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. 2016 Aug 30;3(4):286–292. doi: 10.1016/j.ajur.2016.08.006

Table 1.

Trials of adjuvant targeted therapy in RCC.

Trial (sponsor) Randomization Treatment duration (year) n Limited to clear cell Inclusion criteria Details
Reported trials
ASSURE (ECOG) Sunitinib vs. sorafenib vs. placebo 1 1943 No pT1b (G3-4) or pT2-4 or N+
  • •

    Study showed no significant difference in DFS across arms
S-TRAC (Pfizer) Sunitinib vs. placebo 1 670 Yes pT3-4 or N+
  • •

    Press release indicates study met primary endpoint

  • •

    Further study results to be presented at upcoming meeting

  • Unreported trials

ATLAS (Pfizer) Axitinib vs. placebo 3 592 Yes pT2-4 or N+
  • •

    Study employs a longer duration of axitinib therapy

  • •

    Small sample size relative to other adjuvant trials
EVEREST (SWOG) Everolimus vs. placebo 1 1218 No pT1b (G3-4) or pT2-4 or N+
  • •

    Study nearing completion of accrual

  • •

    Only adjuvant trial to assess an mTOR inhibitor
PROTECT (GSK) Pazopanib vs. placebo 1 1500 Yes pT1b (G3-4) or pT2-4 or N+
  • •

    Projected accrual per arm (n = 750) makes this the most sizeable exploration of a VEGF-TKI in a single study
SORCE (MRC) Sorafenib vs. placebo 3 1420 No Leibovich score 3-11
  • •

    Only study to utilize Leibovich scoring criteria

  • •

    Leibovich scoring utilizes pathologic elements such as tumor necrosis, which are subject to variability amongst reviewers

ECOG, Eastern Cooperative Oncology Group; DFS, disease-free survival; mTOR, mammalian target of rapamycin; GSK, GlaxoSmithKline; VEGF-TKI, vascular endothelial growth factor tyrosine kinase inhibitor; MRC, Medical Research Council; RCC, renal cell carcinoma.