To evaluate the predictive capability of the pre- and post-pembrolizumab vesical imaging-reporting and data system (VI-RADS) to identify ypT0N0 or ypT≤1N0 response in muscle-invasive bladder cancer (MIBC) within the PURE-01 trial.
Patients were staged with bladder multiparametric magnetic resonance imaging (mpMRI) before and after treatment (three cycles of pembrolizumab) prior to radical cystectomy (RC). Logistic regression models were used to analyze the pre- and post-pembro VI-RADS against ypT≤1N0 and ypT0N0 response. The VI-RADS scores were dichotomized between 0-3 (0=no evidence of disease) and 4-5. Event-free survival (EFS) and overall survival (OS) analyses were performed. Comprehensive genomic profiling and transcriptome-wide expression profiling data were matched with the VI-RADS scores.
In total, 110 patients underwent centrally reviewed scans (N=220 mpMRI), treated between 02/17 and 07/20. Both pre-pembrolizumab and post-pembrolizumab VI-RADS 0-3 scores were the only significant covariates that predicted the ypT≤1N0 endpoint in multivariable analyses (MVA), and the strongest effect was seen with post-pembrolizumab VI-RADS 0-3 predicting the ypT≤1N0 response (p<0.0001). The area under the curve (AUC) for this model was 0.90. Post-pembrolizumab VI-RADS 0-3 also predicted a longer EFS (p<0.001) and OS (p=0.044). The scores of several gene signatures from baseline tumors differed between the pre-pembrolizumab VI-RADS 0-3 and 4-5 categories.
Post-pembrolizumab VI-RADS scores are strongly associated with pathological downstaging and survival. VI-RADS scores were also characterized by distinct biomarker features. These results indicate that the VI-RADS is emerging as an important tool for designing next-generation trials for MIBC.
BJU international. 2023 Oct 06 [Epub ahead of print]
Andrea Necchi, Giuseppe Basile, Ewan A Gibb, Daniele Raggi, Giuseppina Calareso, Tiago Costa de Padua, Damiano Patanè, Emanuele Crupi, Chiara Mercinelli, Antonio Cigliola, Valentina Tateo, Patrizia Giannatempo, Marco Moschini, Alberto Briganti, Francesco Montorsi, Antonella Messina, Jeffrey S Ross, Dean Pavlick, Francesco De Cobelli, Giorgio Brembilla
Department of Medical Oncology, IRCCS Ospedale San Raffaele, Milan, Italy., Department of Urology, IRCCS Ospedale San Raffaele, Milan, Italy., Veracyte, Inc, San Francisco, CA, United States., Department of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Vita-Salute San Raffaele University, Milan, Italy., Foundation Medicine Inc, Cambridge, MA, United States., Department of Radiology, IRCCS Ospedale San Raffaele, Milan, Italy.