Urothelial bladder cancer constitutes one of the most common malignancies of the urinary tract, comprising 90-95% of urothelial carcinomas. Only 25% of patients present with muscle-invasive bladder cancer (MIBC), a neoplasm associated with higher morbidity and mortality. Concerning localized MIBC, cisplatin-based chemotherapy remains the standard neoadjuvant treatment; however, its survival benefits are limited, and its use is restricted to patients with adequate performance status and renal function. Current clinical guidelines recommend neoadjuvant immunotherapy as a first- or second-line option, especially for cisplatin-ineligible patients. Neoadjuvant immunotherapy as monotherapy or in combination with chemotherapy or other immune checkpoint inhibitors is under active investigation. In the ABACUS trial, atezolizumab monotherapy achieved a 31% pathological complete response (pCR). The NCT03520491 trial showed a pCR rate of up to 46% with nivolumab and ipilimumab. The KCT0003804 trial, evaluating immunotherapy plus chemotherapy, reported a 59% pCR and 81.8% 1-year disease-free survival. This review provides an updated overview of clinical trials on neoadjuvant immunotherapy for MIBC, highlighting its therapeutic potential and safety.
Immunotherapy. 2025 May 06 [Epub ahead of print]
Ilias Giannakodimos, Afroditi Ziogou, Alexios Giannakodimos, Konstantinos Tzelepis, Zisis Kratiras, Evangelos Fragkiadis, Ioannis Zachos, Vasileios Tzortzis, Michael Chrisofos, Nikolaos Charalampakis
Third Department of Urology, Attikon University Hospital, School of Medicine, National and Kapodistrian, University of Athens, Athens, Greece., Department of Medical Oncology, Metaxa Cancer Hospital, Athens, Greece., Department of Cardiology, General Hospital of Tzaneio, Athens, Greece., Department of Urology, Geniko Kratiko Nikaias General Hospital, Athens, Greece., Department of Urology, National and Kapodistrian University of Athens, Laikon General Hospital, Athens, Greece., Department of Urology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece.