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
776 Background: The ENVISION phase 3 study (NCT05243550) treated patients withlow-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) with UGN-102, a reverse thermal hydrogel containing mitomycin. Primary efficacy and safety results were previously reported. Complete response (CR) rate at 3 months was 79.6%, with an 82.3% probability of remaining in response 12 months later by Kaplan-Meier estimate. We conducted a post-hoc analysis to evaluate if certain tumor characteristics influenced response rate and durability. Methods: In the single-arm ENVISION study, 240 patients with LG-IR-NMIBC received at lease one dose of UGN-102, 95% (228) received all 6 weekly doses; 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 CR (no detectable disease) entered the follow-up period and were surveilled regularly for recurrence. Between group comparisons were performed for CR rate (CRR) at 3 months and duration of response (DOR) 12 months after achieving CR in patients with tumor burden ≤ or >3 cm (calculated as total length of all tumors), and for single vs multiple tumors. Hazard ratios (HRs) of DOR were calculated using a Cox Proportional Hazards (PH) model, and p-values calculated using a log-rank test; p-values for the comparison of CRR were calculated using Fisher’s Exact Test. Results: CRR at 3 months was 82.8% vs 73.2% for patients with tumor burden ≤3 cm and >3 cm, respectively. Of the patients with CR at 3 months, 15.4% vs 20% experienced recurrence of LG disease, progression (either in stage or grade), or death by 15 months. In patients with multiple vs single tumors, 3-month CR was 79.3% vs 82.9%, with recurrence rates of 18.5% vs 11.8%. DOR HRs were not statistically significant for any comparison made (table). Conclusions: Although a non-significant higher event rate was observed at 3 months for patients with a higher tumor burden, the CRR was robust, and the majority of patients remained event free at 15 months. These results demonstrate that chemoablation using UGN-102 results in a high, clinically meaningful CRR in patients with recurrent LG-IR-NMIBC, regardless of tumor burden or multifocality. Study limitations were the small sample size of the 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(95% CI) / p value* Recurrence within 15 months DOR HR(95% CI) / p value* Tumor size ≤3 cm>3cm 149/180 (82.8%)30/41 (73.2%) 1.13 (0.93–1.38) / p=0.1854 23/149 (15.4%)6/30 (20.0%) 0.777 (0.317–1.909) / p=0.5816 Tumor count MultipleSingle 157 /198 (79.3%)34/41 (82.9%) 0.96 (0.82 –1.12) / p=0.6740 29/157 (18.5%)4/34 (11.8%) 1.644 (0.578–4.677) / p=0.3459 *Nominal.
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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
- 10/02/2025
- 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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Morristown Medical Center 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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Johns Hopkins Bayview Medical Center pays non établi dans la noticeÉtablissement de santé
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NYU Langone Health 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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Atlantic Medical Center pays non établi dans la noticeÉtablissement de santé
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University Multiprofile Hospital for Active Treatment Urology Department pays non établi dans la noticeUniversité ou école supérieure
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Multiprofile Hospital for Active Treatment Varna pays non établi dans la noticeÉtablissement de santé
Morristown Medical Center, National Institute of Emergency Medicine "Pirogov" et Johns Hopkins University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.