Pd36-04 utility of pre- and post-pembrolizumab vesical imaging – reporting and data system (virads) to predict the pathological response in muscle-invasive urothelial bladder cancer (mibc): an analysis of the pure-01 cohort

The Journal of Urology(2023)

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You have accessJournal of UrologyCME1 Apr 2023PD36-04 UTILITY OF PRE- AND POST-PEMBROLIZUMAB VESICAL IMAGING – REPORTING AND DATA SYSTEM (VIRADS) TO PREDICT THE PATHOLOGICAL RESPONSE IN MUSCLE-INVASIVE UROTHELIAL BLADDER CANCER (MIBC): AN ANALYSIS OF THE PURE-01 COHORT Giuseppe Basile, Giorgio Brambilla, Marco Bandini, Daniele Raggi, Laura Marandino, Tiago Costa De Padua, Emanuele Crupi, Renzo Colombo, Maurizio Colecchia, Roberta Lucianò, Marco Moschini, Jeffrey S Ross, Alberto Briganti, Francesco Montorsi, Francesco De Cobelli, and Andrea Necchi Giuseppe BasileGiuseppe Basile More articles by this author , Giorgio BrambillaGiorgio Brambilla More articles by this author , Marco BandiniMarco Bandini More articles by this author , Daniele RaggiDaniele Raggi More articles by this author , Laura MarandinoLaura Marandino More articles by this author , Tiago Costa De PaduaTiago Costa De Padua More articles by this author , Emanuele CrupiEmanuele Crupi More articles by this author , Renzo ColomboRenzo Colombo More articles by this author , Maurizio ColecchiaMaurizio Colecchia More articles by this author , Roberta LucianòRoberta Lucianò More articles by this author , Marco MoschiniMarco Moschini More articles by this author , Jeffrey S RossJeffrey S Ross More articles by this author , Alberto BrigantiAlberto Briganti More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , Francesco De CobelliFrancesco De Cobelli More articles by this author , and Andrea NecchiAndrea Necchi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003334.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The possibility to predict the pathologic complete response (pT0) or downstaging (pT≤1) after neoadjuvant therapy may have profound impact on the management of MIBC and orient next-generation bladder-sparing trials. The VIRADS is a standardized reporting system that uses mpMRI parameters to predict the probability of MIBC. No studies have analyzed the ability of VIRADS to predict the pT0 or pT≤1 response post-immunotherapy (IO). METHODS: In PURE-01 patients (pts) were staged with bladder multiparametric magnetic resonance imaging (mpMRI: T2-weighted imaging, diffusion-weighted imaging, dynamic contrast enhancement) before and after treatment (3 cycles of pembro) prior to radical cystectomy (RC). All mpMRI scans were centrally reviewed. Logistic regression models analyzed pre- and post-pembro VIRADS against pT≤1 (primary endpoint) and pT0 (secondary endpoint). VIRADS scores were dichotomized between 0-3 and 4-5. Covariates included cT-stage, age, gender, PD-L1 combined positive score (CPS), tumor mutational burden (TMB) and molecular subtype (Decipher). RESULTS: Overall, 58 pts had MRI scans (N=116 mpMRI), treated between 02/17 and 08/18. Median age was 65 years, 25 (43.1%) had cT3-4N0 MIBC. Pre-pembro: 8 pts (13.8%) had no measurable disease (VIRADS=0), 20 (34.5%) a VIRADS 1-3 score, and 30 (51.7%) had a VIRADS 4-5 score. Six pts (10.3%) had a downstage from VIRADS 4-5 to VIRADS 0-3 post-pembro. Both pre-pembro and post-pembro VIRADS 0-3 scores were significantly associated with pT≤1 endpoint on multivariable analyses (MVA): the strongest effect was seen with post-pembro VIRADS 0-3 against pT≤1 response (OR: 30.2, 95%CI: 6.2-223.2, p<0.0001, AUC: 0.92). Regarding pre-pembro VIRADS 0-3: (OR: 4.35, 95%CI: 1.1-19.7, p=0.04; AUC: 0.83). CPS was another significant variable for pT≤1 endpoint only in MVA using pre-pembro VIRADS 0-3 (OR: 1.02, 95%CI: 1-1.05, p=0.02). Post-pembro VIRADS 0-3 was also associated with pT0 on MVA (OR: 4.59, 95%CI: 1.2-19.6, p=0.02; AUC: 0.78), whereas pre-pembro VIRADS was not (p=0.13). An enrichment of basal-type tumors was seen in VIRADS 0-3 cases and of luminal tumors in VIRADS 4-5 cases post-pembro. CONCLUSIONS: To our knowledge, this is the first evidence establishing the predictivity of the VIRADS score towards the pathological downstaging, both in the pre and post IO settings. Post-pembro VIRADS emerged as an important feature by which selecting pts for bladder-sparing strategies. Source of Funding: No © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e981 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Giuseppe Basile More articles by this author Giorgio Brambilla More articles by this author Marco Bandini More articles by this author Daniele Raggi More articles by this author Laura Marandino More articles by this author Tiago Costa De Padua More articles by this author Emanuele Crupi More articles by this author Renzo Colombo More articles by this author Maurizio Colecchia More articles by this author Roberta Lucianò More articles by this author Marco Moschini More articles by this author Jeffrey S Ross More articles by this author Alberto Briganti More articles by this author Francesco Montorsi More articles by this author Francesco De Cobelli More articles by this author Andrea Necchi More articles by this author Expand All Advertisement PDF downloadLoading ...
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cancer,post-pembrolizumab,muscle-invasive
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