State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes

In recent years, several clinical trials focused on the potential role of immune-checkpoint inhibitors (ICIs) in the adjuvant treatment of muscle-invasive urothelial cancer (UC). Heretofore, only the anti-programmed death protein 1 (anti-PD1) nivolumab received European Medical Agency (EMA) approval...

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Main Authors: Elisa Tassinari, Linda Danielli, Andrea Marchetti, Matteo Rosellini, Costantino Ricci, Pietro Piazza, Angelo Mottaran, Riccardo Schiavina, Matteo Santoni, Veronica Mollica, Francesco Massari
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Human Vaccines & Immunotherapeutics
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Online Access:https://www.tandfonline.com/doi/10.1080/21645515.2024.2440165
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author Elisa Tassinari
Linda Danielli
Andrea Marchetti
Matteo Rosellini
Costantino Ricci
Pietro Piazza
Angelo Mottaran
Riccardo Schiavina
Matteo Santoni
Veronica Mollica
Francesco Massari
author_facet Elisa Tassinari
Linda Danielli
Andrea Marchetti
Matteo Rosellini
Costantino Ricci
Pietro Piazza
Angelo Mottaran
Riccardo Schiavina
Matteo Santoni
Veronica Mollica
Francesco Massari
author_sort Elisa Tassinari
collection DOAJ
description In recent years, several clinical trials focused on the potential role of immune-checkpoint inhibitors (ICIs) in the adjuvant treatment of muscle-invasive urothelial cancer (UC). Heretofore, only the anti-programmed death protein 1 (anti-PD1) nivolumab received European Medical Agency (EMA) approval for cisplatin-unfit patients. In our work, we deeply analyzed the results of the three pivotal studies in view of the rapidly evolving therapeutic advanced UC’s scenario. Furthermore, there are several ongoing research to investigate ICIs and other emerging immune agents in this setting; results are awaited. Additionally, current efforts have been made to assess the role of these agents in earlier disease settings, particularly in high-risk non-muscle-invasive bladder cancer (NMIBC). In our review, we analyzed the potential role of predictive and/or prognostic biomarkers that may improve patient selection and treatment efficacy. To conclude, we highlighted the upcoming changes that could redefine the standard of care for patients with early-stage UC.
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publishDate 2025-12-01
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series Human Vaccines & Immunotherapeutics
spelling doaj-art-6a39bfc75398414b9d0c8f3b993328cc2025-08-20T02:34:53ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2024.2440165State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changesElisa Tassinari0Linda Danielli1Andrea Marchetti2Matteo Rosellini3Costantino Ricci4Pietro Piazza5Angelo Mottaran6Riccardo Schiavina7Matteo Santoni8Veronica Mollica9Francesco Massari10Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalyMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalyMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalyMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalyPathology Unit, DIAP-Dipartimento InterAziendale di Anatomia Patologica di Bologna, Maggiore Hospital-AUSL Bologna, Bologna, ItalyDepartment of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, ItalyDepartment of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, ItalyDepartment of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, ItalyOncology Unit, Macerata Hospital, Macerata, ItalyMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalyMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalyIn recent years, several clinical trials focused on the potential role of immune-checkpoint inhibitors (ICIs) in the adjuvant treatment of muscle-invasive urothelial cancer (UC). Heretofore, only the anti-programmed death protein 1 (anti-PD1) nivolumab received European Medical Agency (EMA) approval for cisplatin-unfit patients. In our work, we deeply analyzed the results of the three pivotal studies in view of the rapidly evolving therapeutic advanced UC’s scenario. Furthermore, there are several ongoing research to investigate ICIs and other emerging immune agents in this setting; results are awaited. Additionally, current efforts have been made to assess the role of these agents in earlier disease settings, particularly in high-risk non-muscle-invasive bladder cancer (NMIBC). In our review, we analyzed the potential role of predictive and/or prognostic biomarkers that may improve patient selection and treatment efficacy. To conclude, we highlighted the upcoming changes that could redefine the standard of care for patients with early-stage UC.https://www.tandfonline.com/doi/10.1080/21645515.2024.2440165Urothelial cancerbladder canceradjuvant therapyimmunotherapymuscle-invasive bladder cancernon-muscle invasive bladder cancer
spellingShingle Elisa Tassinari
Linda Danielli
Andrea Marchetti
Matteo Rosellini
Costantino Ricci
Pietro Piazza
Angelo Mottaran
Riccardo Schiavina
Matteo Santoni
Veronica Mollica
Francesco Massari
State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes
Human Vaccines & Immunotherapeutics
Urothelial cancer
bladder cancer
adjuvant therapy
immunotherapy
muscle-invasive bladder cancer
non-muscle invasive bladder cancer
title State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes
title_full State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes
title_fullStr State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes
title_full_unstemmed State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes
title_short State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes
title_sort state of the art of adjuvant immunotherapy in urothelial cancer new developments and upcoming changes
topic Urothelial cancer
bladder cancer
adjuvant therapy
immunotherapy
muscle-invasive bladder cancer
non-muscle invasive bladder cancer
url https://www.tandfonline.com/doi/10.1080/21645515.2024.2440165
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