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

Autor:	Stover AM; Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.; Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina., Basak R; Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina., Mueller D; Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina., Lipman R; Bladder Cancer Advocacy Network, Bethesda, Maryland., Teal R; Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.; Connected Health Applications & Interventions (CHAI) Core, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina., Hilton A; Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.; Connected Health Applications & Interventions (CHAI) Core, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina., Giannone K; Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.; Connected Health Applications & Interventions (CHAI) Core, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina., Waheed M; Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.; Connected Health Applications & Interventions (CHAI) Core, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina., Smith AB; Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.; Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Jazyk:	angličtina
Zdroj:	The Journal of urology [J Urol] 2022 Sep; Vol. 208 (3), pp. 580-588. Date of Electronic Publication: 2022 May 31.
DOI:	10.1097/JU.0000000000002747
Abstrakt:	Purpose: Optima II ("OPTimized Instillation of Mitomycin for Bladder Cancer Treatment," clinicaltrials.gov: NCT03558503) was a phase 2b trial evaluating a nonsurgical alternative as a primary treatment for nonmuscle-invasive bladder cancer (NMIBC). Patients received 6 weekly instillations of UGN-102, a mitomycin-containing reverse thermal gel. This is the first study to report on patient-reported side effects of UGN-102. Materials and Methods: 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 assessing side effects. Changes in side effects were evaluated using the Wilcoxon signed-rank test. Associations of 3-month outcomes with demographic and clinical characteristics were examined with regression, controlling for baseline values. Ten of 44 patients (23%) were interviewed after the trial to understand tolerability for future patients making treatment decisions. Transcripts were double-coded using standard methods. Results: In the patient-reported outcome measure cohort (44), 61% were men, 57% aged 65+ years and 89% were 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 was associated with transurethral resection of bladder tumor within 12 months. In interviews, patients appreciated a nonsurgical alternative, would recommend the gel to other patients and would choose the gel over surgery. Conclusions: A nonsurgical, chemoablative gel (UGN-102) used as a primary treatment for NMIBC offers a more patient-centered therapeutic approach than standard treatments.
Databáze:	MEDLINE
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