Low-Grade Bladder Cancer: Can Mitomycin-Based Chemoablation Reduce the Need for Surgery?
Posted: Monday, October 25, 2021
Primary chemoablation with the agent UGN-102 resulted in a high rate of eradication of low-grade, intermediate-risk non–muscle-invasive bladder cancer with “encouraging durability,” according to Kent Chevli, MD, of Erie County Medical Center, Buffalo, New York, and colleagues. The results of their phase IIb trial evaluating this nonsurgical treatment method with UGN-102, a mitomycin-containing reverse thermal gel, warranted a phase III trial, which is now underway (ClinicalTrials.gov identifier NCT03558503). The team presented its work during the 2021 American Urological Association (AUA) Annual Meeting (Abstract PD43-02) and also published their findings in The Journal of Urology.
The current standard-of-care treatment for this disease is transurethral resection of bladder tumor under general anesthesia. “Patients often endure repeated surgeries that may be associated with significant postoperative and long-term morbidity” because this type of bladder cancer recurs often, explained the authors.
In the open-label, single-arm study, 63 patients with this type of bladder cancer (mean age, 71 years; 60.3%, male) received six in-office installations of UGN-102, spaced 1 week apart. The disease was already recurrent in 78% of the participants; in these patients, the mean numbers of prior episodes and of transurethral resections were each about four.
Complete response, this trial’s primary endpoint, was achieved by 65% of patients at 3 months. Of these responders, 39 (95%), 30 (73%), and 25 (61%) remained disease-free at 6, 9, and 12 months after treatment initiation, respectively, noted Dr. Chevli and co-investigators. Further, any adverse events were reported to be primarily mild or moderate. The most common adverse events observed (≥ 10% of patients) were dysuria, pollakiuria, hematuria, micturition urgency, urinary tract infection, and fatigue.
Disclosure: The study authors’ disclosure information can be found at auajournals.org.