Dr. Shuch on the Impact of the SURTIME Trial in Advanced RCC

Brian M. Shuch, MD, director, Kidney Cancer Program, Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research, University of California, Los Angeles Institute of Urologic Oncology, discusses the impact of the phase III SURTIME study in advanced renal cell carcinoma (RCC).

The SURTIME study took an alternative approach to the CARMENA trial. Instead of patients undergoing cytoreductive nephrectomy upfront and then receiving sunitinib (Sutent), patients in the SURTIME trial received sunitinib (monotherapy) and then cytoreductive nephrectomy. The investigators had a goal of accruing 450 patients but fell short of that goal, says Shuch. The primary endpoint of the study was progression-free survival (PFS), but due to the poor accrual, the primary endpoint was altered to look at PFS at 28 weeks instead.

Although the study did not meet its primary endpoint, investigators noted a difference in overall survival (OS), which served as a secondary endpoint. The patients who had systemic therapy and went on to surgery if they did not have disease progression had an OS at 32 months compared with 15 months in the immediate nephrectomy group, adds Shuch.

However, the study may have been underpowered to show that delayed nephrectomy is beneficial, he cautions. Nonetheless, it shows that with the TKIs, if there are patients who will do poorly with systemic therapy and are going to be put through upfront surgery, some of them are not going to do well. By the time they are ready to receive systemic therapy, they may no longer be a candidate for that approach, as they might be too frail.

Delaying systemic therapy and re-imaging at 3 or 4 months could eliminate that problem and surgery altogether. However, this will have to be studied further as it was a secondary endpoint of a small trial that now has to be considered in the newer targeted immunotherapy era, concludes Shuch.