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

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

doi:10.1016/s1470-2045(20)30147-9

Cited by 100 publications

(99 citation statements)

References 29 publications

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“… 16 , 17 In one study using UGN-101 in the upper tracts, only one patient developed pancytopenia. 9 These pharmacologic results were confirmed in an animal study using retrograde instillation of UGN-101 at once-weekly intervals for 6 consecutive weeks. 18 …”

Section: Development Safety and Feasibility Of Ugn-101: Preclinical mentioning

confidence: 68%

“…Final results with longer follow up were just published and consistent with these same outcomes. 9 The OLYMPUS study is the first well-designed, prospective trial to demonstrate a complete and durable chemo-ablative response to intracavitary therapy for low-grade UTUC. Since the unique hydrogel is technically considered a delivery device, the compound is considered a drugdevice combination, and indeed, was recently approved by the FDA as the first treatment for low-grade UTUC.…”

Section: Use Of MMC and Ugn-101 For Treatment Of Utuc: Retrospective mentioning

confidence: 99%

“…Preliminary clinical trial results are highly favorable, and suggest a durable treatment response for patients with low-risk disease following therapy with UGN-101, which was subsequently confirmed with longer follow up. 6 – 9 …”

Section: Introductionmentioning

confidence: 99%

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UGN-101 (mitomycin gel): a novel treatment for low-grade upper tract urothelial carcinoma

Kokorovic

Matin

2020

Ther Adv Med Oncol

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Upper tract urothelial carcinoma (UTUC) is a rare malignancy. The standard treatment for localized high-risk disease is radical nephroureterectomy, which confers significant morbidity and is not appropriate for all patients. Patients harboring low-risk, non-invasive disease may be candidates for organ-sparing treatment, which includes endoscopic resection with or without intracavitary drug therapy. Successful administration of intracavitary chemotherapy to the upper tracts is impeded by rapid washout of the agent and short dwell times. This has limited the clinical utility of mitomycin C for treatment of upper tract tumors, despite the successful outcomes observed in low-grade urothelial carcinoma of the bladder. Currently, there is an unmet need for development of a technically feasible and oncologically sound intracavitary therapy for management of low-grade UTUC. UGN-101 (Jelmyto™) is a novel formulation of mitomycin C that uses a unique hydrogel designed to increase urinary dwell time, and thereby efficacy of treatment. Preclinical data demonstrated promising results regarding the safety and feasibility of this agent. Preliminary results of a phase III trial (OLYMPUS study) [ClinicalTrials.gov identifier: NCT02793128] demonstrated the efficacy of UGN-101 as a successful chemo-ablative agent for low-grade upper tract tumors. UGN-101 may represent a pivotal paradigm shift in the treatment of low-grade UTUC. Indeed, the drug has recently been granted approval by the US Food and Drug Administration as the first treatment for low-grade UTUC, which may lead to significant improvements in patient care and a long-awaited decrease in the burden of disease.

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Section: Development Safety and Feasibility Of Ugn-101: Preclinical mentioning

confidence: 68%

Section: Use Of MMC and Ugn-101 For Treatment Of Utuc: Retrospective mentioning

confidence: 99%

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UGN-101 (mitomycin gel): a novel treatment for low-grade upper tract urothelial carcinoma

Kokorovic

Matin

2020

Ther Adv Med Oncol

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“…Improving outcomes for UTUC may include consideration of novel ablative technologies which have been introduced in the lower urinary tract. Overall, patient selection for endoscopic treatment remains critical and consideration must also be given to multimodal therapy with topical chemotherapeutic strategies [ 10 ].…”

Section: Discussionmentioning

confidence: 99%

532 nm green-light laser vaporization of upper tract urothelial carcinoma

Dursun¹,

Pan²,

Morgan³

et al. 2020

BMC Urol

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Background Endoscopic management of low risk upper tract urothelial carcinoma (UTUC) may be considered in select clinical scenarios, which allows sparing the morbidity of radical nephroureterectomy while achieving acceptable oncological outcomes and preservation of kidney function. Herein, we present a case with UTUC in a solitary kidney managed with 532 nm laser vaporization through a percutaneous approach. Case presentation The patient in this video (Additional file 1) is an 85-year-old woman who presented with a bulky tumor in the collecting system of a congenital solitary left kidney, which was a biopsy proven low grade urothelial carcinoma. Prior to the procedure, a lower pole percutaneous nephrostomy tube was successfully placed under sedation by Interventional Radiology. The procedure was done in a prone split leg position. The mass, which was predominantly localized to the renal pelvis was efficiently vaporized with the 532 nm laser in a systematic manner with continuous irrigation of normal saline through the cystoscope. The patient was discharged home on postoperative day 2 with the nephroureterostomy catheter open to drainage. This catheter was subsequently clamped and removed two weeks later without complications. Follow up uretroscopy showed excellent treatment response and the patient remains well without complications. Conclusion This case report details the potential utility of 532 nm laser vaporization of UTUC, however, ongoing studies are required to demonstrate peri-operative safety and durable oncologic efficacy.

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“…In the search for new effective therapies to combine with surgery, low‐grade urothelial carcinoma represents a challenge for clinical research, and few advances have been made in medical therapy in the last decades. Very recently, alternative techniques of chemotherapy delivery, represented by UGN‐101, a mitomycin‐containing reverse thermal gel, have been tested in a phase 3 study, resulting in pathological complete responses in almost 60% of patients with low‐grade upper tract urothelial carcinoma [4]. Based on these results, UGN‐101 has been approved by the US Food and Drug Administration.…”

mentioning

confidence: 99%

CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin‐C vs surgical management in low‐risk non‐muscle‐invasive bladder cancer

2020

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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

Cited by 100 publications

References 29 publications

UGN-101 (mitomycin gel): a novel treatment for low-grade upper tract urothelial carcinoma

UGN-101 (mitomycin gel): a novel treatment for low-grade upper tract urothelial carcinoma

532 nm green-light laser vaporization of upper tract urothelial carcinoma

CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin‐C vs surgical management in low‐risk non‐muscle‐invasive bladder cancer

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