Cystoscopy showed alarming limitations, including failure to detect residual muscle invasive bladder cancer (MIBC) in one-fourth of patients at the time of radical cystectomy, according to findings from a prospective study published in the Journal of Urology.1,2
In the single-arm study, 61 patients underwent Systematic Endoscopic Evaluation (SEE) and radical cystectomy. The SEE process comprised cystoscopy along with tissue sampling at the time of radical cystectomy.
“The idea of this study was if we took all of these patients and, in a standardized way, looked into their bladder with surgeons who have a lot of expertise, we thought we could show that we can predict quite well who has disease left inside the bladder and who doesn’t,” Matthew R. Zibelman, MD, first author on the study and an assistant professor in the Department of Hematology/Oncology at Fox Chase, stated in a press release.
The SEE results indicated that 50.8% (n = 31) of patients showed no visual or biopsy-based evidence of disease (seeT0); however, radical cystectomy pathology demonstrated that 16 (51.6%) of these 31 patients harbored residual disease (>pT0). Further, radical cystectomy pathology showed that 25.8% (n = 8) of these 31 individuals were harboring residual MIBC (≥pT2 disease), including 5 patients with pT3 or pT4 disease.
Based on these data, the negative predictive value of SES predicting a pT0 bladder was 48.4% (15/31), which was lower than the prespecified trial target, resulting in the termination of the study for futility.
“There were reports over the years stating that you could miss tumors through endoscopic assessment. Yet, the issue was never approached systematically and tackled in a standardized way,” Alexander Kutikov, MD, FACS, chief of the Division of Urology and Urologic Oncology, who was the primary investigator for the trial, stated in a press release.
“There are submucosal tumors that are latent in the bladder walls that you can’t see from the inside. It’s like looking in a room and there’s something behind the wallpaper,” added Kutikov. “This is a novel finding that was surprising. I anticipated that the retrospective literature was overestimating the risk. But there is a risk, and this helps us design further clinical trials and helps us find research directions to overcome this barrier,” he added.
Regarding overall patient characteristics for the study, 42 patients had MIBC and 19 had high-risk non-MIBC. The median patient age was 70 years (interquartile range, 65-76), 93.4% were Caucasian, and 82% were male. Ninety-five percent of patients had an ECOG performance status of 0 or 1. Overall, 38 (62.3%) of patients had received neoadjuvant chemotherapy.
The authors wrote in the conclusion of their paper that, “Future work should focus on novel imaging and biomarker strategies to optimize evaluations before radical cystectomy for improved decision making regarding bladder preservation.”
1. Study Concludes That Cystoscopy Has Major Limitations in Predicting Bladder Cancer. Fox Chase Cancer Center. Published online May 14, 2021. Accessed May 19, 2021. https://bit.ly/348p0MR.
2. Zibelman M, Asghar AM, Parker DC, et al. Cystoscopy and systematic bladder tissue sampling in predicting pT0 bladder cancer: a prospective trial. J Urol. 2021;205(6):1605-1611. doi: 10.1097/JU.0000000000001602