Renal Cell Carcinoma · Medical · Adjuvant Therapy

ASSURE

After nephrectomy for high-risk RCC, does adjuvant sunitinib or sorafenib improve disease-free or overall survival?

Population1,943 patients with resected high-risk RCC.Arms1 year sunitinib, 1 year sorafenib, or placebo.Primary endpointDisease-free survival.Key issueLarge phase III test of postoperative VEGF-targeted therapy.

Absolute Effect

Primary DFS

5-year DFS 54.3% sunitinib vs 56.4% placebo

HR 1.02; no benefit. Sorafenib 54.0% vs 56.4%; HR 0.97; no benefit.

High-risk clear-cell subset

47.7% / 49.9% / 50.0%

Five-year DFS for sunitinib, sorafenib and placebo respectively; neither active drug improved outcome.

Overall survival

In the primary cohort, 5-year OS was 77.9% with sunitinib, 80.5% with sorafenib and 80.3% with placebo. No OS benefit was demonstrated.

Toxicity / burden

Grade ≥3 adverse events were substantially more frequent with sunitinib and sorafenib than placebo. Dose reductions and discontinuation were common, making treatment burden clinically important.

Clinical interpretation

ASSURE is a negative adjuvant trial: neither sunitinib nor sorafenib improved DFS or OS after nephrectomy.

The result is important because the trial was large and randomized, and because it illustrates why relative hazard ratios should be translated into absolute recurrence probabilities before judging postoperative therapy.

NNT / NNH

No NNT is reported because there was no demonstrated efficacy benefit. A broad toxicity NNH should not be calculated from heterogeneous grade ≥3 adverse events without a prespecified patient-important endpoint.

Primary / authoritative sources

Primary ASSURE report — PubMed

High-risk clear-cell subset — PubMed