Minimal Patient-Reported Side Effects for a Chemoablative Gel (UGN-102) Used as Frontline Treatment in Adults with Non-Muscle-Invasive Bladder Cancer.

The trial "OPTimized Instillation of Mitomycin for Bladder Cancer Treatment" (Optima II, clinicaltrials.gov: NCT03558503) was a Phase 2b trial evaluating a nonsurgical alternative as a primary treatment for non-muscle-invasive bladder cancer (NMIBC). Patients received six weekly instillations of UGN-102, a mitomycin-containing reverse thermal gel. This is the first study to report on patientreported side effects of UGN-102.

Sixty-three patients enrolled in Optima II from 20 sites. Of these 63 patients, 44 were in the cohort completing a quarterly patient-reported outcome measure (PROM) assessing side effects. Changes in side effects were evaluated using the Wilcoxon signed rank test. Associations of 3month outcomes with demographic and clinical characteristics were examined with regression, controlling for baseline values. 10/44 patients (23%) were interviewed after the trial to understand tolerability for future patients making treatment decisions. Transcripts were double-coded using standard methods.

In the PROM cohort (n=44), 61% were men, 57% age 65+, and 89% non-Hispanic White. UGN-102 did not cause decrements in patient-reported urinary symptoms, bloating/flatulence, or malaise at the primary endpoint of 3 months. Sexual function mildly worsened. Future health worries improved. Demographics were not correlated with changes. Clinically, sexual function was correlated with new NMIBC, and bloating/flatulence were associated with TURBT within 12 months. In interviews, patients appreciated a nonsurgical alternative, would recommend the gel to other patients, and would choose the gel over surgery.

A nonsurgical, chemoablative gel (UGN-102) used as a primary treatment for NMIBC offers a more patient-centered therapeutic approach than standard treatments.

The Journal of urology. 2022 May 31 [Epub ahead of print]

Angela M Stover, Ramsankar Basak, Dana Mueller, Robert Lipman, Randall Teal, Alison Hilton, Kara Giannone, Myra Waheed, Angela B Smith

Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, NC., Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC., Lineberger Comprehensive Cancer Center, Chapel Hill, NC., Bladder Cancer Advocacy Network, Bethesda, MD, patient advocate.