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Trial | Design | Intervention | N | Inclusion Criteria (stage/grade/histology) | Results | Adverse Events |
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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. |
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