Perceived impact on patient routines/responsibilities for surgery and a non-surgical primary treatment option in recurrent LG-IR-NMIBC: findings from the ENVISION phase 3 trial.

Abstract

Purpose: Adults with low-grade intermediate risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) commonly ask urologists how their routine/responsibilities will be affected by treatments, including the standard of care, transurethral resection of bladder tumor (TURBT). We asked patients in the ENVISION trial (NCT05243550) to compare TURBT to a non-surgical primary treatment (UGN-102 containing mitomycin) for acceptability and impact on their routine/responsibilities.

Materials and methods: ENVISION (NCT05243550) is a phase 3, single arm trial where UGN-102 was administered as six weekly intravesical instillations. Interviews with U.S. patients were conducted at enrollment (before instillations) and 3 months (primary trial endpoint). Transcripts were coded by three coders using the gold standard of content analysis to derive interview themes.

Results: Forty-one U.S. patients from 31 sites were eligible, and 29/41 completed both interviews. Most participants were men (62%), White (83%), and age 65+ (69%). Three themes were derived: 1) Patients perceived that TURBT interfered more with their routine/responsibilities. 2) Urinary symptoms were perceived to be similar, but bleeding, catheter issues, and time to resuming sexual activity lasted longer with TURBT. For UGN-102, uncommon reports were internal itching and difficulty keeping gel in the bladder during instillations. 3) Patients would recommend UGN-102 to other patients because it was perceived to be less invasive, painful, and time-consuming than TURBT.

Conclusion: Patients perceived UGN-102 to be a favorable primary treatment alternative to traditional surgical resections for LG-IR-NMIBC. By focusing on the underexplored area of patient perceptions, this study provides key information urologists will need to conduct shared decision-making conversations.