2026-02-19 マウントサイナイ医療システム(MSHS)
<関連情報>
- https://www.mountsinai.org/about/newsroom/2026/mount-sinai-study-may-help-cancer-patients-keep-their-bladder
- https://www.pnas.org/doi/10.1073/pnas.2533449123
筋層浸潤性膀胱がん患者に対する膀胱温存療法の検討を目的とした血漿および尿中の腫瘍由来DNAのモニタリング Monitoring of plasma and urine tumor-derived DNA to inform bladder-sparing approaches for patients with muscle-invasive bladder cancer
Matthew D. Galsky, Sudeh Izadmehr, Menggang Yu, +24 , and Yuxuan Wang
Proceedings of the National Academy of Sciences Published:February 18, 2026
Significance
Radical cystectomy—surgical removal of the bladder and creation of permanent urinary diversion—has historically been used to treat muscle-invasive bladder cancer, but is life-altering with permanent changes to urinary function, sexuality, and daily routine. We show here that systemic therapy, without cystectomy, can lead to durable remission in a subset of patients with muscle-invasive bladder cancer. Furthermore, we show that the measurement of circulating tumor DNA (ctDNA) and urine tumor DNA (utDNA) can identify patients who are most likely to remain cancer-free following this systemic therapy and bladder-preserving approach.
Abstract
We previously reported initial results from a clinical trial testing a strategy in which patients with muscle-invasive bladder cancer (MIBC) achieving a clinical complete response after cystoscopic resection of the bladder tumor plus systemic therapy could forgo removal of their entire bladder (cystectomy). While the results were highly promising, a subset of patients omitting initial cystectomy developed recurrence highlighting the need for biomarkers to refine selection of patients for this approach. We here report long-term follow-up of these patients and investigate whether tumor DNA in the plasma (ctDNA) or urine (utDNA) could inform prognosis and the need for cystectomy. Three-year bladder-intact survival among patients with a complete clinical response following four rounds of systemic therapy was 69%. Metastatic risk was significantly higher for patients with detectable versus undetectable ctDNA presystemic therapy (HR 4.68; 95% CI 1.10-43.35; log-rank P = 0.036). Only 4.5% (1 of 22) of patients with undetectable baseline ctDNA developed metastatic disease. Undetectable ctDNA before or after systemic therapy was associated with extremely low metastatic risk. Urine utDNA was more sensitive than plasma ctDNA at detecting residual disease within the bladder, and detectable urine utDNA in patients with a complete clinical response was associated with shorter bladder-intact survival (HR 6.47, 95% CI 1.34-31.31; log-rank P = 0.008). These findings establish the conceptual and experimental foundation for incorporating ctDNA and utDNA assays into the management of patients with MIBC, particularly with respect to the need for cystectomy.
