A Snapshot from the Italian Clinical Practice Regarding Efficacy and Utility Rate of Perioperative Chemotherapy in Muscle-invasive Bladder Cancer: The RealBLADDER Study.

BACKGROUND/AIM: The standard of care for patients with muscle-invasive bladder cancer (MIBC) is treatment with radical cystectomy (RC) and perioperative platinum-based chemotherapy (neoadjuvant or adjuvant). Perioperative treatment can improve overall survival (OS), and the most robust evidence favors neoadjuvant chemotherapy (NAC). The RealBLADDER study assessed the efficacy and safety of perioperative chemotherapy in patients with MIBC in an Italian real-world setting. PATIENTS AND METHODS: RealBLADDER enrolled patients with MIBC treated with perioperative chemotherapy from June 2018 to June 2023. The primary endpoint was the rate of non-invasive downstaging (NID) (ypT0/pTis/pTaN0 or <ypT1N0) and complete pathological response (pCR) (yp0N0), defined as the absence of residual tumor cells in the bladder and lymph nodes at the pathological examination after NAC. Secondary endpoints were disease-free survival (DFS), OS and surgical outcomes. RESULTS: A total of 173 eligible patients were identified. One hundred and thirty-seven patients (79.2%) received NAC and 36 (20.8%) received adjuvant chemotherapy (AC). The NID rate was 36.8%, and pCR achieved in 33.6% of patients treated with NAC. The rate of surgical morbidity and mortality were 20.9% and 0%, respectively. The 12-month DFS was 73.7% [95% confidence interval (CI)=0.672-0.808]. The 12-month OS rate in the entire population was 92.1% (95%CI=0.880-0.963). Compared to AC, DFS was improved in patients treated with NAC (p=0.019). CONCLUSION: NAC is associated with an improved DFS compared to AC, a high rate of NID and pCR and low rate of surgical morbidity and mortality, supporting NAC as the preferred perioperative strategy for MIBC in clinical practice.