Table 1.

Summary of phase III randomized trials of targeted therapy in patients with advanced renal cell carcinoma (RCC).

	Sunitinib	Sorafenib	Bevacizumab	Temsirolimus	Everolimus
Study arms	Sunitinib (50 mg PO OD 4 weeks on, 2 weeks off) versus INF-α (9 MU SC thrice weekly)	Sorafenib (400 mg BID) versus placebo	Bevacizumab (10 mg/kg IV every 2 weeks) plus INF-α (9 MU SC thrice weekly) versus INF-α alone	Temsirolimus (25 mg IV weekly) versus INF-α (3 MU SC thrice weekly, ↑ to 18 MU) versus temsirolimus (15 mg IV weekly) plus INF-α (6 MU SC thrice weekly)	Everolimus (10 mg OD) versus placebo
Patient population	Treatment naïve metastatic RCC	Metastatic RCC following failure of one line of immunotherapy	Treatment naïve metastatic RCC	Treatment naïve metastatic RCC with poor-prognosis features	Metastatic RCC following failure of sunitinib, sorafenib or both
Median PFS	11 mo versus 5 mo (p < 0.001)	5.5 mo versus 2.8 mo (p < 0.000001)	10.2 mo versus 5.4 mo (p = 0.0001) and 8.5 mo versus 5.2 mo (p < 0.0001)	5.5 mo versus 3.1 mo versus 4.7 mo (p = NA)	4 mo versus 1.9 mo (p < 0.001)
Median OS (ITT)	26.4 mo versus 21.8 mo (p = 0.013)*	17.8 mo versus 15.2 mo (p = 0.146)	23.3 mo versus 21.3 mo (p = 0.1291) and 18.3 mo versus 17.4 mo (p = 0.097)	10.9 mo versus 7.3 mo (p < 0.01) versus 8.4 mo	NA

BID, twice daily; INF-α, interferon alpha; ITT, intention-to-treat analysis; IV, intravenous; mo, months; MU, million units; NA, not available; NS, not significant; OD, once daily; OS, overall survival; PFS, progression-free survival; PO, orally; RCC, renal cell carcinoma; SC, subcutaneous.

^*unstratified Wilcoxon test.