Diagnostic accuracy and inter-reader agreement of the nacVI-RADS for bladder cancer treated with neoadjuvant chemotherapy: a prospective validation study.

The primary aim was to determine the performance of neoadjuvant chemotherapy VI-RADS (nacVI-RADS) in predicting response to systemic therapy in patients with MIBC and to evaluate its inter-reader agreement.

Prospective study, including patients with non-metastatic muscle-invasive bladder cancer (MIBC) who underwent neoadjuvant chemotherapy before radical cystectomy (RC). Patients underwent pre- and post-treatment MRI. Radiological response was evaluated by two experienced radiologists using nacVI-RADS scoring system. Reference standard was defined using histopathological findings. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and accuracy were calculated to assess nacVI-RADS performance for each reader. Inter-reader agreement was determined with Cohen's k statistics.

Fifty-five patients with non-metastatic MIBC, 46 males (84%) and 9 females (16%) with a median age of 69 (interquartile range (IQR) 66-72 years) were enrolled. Diagnostic performance of nacVI-RADS in detecting complete response to neoadjuvant chemotherapy showed a sensitivity of 76.5-85.3% and specificity of 76.2-81%. The area under the curve was 0.93 (95% CI: 0.86-0.99) for detecting any residual tissue, for the more experienced reader. Inter-reader agreement was optimal with a K of 0.85. In the multivariable logistic regression model, the variables showing independent correlation with response prediction to neoadjuvant therapy were nacVI-RADS score (p = 0.01 for the more experienced reader) and tumor regression grade (TRG; p < 0.001).

NacVI-RADS scoring system offers a reliable and reproducible approach, employing a well-structured and easily interpretable method, to assess the response to systemic therapy in patients with MIBC.

Question There is a lack of a standardized approach to distinguish between responders and non-responders to neoadjuvant chemotherapy for muscle-invasive bladder cancer. Findings The neoadjuvant chemotherapy VI-RADS (nacVI-RADS) score diagnostic performance for detecting complete response to neoadjuvant chemotherapy showed 85.3% sensitivity, 81% specificity, and an AUC of 0.93. Clinical relevance NacVI-RADS score represents a valid predictor of response to neoadjuvant systemic therapy, impacting therapeutic decision-making and improving overall patients' management.

European radiology. 2024 Dec 31 [Epub ahead of print]

Ailin Dehghanpour, Martina Pecoraro, Emanuele Messina, Ludovica Laschena, Antonella Borrelli, Simone Novelli, Daniele Santini, Giuseppe Simone, Rossano Girometti, Valeria Panebianco

Department of Radiological Sciences, Oncology and Pathology, Sapienza University/Policlinico Umberto I, Rome, Italy., Department of Mechanical and Aerospace Engineering, Sapienza University, Rome, Italy., Division of Medical Oncology A, Policlinico Umberto I, Rome, Italy., Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Rome, Italy., Institute of Radiology, Department of Medicine, University of Udine, University Hospital S. Maria della Misericordia, Udine, Italy., Department of Radiological Sciences, Oncology and Pathology, Sapienza University/Policlinico Umberto I, Rome, Italy. .