sorafenib

Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial

In the December 1, 2020 edition of Journal of Clinical Oncology, Tim Eisen and colleagues report on the long-term results of adjuvant sorafenib therapy in patients with intermediate and high risk renal cell carcinoma was undergone surgical resection.

PURPOSE

The SORCE trial randomized, double-blind, 3-arm trial of sorafenib in the adjuvant setting after surgical excision of primary renal cell carcinoma (RCC) for intermediate and high risk disease patients

PATIENTS AND METHODS

Patient underwent a 2:3:3 randomization to 3 years of placebo (arm A), 12 months of sorafenib followed by 24 months of placebo (arm B), or 36 months of sorafenib (arm C).  Sorafenib was initially dosed at 400 mg twice per day orally, which was done amended to 400 mg daily. The primary outcome analysis was investigator-reported disease-free survival (DFS) comparing 3 years of sorafenib versus placebo, but this was revised as a result of external results.

RESULTS

1,711 participants were randomized (430, 642, and 639 participants in arms A, B, and C, respectively). The median age was 58 years, 71% of patients being men, 84% with clear cell histology, 53% had an intermediate risk of recurrence, 47% were high risk of recurrence.  There were no differences noted in DFS or OS in all randomly assigned patients, patients with high risk of recurrence, with clear cell RCC only. The median DFS was not reached for 36 months of sorafenib or for placebo (HR, 1.01; 95% CI, 0.83 to 1.23; P = .95). Nonproportional hazards were observed; the restricted mean survival time was 6.81 years for 3 years of sorafenib and 6.82 years for placebo (difference, 0.01 year; 95% CI, −0.49 to 0.48 year; P = .99).  50 percent of patients stopped treatment by 12 months. 24% of patients on sorafenib had grade 3 hand-foot syndrome.

The authors concluded “ sorafenib should not be used as adjuvant therapy for RCC. 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.”

Reference:

Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial

https://ascopubs.org/doi/full/10.1200/JCO.20.01800

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