Table 1.
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.