Browsing by Author "Smith, Angela B."

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    Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report
    (AUA, 2022-04) Matin, Surena F.; Pierorazio, Phillip M.; Kleinmann, Nir; Gore, John L.; Shabsigh, Ahmad; Hu, Brian; Chamie, Karim; Godoy, Guilherme; Hubosky, Scott G.; Rivera, Marcelino; O'Donnell, Michael; Quek, Marcus; Raman, Jay D.; Knoedler, John J.; Scherr, Douglas; Weight, Christopher; Weizer, Alon; Woods, Michael; Kaimakliotis, Hristos; Smith, Angela B.; Linehan, Jennifer; Coleman, Jonathan; Humphreys, Mitchell R.; Pak, Raymond; Lifshitz, David; Verni, Michael; Klein, Ifat; Konorty, Marina; Strauss-Ayali, Dalit; Hakim, Gil; Seltzer, Elyse; Schoenberg, Mark; Lerner, Seth P.; Urology, School of Medicine
    Purpose: Our goal was to evaluate long-term safety and durability of response to UGN-101, a mitomycin-containing reverse thermal gel, as primary chemoablative treatment for low-grade upper tract urothelial carcinoma. Materials and Methods: In this open-label, single-arm, multicenter, phase 3 trial (NCT02793128), patients ≥18 years of age with primary or recurrent biopsy-proven low-grade upper tract urothelial carcinoma received 6 once-weekly instillations of UGN-101 via retrograde catheter to the renal pelvis and calyces. Those with complete response (defined as negative ureteroscopic evaluation, negative cytology and negative for-cause biopsy) 4–6 weeks after the last instillation were eligible for up to 11 monthly maintenance instillations and were followed for ≥12 months with quarterly evaluation of response durability. Durability of complete response was determined by ureteroscopic evaluation; duration of response was estimated by the Kaplan-Meier method. Treatment-emergent adverse events (TEAEs) were monitored. Results: Of 71 patients who initiated treatment, 41 (58%) had complete response to induction therapy and consented to long-term followup; 23/41 patients (56%) remained in complete response after 12 months (95% CI 40, 72), comprising 6/12 (50%) who did not receive any maintenance instillations and 17/29 (59%) who received ≥1 maintenance instillation. Kaplan-Meier analysis of durability was estimated as 82% (95% CI 66, 91) at 12 months. Ureteric stenosis was the most frequently reported TEAE (31/71, 44%); an increasing number of instillations appeared to be associated with increased incidence of urinary TEAEs. Conclusions: Durability of response to UGN-101 with or without maintenance treatment is clinically meaningful, offering a kidney-sparing therapeutic alternative for patients with low-grade disease.
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    Quality of Life and Health State Utilities in Bladder Cancer
    (IOS Press, 2022-03-11) Smith, Angela B.; McCabe, Sean; Deal, Allison M.; Guo, Amy; Gessner, Kathryn H.; Lipman, Robert; Chisolm, Stephanie; Ahlschlager, Lauren; Gore, John L.; Urology, School of Medicine
    Background: Bladder cancer treatments may variably impact health-related quality of life (QOL). Objective: To characterize the quality of life of patients with bladder cancer at various time points across the continuum of bladder cancer care from non-muscle-invasive disease to metastatic bladder cancer and develop utility scores to inform cost-effective analyses. Methods: We performed a cross-sectional survey of bladder cancer patients in the Bladder Cancer Advocacy Network Patient Survey Network. Participants were classified into mutually exclusive health states based upon non-muscle invasive (NMIBC), muscle-invasive (MIBC), or metastatic bladder cancer and completed surveys of generic cancer and bladder cancer-specific quality of life, financial toxicity, and work impairment. We constructed generalized linear mixed models to identify patient, clinical, and treatment factors associated with quality of life over time and derived health state utilities. Results: Among 911 self-identified patients with bladder cancer, overall QOL scores and function domains were worse among those with advanced cancer. Financial toxicity was similar among non-metastatic disease states. Work and activity impairment increased with advancing disease (13%and 12%among non-recurrent NMIBC to 63%and 31%for metastatic disease respectively; p < 0.01). On multivariable analysis, bowel-related QOL was diminished among patients with MIBC, with urinary symptoms and physical function most diminished among patients with metastatic disease. Patients with metastatic and MIBC experienced worse emotional functioning (p = 0.04; p = 0.048). Health state utilities were calculated, highest among those with non-recurrent NMIBC and lowest among those with metastatic disease. Conclusion: Generic and bladder cancer-specific QOL diminishes with advancing disease. Health state utility estimates derived from this study can inform shared decision making with patients and may be used to inform future cost-effective analyses.