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. Author manuscript; available in PMC: 2019 Jun 1.
Published in final edited form as: Eur Urol Oncol. 2018 Mar 15;1(2):101–108. doi: 10.1016/j.euo.2018.03.012

Table 1.

Studies included in our meta-analysis

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.