S-TRAC provides weak evidence when we assess the value of health care, looking at quality of evidence, harms-to-benefit ratio, patient’s values and preferences, and cost. To change my mind, I would need to see an overall survival benefit.— Axel Bex, MD, PhD
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The formal discussant of this trial, Axel Bex, MD, PhD, of The Netherlands Cancer Institute in Amsterdam, was cautious in interpreting these results to be practice-changing. “I congratulate the investigators for the first-ever positive trial for adjuvant treatment of renal cell carcinoma,” he stated.
Comparing S-TRAC With ASSURE
Dr. Bex compared S-TRAC with ASSURE, which evaluated adjuvant sunitinib (Sutent) and sorafenib (Nexavar). ASSURE found no disease-free or overall survival benefit for either sorafenib or sunitinib in unfavorable-risk renal cell carcinoma.1 “We do not recommend adjuvant therapy based on ASSURE,” Dr. Bex told listeners. However, the trials differed in size of enrollment, risk-group selection, and dosing schedules, so they may not be directly comparable.
“If S-TRAC were practice-changing, it would have to show a survival benefit. I believe that S-TRAC provides weak evidence when we assess the value of health care, looking at quality of evidence, harms-to-benefit ratio, patient’s values and preferences, and cost,” he said.
There was no survival benefit for sunitinib, the rate of grade 3/4 adverse events was threefold higher for patients on sunitinib, and patients experienced significant reductions in quality of life for loss of appetite and diarrhea.
“Many patients were exposed to sunitinib who may never experience recurrence. Is it worth it to treat a year to delay mostly asymptomatic recurrences? We asked 17 members of the EAU [European Association of Urology] guideline committee what would constitute a practice-changing study, and most would have wanted to see a survival difference,” Dr. Bex shared. “To change my mind, I would need to see an overall survival benefit. We await further results from other studies.” ■
Disclosure: Dr. Bex is on the advisory board for Pfizer, Roche, Novartis Eisai, and Ipsen.
1. Haas NB, Manola J, Uzzo RG, et al: Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): A double-blind, placebo-controlled, randomised, phase 3 trial. Lancet 387:2008-2016, 2016.
Sunitinib (Sutent) improved disease-free survival by more than 1 year when used as adjuvant treatment for high-risk locoregional renal cell carcinoma following nephrectomy, but with the cost of toxicity. S-TRAC is the first phase III trial showing a benefit for adjuvant therapy in renal cell...