AUA 2022: 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)

(UroToday.com)  The 2022 Annual Meeting of the American Urological Association was host to a moderated poster session for non-invasive bladder cancer. Dr. Smith presented the health-related quality of life outcomes results for low-grade non-muscle invasive bladder cancer (LG NMIBC) patients receiving UGN-102, a mitomycin containing reverse thermal gel.


Management of LG NMIBC requires frequent cystoscopic surveillance and occasional endoscopic resection procedures that can be time consuming and financially prohibitive. Furthermore, TURBT can worse health-related quality of life (HRQOL) outcomes. In the “OPTimized Instillation of Mitomycin for Bladder Cancer Treatment” (Optima II, clinicaltrials.gov: NCT03558503) trial, patients received six weekly instillations of UGN-102, a mitomycin-containing reverse thermal gel.

 

This study was a Phase 2b, open label, multicenter trial. The aim was to evaluate HRQOL changes at 3 months (primary endpoint). Secondary endpoints included complete response defined as a negative endoscopic examination, cytology, and for-cause biopsy. This trial enrolled 63 patients, 44 of whom were included in the HRQOL cohort and completed the quarterly questionnaires. Of these 44 patients, 61% were men, 57% were 65 years of age or older, and 89% were 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.

 

No changes in patient-reported urinary symptoms, bloating/flatulence, or malaise were noted at 3 months with UGN-102. Sexual function mildly worsened. HRQOL changes did not correlate with demographic or clinical characteristics. Complete response at 3 months was achieved by 31 (70%) of the patients. In interviews, patients appreciated a nonsurgical alternative, would recommend the gel to other patients, and would choose the gel over TURBT.
 

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Dr. Smith concluded that 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 is needed to further corroborate these results.
 

Presented by: Angela Smith, MD, MS, Associate Professor, Department of Urology, University of North Carolina, Chapel Hill, NC 

Written by: Rashid Sayyid, MD, MSc – Urology Chief Resident, Augusta University/Medical College of Georgia, @rksayyid on Twitter during the 2022 American Urological Association (AUA) Annual Meeting, New Orleans, LA, Fri, May 13 – Mon, May 16, 2022.

 

 

 

 

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