Treatment Pathway and Clinical Outcomes of the Population with Muscle-invasive Bladder Cancer in Italy: A Real-world Analysis with Administrative Databases

Introduction: In Italy, real-world data on muscle-invasive bladder cancer (MIBC) are scanty. This analysis exploited administrative databases to describe the clinical characteristics and treatment outcomes of patients with MIBC. Methods: Adults hospitalized for non-metastatic bladder cancer who underwent cystectomy in 2018 were proxied for MIBC. The following variables were examined: demographic and clinical characteristics, number of transurethral resections of the bladder tumor (TURBs) and time to cystectomy to discriminate de novo diagnoses from progressions; chemotherapy ± 6 months before/after cystectomy to distinguish neoadjuvant or adjuvant regimens; creatinine clearance (CrCl) as an indicator of renal function for cisplatin eligibility; disease-free survival (DFS) and overall survival (OS) using Kaplan-Meier method. Results: Among 394 patients included, 79.4% were men; mean age was 72.5 years and Charlson comorbidity index (CCI) 0.6. Three hundred thirty-nine (86%) had ≥ 1 TURBs pre-cystectomy: 222 (56%) were de novo diagnoses and 117 (30%) progressions from non-muscle-invasive disease. After stratification by CrCl (< 40, 40–60, and ≥ 60 ml/min), patients with lower renal function showed older age (76.8, 77.0, and 69.1 years), worse comorbidity profile (CCI: 1.5, 0.7, and 0.6), and markedly higher mortality rates (95.0%, 92.9%, and 42.3%). One hundred ninety-five patients (49.5%) underwent surgery-only, 199 (50.5%) received chemotherapy: 47 (12%) as neoadjuvant, 132 (33.5%) as adjuvant, and 20 (5%) as perioperative treatment. Median DFS was 0.9 years with a time to progression of 2.1 years; median OS was 2.1 years with a 5-year OS rate of 43%. Conclusions: From this real-world analysis, Italian patients with MIBC emerged as a population of elderly subjects (> 75 years) burdened by comorbidities. Treatment choice was influenced by other factors rather than cisplatin eligibility since only 11% of patients with CrCl ≥ 60 ml/min in 2018 and 20% in 2022 were treated before cystectomy, highlighting a scenario of low adherence to guidelines with underutilization of neoadjuvant chemotherapy.