Table 1.
Trial | Regimen | Pts (n) |
Study sites | Funding | Pathological inclusion criteria | Median age, yr (range) | DFS | OS |
---|---|---|---|---|---|---|---|---|
ASSURE 2016 [7] | Sunitinib Sorafenib Placebo |
647 649 647 |
226 centers; USA and Canada | US NCI, ECOG-ACRIN, Pfizer, and Bayer | CC and NCC RCC; pT1b G3-4 N0 M0 or T(any) G(any) N+ (resected) M0 | 56 (49-64) 55(48-63) 57(46-64) |
70 mo 73.4 mo 79.6 mo |
5-yr 77.9% 5-yr 80.5% 5-yr 80.3% |
ASSURE high risk 2017 [4] | Sunitinib Sorafenib Placebo |
358 355 356 |
Same as ASSURE 2016 | Only CC RCC; pT3/pT4 or N+ disease | 59 (31-83) 56 (20-84) 58 (19-84) |
5-yr 47.7% 5-yr 49.9% 5-yr 50% |
5-yr 75.2% 80.20% 76.50% |
|
S-TRAC 2016 [5] | Sunitinib Placebo |
309 306 |
99 centers; 21 countries | Pfizer | CC RCC; T3/T4, no or undetermined nodal involvement, or any T stage with local nodal involvement; any Fuhrman grade | 57 (25-83) 58 (21-82) |
6.8 yr 5.6 yr |
HR 1.01 (0.72-1.44; P=0.94) |
S-TRAC 2017 [6] | Sunitinib Placebo |
194 194 |
Pfizer | T3, no or undetermined nodal involvement, Fuhrman grade ≥2, and ECOG PS ≥1; T4 and/or nodal involvement | NR NR |
6.2 yr 4 yr |
Median NR (HR 0.92, 95% CI 0.66-1.28; p = 0.6) Median NR | |
PROTECT [3] | Pazopanib Placebo |
571 564 |
263 centers in 26 countries |
Novartis | Nonmetastatic CC RCC; pT2 G3-4 N0, pT3-4 G any N0, or pT any G any N1 | 58 (22-83) 58 (21-82) |
3-yr 67% 3-yr 64% |
HR 0.79, 95% CI 0.57-1.09; p = 0.16 |
ACRIN = American College of Radiology Imaging Network; CC = clear cell; DFS = disease-free survival; ECOG = Eastern Cooperative Oncology Group; NCC = non–clear cell; NCI = National Cancer Institute; NR = not reached; OS = overall-survival; PS = performance score; Pts = patients; RCC = renal cell carcinoma.