ECOG 2805 — Adjuvant Sunitinib or Sorafenib for High-Risk, Non-Metastatic Renal-Cell Carcinoma (ECOG-ACRIN E2805): A Double-Blind, Placebo-Controlled, Randomised, Phase 3 Trial

Phase 3 · 2016 · Renal Cell Carcinoma

Design

Double-blind, placebo-controlled, randomized phase III trial of one year of adjuvant sunitinib, sorafenib, or placebo after nephrectomy.

Population

1,943 patients with resected high-risk, non-metastatic (locally advanced) renal-cell carcinoma.

Primary Endpoint

Disease-free survival

Key Result

Neither drug improved disease-free survival (median 5.8 years sunitinib, 6.1 years sorafenib, 6.6 years placebo; sunitinib vs placebo HR 1.02, sorafenib vs placebo HR 0.97) or overall survival.

Guideline Impact

Argued against routine adjuvant sunitinib/sorafenib in resected high-risk RCC guidelines.