Posted: Tuesday, August 8, 2023
Chiara Mercinelli, MD, of the IRCCS Ospedale San Raffaele, Milan, and colleagues conducted a study to assess the predictive utility of vesical imaging–reporting and data system (VI-RADS) scores from both before and after neoadjuvant immunotherapy for pathologic response and efficacy outcomes in patients with muscle-invasive urothelial bladder cancer. The full data analysis from the PURE-01 trial, which was presented during the 2023 American Society of Clinical Oncology (ASCO) Breakthrough meeting (Abstract 65) in Yokohama, Japan, underscores the potential of this tool for designing next-generation trials.
“VI-RADS scores post pembrolizumab revealed a robust association with pathologic downstaging and survival,” the investigators commented. “VI-RADS scores were also characterized by distinct biomarker features.”
Prior to radical cystectomy, 110 patients underwent staging multiparametric MRI both before and after receiving three cycles of immunotherapy with pembrolizumab. VI-RADS scores were classified into two sets: 0 to 3 (before immunotherapy, 0: n = 21; 1–3: n = 34) and 4 to 5 (n = 55). Scores of 0 and 5 indicated no evidence of disease and extension to extravesical fat, respectively.
Based on multivariable analyses, VI-RADS scores between 0 and 3 both before and after immunotherapy were the only significant covariates that predicted pathologic responses of up to T1 N0 after neoadjuvant therapy; the strongest effect was observed with scores after immunotherapy (odds ratio = 23.4; P < .0001). The area under the curve of this model was 0.90. VI-RADS scores between 0 and 3 after immunotherapy were also found to predict prolonged durations of event-free (P < .001) and overall (P = .044) survival. The scores of several gene signatures from baseline tumors appeared to differ between the VI-RADS 0 to 3 and 4 to 5 score categories before immunotherapy. According to the investigators, in patients who had a VI-RADS score of 0 to 3 before immunotherapy, RAF1 mutations were enriched (P = .045).
Disclosure: Dr. Mercinelli reported no conflicts of interest. For full disclosures of the other study authors, visit coi.asco.org.