- Adjuvant therapy with pazopanib vs placebo does not confer an OS benefit in patients with locally advanced renal cell carcinoma (RCC) at high risk for relapse after nephrectomy.
Why this matters
- Based on these findings, pazopanib is not recommended as adjuvant therapy following resection of locally advanced RCC.
- Final analysis of phase 3, double-blind PROTECT study, which evaluated 1538 patients with locally advanced RCC at high risk for relapse after nephrectomy.
- 403 patients were randomly assigned to receive an 800-mg starting dose (pazopanib, n=198; placebo, n=205), and 1135 patients to receive the 600-mg starting dose (pazopanib, n=571; placebo, n=564).
- Funding: Novartis.
- Median follow-up was 76 months in the pazopanib group and 77 months in the placebo group.
- OS was not significantly different between the pazopanib and placebo groups (HR, 1.0; P>.9).
- OS was worse for patients with T4 vs T1/T2 disease:
- HR: 3.312 (P<.001>
- OS was superior in patients with BMI ≥30 kg/m2 vs those with lower BMI:
- HR: 0.592 (P=.001).
- OS was significantly higher in patients who remained disease-free at 2 years after treatment vs those who experienced relapse within 2 years:
- 94% vs 51% (P<.0001>
- None reported.