Patient-Reported Outcomes Following UGN-102 Treatment in Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: An Analysis of 3 Clinical Trials.

introductionUGN-102 is a reverse thermal hydrogel formulation of mitomycin indicated for nonsurgical intravesical treatment of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG-IR-NMIBC). This analysis evaluates patient-reported outcomes (PROs) for quality of life (QoL), functioning, and symptom burden across 3 late-phase clinical trials of UGN-102.

methodsOPTIMA II (Phase 2b), ATLAS (Phase 3), and ENVISION (Phase 3, pivotal) were included. The Quality-of-Life Questionnaire for NMIBC (QLQ-NMIBC24) was administered in each trial and the QLQ-Core 30 was administered in ENVISION. Mean baseline PRO scores and changes from baseline were calculated for each trial. Minimal clinically important differences were used to identify clinically meaningful changes. QLQ-NMIBC24 urinary symptom scores were assessed in patients with and without urinary treatment-emergent adverse events with UGN-102 in ATLAS and ENVISION.

resultsPRO completion rates (ATLAS and ENVISION) were generally ≥ 90%. Mean baseline PRO scores were mostly indicative of low patient-perceived symptom burden and high level of functioning and QoL. Most PRO scores were similar to or better than baseline during and after UGN-102 treatment across trials. In ATLAS, clinically meaningful improvements from baseline in QLQ-NMIBC24 urinary symptoms, future worries, malaise, and bloating/flatulence were observed from month 3 up to month 18 or 21. Urinary treatment-emergent adverse event occurrence during UGN-102 treatment was associated with transient worsening in mean QLQ-NMIBC24 urinary symptom scores that resolved by the 3-month visit.

conclusionsIn these analyses, patients with LG-IR-NMIBC receiving UGN-102 did not report worsening QoL, functioning, or symptom burden, supporting its use as a nonsurgical treatment for LG-IR-NMIBC.