Dr Ryan on the Role of Adjuvant Therapy in RCC

Christopher W. Ryan, MD, professor of medicine, School of Medicine, the Oregon Health & Science University, discusses the role of adjuvant therapy for patients with renal cell carcinoma (RCC).

Five clinical trials have evaluated the use of a TKI in the adjuvant setting for patients with RCC; however, only 1 showed benefit, according to Ryan. The phase 3 S-TRACT trial (NCT00375674) with sunitinib (Sutent) showed that the TKI led to an improvement in disease-free survival (DFS) at 6.8 years compared with 5.6 years for placebo.

Regarding adjuvant immunotherapy, the phase 3 KEYNOTE-564 trial (NCT03142334) was the first study to produce data, Ryan notes. Updated findings reported at the 2022 Genitourinary Cancers Symposium showed that adjuvant pembrolizumab (Keytruda) elicited a statistically significant and clinically meaningful DFS benefit vs placebo in the intent-to-treat population (HR, 0.68, 95% CI: 0.53-0.87, P = .001). Prior data from the study supported the FDA approval of pembrolizumab for the adjuvant treatment of patients with RCC who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, which added another option for patients to consider when pursuing adjuvant treatment, Ryan notes.

Although adjuvant pembrolizumab quickly established a role in clinical practice following the FDA approval, there is an absence of data regarding overall survival, Ryan explains. Additionally, using immunotherapy in the adjuvant setting could have implications for later treatment decisions if a patient relapses with metastatic disease, Ryan explains.

However, given the DFS benefit, adjuvant pembrolizumab is a reasonable treatment option for patients with RCC, Ryan says. This treatment option is something to discuss with high-risk patients following surgery, Ryan concludes.