Table 7.
First-line randomized treatment trials for advanced clear cell RCC.
| Study | Agents | Number of patients | ORR | Median PFS in months | Median OS in months |
|---|---|---|---|---|---|
| Motzer et al. [2009b] | Sunitinib (50 mg od 4/2) versus IFN-α (9 MU sc t.i.w.) |
750 | Sunitinib 47% versus IFN-α 12% (p < 0.001) |
Sunitinib 11 versus IFN-α 5 (HR = 0.539; 95% CI 0.451–0.643; p < 0.001) |
Sunitinib 26.4 versus IFN-α 21.8 (HR = 0.818; 95% CI 0.669–0.999; p = 0.049) |
|
Motzer et al. [2013]
COMPARZ trial |
Pazopanib (800 mg od) versus sunitinib (50 mg od 4/2) |
1100 | Pazopanib 31% versus sunitinib 25% (p = 0.03) |
Pazopanib 8.4 versus sunitinib 9.5 (HR = 1.05; 95% CI 0.90–1.22) |
Pazopanib 28.4 versus sunitinib 29.3 (HR = 0.91; 95% CI 0.76–1.08; p = 0.28) |
|
Escudier et al. [2014b] PISCES trial |
Pazopanib (800 mg od) for 10 weeks → 2-week washout → sunitinib (50 mg od 4/2) for 10 weeks versus reverse sequence |
169 | NA | NA | NA |
| Morales et al. [2016]* | Sunitinib versus pazopanib |
3606 (sunitinib 3226 versus pazopanib 380) |
Sunitinib 30.2% versus pazopanib 25.7% |
Sunitinib 7.2 versus pazopanib 6.8 (HR = 1.052; 95% CI 0.908–1.220; p = 0.49) |
Sunitinib 20.1 versus pazopanib 23.7 HR = 0.952; 95% CI 0.788–1.150; p = 0.61) |
|
Escudier et al. [2007b, 2010] AVOREN trial |
Bevacizumab (10 mg/kg q2w) plus IFN-α (9 MU sc t.i.w.) versus IFN-α (9 MU sc t.i.w.) |
649 | Bevacizumab plus IFN-α 31% versus IFN-α 13% (p < 0.001) |
Bevacizumab plus IFN-α 10.2 versus IFN-α 5.4 (HR = 0.63; 95% CI 0.52–0.75; p = 0.0001) |
Bevacizumab plus IFN-α 23.3 versus IFN-α 21.3 (HR = 0.86; 95% CI 0.72–1.04; p = 0.1291) |
|
Rini et al. [2008b, 2010b] CALGB 90206 trial |
Bevacizumab (10 mg/kg q2w) plus IFN-α (9 MU sc t.i.w.) versus IFN-α (9 MU sc t.i.w.) |
732 | Bevacizumab plus IFN-α 25.5% versus IFN-α 13.1% (p < 0.0001) |
Bevacizumab plus IFN-α 8.2 versus IFN-α 5.2 (HR = 0.71; 95% CI 0.61–0.83; p < 0.0001) |
Bevacizumab plus IFN-α 18.3 versus IFN-α 17.4 months (HR = 0.86; 95% CI 0.73–1.01; p = 0.069) |
| Escudier et al. [2009] | Sorafenib (400 mg bid) versus IFN-α (9 MU sc t.i.w.) |
189 | Sorafenib 5.2% versus IFN-α 7.6% |
Sorafenib 5.7 versus IFN-α 5.6 (HR (IFN-α/sorafenib) = 0.88; 95% CI 0.61–1.27; p = 0.504) |
NA |
4/2, 4 weeks on, 2 weeks off schedule; Bid, twice daily; CI, confidence interval; HR, hazard ratio; IFN-α, interferon-alpha; NA, not available; od, once daily; ORR, objective response rate; OS, overall survival; PFS, progression free survival; q2w, every 2 weeks; RCC, renal cell carcinoma; sc, subcutaneously; t.i.w., three times a week.