膀胱内治疗 (IVT) 是降低高级别非肌层浸润性膀胱癌复发和进展风险的标准治疗方法。然而，IVT 后复发仍然很常见，并且在 IVT 之前或之后对患者进行风险分层的能力有限。在这项前瞻性设计和累积的队列研究中，我们研究了尿液综合基因组分析 (uCGP) 在预测经尿道膀胱肿瘤切除术 (TURBT) 后复发风险和评估纵向 IVT 反应中的效用。在 IVT 滴注之前和之后收集尿液，并使用 UroAmp™ 平台进行 uCGP 测试。 TURBT 后的基线 uCGP 确定了具有高 (61%) 和低 (39%) 复发风险的患者。 24 个月时，低风险患者的无复发生存率 (RFS) 为 100%，高风险患者的无复发生存率为 45%，风险比 (HR) 为 9.3。纵向 uCGP 将患者分类为微小残留病 (MRD) 阴性、IVT 有应答者或 IVT 难治性，24 个月 RFS 分别为 100%、50% 和 32%。与 MRD 阴性患者相比，IVT 难治性患者的 HR 为 10.5。总的来说，uCGP 能够对 TURBT 和诱导 IVT 后的患者进行无创风险评估。 uCGP 可以为监测膀胱镜检查时间表提供信息，并识别需要额外治疗的高危患者。© 2023 作者。约翰·威利出版的《分子肿瘤学》

Intravesical therapy (IVT) is the standard of care to decrease risk of recurrence and progression for high-grade nonmuscle-invasive bladder cancer. However, post-IVT recurrence remains common and the ability to risk-stratify patients before or after IVT is limited. In this prospectively designed and accrued cohort study, we examine the utility of urinary comprehensive genomic profiling (uCGP) for predicting recurrence risk following transurethral resection of bladder tumor (TURBT) and evaluating longitudinal IVT response. Urine was collected before and after IVT instillation and uCGP testing was done using the UroAmp™ platform. Baseline uCGP following TURBT identified patients with high (61%) and low (39%) recurrence risk. At 24 months, recurrence-free survival (RFS) was 100% for low-risk and 45% for high-risk patients with a hazard ratio (HR) of 9.3. Longitudinal uCGP classified patients as minimal residual disease (MRD) Negative, IVT Responder, or IVT Refractory with 24-month RFS of 100%, 50%, and 32%, respectively. Compared with MRD Negative patients, IVT Refractory patients had a HR of 10.5. Collectively, uCGP enables noninvasive risk assessment of patients following TURBT and induction IVT. uCGP could inform surveillance cystoscopy schedules and identify high-risk patients in need of additional therapy.© 2023 The Authors. Molecular Oncology published by John Wiley & Sons Ltd on behalf of Federation of European Biochemical Societies.