Impact of tumor burden or focality in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer on response to treatment with UGN-102: A substudy of the phase 3 ENVISION trial.
Rattachement africain : us, bg. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
4597 Background: In the ENVISION pivotal phase 3 study (NCT05243550) patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) were treated with UGN-102, a reverse thermal hydrogel containing mitomycin. Primary efficacy and safety results were previously reported. Complete response rate (CRR) at 3 months was 79.6%, with an 82.3% probability of remaining in response at 12 months by Kaplan–Meier estimate. Here, we present a post-hoc analysis evaluating if multifocality and tumor size influenced response rate and durability. Methods: In the single-arm ENVISION study, 240 patients with LG-IR-NMIBC received 6 weekly intravesical instillations of UGN-102; 3 months after the first dose, patients were examined for the presence of bladder cancer using cystoscopy, urine cytology testing, and for-cause biopsy. Patients achieving complete response (CR; no detectable disease) underwent follow-up with surveillance cystoscopy. In pre-specified subgroups, comparisons of patients with tumor burden (calculated as total length of all tumors) ≤3cm vs > 3 cm and single vs multiple tumors were performed for CRR at 3 months and hazard ratios (HRs) of duration of response (DoR) at 12 months after achieving CR. For the comparison of CRR, p values were calculated using Fisher’s Exact Test. HRs of DoR were calculated using a Cox proportional hazards model, and p values calculated using a log-rank test. Comparisons were not powered to identify a difference and p values were unadjusted for multiple comparisons. Results: CRR at 3 months was 82.8% vs 73.2% for patients with tumor burden ≤3 cm and > 3 cm, respectively. Of patients with CR at 3 months with tumor burden ≤3 cm and > 3 cm, 15.4% vs 20%, respectively, experienced either recurrence of LG disease, progression (either stage or grade), or death by 15 months. In patients with multiple vs single tumors, 3-month CR was 79.3% vs 82.9%; recurrence rates were 18.5% vs 11.8%. DoR HRs were not statistically significant for any comparison made (Table). Conclusions: The CRR and DoR were favorable in all subgroups and no significant differences were observed. Study limitations were the small sample size of comparator groups, single arm design, and post-hoc nature of the analysis. UGN-102 may represent a valuable treatment option for many patients with LG-IR-NMIBC. Clinical trial information: NCT05243550 . CR at 3 months CRR ratio(95% CI)/p value Recurrence within 15 months a DoR HR (95% CI)/p value Tumor burden≤3 cm>3 cm 149/180 (82.8%)30/41 (73.2%) 1.13 (0.93, 1.38)p=0.1854 b 23/149 (15.4%)6/30 (20.0%) 0.777 (0.317, 1.909)p=0.5816 b Tumor countMultipleSingle 157/198 (79.3%)34/41 (82.9%) 0.96 (0.82, 1.12)p=0.6740 b 29/157 (18.5%)4/34 (11.8%) 1.644 (0.578, 4.677)p=0.3459 b a 3-month CR patients only. b Nominal. CI, confidence interval.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Impact of tumor burden or focality in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer on response to treatment with UGN-102: A substudy of the phase 3 ENVISION trial.
- Date Crossref
- 01/06/2025
- Éditeur
- American Society of Clinical Oncology (ASCO)
- 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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Icahn School of Medicine at Mount Sinai Department of Urology pays non établi dans la noticeUniversité ou école supérieure
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National Institute of Emergency Medicine "Pirogov" pays non établi dans la noticeÉtablissement de santé
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Medical University of Varna pays non établi dans la noticeUniversité ou école supérieure
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Military Medical Academy 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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Johns Hopkins Medicine pays non établi dans la noticeÉtablissement de santé
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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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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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University Multiprofile Hospital for Active Treatment Department of Urology pays non établi dans la noticeUniversité ou école supérieure
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Georgia Israel Joint Clinic Gidmedi Urology Department pays non établi dans la noticeÉtablissement de santé
Department of Urology — Icahn School of Medicine at Mount Sinai, National Institute of Emergency Medicine "Pirogov" et Medical University of Varna, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.