BJU Int. 2023 Jan 29. doi: 10.1111/bju.15981. Online ahead of print.
ABSTRACT
OBJECTIVES: To synthesize available data regarding the disease-free survival (DFS) benefit of adjuvant immune checkpoint inhibitors (ICIs) for patients with RCC and evaluate the overall safety profile of ICIs in this setting.
MATERIALS AND METHODS: We utilized PubMed, Embase, and relevant conference proceedings to identify phase III randomized controlled trials comparing adjuvant ICI versus placebo/observation for RCC. The primary outcome of interest was DFS. Variables for subgroup analyses were program death-ligand 1 (PD-L1) expression, sarcomatoid features, nephrectomy type, and disease-risk category. Secondary outcomes included grade ≥ 3 adverse events (AEs), immune-related AEs, and treatment discontinuation due to AEs. All outcomes were analyzed using random-effects models owing to inter-study heterogeneity.
RESULTS: Among the four included studies, one demonstrated a significant DFS benefit. There was considerable clinical and statistical heterogeneity (I2 =64%) due to differences in inclusion criteria and interventions. While pooled results across the four studies did not demonstrate a significant benefit in DFS overall (HR 0.85, 95% CI 0.69-1.04), there was significant benefit among patients with positive PD-L1 expression (HR 0.72, 95% CI 0.55-0.94) and sarcomatoid features (HR 0.59, 95% CI 0.38-0.91).
CONCLUSION: The evidence base to date regarding ICI as adjuvant therapy in RCC is mixed – conclusions are limited by considerable heterogeneity between studies. However, pooled analyses suggest that patients with positive PD-L1 expression or sarcomatoid features are most likely to benefit from adjuvant immunotherapy.
PMID:36709462 | DOI:10.1111/bju.15981
