Peer-Reviewed Publication
Clin Genitourin Cancer2026;24(7):102638.October 1, 2026Journal Article

Tumor Mutational Burden Predicts the Outcome of Patients With Muscle-invasive bladder Cancer Undergoing Immune-checkpoint Inhibitor-Based Neoadjuvant Therapy.

Chiara Mercinelli1, Giuseppe Basile2, Giovanni L Pastorino3, Antonio Cigliola3, Brigida A Maiorano4, Valentina Tateo4, Michela Piacentini4, Debora Serafin5, Gualtiero Guandalini3, Roberta Lacava4, Gaia Latini4, Maurizio Colecchia6, Alberto Briganti7, Marco Moschini8, Francesco Montorsi7, Dean Pavlick9, Jeffrey S Ross10, Andrea Necchi3
1Università Vita-Salute San Raffaele, Milan, Italy; Medical Oncology Department, Comprehensive Cancer Center, IRCCS San Raffaele Hospital, Milan, Italy. Electronic address: mercinelli.chiara@hsr.it.
2Urology Department, The Royal Free London Foundation Trust, London, UK; Urology Department, IRCCS Ospedale San Raffaele, Milan, Italy.
3Università Vita-Salute San Raffaele, Milan, Italy; Medical Oncology Department, Comprehensive Cancer Center, IRCCS San Raffaele Hospital, Milan, Italy.
4Medical Oncology Department, Comprehensive Cancer Center, IRCCS San Raffaele Hospital, Milan, Italy.
5Università Vita-Salute San Raffaele, Milan, Italy; Medical Oncology Unit 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
6Università Vita-Salute San Raffaele, Milan, Italy; Department of Pathology and Laboratory Medicine, IRCCS Ospedale San Raffaele, Milan, Italy.
7Università Vita-Salute San Raffaele, Milan, Italy; Urology Department, IRCCS Ospedale San Raffaele, Milan, Italy.
8Urology Department, IRCCS Ospedale San Raffaele, Milan, Italy.
9Foundation Medicine Inc, Cambridge, MA.
10Foundation Medicine Inc, Cambridge, MA; Upstate Medical University, Syracuse, NY.

Abstract

INTRODUCTION: Immune checkpoint inhibitors (ICI) have demonstrated meaningful activity as neoadjuvant therapy in muscle-invasive bladder cancer (MIBC). Identifying patients most likely to respond to ICI-based neoadjuvant strategies remains an unmet need. MATERIALS AND METHODS: Tumor mutational burden (TMB) from baseline transurethral resection of bladder (TURB) tumor samples of MIBC patients trea…

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