- 32-patient, multi-center study showed 9% occurrence of ureteral stenosis and 10% discontinuation rate
- All three stenosis patients were treated without later recurrence or chronic stenosis
This retrospective study assessed the safety and feasibility of antegrade administration of JELMYTO via a percutaneous nephrostomy tube (PCNT) in 32 patients from four institutions. Each patient received at least one dose of JELMYTO via PCNT for UTUC, 29 of whom completed induction (at least 5 of 6 doses) and underwent primary disease evaluation (PDE) at a median 17 weeks after the last dose of therapy. At a median follow-up of 15 months following initiation of induction therapy, ureteral stenosis (defined as a discrete narrowing of the ureter on direct visual ureteroscopy, or a constriction identified on retrograde pyelogram at the time of ureteroscopy that required dilation or stenting to pass a ureteroscope for upstream visualization) occurred in three (9%) of patients. None of these patients had recurrent stenosis at a median 16 months follow-up. Other adverse events included fatigue (27%), flank pain (19%), urinary tract infection (12%), sepsis (8%), and hematuria (8%). No patient had impaired renal function during follow-up and there were no treatment-related deaths. Seventeen patients (59%) had no evidence of disease at PDE and had not recurred at a median follow-up of 13 months post induction.
In both retrograde and antegrade approaches, JELMYTO can be administered as an outpatient procedure in the clinic. Retrograde administration requires administration by a physician via a ureteral catheter which requires fluoroscopic guidance. Antegrade administration may be performed by trained nursing professionals under clean rather than sterile conditions and does not require fluoroscopy once tube placement is confirmed via nephrostogram at the first instillation.
“We found that antegrade administration of JELMYTO via a nephrostomy tube offered a low rate of ureteral stenosis and a favorable safety and tolerability profile overall,” said Kyle Rose, M.D., Urologic Oncology Fellow at Moffitt Cancer Center in Tampa, Fla., and study investigator. “This study adds to the evidence that this form of administration is beneficial in many ways, including the ability to treat the elderly without the use of anesthesia, which can have negative cumulative effects when used repetitively.”
“JELMYTO is approved for antegrade and retrograde administration in patients with LG-UTUC, which gives physicians the added convenience of choosing a method that works best for them and their patients,” said Mark Schoenberg, Chief Medical Officer, UroGen. “Retrograde administration was the only method used in the pivotal OLYMPUS trial. Therefore, UroGen is pleased that this study adds to the growing body of real-world evidence demonstrating that antegrade administration of JELMYTO is a feasible alternative for patients with LG-UTUC.”
Source: “Urogen Highlights New Real-World Safety Data Published in the British Journal of Urology International That Showed a Low Rate of Ureteral Stenosis When Antegrade Administration of JELMYTO® Was Used in Patients with Upper Tract Urothelial Carcinoma.” Urogen Pharma Inc. Accessed November 14, 2022.
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