Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
Division of Urological Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
J Urol. 2021 Jun;205(6):1605-1611. doi: 10.1097/JU.0000000000001602. Epub 2021 Feb 4.
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.
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.
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.
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.
由于临床分期与最终病理结果之间存在差异，目前对适合接受根治性膀胱切除术的患者进行管理时，人们对此十分关注。因此，我们旨在前瞻性研究在接受根治性膀胱切除术的患者中，膀胱镜评估的可靠性和局限性。
患有尿路上皮癌并接受根治性膀胱切除术的患者被纳入一项前瞻性单臂研究中，以评估系统性内镜评估预测膀胱癌 pT0 的可靠性（NCT02968732）。系统性内镜评估包括根治性膀胱切除术时的膀胱镜检查和组织取样。将系统性内镜评估结果与根治性膀胱切除术病理进行比较。主要终点是系统性内镜评估结果预测根治性膀胱切除术病理的阴性预测值。
共有 61 例患者接受了系统性内镜评估和根治性膀胱切除术。适应证包括肌层浸润性膀胱癌 42 例（68.9%）和高危非肌层浸润性膀胱癌 19 例（31.1%）。所有患者中，38 例（62.3%，肌层浸润性膀胱癌患者的 90.5%）接受了新辅助化疗。在系统性内镜评估中，31 例（50.8%）患者无肉眼或活检证据显示疾病（见 T0），但其中 16/31（51.6%）例患者存在残留疾病（>pT0），包括 8 例（8/31，25.8%）患者在根治性膀胱切除术后存在残留≥pT2 疾病。系统性内镜评估预测 pT0 膀胱的阴性预测值为 48.4%（95%CI：30.2-66.9），低于我们预先设定的假设。因此，该试验因无效而停止。
在接受根治性膀胱切除术的患者中，约有 1/4 例患者在手术时见 T0，但存在残留的肌层浸润性膀胱癌。这些前瞻性数据明确证实了内镜评估对 pT0 膀胱癌的主要局限性。未来的工作应集中在新型影像学和生物标志物策略上，以优化根治性膀胱切除术前的评估，从而改善关于膀胱保留的决策。
