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11-05-2020 | Urothelial cancer | News

OLYMPUS points to kidney-sparing option for low-grade UTUC

Author: Laura Cowen

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medwireNews: More than half of patients with low-grade upper tract urothelial cancer (UTUC) have a complete response to instillation treatment with the mitomycin-containing reverse thermal gel UGN-101, results of the phase 3 OLYMPUS trial show.

Seth Lerner (Baylor College of Medicine, Houston, Texas, USA) and co-investigators say their findings “suggest that this alternative kidney-sparing treatment might be considered for patients with low-grade upper tract urothelial cancer, including those with multifocal disease and those who are not candidates for endoscopic ablation.”

The researchers report in The Lancet Oncology that 59% of the 71 trial participants, had a complete response, defined as negative ureteroscopic evaluation, negative cytology, and negative for-cause biopsy, to UGN-101 treatment within 6 weeks of completion of the initial therapy.

The therapy consisted of up to six weekly instillations of UGN-101 (mitomycin 4 mg/mL, maximum 60 mg/instillation according to renal pelvis and calyces volume) via retrograde catheter to the renal pelvis and calyces. At baseline the patients had an average of 2.2 papillary tumors, with the largest measuring a mean 14.8 mm in diameter.

Of the 42 patients with a complete response at the primary disease evaluation, 41 entered follow-up and were eligible for up to 11 monthly maintenance treatments with UGN-101. Of these, 20 had a 12-month assessment, which revealed a durable complete response in 70% of those assessed.

Using this information, the investigators estimated that durability of response was 84.2% at 12 months after the primary disease evaluation, and the estimated median time to recurrence was 13 months.

Furthermore, the results were consistent in subgroup analyses by key baseline characteristics.

Nearly all (94%) participants experienced at least one adverse event, most commonly ureteric stenosis (44%), urinary tract infection (32%), hematuria (31%), flank pain (30%), and nausea (24%).

Study drug- or procedure-related serious adverse events were reported in 27% including ureteric stenosis (7%), hydronephrosis (6%), flank pain (4%), and urosepsis (4%).

Half of the 48 patients who had an adverse event related to the renal-urinary system required temporary ureteral stent placement and 23% required a long-term stent.

Lerner and team say that they will now “continue to follow up this patient cohort and will provide an update on durability when data are available.”

In the meantime, they conclude: “This novel kidney-sparing approach might offer an important alternative for patients with low-grade upper tract urothelial cancer and expand the treatment options for patients with tumours that are difficult to treat endoscopically.”

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group

Lancet Oncol 2020; doi:10.1016/S1470-2045(20)30147-9

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