Investigators reported that mitomycin gel was not associated with decrements in urinary symptoms, bloating and flatulence, or malaise, and that sexual function only mildly worsened.
UGN-102, a hemoablative mitomycin-containing reverse thermal gel, was associated with maintained health-related quality of life (HRQOL) in patients with low grade non–muscle invasive bladder cancer (NMIBC), according to findings from the single-arm phase 2b Optima II trial (NCT03558503), which were presented during the AUA 2022 Annual Meeting.
Traditionally, low-grade NMIBC is treated by transurethral resection of the bladder (TURBT), which can lead to worsening health-relate quality of life (HRQOL), 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, noted in a presentation of the findings. Investigators evaluated HRQOL through patient-reported questionnaires 3 months after initiation of the noninvasive study medication. Eleven QOL measures were evaluated including questions concerning 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, as well as 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 were ineligible if they have received Bacillus Calmette-Guérin treatment for urothelial carcinoma within the past 2 years, if they had a history of neurogenic bladder, active urinary retention, or any condition that would prohibit normal voiding.
A total of 63 patients enrolled in the trial and received 6 weekly doses UGN-102, which has a sustained release time of up to 8 hours. Forty-four patients were designated for the HRQOL cohort and completed the questionnaire. The majority of individuals in the HRQOL cohort were men (61%), 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.
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). J Urol. 2022;207(suppl 5):e928. doi:10.1097/JU.0000000000002633.06