Introduction:

Low-grade (LG), intermediate-risk (IR) non-muscle-invasive bladder cancer (NMIBC) is a chronically relapsing disease, and the standard of care for its treatment is transurethral resection of bladder tumor (TURBT) under anesthesia. Recent experience suggests that many patients with LG-IR-NMIBC can be successfully treated with UGN-102, a reverse thermal gel containing mitomycin administered via intravesical instillation in the outpatient setting, without the need for surgery. In this report, we document the experience of administering UGN-102 in the home, to examine the feasibility of treating selected individuals outside of the traditional venue for intravesical management of bladder cancer.

Methods:

Enrolled patients received 6 weekly intravesical instillations of UGN-102, a reverse thermal hydrogel containing mitomycin (75 mg). The first treatment was administered at the investigative site, and the following 5 were administered at the patient’s home by a trained healthcare professional (HCP). Patients, HCPs, and investigators completed questionnaires rating their experience after each home instillation and at the end of the study. The primary endpoint was feasibility, assessed as safety, discontinuation rate, and questionnaire feedback. The secondary endpoint was complete response (CR) (absence of bladder cancer) at the 3-month visit, determined by endoscopic evaluation, urine cytology, and for-cause biopsy.

Results:

Eight patients with LG-IR-NMIBC meeting eligibility criteria were enrolled and treated with UGN-102; 6 patients (75.0%) completed study-treatment (6 instillations); 2 (25.0%) discontinued due to an adverse event (AE). Median age was 75.0 years (range 55–84). Most were male (62.5%), all were White; all had prior LG-NMIBC and had previously undergone TURBT. Median number of prior TURBTs was 4.0 (range 1–7). Most had multiple tumors (62.5%) and 50.0% had a tumor burden >3cm. Standardized feasibility-questionnaires highlighted all 8 patients preferring at-home to in‑office treatment; 5/6 patients recommended UGN‑102 home instillation over TURBT. Home instillation was reported as feasible by visiting HCPs; 3/4 of investigators considered at-home treatment “not different” from in-office treatment. 6/8 (75%) of participants achieved CR at the 3-month visit, with the 2 patients who discontinued counted as non-responders. Most patients had mild-to-moderate AEs that resolved or were resolving. Serious AEs occurred in 3 patients; none were considered treatment-related.

Conclusion:

Results from this study demonstrate that home instillation of the chemoablation agent UGN-102 for the treatment of LG-IR-NMIBC is feasible, convenient, and results in a high CR rate. The overall safety profile was consistent with that observed in the rest of the UGN-102 development program. Home instillation was rated highly by patients, HCPs, and investigators. With trained home healthcare personnel, home instillation of UGN-102 may provide patients with a convenient alternative to in-clinic instillation.

Funding: UroGen Pharma