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

Surena F. Matin, Phillip M. Pierorazio, Nir Kleinmann, John L. Gore, Ahmad Shabsigh, Brian Hu, Karim Chamie, Guilherme Godoy, Scott G. Hubosky, Marcelino Rivera, Michael O'Donnell, Marcus Quek, Jay D. Raman, John J. Knoedler, Douglas Scherr, Christopher Weight, Alon Weizer, Michael Woods, Hristos Kaimakliotis, Angela B. SmithJennifer Linehan, Jonathan Coleman, Mitchell R. Humphreys, Raymond Pak, David Lifshitz, Michael Verni, Ifat Klein, Marina Konorty, Dalit Strauss-Ayali, Gil Hakim, Elyse Seltzer, Mark Schoenberg, Seth P. Lerner

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)779-788
Number of pages10
JournalJournal of Urology
Volume207
Issue number4
DOIs
StatePublished - Apr 1 2022

Keywords

  • clinical trial
  • mitomycin
  • urinary bladder neoplasms

ASJC Scopus subject areas

  • Urology

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