Liquid biopsy comprehensive genomic profiling of lung cancer in the Italian population: A real-world experience.

OBJECTIVES: Liquid biopsy with next-generation sequencing (NGS) has emerged as a promising tool for tumor mutation profiling. In this study, we describe the genomic profile of Italian lung cancer patients tested with blood-based comprehensive genomic profiling (CGP) to assess the genomic landscape complexity and its impact on enhancing treatment options for patients. MATERIALS AND METHODS: Between January 2021 and December 2021, a total of 229 lung cancer patients were profiled by FoundationOne®Liquid CDx (F1LCDx®) assay on circulating tumor DNA (ctDNA). F1LCDx® reports alterations across 324 cancer-related genes and genomic signatures, including tumor fraction (TF) and blood-based tumor mutational burden (bTMB). Detected variants were classified according to the ESMO Scale of Clinical Actionability for molecular Targets (ESCAT). RESULTS: 90.4% of patients had at least one detectable alteration in plasma. The most frequently mutated genes were TP53 (47.6%), DNMT3A (33.2%), EGFR (20.1%), and KRAS (15.7%). Elevated TF was detected in 18.3% of patients, suggesting high reliability of test results. According to the ESCAT classification, potentially actionable alterations (Tier I-II) were identified in 27.1% of samples. An additional 5.2% harbored an alteration for which an approved drug is available in other cancer types (Tier III). Furthermore, 13.1% of tumors exhibited high bTMB, which may predict response to immunotherapy. Overall, 156 (68.1%) patients were eligible for enrolment in clinical trials. CONCLUSION: Liquid biopsy NGS is a viable and valuable approach to guide personalized therapy. The use of blood-based CGP may help identify a larger number of actionable mutations and increase chances of enrolment in clinical trials.

Benefits of MR-proADM-guided decision-making in the emergency department: clinical and economic evaluation in Italy, Germany, Spain, and the UK.

AIM: In a randomized control trial mid-regional proadrenomedullin (MR-proADM)-guided decision-making has been proven to safely reduce hospital admissions based on an accurate assessment of disease severity in the Emergency Department (ED). This study aimed to assess the impact of a MR-proADM-Guided Triage (MR-GT) versus standard Hospital Triage (HT) on clinical and economic outcomes in ED patients with suspected infection in Spain, Italy, Germany, and the UK, using Patient-Level Data (PLD) from two observational studies. METHODS: PLD was collected from patients enrolled at a Spanish hospital during two observational studies. Logistic regression was used to identify predictors of hospitalization. A patient-level simulation model was subsequently developed to evaluate the clinical and economic impact of MR-GT versus HT using results from the statistical analysis and country-specific cost data from the published literature. Probabilistic and deterministic sensitivity analyses were carried out. RESULTS: Four hundred seventy-three patients were enrolled in this study. MR-proADM had the strongest association with hospital admission, followed by age and National Early Warning Score (NEWS). In the simulation model, MR-GT was associated with an overall reduction in hospitalization relative to HT, equal to 22.6 percentage points (40.9 vs. 63.5%). In addition, the use of MR-GT would reduce the total hospital cost per patient presenting to the ED with suspected infection by roughly 30%, with a mean cost saving per patient of €626, €1,484, €1,154, and £1,113 in Spain, Italy, Germany, and the UK, respectively. The robustness of these findings was confirmed by sensitivity analyses. LIMITATIONS: The statistical analyses were not performed on the same population simulated in the model. Clinical input parameters were assumed to be the same for all countries. CONCLUSIONS: MR-proADM showed to be the main predictor of hospitalization. An MR-proADM decision algorithm provides cost savings in Spain, Italy, Germany, and the UK.

Cost-Impact Analysis of a Novel Diagnostic Test to Assess Community-Acquired Pneumonia Etiology in the Emergency Department Setting: A Multi-Country European Study.

BACKGROUND: We aimed to estimate the economic and clinical impacts of a novel diagnostic test called LIAISON® MeMed BV® (LMMBV), which can differentiate bacterial from viral infections, in patients with community-acquired pneumonia (CAP) in emergency departments. METHODS: A cost-impact simulation model was developed to investigate the financial consequences of the introduction of LMMBV into the standard of care (SOC) diagnostic process in Italy, Germany, and Spain. Clinical outcomes were expressed as antibiotic patients and days saved, reduced hospital admissions, and shortened hospital length of stay (LOS). Cost savings were evaluated from the perspectives of third-party payers and hospitals. A deterministic sensitivity analysis (DSA) was carried out. RESULTS: LMMBV was associated with a reduction in antibiotic prescriptions, treatment duration, and LOS. Furthermore, the adoption of LMMBV would allow savings per patient up to EUR 364 and EUR 328 for hospitals and EUR 91 and EUR 59 for payers in Italy and Germany, respectively. In Spain, average savings per patient could reach up to EUR 165 for both payers and hospitals. Savings were most sensitive to test accuracy, with DSA confirming the robustness of the results. CONCLUSIONS: Combining LMMBV with the current SOC diagnostic process is expected to provide clinical and economic benefits in Italy, Germany, and Spain.