Long-Term Outcomes of Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma With UGN-101, a Mitomycin Reverse Thermal Gel
Year: 2024
Type: article
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.
Source: The Journal of Urology
Institutions: University of Pennsylvania, Sheba Medical Center, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Loma Linda University, Pennsylvania State University, Penn State Milton S. Hershey Medical Center, Indiana University School of Medicine, Albert Einstein College of Medicine, Johns Hopkins University, UroGen Pharma Ltd. (United States), University of California, Los Angeles, Mount Sinai Medical Center, Columbia University
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,000
Award: G1588314721
OpenAlex ID: W4404515808
