Clinical restaging and cCR definition
malignancy, tumor, tumors
RESIDUAL, TUMOR, TUMORS, METASTATIC DISEASE
After cycle 4 of gemcitabine, cisplatin, plus nivolumab, patients underwent clinical restaging including MRI of the abdomen and pelvis or CT if MRI was contraindicated and CT of the chest, rigid cystoscopy with biopsies and urine cytology. Transurethral resection of any visible tumor and/or the prior tumor site was performed. In addition, biopsies were obtained from the following sites: trigone, left, right, anterior, posterior and dome. In men, prostatic urethral biopsies were performed. A cCR was defined as meeting all of the following: (1) no evidence of malignancy on biopsy with the exception of low-grade papillary (Ta) tumors; (2) no malignant cells on urine cytology; and (3) no evidence of local or metastatic disease on cross-sectional imaging. Residual bladder wall changes on cross-sectional imaging were interpreted by the treating investigator in consultation with the local radiologist and in the context of the bladder biopsy results. A blinded post hoc central review of the restaging MRI scans was completed by two study radiologists (S.L. and B.E.A.) to assign a VI-RADS