While studies have demonstrated an association between preoperative hypoalbuminemia and adverse clinical outcomes, the optimal serum albumin threshold for risk-stratification in the broader surgical population remains poorly defined. We sought define the optimal threshold of preoperative serum albumin concentration for risk-stratification of adverse post-operative outcomes. Using the American College of Surgeons National Surgical Quality Improvement Program Database, we identified 842,672 patients that had undergone a common surgical procedure in one of eight surgical specialties. An optimal serum albumin concentration threshold for risk-stratification was determined using receiver-operating characteristic analysis. Multivariable logistic regression analysis was used to evaluate the odds of adverse surgical events; a priori defined subgroup analyses were performed. A serum albumin threshold of 3.4 g/dL optimally predicted adverse surgical outcomes in the broader cohort. After multivariable analysis, patients with hypoalbuminemia had increased odds of death within 30 days of surgery (odds ratio [OR] 2.01, 95% confidence interval [CI] 1.94–2.08). Hypoalbuminemia was associated with greater odds of primary adverse events among patients with disseminated cancer (OR 2.03, 95% CI 1.88–2.20) compared to patients without disseminated cancer (OR 1.47, 95% CI 1.44–1.51). The standard clinical threshold for hypoalbuminemia is the optimal threshold for preoperative risk assessment.
Objectives
To synthesise available data regarding the disease‐free survival (DFS) benefit of adjuvant immune checkpoint inhibitors (ICIs) for patients with renal cell carcinoma (RCC) and evaluate the overall safety profile of ICIs in this setting.
Materials and Methods
We utilised PubMed, Embase, and relevant conference proceedings to identify phase III randomised controlled trials comparing adjuvant ICIs vs placebo/observation for RCC. The primary outcome of interest was DFS. Variables for subgroup analyses were programmed 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 analysed 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 (hazard ratio [HR] 0.85, 95% confidence interval [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 ICIs 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.
671 Background: There has been interest in adjuvant immune checkpoint inhibition (ICI) following surgical resection in patients with high-risk renal cell carcinoma (RCC) given high recurrence rates and approvals of ICI in metastatic RCC. The primary objective of this analysis was to synthesize available data regarding the disease-free survival (DFS) benefit of adjuvant ICIs for patients with RCC. Methods: This systematic review was performed according to the PRISMA guidelines. The protocol was registered in PROSPERO (CRD42022361599). We searched PubMed, EMBASE, and relevant conference proceedings to identify phase III randomized controlled trials (RCTs) comparing adjuvant ICI versus placebo/observation. The primary outcome of interest was DFS. 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) or sarcomatoid features (HR 0.59, 95% CI 0.38-0.91). Conclusions: 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 PDL1 expression or sarcomatoid features are most likely to benefit from adjuvant immunotherapy.
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