Dr Braun on the Role of Biomarkers in Guiding Adjuvant Treatment for RCC

David A. Braun, MD, PhD, assistant professor, medical oncology, Louis Goodman and Alfred Gilman Yale Scholar, member, Center of Molecular and Cellular Oncology, Yale Cancer Center, discusses the role of biomarkers in optimizing adjuvant treatment strategies for renal cell carcinoma (RCC).

Although biomarkers are commonly thought of as factors to help guide treatment in the metastatic setting, Braun explains the need for their integration in the adjuvant setting to better guide treatment decisions.

Currently, many patients who undergo surgery for localized RCC are effectively cured by surgery alone and do not benefit from adjuvant therapies, Braun continues. This presents a significant clinical challenge, as these patients may be exposed to unnecessary toxicity from adjuvant treatment without gaining any therapeutic advantage, Braun says.

To help mitigate and avoid these toxicities, Braun highlights the importance of identifying biomarkers that can accurately differentiate patients who are at a higher risk of recurrence from those who are likely to remain disease-free without additional therapy.

Braun explains that efforts to identify reliable biomarkers for RCC are ongoing, and one promising area of research is circulating plasma levels of KIM-1. This biomarker has demonstrated potential in indicating recurrence risk, demonstrated in the in the randomized, phase 3 ECOG-ACRIN E2805 (ASSURE) trial (NCT00326898).

This trial evaluated adjuvant sunitinib (Sutent), sorafenib (Nexavar), or placebo in patients with resected high-risk RCC. In a biomarker analysis, KIM-1 levels from banked plasma at trial enrollment 4 to 12 weeks post-nephrectomy were examined. The analysis showed that elevated levels of KIM-1 were associated with worse DFS across all study arms, suggesting that this biomarker could be used to identify patients who may benefit from adjuvant therapy.

Although KIM-1 is still under investigation as a potential biomarker, early data suggest it could play a key role in risk stratification to help tailor adjuvant treatment approaches based on individual patient profiles.

Braun concludes that developing biomarkers like KIM-1 is crucial for refining adjuvant therapy strategies in RCC, allowing for tailored treatment that minimizes toxicity in patients at a lower risk of recurrence and maximizes the benefits of adjuvant therapy for those at a higher risk of recurrence.