For patients who are at intermediate or high risk of renal cell carcinoma (RCC) recurrence, adjuvant sorafenib after surgery offered no survival advantage compared with placebo, according to findings from the randomized, double-blind SORCE trial (ClinicalTrials.gov Identifier: NCT00492258; ISRCTN38934710; EudraCT: 2006-006079-19). Study data were presented at the European Society of Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain.1
“Sorafenib should not be used as adjuvant therapy for RCC,” reported Tim Q. Eisen, PhD, of the University of Cambridge in England, in the study abstract. “We observed no differences in DFS [disease-free survival] or OS [overall survival] in any of our preplanned and prepowered analyses: all randomized patients, high-risk patients only, and patients with clear cell RCC only” (P =.95).
Between 2007 and 2013, 1711 patients were randomly assigned to receive 3 years of placebo (430 individuals), 1 year of sorafenib followed by 2 years of placebo (642 individuals), or 3 years of sorafenib (639 individuals). Eighty-four percent of patients had clear cell RCC. Initially, patients were given 400 mg sorafenib twice daily orally, but the trial protocol was amended to halve the starting dose to 400 mg once daily.
Grade 3 hand-foot syndrome affected 24% of patients who were administered sorafenib.
“Despite offering treatment adaptations, over half of patients stopped treatment early,” Dr Eisen noted.
Active surveillance “remains the standard of care for patients at intermediate or high risk of recurrence following nephrectomy,” the researchers concluded. “[I]t is the appropriate control of our current international adjuvant RCC trial, RAMPART.”
- TQG Eisen, Frangou E, Smith B, et al. Primary efficacy analysis results from the SORCE trial (RE05): Adjuvant sorafenib for renal cell carcinoma at intermediate or high risk of relapse: An international, randomised double-blind phase III trial led by the MRC CTU at UCL. Presented at: European Society of Medical Oncology (ESMO) Congress 2019; September 27-October 3, 2019: Barcelona, Spain. Abstract LBA56.
This article originally appeared on Cancer Therapy Advisor