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. 2019 Apr 1;2019:7309205. doi: 10.1155/2019/7309205

Table 2.

Summary of adjuvant trials: completed and reported.

Trial Design Intervention N Inclusion Criteria (stage/grade/histology) Results Adverse Events
ASSURE, Haas et al. (2016) [21] Randomized, Double-blinded, Placebo-controlled Sunitinib or Sorafenib 1943 T1b N0 M0 (grade 3-4), pT2–pT4 N0 
M0, pT(any) N1 M0; Clear Cell and Non-clear Cell
No difference in median DFS (HR 1.02, 97.5% CI 0.85-1.23) Grade 3+ toxicities of sunitinib, sorafenib: hypertension (17%, 16%), hand-foot syndrome (15%, 33%), rash (2%, 15%), fatigue (18%, 7%)
PROTECT, Motzer et al. (2017) [22] Randomized, Double-blinded, Placebo-controlled Pazopanib 1538 pT2 N0 M0 (grades 3–4), pT3–4 N0 M0, pT (any) N1 M0; Clear Cell No differences in median DFS (HR 0.86, 95% CI 0.70-1.06) Increased ALT/AST lead to treatment discontinuation in 600 mg (ALT 16%/AST 5%) and 800 mg (ALT 18%/AST 7%) mg.
ATLAS, Gross-Goupil et al. (2018) [23] Randomized, Double-blinded, Placebo-controlled Axitinib 724 pT2–4 N0 M0, pT (any) N1 M0; Clear Cell No difference in median DFS (HR 0.87, 95% CI 0.66-1.15, p=0.321) Similar and serious adverse events between groups; more grade 3/4 (61% vs. 30%) for axitinib
S-TRAC, Ravaud et al. (2016) [24] Randomized, Double-blinded, Placebo-controlled Sunitinib 615 pT3 N0 M0 (grades 2–4), pT4 N0 M0, pT (any) N1 M0; Clear Cell Improved median DFS (6.8 years v 5.6; HR 0.76, 95% CI 0.59-0.98) Increased Grade 3 (48.4% vs. 15.8%); Grade 4 (12.1% vs. 3.6%) in sunitinib; Similar serious event rate.