New Treatment Provides Hope for Patients Facing Bladder Removal
The study’s results demonstrate the highest reported complete response and partial response rates and one-year recurrence free survival of any phase 1 trial.
For patients with BCG-unresponsive non-muscle invasive bladder cancer, radical cystectomy or salvage intravesical therapies have been the only therapeutic choices available. Cystectomy, or bladder removal, is accompanied by a high rate of complications, while past trials of salvage intravesical treatments have been disappointing.
This is now about to change with the results of a new study of an intravesical triple chemotherapy regimen led by James McKiernan, MD, Chair, Department of Urology, Joel DeCastro, MD, MPH, and their colleagues at NewYork-Presbyterian/Columbia University Irving Medical Center. The phase 1 clinical trial of intravesical cabazitaxel, gemcitabine, and cisplatin for the treatment of BCG-unresponsive urothelial carcinoma of the bladder is bringing optimism to patients and physicians alike.
The study builds on earlier investigations conceived by Dr. McKiernan, Cory Abate-Shen, PhD, and their teams beginning with a preclinical trial in genetically engineered mice in 2013, followed one year later by their first phase 1 trial to explore the safety and toxicity of this novel combinatorial intravesical chemotherapeutic strategy, which demonstrated favorable results.
In the current single-institution study, the 18 study participants represented a particularly high-risk group and all had previously been through a number of intravesical therapies.
Despite this daunting profile, the study’s results, published online on March 2, 2020, in Journal of Urology, include the highest reported complete response and partial response rates (89 percent and 94 percent, respectively) and one-year recurrence free survival (83 percent) of any phase 1 trial in non-muscle invasive bladder cancer. With a median follow up of 27.8 months, only 3 of the 18 patients recurred at one year, and two of these patients did so only within the prostatic urethra. While these results need to be validated in larger cohort studies with long-term follow-up, the message is indeed promising.
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