Adjuvant Immunotherapy in RCC: A Systematic Review and Meta-Analysis

Emily Y. Huang, MD, BA, Houston Methodist Hospital, presented at the American Urological Association 2023 meeting the results of a systematic review and meta-analysis of randomized clinical trials that showed the evidence base to date regarding immune checkpoint inhibitors (ICIs) as adjuvant therapy in renal cell carcinoma (RCC) is “mixed.”

Many patients with high-risk RCC experience disease recurrence after surgical resection. Multiple approvals in metastatic RCC have led to considerable interest in using ICIs in the adjuvant setting.

Dr. Yuang and colleagues designed a study to synthesize available data regarding the disease-free survival (DFS) benefit of adjuvant ICIs for patients with RCC as well as to evaluate the overall safety profile of ICIs in this setting. Researchers utilized PubMed, Embase, and relevant conference proceedings to identify phase 3 randomized controlled trials comparing adjuvant ICIs versus placebo or observation up to September 18, 2022.

A total of 4 studies were identified. Among those studies, only 1 demonstrated a significant DFS benefit. Researchers noted “considerable clinical and statistical heterogeneity” due to differences in inclusion criteria and interventions.

While pooled results across the four studies did not demonstrate a significant benefit in DFS overall (hazard ratio [HR], 0.85; 95% CI, 0.69-1.04), researchers reported significant benefit among patients with positive PD-L1 expression (HR, 0.72; 95% CI, 0.55-0.94) or sarcomatoid features (HR, 0.59; 95% CI, 0.38-0.91).

“The evidence base to date regarding ICI as adjuvant therapy in RCC is mixed – conclusions are limited by considerable heterogeneity between studies,” Dr Yuang and co-authors concluded. “However, pooled analyses suggest that patients with positive PD-L1 expression or sarcomatoid features are most likely to benefit from adjuvant immunotherapy.”