Table 1. Efficacy results from phase III studies with NCCN recommended first-line therapies for advanced RCC.
Test agent | Comparator | Progression-free survival | Overall survival | ||||||
---|---|---|---|---|---|---|---|---|---|
Median (months) | HR (95% CI) | p-value | Median (months) | HR (95% CI) | p-value | ||||
Test | Comparator | Test | Comparator | ||||||
Sunitinib (12) | IFN-α | 11.0 | 5.0 | 0.539 (0.451-0.643) | <0.001 | 26.4 | 21.8 | 0.821 (0.673-1.001) | 0.051 |
Bevacizumab+IFN-α (13, 14) | IFN-α+placebo | 10.2 | 5.4 | 0.63 (0.52-0.75) | 0.0001 | 23.3 | 21.3 | 0.91 (0.76-1.10) | 0.3360 |
Pazopanib (15, 16) | Placebo | 9.2 | 4.2 | 0.46 (0.34-0.62) | <0.0001 | 22.9 | 20.5* | 0.91 (0.71-1.16) | 0.224 |
Pazopanib (17) | Sunitinib | 8.4 | 9.5 | 1.05 (0.90-1.22) | NR | 28.4† | 29.3† | 0.91 (0.76-1.08) | 0.28 |
Temsirolimus (18) | IFN-α | 5.5 | 3.1 | NR | NR | 10.9 | 7.3 | 0.73 (0.58-0.92) | 0.008 |
Overall survival analysis confounded by the early, high rate (54%) of crossover to placebo from pazopanib.
Interim analysis of overall survival.
CI=confidence interval; HR= hazard ratio; IFN-α= interferon-α; NCCN= National Comprehensive Cancer Network; NR= not reported; RCC= renal cell carcinoma.