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Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a
K Kent Chevli1, Neal D Shore2, Andrew Trainer3
1State University of New York at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.
The Journal of Urology
|August 26, 2021
Summary
Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) can be treated with UGN-102 chemoablation. This nonsurgical approach showed a 65% complete response rate at 3 months, offering a durable alternative to surgery.
Area of Science:
- Urology
- Oncology
- Pharmacology
Background:
- Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is characterized by high recurrence rates.
- Current treatment often involves repeated transurethral resection of bladder tumor (TURBT) under general anesthesia.
- There is a need for effective, less invasive therapeutic alternatives.
Purpose of the Study:
- To evaluate the efficacy and safety of UGN-102, a novel mitomycin-containing reverse thermal gel.
- To assess UGN-102 as a primary chemoablative treatment for LG IR NMIBC.
- To determine if UGN-102 can serve as an alternative to TURBT.
Main Methods:
- A prospective, phase 2b, open-label, single-arm clinical trial was conducted.
- 63 patients with biopsy-proven LG IR NMIBC received 6 weekly intravesical instillations of UGN-102.
- Primary endpoint was complete response (CR) rate at 3 months; durability and safety were monitored up to 12 months.
Main Results:
- 65% (41/63) of patients achieved CR at 3 months.
- Durability of response was significant, with 73% remaining disease-free at 9 months post-CR (12 months post-treatment).
- Common adverse events included dysuria, urinary frequency, hematuria, and fatigue.
Conclusions:
- Nonsurgical primary chemoablation with UGN-102 demonstrated significant treatment response and sustained durability in LG IR NMIBC.
- UGN-102 presents a promising alternative to repetitive surgical interventions for patients with LG IR NMIBC.
- The chemoablative approach offers a potentially less invasive treatment option for this patient population.
