Journal article
Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial
The lancet oncology, Vol.21(6), pp.776-785
06/2020
DOI: 10.1016/S1470-2045(20)30147-9
PMID: 32631491
Abstract
Most patients with low-grade upper tract urothelial cancer are treated by radical nephroureterectomy. We aimed to assess the safety and activity of a non-surgical treatment using instillation of UGN-101, a mitomycin-containing reverse thermal gel.
In this open-label, single-arm, phase 3 trial, participants were recruited from 24 academic sites in the USA and Israel. Patients (aged ≥18 years) with primary or recurrent biopsy-proven, low-grade upper tract urothelial cancer (measuring 5-15 mm in maximum diameter) and an Eastern Cooperative Oncology Group performance status score of less than 3 (Karnofsky Performance Status score >40) were registered to receive six instillations of once-weekly UGN-101 (mitomycin 4 mg per mL; dosed according to volume of patient's renal pelvis and calyces, maximum 60 mg per instillation) via retrograde catheter to the renal pelvis and calyces. All patients had a planned primary disease evaluation 4-6 weeks after the completion of initial therapy, in which the primary outcome of complete response was assessed, defined as negative 3-month ureteroscopic evaluation, negative cytology, and negative for-cause biopsy. Activity (complete response, expected to occur in >15% of patients) and safety were assessed by the investigator in all patients who received at least one dose of UGN-101. Data presented are from the data cutoff on May 22, 2019. This study is registered with ClinicalTrials.gov, NCT02793128.
Between April 6, 2017, and Nov 26, 2018, 71 (96%) of 74 enrolled patients received at least one dose of UGN-101. 42 (59%, 95% CI 47-71; p<0·0001) patients had a complete response at the primary disease evaluation visit. The median follow-up for patients with a complete response was 11·0 months (IQR 5·1-12·4). The most frequently reported all-cause adverse events were ureteric stenosis in 31 (44%) of 71 patients, urinary tract infection in 23 (32%), haematuria in 22 (31%), flank pain in 21 (30%), and nausea in 17 (24%). 19 (27%) of 71 patients had study drug-related or procedure-related serious adverse events. No deaths were regarded as related to treatment.
Primary chemoablation of low-grade upper tract urothelial cancer with intracavitary UGN-101 results in clinically significant disease eradication and might offer a kidney-sparing treatment alternative for these patients.
UroGen Pharma.
Details
- Title: Subtitle
- Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial
- Creators
- Nir Kleinmann - Sheba Medical CenterSurena F Matin - The University of Texas MD Anderson Cancer CenterPhillip M Pierorazio - Johns Hopkins UniversityJohn L Gore - University of WashingtonAhmad Shabsigh - The Ohio State UniversityBrian Hu - Loma Linda University Health CareKarim Chamie - University of California, Los AngelesGuilherme Godoy - Baylor College of MedicineScott Hubosky - Thomas Jefferson UniversityMarcelino Rivera - Mayo ClinicMichael O'Donnell - University of IowaMarcus Quek - Loyola University ChicagoJay D Raman - Pennsylvania State UniversityJohn J Knoedler - Pennsylvania State UniversityDouglas Scherr - Cornell UniversityJoshua Stern - Yeshiva UniversityChristopher Weight - University of MinnesotaAlon Weizer - University of Michigan–Ann ArborMichael Woods - Loyola University ChicagoHristos Kaimakliotis - Indiana University BloomingtonAngela B Smith - University of North Carolina at Chapel HillJennifer Linehan - Saint John's Health CenterJonathan Coleman - Memorial Sloan Kettering Cancer CenterMitchell R Humphreys - Mayo Clinic, Scottsdale AZ.Raymond Pak - Mayo Clinic in FloridaDavid Lifshitz - Rabin Medical CenterMichael Verni - Fertility Center of Las VegasMehrad Adibi - The University of Texas MD Anderson Cancer CenterMahul B Amin - University of Tennessee Health Science CenterElyse Seltzer - Urogen PharmaIfat Klein - UroGen Pharma Ltd.Marina Konorty - UroGen Pharma Ltd.Dalit Strauss-Ayali - UroGen Pharma Ltd.Gil Hakim - UroGen Pharma Ltd.Mark Schoenberg - Yeshiva UniversitySeth P Lerner - Baylor College of Medicine
- Resource Type
- Journal article
- Publication Details
- The lancet oncology, Vol.21(6), pp.776-785
- DOI
- 10.1016/S1470-2045(20)30147-9
- PMID
- 32631491
- ISSN
- 1470-2045
- eISSN
- 1474-5488
- Language
- English
- Date published
- 06/2020
- Academic Unit
- Urology
- Record Identifier
- 9984319969902771
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