Findings from the single-arm phase 2b Optima II trial shared during the 2022 AUA Annual Meeting showed that health-related quality-of-life (HRQOL) outcomes were maintained with the mitomycin-containing reverse thermal gel UGN-102 in patients with low-grade non–muscle-invasive bladder cancer (NMIBC).1
Traditionally, low-grade NMIBC is treated by transurethral resection of the bladder (TURBT), which can lead to worsening health-relate quality of life (HRQOL), according to lead presenter Angela B. Smith, MD, MS, vice chair of academic affairs, director of urologic oncology, and associate professor of urology at the University of North Carolina School of Medicine in Chapel Hill.
This noninvasive approach evaluated HRQOL through patient-reported questionnaires 3 months after initiation of study medication. Eleven QOL measures were evaluated including questions about urinary symptoms, malaise, future worries, bloating/flatulence, intravesical treatment issues, male sexual problems, sexual intimacy, partner contamination, female sexual problems, sexual function, and sexual enjoyment.
Investigators reported that the gel did not lead to decrements in urinary symptoms, bloating/flatulence, or malaise; further, sexual function mildly worsened. Among patients who completed the questionnaire, 70% (31 of 44) achieved a complete response, defined as having a negative endoscopic examination, cytology, and for-cause biopsy. Demographic and clinical characteristics were not correlated with HRQOL changes, reported the investigators.
Primary outcome measures included complete response rate, and secondary outcome measures included durable complete response, and frequency, seriousness, and severity of adverse events. Area under the curve, concentration, and maximum concentration were also measured.
Eligibility requirements included patients with newly diagnosed or historic low grade NMIBC who are at intermediate risk for progression, defined as having the presence of multiple tumors, recurrence, or a solitary tumor greater than 3 cm. Patients are ineligible if they have received Bacillus Calmette-Guérin treatment for urothelial carcinoma within the past 2 years and a history of neurogenic bladder, active urinary retention, and any condition that would prohibit normal voiding.
A total of 63 patients enrolled in the trial (NCT03558503) and received 6 weekly doses of the mitomycin-containing thermal gel with a sustained release time of up to 8 hours. Forty-four patients were designated for the HRQOL cohort and completed questionnaire. The majority of the HRQOL cohort was comprised of men (61%), patients over 65 years of age (57%), and non-Hispanic Whites (89%). The Sign test was used to measure longitudinal changes, and demographic and clinical characteristics were evaluated using regression testing.
Investigators reported that 10 patients (23%) were interviewed, and transcripts were double-coded using standard methods. In this subcohort, the majority were female (60%), non-Hispanic White (90%), and had a mean age of 65.6 years (8.4%).
During the interview sessions, patients expressed an appreciation of the nonsurgical treatment option and would recommend the gel to other patients, choosing the gel over TURBT. Additionally, patients noted that the gel did not require a long recovery period. Regarding safety, patients recalled minimal adverse events; however, frequent urination, restricted urethra, and blood in the urine were recorded.
The investigators concluded that a phase 3 trial is warranted.
1. Smith AB, Basak R, Mueller D, et al. 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). Presented at: 2022 American Urology Association Annual Meeting; May 13-16, 2022; New Orleans, LA. Abstract MP54-06. Accessed May 15, 2022. https://bit.ly/3yEN9v3