Materials and Methods: Patients who participated in the OLYMPUS trial (TC-UT-03, NCT02793128) and achieved a complete response after 6 weekly doses of UGN-101 were followed up to 12 months after initial complete response. Those with complete response 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 complete response 4-6 weeks after completing ≥1 instillation of UGN-101. Amongst the 41 patients followed after initial complete response, 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).
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 last follow-up, with median duration of response not estimable (95% CI 43.5, not estimable) due to 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.
Guilherme Godoy,1 Seth Lerner,1 John Gore,2 Scott Hubosky,3 Marcus Quek,4 Joshua M. Stern,5 Surena F. Matin,6 Christopher J. Weight,7 Angela Smith,8 Jonathan Coleman,9 Jennifer Linehan,10 Mitchell R. Humphreys,11 David Lifshitz,12 Michael Verni,13 Robert McLaren,14 Matthew Nielsen,15 Douglas Scherr,16 Raymond Pak17
- Baylor College of Medicine Medical Center, Houston, TX, USA
- University of Washington Medical Center, Seattle, WA, USA
- Thomas Jefferson University, Philadelphia, PA, USA
- Loyola University Chicago, performing research at Loyola University Medical Center, Maywood, IL, USA
- Montefiore Medical Center Hutch Center, Bronx, NY, USA
- The University of Texas MD Anderson Cancer Center, Houston, TX, USA
- University of Minnesota Fairview Hospital, Minneapolis, MN, USA
- University of North Carolina Chapel Hill Memorial Hospital, Chapel Hill, NC, USA
- Memorial Sloan Kettering Cancer Center, New York, NY, USA
- Providence Saint John’s Health Center, Santa Monica, CA, USA
- Mayo Clinic, Phoenix, AZ, USA
- Rabin Medical Center, Petah Tikva, Israel
- Summerlin Hospital, Las Vegas, NV, USA
- The Mayo Clinic, Rochester, MN, USA
- University of North Carolina School of Medicine, Chapel Hill, NC, USA
- Department of Urology, Weill Medical College of Cornell University, New York, NY, USA
- Department of Urology, Mayo Clinic Jacksonville, Jacksonville, FL, USA
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New Data from a Long-Term Follow-up Study to the OLYMPUS Trial Show Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO®