The findings of the trial help confirm the results of the CARMENA phase 3 trial: In mRCC with intermediate-risk disease, it may be appropriate to defer surgery and treat with a systemic VEGF TKI therapy such as sunitinib or pazopanib, said Naomi B. Haas, MD, the University of Pennsylvania, Philadelphia, who was not involved in the trial.2 The appropriate treatment for patients with intermediate-risk disease has been debated, whereas for patients with good-risk disease, CN followed by systemic therapy is generally the standard of care, and in patients with poor-risk disease, CN would be avoided, Dr Haas added.
The CARMENA trial randomly assigned 450 patients with poor- and intermediate-risk clear cell mRCC to undergo CN followed by sunitinib therapy or receive sunitinib alone. In regard to median OS, an interim analysis revealed that sunitinib alone was noninferior to the standard therapy of surgery followed by sunitinib based on median OS. In Dr Haas’ opinion, SURTIME is a better-designed trial, because it focused predominantly on the intermediate-risk group for whom the most appropriate treatment is still unknown.
SURTIME also addresses concerns about whether sunitinib is safe to give before surgery, as it is known to inhibit wound healing and can increase the risk of complications such as cardiac events, Dr Haas said. Patients in the pretreatment arm had surgery the day after stopping sunitinib therapy, and patients in both arms without disease progression received sunitinib 4 weeks after surgery.
The rates of surgical complications were similar between the pretreatment arm (53%) and immediate CN arm (52%), which is “somewhat reassuring,” Dr Haas said. In addition, rates of disease progression were similar between the pretreatment arm (24%) and immediate CN arm (20%).
A benefit of pretreating with systemic therapy among patients with intermediate-risk disease is that it could identify patients with aggressive disease who do not respond, may have a poor prognosis, and would be less likely to benefit from surgery. “Using a VEGF TKI ahead of surgery is a useful litmus test for who is an appropriate candidate for CN at a later date when they’re in this intermediate group,” Dr Haas said.