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SORCE Trial: Active Surveillance or Sorafenib After Surgery in Renal Cell Carcinoma?

By: Joseph Fanelli
Posted: Thursday, January 28, 2021

According to findings presented in the Journal of Clinical Oncology, results from the phase III SORCE trial “unequivocally confirmed” that sorafenib should not be used as adjuvant therapy for patients with renal cell carcinoma who have an intermediate or high risk of relapse. Tim Eisen, MB BChir, PhD, of the Cambridge University Hospitals National Health Service Foundation Trust, United Kingdom, and colleagues noted that the kinase inhibitor offered no disease-free survival benefit when compared with a placebo

“Active surveillance remains the standard of care for patients at intermediate or high risk of recurrence after nephrectomy and is the appropriate control of our current international adjuvant RCC trial, RAMPART,” the authors concluded. “Sorafenib should not be used as adjuvant therapy for renal cell carcinoma.”

In the SORCE trial, the authors focused on 1,711 patients with renal cell carcinoma who had an intermediate or high risk of recurrence. The patients received 3 years of treatment with placebo (430 patients), 1 year of treatment with sorafenib followed by 2 years of placebo (642 patients), or 3 years of treatment with sorafenib (639 patients). Of those involved, 84% had clear cell histology, 53% were at intermediate risk for recurrence, and 47% were considered to be at high risk for recurrence.

The authors found that median disease-free survival was not reached for the patients treated with sorafenib or placebo (hazard ratio = 1.01). For those who received sorafenib for 3 years, the restricted mean survival time was 6.81 years, compared with 6.82 years for 3 years of treatment with placebo.

Despite offering treatment adaptations, the authors noted that more than half of patients stopped treatment by 12 months. Grade 3 hand-foot skin reactions were reported in 24% of the patients who received sorafenib.

Disclosure: For a full disclosure of the study authors, visit ascopubs.org.



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