Dr. Yekedüz on the importance of the KEYNOTE-564 study in adjuvant ccRCC

Emre Yekedüz, MD, a research associate at Dana-Farber Cancer Institute, discusses the results of a case study of a patient with clear cell renal cell carcinoma (ccRCC) and highlights adjuvant treatment options for this individual.

Yekedüz used social media to survey members of the oncology community about the treatment of RCC to raise awareness for World Kidney Cancer Day, which occurs on June 20, 2024. The survey asked: “A 62-year-old man underwent radical nephrectomy for a 75 mm left renal mass diagnosed as ccRCC with sarcomatoid features. The tumor invaded the perirenal sinus fat, [extend] beyond the Gerota fascia, with clear surgical margins. Imaging showed no distant metastases. What is [the] next step?”

Some survey respondents chose adjuvant sunitinib (Sutent) as a treatment option for this patient, Yekedüz begins. This decision, according to Yekedüz, was likely influenced by clinical trial data showing that adjuvant sunitinib can improve disease-free survival. However, it is important to note that despite this benefit, sunitinib did not provide an overall survival (OS) benefit in this context, he explains. Therefore, it is important to consider pembrolizumab (Keytruda) as an adjuvant treatment option for RCC, he notes. The rationale for this consideration comes from the results of the Phase 3 KEYNOTE-564 trial (NCT03142334), which indicate that pembrolizumab should be an important option in the adjuvant setting for this patient group, Yekedüz emphasizes.

The importance of discussing how oncologists approach adjuvant therapy in ccRCC cannot be overstated, he says. KEYNOTE-564 was a groundbreaking trial because it was the first to show an improvement in OS in the adjuvant setting in patients with ccRCC. This breakthrough makes it imperative to evaluate patients according to their risk categories – particularly those with intermediate/high or high risk of disease, Yekedüz emphasizes. For patients who fall into these categories, pembrolizumab should be seriously considered as a treatment option in the adjuvant setting, he says.

Understanding risk stratification is also crucial, he adds. Patients with T2, T3 or grade 4 or those with sarcomatoid features can be classified as having intermediate/high risk of disease, and patients with T4 and lymph node-positive disease are considered having high risk of disease. In addition, in the metastatic stage, when there is no evidence of disease, adjuvant pembrolizumab should be considered, explains Yekedüz. This approach aims to maximize the potential benefits of adjuvant therapy and thus improve outcomes for patients with RCC, Yekedüz concludes.