MP54-06 LONGITUDINAL HEALTH-RELATED QUALITY OF LIFE OUTCOMES IN ADULTS WITH NON-MUSCLE-INVASIVE BLADDER CANCER RECEIVING A CHEMOABLATIVE GEL AS A PRIMARY TREATMENT (OPTIMA II: PHASE 2B, SINGLE ARM, OPEN-LABEL TRIAL)

Abstract

You have accessJournal of UrologyCME1 May 2022MP54-06 LONGITUDINAL HEALTH-RELATED QUALITY OF LIFE OUTCOMES IN ADULTS WITH NON-MUSCLE-INVASIVE BLADDER CANCER RECEIVING A CHEMOABLATIVE GEL AS A PRIMARY TREATMENT (OPTIMA II: PHASE 2B, SINGLE ARM, OPEN-LABEL TRIAL) Angela Smith, Ramsankar Basak, Dana Mueller, Robert Lipman, Randall Teal, Alison Hilton, Kara Giannone, Myra Waheed, and Angela Stover Angela SmithAngela Smith More articles by this author , Ramsankar BasakRamsankar Basak More articles by this author , Dana MuellerDana Mueller More articles by this author , Robert LipmanRobert Lipman More articles by this author , Randall TealRandall Teal More articles by this author , Alison HiltonAlison Hilton More articles by this author , Kara GiannoneKara Giannone More articles by this author , Myra WaheedMyra Waheed More articles by this author , and Angela StoverAngela Stover More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002633.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Low-grade non-muscle-invasive bladder cancer (LG NMIBC) is treated with transurethral resection of the bladder tumor (TURBT), which can worsen health-related quality of life (HRQOL). The trial “OPTimized Instillation of Mitomycin for Bladder Cancer Treatment” (Optima II, clinicaltrials.gov: NCT03558503) is a Phase 2b, open label, multicenter trial evaluating a nonsurgical alternative as a primary treatment. Patients receive six weekly instillations of UGN-102, a mitomycin-containing reverse thermal gel. We report on HRQOL changes at the primary endpoint of 3 months. METHODS: Of 63 patients enrolled in the Optima II trial, 44 were in the HRQOL cohort and completed quarterly questionnaires (61% men, 57% age 65+, and 89% non-Hispanic White). Longitudinal changes were evaluated using the Sign test and correlations with demographic and clinical characteristics with regression. Ten patients (23%) were interviewed and transcripts were double-coded using standard methods. RESULTS: The chemoablative reverse thermal gel did not cause decrements in patient-reported urinary symptoms, bloating/flatulence, or malaise (Figure). Sexual function mildly worsened. Demographic and clinical characteristics were not correlated with HRQOL changes. By 3 months, 31/44 (70%) LG NMIBC patients achieved a complete response (negative endoscopic examination, cytology, and for-cause biopsy). In interviews, patients appreciated a nonsurgical alternative, would recommend the gel to other patients, and would choose the gel over TURBT. CONCLUSIONS: Adults with LG NMIBC receiving a nonsurgical, chemoablative gel as a primary treatment maintained their HRQOL through 3 months, and interviewed patients would recommend the gel to other patients. A Phase 3 trial is warranted. Source of Funding: Bladder Cancer Advocacy Network Patient Survey Network Award, supported by Urogen Pharma © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e928 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Angela Smith More articles by this author Ramsankar Basak More articles by this author Dana Mueller More articles by this author Robert Lipman More articles by this author Randall Teal More articles by this author Alison Hilton More articles by this author Kara Giannone More articles by this author Myra Waheed More articles by this author Angela Stover More articles by this author Expand All Advertisement PDF DownloadLoading ...