Prasad Sandip M, Shishkov Dimitar, Mihaylov Nikola Vladimirov, Khuskivadze Alexandre, Genov Pencho, Terzi Vasyl, Kates Max, Huang William C, Louie Michael J, Raju Sunil, Burger Brent, Meads Andrew, Schoenberg Mark
Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, New Jersey.
Department of Urology, University Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria.
J Urol. 2025 Feb;213(2):205-216. doi: 10.1097/JU.0000000000004296. Epub 2024 Oct 24.
We evaluate the efficacy and safety of UGN-102 chemoablation for the primary treatment of patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer.
ENVISION is an ongoing, multinational, single-arm, phase 3 study in patients with a biopsy-proven recurrence of untreated low-grade intermediate-risk nonmuscle-invasive bladder cancer. Patients received 6 weekly intravesical instillations of UGN-102 (mitomycin; outpatient setting) and were evaluated at 3 months. Patients achieving complete response (CR; negative cystoscopic examination, cytology, and for-cause biopsy) were surveilled regularly until recurrence, progression, or death. Patients who remain disease-free will be followed up to 5 years, and further results will be reported in the future.
Of 240 patients enrolled, 228 (95%) received all 6 planned doses; 191 (80%; 95% CI, 73.9-84.5) achieved CR at 3 months, with an 82% (95% CI, 75.9-87.1) probability of response 12 months later. Median duration of response was not estimable over a median 13.9-month follow-up period. The most common adverse events (≥5.0% of patients) were dysuria, hematuria, UTI, pollakiuria, fatigue, and urinary retention; generally mild/moderate and resolved/resolving. Serious adverse events were observed in 29/240 (12.1%); 2 were treatment related (urinary retention/urethral stenosis), and both resolved.
Primary chemoablation with UGN-102 in patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer resulted in an 80% CR rate. Patients achieving a CR had an 82% likelihood of remaining disease-free 1 year later. The benefit-risk profile was favorable, supporting UGN-102 as a nonsurgical alternative for transurethral resection of bladder tumors in this patient population. Limitations of this study included lack of tumor sizing after the diagnostic biopsy.
ClinicalTrials.gov Identifier: NCT05243550.
我们评估UGN-102化学消融术对复发性低级别中危非肌层浸润性膀胱癌患者进行初始治疗的疗效和安全性。
ENVISION是一项正在进行的多国单臂3期研究，研究对象为经活检证实为未经治疗的复发性低级别中危非肌层浸润性膀胱癌患者。患者接受为期6周的UGN-102膀胱内灌注（丝裂霉素；门诊治疗），并在3个月时进行评估。达到完全缓解（CR；膀胱镜检查、细胞学检查及因症活检均为阴性）的患者定期监测直至复发、进展或死亡。无疾病进展的患者将随访5年，进一步结果将在未来报告。
240例入组患者中，228例（95%）接受了全部6剂计划剂量；191例（80%；95%CI，73.9-84.5）在3个月时达到CR，12个月后缓解概率为82%（95%CI，75.9-87.1）。在中位13.9个月的随访期内，中位缓解持续时间无法估计。最常见的不良事件（≥5.0%的患者）为排尿困难、血尿、尿路感染、尿频、疲劳和尿潴留；一般为轻/中度，且已缓解/正在缓解。29/240例（12.1%）观察到严重不良事件；2例与治疗相关（尿潴留/尿道狭窄），均已缓解。
UGN-102对复发性低级别中危非肌层浸润性膀胱癌患者进行初始化学消融术的CR率为80%。达到CR的患者1年后无疾病进展的可能性为82%。获益风险比良好，支持UGN-102作为该患者群体膀胱肿瘤经尿道切除术的非手术替代方案。本研究的局限性包括诊断性活检后未进行肿瘤大小测量。
ClinicalTrials.gov标识符：NCT05243550。
