AUA 2021: Initial Study Findings With Large Surface Area Microparticle Docetaxel in Bladder Cancer
Posted: Tuesday, September 14, 2021
Max Kates, MD, of Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, and colleagues evaluated the efficacy, safety, and immune effect of large surface area microparticle docetaxel in patients with non–muscle-invasive bladder cancer. Presented during the 2021 American Urological Association (AUA) Annual Meeting (Abstract LBA02-02), the results of this phase I/II trial concluded that this treatment was safe, by both intravesical instillation and intramural injection, and demonstrated promising efficacy.
“Preliminary efficacy data suggest post-transurethral resection of bladder tumor intramural injection and intravesical instillation of high dose large surface area microparticle docetaxel may prevent recurrence in patients with high-risk non–muscle-invasive bladder cancer for 6 months,” stated the investigators. “Data show infiltration of favorable immune cells and suggest a potential for enhanced tumor cell sensitivity to immune checkpoint blockade.”
The researchers focused on 19 patients with high-risk non–muscle-invasive bladder cancer following a 3+3 dose escalation of four docetaxel concentrations from 3 to 15 mg. After transurethral resection of the bladder tumor, large surface area microparticle docetaxel was injected into and around the resection bed, followed by intravesical instillation of 50 to 70 mg/mL. An increase in the concentration of natural killer cells, and PD-L1–positive tumor cells, regulatory T cells, and macrophages was observed in three of four biopsies via macrophage migration inhibitory factor analysis; an increase in immune effector T-cell density was also observed.
A total of 12 participants had not responded to the bacillus Calmette-Guérin-vaccine. No severe adverse events, adverse events of grade 3 to 5, or drug-related systemic toxicities were observed. Of patients who received lower doses (n = 11), two were recurrence-free at 6 months. Of note, all individuals who received the highest doses (n = 6) were recurrence-free at 6 months.
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