PURPOSE: Concern for discordance between clinical staging and final pathology drives current management of patients deemed appropriate candidates for radical cystectomy. Therefore, we set out to prospectively investigate reliability and shortcomings of cystoscopic evaluation in radical cystectomy candidates. MATERIALS AND METHODS: Patients undergoing radical cystectomy for urothelial carcinoma were enrolled in a prospective single-arm study to evaluate reliability of Systematic Endoscopic Evaluation in predicting pT0 urothelial carcinoma (NCT02968732). Systematic Endoscopic Evaluation consisted of cystoscopy and tissue sampling at the time of radical cystectomy. Systematic Endoscopic Evaluation results were compared to radical cystectomy pathology. The primary end point was the negative predictive value of Systematic Endoscopic Evaluation findings in predicting radical cystectomy pathology. RESULTS: A total of 61 patients underwent Systematic Endoscopic Evaluation and radical cystectomy. Indications included muscle invasive bladder cancer in 42 (68.9%) and high risk nonmuscle invasive bladder cancer in 19 (31.1%). In all, 38 (62.3%, 90.5% of patients with muscle invasive bladder cancer) received neoadjuvant chemotherapy. On Systematic Endoscopic Evaluation, 31 (50.8%) patients demonstrated no visual nor biopsy-based evidence of disease (seeT0), yet 16/31 (51.6%) harbored residual disease (>pT0), including 8 (8/31, 25.8%) with residual ≥pT2 disease upon radical cystectomy. The negative predictive value of Systematic Endoscopic Evaluation predicting a pT0 bladder was 48.4% (CI 30.2-66.9), which was below our prespecified hypothesis. Therefore, the trial was stopped for futility. CONCLUSIONS: Approximately 1 of 4 patients with seeT0 at the time of radical cystectomy harbored residual muscle invasive bladder cancer. These prospective data definitively confirm major limitations of endoscopic assessment for pT0 bladder cancer. Future work should focus on novel imaging and biomarker strategies to optimize evaluations before radical cystectomy for improved decision making regarding bladder preservation.
PURPOSE: Concern for discordance between clinical staging and final pathology drives current management of patients deemed appropriate candidates for radical cystectomy. Therefore, we set out to prospectively investigate reliability and shortcomings of cystoscopic evaluation in radical cystectomy candidates. MATERIALS AND METHODS: Patients undergoing radical cystectomy for urothelial carcinoma were enrolled in a prospective single-arm study to evaluate reliability of Systematic Endoscopic Evaluation in predicting pT0 urothelial carcinoma (NCT02968732). Systematic Endoscopic Evaluation consisted of cystoscopy and tissue sampling at the time of radical cystectomy. Systematic Endoscopic Evaluation results were compared to radical cystectomy pathology. The primary end point was the negative predictive value of Systematic Endoscopic Evaluation findings in predicting radical cystectomy pathology. RESULTS: A total of 61 patients underwent Systematic Endoscopic Evaluation and radical cystectomy. Indications included muscle invasive bladder cancer in 42 (68.9%) and high risk nonmuscle invasive bladder cancer in 19 (31.1%). In all, 38 (62.3%, 90.5% of patients with muscle invasive bladder cancer) received neoadjuvant chemotherapy. On Systematic Endoscopic Evaluation, 31 (50.8%) patients demonstrated no visual nor biopsy-based evidence of disease (seeT0), yet 16/31 (51.6%) harbored residual disease (>pT0), including 8 (8/31, 25.8%) with residual ≥pT2 disease upon radical cystectomy. The negative predictive value of Systematic Endoscopic Evaluation predicting a pT0 bladder was 48.4% (CI 30.2-66.9), which was below our prespecified hypothesis. Therefore, the trial was stopped for futility. CONCLUSIONS: Approximately 1 of 4 patients with seeT0 at the time of radical cystectomy harbored residual muscle invasive bladder cancer. These prospective data definitively confirm major limitations of endoscopic assessment for pT0 bladder cancer. Future work should focus on novel imaging and biomarker strategies to optimize evaluations before radical cystectomy for improved decision making regarding bladder preservation.
Authors: Guillaume Ploussard; Siamak Daneshmand; Jason A Efstathiou; Harry W Herr; Nicholas D James; Claus M Rödel; Shahrokh F Shariat; William U Shipley; Cora N Sternberg; George N Thalmann; Wassim Kassouf Journal: Eur Urol Date: 2014-02-26 Impact factor: 20.096
Authors: Maximilian Burger; James W F Catto; Guido Dalbagni; H Barton Grossman; Harry Herr; Pierre Karakiewicz; Wassim Kassouf; Lambertus A Kiemeney; Carlo La Vecchia; Shahrokh Shariat; Yair Lotan Journal: Eur Urol Date: 2012-07-25 Impact factor: 20.096
Authors: Bjoern G Volkmer; Rainer Kuefer; Georg Bartsch; Michael Straub; Robert de Petriconi; Juergen E Gschwend; Richard E Hautmann Journal: Cancer Date: 2005-12-01 Impact factor: 6.860
Authors: R Millikan; C Dinney; D Swanson; P Sweeney; J Y Ro; T L Smith; D Williams; C Logothetis Journal: J Clin Oncol Date: 2001-10-15 Impact factor: 44.544
Authors: Siamak Daneshmand; Anne K Schuckman; Bernard H Bochner; Michael S Cookson; Tracy M Downs; Leonard G Gomella; H Barton Grossman; Ashish M Kamat; Badrinath R Konety; Cheryl T Lee; Kamal S Pohar; Raj S Pruthi; Matthew J Resnick; Norm D Smith; J Alfred Witjes; Mark P Schoenberg; Gary D Steinberg Journal: Nat Rev Urol Date: 2014-09-23 Impact factor: 14.432
Authors: Toni K Choueiri; Susanna Jacobus; Joaquim Bellmunt; Angela Qu; Leonard J Appleman; Christopher Tretter; Glenn J Bubley; Edward C Stack; Sabina Signoretti; Meghara Walsh; Graeme Steele; Michelle Hirsch; Christopher J Sweeney; Mary-Ellen Taplin; Adam S Kibel; Katherine M Krajewski; Philip W Kantoff; Robert W Ross; Jonathan E Rosenberg Journal: J Clin Oncol Date: 2014-05-12 Impact factor: 44.544
Authors: J Alfred Witjes; Eva Compérat; Nigel C Cowan; Maria De Santis; Georgios Gakis; Thierry Lebret; Maria J Ribal; Antoine G Van der Heijden; Amir Sherif Journal: Eur Urol Date: 2013-12-12 Impact factor: 20.096