Perioperative therapy in muscle-invasive bladder cancer: real-world evidence from the MINOTAURO study

N. Lainez; M. Martínez-Kareaga; N. Sagastibeltza-Marinalarena; M. Sánchez; A. Díaz de Cerio; R. Sánchez-Escribano; M. Sotelo; S. de la Torre; V. Calderero; J.A. Verdún; I. Gil-Arnáiz; M. Menéndez; A. Moreno; L. de Ávila; R. Fernández; P. Trincado; M. Peláez; U. Anido; M.Á. Climent; I. Durán

Resumen:

Background Radical cystectomy with neoadjuvant and/or adjuvant therapy is the standard treatment of muscle-invasive urothelial cancer (MIUC). Although perioperative immunotherapy use has expanded, real-world data remain limited. The MINOTAURO study evaluated perioperative treatment patterns and outcomes in Spain. Patients and methods This retrospective, multicenter study included adults with MIUC treated at 17 hospitals in Northern and Eastern Spain (April 2022-June 2024). Clinical data were extracted from electronic health records. Outcomes included perioperative treatment patterns, pathological response, safety, recurrence, and survival. Overall survival and disease-free survival were estimated using Kaplan–Meier methods. Results A total of 629 patients were analyzed (median age 71 years; 79.5% male). Most tumors originated in the bladder/urethra (95.0%) and were urothelial (92.8%); 70.4% were clinical stage II. Cisplatin-based neoadjuvant chemotherapy (NAC) was administered to 40% of patients, primarily cisplatin–gemcitabine. The main reasons for not receiving NAC were creatinine clearance <60 mL/min (40.8%), Eastern Cooperative Oncology Group performance status ≥2 (18.4%), and cardiovascular disease (18%). Among NAC-treated patients, 41.3% achieved a pathologically documented complete response, and 50% achieved downstaging. Surgery was carried out in 77% of patients, mainly radical cystectomy. Adjuvant chemotherapy was given to 10.7%, and 46.2% of eligible patients received adjuvant immunotherapy, predominantly nivolumab. Recurrence occurred in 28.9% of patients. At a median follow-up of 18.5 months, 75% were alive and 69.7% were recurrence-free. Conclusions MINOTAURO demonstrates evolving real-world perioperative management of MIUC, with notable use of perioperative immunotherapy in routine clinical practice and outcomes that appear favorable in comparison with historical data, although no formal comparative analysis was carried out.