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During a presentation at GU 2021 in New York 14th edition Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Tumors, hosted by Physicians’ Education Resource, LLC (PER®), presenter Scott G. Hubosky, MD, discussed optimal treatment strategies for treating patients with cell carcinomas transitional upper pathways.1
To do this, Hubosky mainly focused on using UGN-101 (mitomycin gel; Jelmyto) as an adjuvant therapy, due to its ability to reach all surfaces of the luminal space of the upper urinary tract. .
“We’re trying to see if we can expand our reach for conservative management,” said Hubosky, who is vice president of quality improvement and safety at Jefferson Teaching Hospitals in Philadelphia, Pennsylvania. “We were able to chemoablate these lesions; what that tells us is that we are able to expand our reach with conservative management, and that’s attractive.
Mitomycin gel was approved in 2020 based on the results of the pivotal phase 3 OLYMPUS study (NCT02793128),2.3 who examined patients with low-grade tumors who underwent weekly treatment for 6 weeks in the induction phase, followed by ureteroscopic assessment of response. Patients were excluded if they had high-grade carcinoma in situ, received Bacillus Calmette-Guérin (BCG) or systemic chemotherapy, or had invasive urothelial tumors; those who were eligible had to have at least 1 papillary tumor of 5 to 15 mm. The primary endpoint was the number of patients with a complete response (CR) at the end of the treatment period.
The study patient population who completed treatment (n = 71) were predominantly male (68%) and had a mean age of 70.7 years. About half (49%) had multiple tumors at baseline; It was determined that 48% of patients had initially inaccessible tumors.
“These patients were really optimized for this treatment to work. We measured the volume of their collection system to make sure we had enough medicine to [each] single patient, ”said Hubosky. “We also alkalized their urine with sodium bicarbonate because we know that mitomycin works best in an ionized alkaline environment.”
Hubosky described the first of 6 administrations, which is performed during surgery with a retrograde ureteral catheter and retrograde pyelogram to ensure proper access to the collection system. Then a special syringe is used to inject the medicine into the right place.
On primary disease assessment, 42 patients achieved CR (59%). At 12 months, 14 of 20 patients (70%) assessed for follow-up remained disease free. In patients who initially had tumors judged to be endoscopically unresectable at baseline, 59% (20/34) achieved a complete response.
“Over time, as we move away from the primary disease assessment, 3, 6, 9, and 12 months later, what you would expect is what you saw – that the full answer has something to do with it. little decreased, ”Hubosky said. “I just want to point out that this is only 1 year of data. We still have a lot of work to do on what this is going to do over time. “
There were few (2.8%) potentially fatal treatment adverse events (AEs) noted in the trial that were unrelated to the gel or thermal procedure containing mitomycin. The most common AE was ureteral stenosis, leading to the need for a transient stent in 34% of patients. At the time of publication of the data, 11% of patients still had stents placed, of which 3% were permanently stent-dependent. Of note, the two patients with the resulting permanent stents had nephrectomy and no residual carcinoma in the pathology samples.
According to the National Comprehensive Cancer Network guidelines, complete or nearly complete endoscopic resection or ablation is necessary before administering reverse thermal gel containing mitomycin, as it is not a substitute for good endoscopic management, but rather adjuvant therapy.4
“I think this should be appreciated because I’m concerned that if this is used without following the guidelines, we won’t get the results we want to see,” Hubosky said.
Other considerations for urothelial carcinoma of the upper tract
For the general management of upper tract urothelial tumors, Hubosky has detailed considerations for this patient population.
A review of the literature representing more than 1,100 patients treated with endoscopic management of upper tract tumors found that the median rate of ureteral stenosis was approximately 10%.5 “If you look at the patients being treated [by ureteroscopy] for kidney stones, the rate of stenosis is less than 1%, ”said Hubosky. “It’s more than a simple ureteroscopic manipulation. The other things to keep in mind are the locations of the tumor; you are more likely to have stricture if you have a primary ureteral tumor. “
Other concerns for preventing ureteral stenosis include different sources of energy, such as certain lasers that penetrate deeper into the tissue. Hubosky recommended against using lasers that penetrate deep into the ureter as many of these patients will see repeated procedures and manipulations of the tissue throughout their illness.
Additionally, patients with Lynch syndrome tend to have tumors in the upper ureter more often than in the renal pelvis compared to patients who have sporadic upper tract tumors. “This will put them at risk for ureteral strictures,” Hubosky said. “These patients have other things that really predispose them to developing ureteral stenosis, like other pelvic surgeries and pelvic radiation therapy.” This is because other cancers are likely present, such as colorectal cancer or endometrial cancer.
The references:
- Hubosky SG. Upper urinary tract transitional cell carcinomas. Presented at: 2021 New York GU 14th edition Interdisciplinary Congress on Prostate Cancer® and Other Genitourinary Tumors, organized by Physicians’ Education Resource, LLC (PER®); Virtual.
- The FDA approves mitomycin for low grade urothelial upper tract cancer. FDA. April 15, 2020. Accessed March 12, 2021. https://bit.ly/2xxaVMu.
- Kleinmann N, Matin SF, Pierorazio PM, et al. Primary chemoablation of low-grade urothelial upper tract carcinoma using UGN-101, a reverse thermal gel containing mitomycin (OLYMPUS): a single-arm, open-label phase 3 trial. Lancet Oncol. 2020; 21 (6): 776-785. doi: 10.1016 / S1470-2045 (20) 30147-9
- NCCN. Clinical practice guidelines in oncology. Bladder cancer, version 1.2021. Accessed March 12, 2021. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf
- Linehan J, Schoenberg M, Seltzer E, Thacker K, Smith AB. Complications associated with ureteroscopic management of urothelial carcinoma of the upper tract. Urology. 2021; 147: 87-95. doi: 10.1016 / j.urology.2020.09.036
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