Phillip M Pierorazio, Nir Kleinmann, Ahmad Shabsigh, Brian Hu, Jay D Raman, Hristos Kaimakliotis, Alexander Sankin, Nirmish Singla, Andrew Meads, Brent Burger, Sunil Raju, Michael J Louie, Karim Chamie, Alon Weizer, Mark Schoenberg
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引用次数: 0
Abstract
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.
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.