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.
Angela M Stover, Dana Mueller, Jessica Carda-Auten, Alison Hilton, Victoria Tsurutis, Angela B Smith
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引用次数: 0
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.
期刊介绍:
The Official Journal of the American Urological Association (AUA), and the most widely read and highly cited journal in the field, The Journal of Urology® brings solid coverage of the clinically relevant content needed to stay at the forefront of the dynamic field of urology. This premier journal presents investigative studies on critical areas of research and practice, survey articles providing short condensations of the best and most important urology literature worldwide, and practice-oriented reports on significant clinical observations.