Preliminary results presented at the 2017 European Society of Medical Oncology annual meeting.

^***Enrollment ongoing.

CI: confidence interval; CN: cytoreductive nephrectomy; ECOG: Eastern Cooperative Oncology Group; HR: hazard ratio; mRCC: metastatic renal cell carcinoma; OS: overall survival; PFS: progression-free survival.