Trial results, published this week in the Journal of Clinical Oncolgoy by Urological Malignancies Programme member Professor Tim Eisen, have concluded that active observation remains the best care for kidney cancer patients after surgery.
Over 1,700 patients participated in this double-blind, randomised trial assessing the efficacy of sorafenib (a tyrosine kinase inhibitor also known as Nexavar) for prolonging life and preventing recurrence of kidney cancer in patients who are at medium or high risk of their cancer returning.
All participants had surgery to remove their cancer and showed no sign of disease when they began drug treatment.
Participants were randomly allocated to one of three treatment arms;
(1) three years of placebo drug and active observation (the same treatment they would have received without participating in the SORCE trial);
(2) one year of sorafenib then two years of placebo drug; or
(3) three years of sorafenib.
The trial found no benefit for treatment with sorafenib, whether given for one year or three years. Many patients stopped treatment early due to side-effects from sorafenib.
Professor Eisen said: “The SORCE study definitively ends the discussion about whether anti-angiogenic tyrosine kinase inhibitors benefit people who have had a kidney cancer removed: they are of no benefit and should not be used.
"Although a negative result is always disappointing, a definitive result does move things on in this most important of all the questions in the treatment of kidney cancer. Already, the excellent MRC Clinical Trial Unit international group is addressing the use of drugs to activate the immune system against kidney cancer in the RAMPART trial.”
SORCE was funded by Cancer Research UK.
Eisen, T et al Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial J Clin Oncol, 2020