Thomas Powles, MBBS, MRCP, MD from Barts Cancer Institute, London, UK gives an overview of the S-TRAC Phase III trial of sunitinib compared against placebo (NCT00375674) in high-risk renal cell cancer patients who had already undergone a nephrectomy. The trial shows a statistically significant progression-free survival (PFS) advantage, with a hazard ratio of 0.76. However, the central independent and the investigators’ review are different from one another and the results could be described as marginal. Additionally, there was found to be no overall survival (OS) advantage in this trial with a hazard ratio of 1.0. Another similarly designed trial that had been done previously, showed the same negative results. Prof. Powles explains that although sunitinib showed signs that it might improve PFS, there was no evidence showing that it improves OS, which is the goal. Prof. Powles would like to see a positive PFS meta-analysis, future trials that are positive or indication that the drug improves OS.
Recorded at the European Society of Medical Oncology (ESMO) 2016 Congress, held in Copenhagen, Denmark.