Renal Cell Carcinoma · Medical · Adjuvant Therapy

SORCE

After nephrectomy for intermediate- or high-risk RCC, does one or three years of adjuvant sorafenib improve disease-free survival?

Population1,711 patients with resected RCC at intermediate or high risk of recurrence.Arms3 years placebo; 1 year sorafenib then placebo; or 3 years sorafenib.Primary comparison3 years sorafenib versus placebo for disease-free survival.DesignInternational, randomized, double-blind phase III trial.

Absolute Effect

Disease-free survival

HR 1.01; P=.95

Median DFS was not reached in either the 3-year sorafenib or placebo groups. RMST was 6.81 vs 6.82 years.

Clinical magnitude

RMST difference 0.01 year

95% CI −0.49 to 0.48 year, showing essentially no difference in restricted mean DFS over the analysed horizon.

Treatment burden

More than half of participants stopped treatment by 12 months despite treatment adaptations. Grade 3 hand-foot skin reaction occurred in 24% of participants receiving sorafenib.

Clinical interpretation

SORCE found no meaningful DFS or OS improvement with adjuvant sorafenib.

The trial is especially useful for the Absolute Effect framework because the RMST difference was essentially zero, despite the large randomized sample.

NNT / NNH

No NNT is appropriate because there was no efficacy benefit. A single NNH should not be inferred from one toxicity alone, although the 24% grade 3 hand-foot skin reaction rate demonstrates clinically relevant treatment burden.

Limitations

The trial included intermediate- and high-risk patients and three treatment-duration strategies. Contemporary adjuvant immunotherapy has changed the therapeutic landscape, so SORCE is historical evidence against adjuvant sorafenib rather than a statement about all current adjuvant therapies.

Primary / authoritative sources

SORCE primary report — PubMed