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Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial
Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumor under general anesthesia. We evaluated the efficacy and safety of UGN-102, a mitomycin-containing reverse thermal gel, as a primary che...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8667793/ https://www.ncbi.nlm.nih.gov/pubmed/34433303 http://dx.doi.org/10.1097/JU.0000000000002186 |
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author | Chevli, K. Kent Shore, Neal D. Trainer, Andrew Smith, Angela B. Saltzstein, Daniel Ehrlich, Yaron Raman, Jay D. Friedman, Boris D’Anna, Richard Morris, David Hu, Brian Tyson, Mark Sankin, Alexander Kates, Max Linehan, Jennifer Scherr, Douglas Kester, Steven Verni, Michael Chamie, Karim Karsh, Lawrence Cinman, Arnold Meads, Andrew Lahiri, Soumi Malinowski, Madlen Gabai, Nimrod Raju, Sunil Schoenberg, Mark Seltzer, Elyse Huang, William C. |
author_facet | Chevli, K. Kent Shore, Neal D. Trainer, Andrew Smith, Angela B. Saltzstein, Daniel Ehrlich, Yaron Raman, Jay D. Friedman, Boris D’Anna, Richard Morris, David Hu, Brian Tyson, Mark Sankin, Alexander Kates, Max Linehan, Jennifer Scherr, Douglas Kester, Steven Verni, Michael Chamie, Karim Karsh, Lawrence Cinman, Arnold Meads, Andrew Lahiri, Soumi Malinowski, Madlen Gabai, Nimrod Raju, Sunil Schoenberg, Mark Seltzer, Elyse Huang, William C. |
author_sort | Chevli, K. Kent |
collection | PubMed |
description | Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumor under general anesthesia. We evaluated the efficacy and safety of UGN-102, a mitomycin-containing reverse thermal gel, as a primary chemoablative therapeutic alternative to transurethral resection of bladder tumor for patients with LG IR NMIBC. MATERIALS AND METHODS: This prospective, phase 2b, open-label, single-arm trial recruited patients with biopsy-proven LG IR NMIBC to receive 6 once-weekly instillations of UGN-102. The primary end point was complete response (CR) rate, defined as the proportion of patients with negative endoscopic examination, negative cytology and negative for-cause biopsy 3 months after treatment initiation. Patients with CR were followed quarterly up to 12 months to assess durability of treatment effect. Safety and adverse events were monitored throughout the trial. RESULTS: A total of 63 patients (38 males and 25 females 33–96 years old) enrolled and received ≥1 instillation of UGN-102. Among the patients 41 (65%) achieved CR at 3 months, of whom 39 (95%), 30 (73%) and 25 (61%) remained disease-free at 6, 9 and 12 months after treatment initiation, respectively. A total of 13 patients had documented recurrences. The probability of durable response 9 months after CR (12 months after treatment initiation) was estimated to be 73% by Kaplan-Meier analysis. Common adverse events (incidence ≥10%) included dysuria, urinary frequency, hematuria, micturition urgency, urinary tract infection and fatigue. CONCLUSIONS: Nonsurgical primary chemoablation of LG IR NMIBC using UGN-102 resulted in significant treatment response with sustained durability. UGN-102 may provide an alternative to repetitive surgery for patients with LG IR NMIBC. |
format | Online Article Text |
id | pubmed-8667793 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Wolters Kluwer |
record_format | MEDLINE/PubMed |
spelling | pubmed-86677932021-12-15 Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial Chevli, K. Kent Shore, Neal D. Trainer, Andrew Smith, Angela B. Saltzstein, Daniel Ehrlich, Yaron Raman, Jay D. Friedman, Boris D’Anna, Richard Morris, David Hu, Brian Tyson, Mark Sankin, Alexander Kates, Max Linehan, Jennifer Scherr, Douglas Kester, Steven Verni, Michael Chamie, Karim Karsh, Lawrence Cinman, Arnold Meads, Andrew Lahiri, Soumi Malinowski, Madlen Gabai, Nimrod Raju, Sunil Schoenberg, Mark Seltzer, Elyse Huang, William C. J Urol Adult Urology Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumor under general anesthesia. We evaluated the efficacy and safety of UGN-102, a mitomycin-containing reverse thermal gel, as a primary chemoablative therapeutic alternative to transurethral resection of bladder tumor for patients with LG IR NMIBC. MATERIALS AND METHODS: This prospective, phase 2b, open-label, single-arm trial recruited patients with biopsy-proven LG IR NMIBC to receive 6 once-weekly instillations of UGN-102. The primary end point was complete response (CR) rate, defined as the proportion of patients with negative endoscopic examination, negative cytology and negative for-cause biopsy 3 months after treatment initiation. Patients with CR were followed quarterly up to 12 months to assess durability of treatment effect. Safety and adverse events were monitored throughout the trial. RESULTS: A total of 63 patients (38 males and 25 females 33–96 years old) enrolled and received ≥1 instillation of UGN-102. Among the patients 41 (65%) achieved CR at 3 months, of whom 39 (95%), 30 (73%) and 25 (61%) remained disease-free at 6, 9 and 12 months after treatment initiation, respectively. A total of 13 patients had documented recurrences. The probability of durable response 9 months after CR (12 months after treatment initiation) was estimated to be 73% by Kaplan-Meier analysis. Common adverse events (incidence ≥10%) included dysuria, urinary frequency, hematuria, micturition urgency, urinary tract infection and fatigue. CONCLUSIONS: Nonsurgical primary chemoablation of LG IR NMIBC using UGN-102 resulted in significant treatment response with sustained durability. UGN-102 may provide an alternative to repetitive surgery for patients with LG IR NMIBC. Wolters Kluwer 2022-01 2021-08-26 /pmc/articles/PMC8667793/ /pubmed/34433303 http://dx.doi.org/10.1097/JU.0000000000002186 Text en © 2021 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | Adult Urology Chevli, K. Kent Shore, Neal D. Trainer, Andrew Smith, Angela B. Saltzstein, Daniel Ehrlich, Yaron Raman, Jay D. Friedman, Boris D’Anna, Richard Morris, David Hu, Brian Tyson, Mark Sankin, Alexander Kates, Max Linehan, Jennifer Scherr, Douglas Kester, Steven Verni, Michael Chamie, Karim Karsh, Lawrence Cinman, Arnold Meads, Andrew Lahiri, Soumi Malinowski, Madlen Gabai, Nimrod Raju, Sunil Schoenberg, Mark Seltzer, Elyse Huang, William C. Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial |
title | Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial |
title_full | Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial |
title_fullStr | Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial |
title_full_unstemmed | Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial |
title_short | Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial |
title_sort | primary chemoablation of low-grade intermediate-risk nonmuscle-invasive bladder cancer using ugn-102, a mitomycin-containing reverse thermal gel (optima ii): a phase 2b, open-label, single-arm trial |
topic | Adult Urology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8667793/ https://www.ncbi.nlm.nih.gov/pubmed/34433303 http://dx.doi.org/10.1097/JU.0000000000002186 |
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