Review Article

Current Status of Immunotherapy for Localized and Locally Advanced Renal Cell Carcinoma

Table 2

Summary of adjuvant trials: completed and reported.

TrialDesignInterventionNInclusion Criteria (stage/grade/histology)ResultsAdverse Events

ASSURE, Haas et al. (2016) [21]Randomized, Double-blinded, Placebo-controlledSunitinib or Sorafenib1943T1b 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-controlledPazopanib1538pT2 N0 M0 (grades 3–4), pT3–4 N0 M0, pT (any) N1 M0; Clear CellNo 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-controlledAxitinib724pT2–4 N0 M0, pT (any) N1 M0; Clear CellNo 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-controlledSunitinib615pT3 N0 M0 (grades 2–4), pT4 N0 M0, pT (any) N1 M0; Clear CellImproved 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.