The Journal of urology · 2024
Long-Term Outcomes of Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma With UGN-101, a Mitomycin Reverse Thermal Gel.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Pierorazio Phillip M, Kleinmann Nir, Shabsigh Ahmad, Hu Brian, Raman Jay D, Kaimakliotis Hristos, Sankin Alexander, Singla Nirmish, Meads Andrew, Burger Brent, Raju Sunil, Louie Michael J, Chamie Karim, Weizer Alon, Schoenberg Mark
Аннотация
PURPOSE: We evaluate long-term outcomes of primary chemoablation using a mitomycin reverse thermal gel (UGN-101) in patients with low-grade upper tract urothelial carcinoma.
MATERIALS AND METHODS: Patients who participated in the OLYMPUS trial (IRB No. TC-UT-03, NCT02793128) and achieved a complete response (CR) after 6 weekly doses of UGN-101 were followed up to 12 months after initial CR. Those with CR at study completion were eligible for long-term follow-up for up to 5 years or until disease recurrence, progression, or death.
RESULTS: Of the 71 patients enrolled in the OLYMPUS trial, 42 patients achieved CR 4 to 6 weeks after completing ≥ 1 instillation of UGN-101. Among the 41 patients followed after initial CR, median follow-up was 28.1 months (95% CI, 13.1-57.5), and median duration of response was 47.8 months (95% CI, 13.0-not estimable [NE]). Twenty patients (49%) had long-term follow-up (median 53.3 months [95% CI, 27.9-65.3]). Seventy-five percent of patients had no evidence of recurrence at the last follow-up, with median duration of response NE (95% CI, 43.5-NE) because of a low event rate.
CONCLUSIONS: Primary intracavitary chemoablation with UGN-101 for low-grade upper tract urothelial carcinoma is associated with favorable long-term durability.
MATERIALS AND METHODS: Patients who participated in the OLYMPUS trial (IRB No. TC-UT-03, NCT02793128) and achieved a complete response (CR) after 6 weekly doses of UGN-101 were followed up to 12 months after initial CR. Those with CR at study completion were eligible for long-term follow-up for up to 5 years or until disease recurrence, progression, or death.
RESULTS: Of the 71 patients enrolled in the OLYMPUS trial, 42 patients achieved CR 4 to 6 weeks after completing ≥ 1 instillation of UGN-101. Among the 41 patients followed after initial CR, median follow-up was 28.1 months (95% CI, 13.1-57.5), and median duration of response was 47.8 months (95% CI, 13.0-not estimable [NE]). Twenty patients (49%) had long-term follow-up (median 53.3 months [95% CI, 27.9-65.3]). Seventy-five percent of patients had no evidence of recurrence at the last follow-up, with median duration of response NE (95% CI, 43.5-NE) because of a low event rate.
CONCLUSIONS: Primary intracavitary chemoablation with UGN-101 for low-grade upper tract urothelial carcinoma is associated with favorable long-term durability.