Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION)
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Le résumé fourni par la source
PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05243550.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION)
- Date Crossref
- 01/02/2025
- Éditeur
- Ovid Technologies (Wolters Kluwer Health)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Morristown Medical Center pays non établi dans la noticeÉtablissement de santé
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Atlantic Health System pays non établi dans la noticeÉtablissement de santé
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National Institute of Emergency Medicine "Pirogov" pays non établi dans la noticeÉtablissement de santé
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Johns Hopkins University pays non établi dans la noticeUniversité ou école supérieure
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Urology Associates pays non établi dans la noticeÉtablissement de santé
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UroGen Pharma Ltd. (United States) pays non établi dans la noticeEntreprise
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Albert Einstein College of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Montefiore Medical Center pays non établi dans la noticeÉtablissement de santé
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University Multiprofile Hospital for Active Treatment Department of Urology pays non établi dans la noticeUniversité ou école supérieure
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Department of Urology pays non établi dans la noticeInstitution
Morristown Medical Center, Atlantic Health System et National Institute of Emergency Medicine "Pirogov", avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.