A groundbreaking chemotherapy regimen created by the University of Iowa Department of Urology to treat non-muscle invasive bladder cancer (NMIBC) would become more convenient for patients when delivered using a device being developed in a UI biomedical engineering lab.

The drug-releasing intravesical floating technology (DRIFT) device is designed to be placed in the bladder through a catheter, enabling timed release of the second drug of a sequential, two-drug regimen known as gem/doce.

The DRIFT device, developed in the lab of James Byrne, MD, PhD, UI assistant professor of radiation oncology, is described in a study published in BJU International.

Standard management of NMIBC involves transurethral resection of the tumor followed by adjuvant therapy to kill tumor cells remaining in the bladder. Since the 1970s, the first-line drug used for NMIBC treatment is an immunotherapy known as BCG. For patients whose tumor cells did not respond to that treatment, the primary alternative was removal of the bladder.

DRIFT study co-author Michael A. O’Donnell, MD, director of urologic oncology at the UI and Richard D. Williams Professor of Urology, invented the gem/doce regimen — sequential doses of gemcitabine and docetaxel administered intravesically — to salvage the bladders of patients who had failed BCG.

Since 2015, O’Donnell and his colleagues have published a series of studies describing gem/doce results that equal or surpass BCG's effectiveness in various risk levels of the disease, leading to ever-increasing uptake of the gem/doce regimen by urologic oncologists. Gem/doce is now undergoing prospective evaluation in the nationwide BRIDGE clinical trial, with the potential to become a new first-line standard of care for NMIBC.

One of the challenges of the regimen is that it can require patients to spend up to 4 hours in an outpatient clinic, with limited mobility, as a dose of gemcitabine is administered and removed two hours later, followed by a dose of docetaxel that is eliminated two hours later. DRIFT offers the prospect of drastically reducing the length of that clinic visit.

“While gem/doce and other sequentially administered doublet chemotherapy bladder cancer treatments are rapidly undergoing worldwide adoption, the biggest logistical challenge has been the extended clinic time required," Dr. O’Donnell says. "This new invention cleverly allows joint administration of both drugs at the same time with a timed release of the second agent to functionally act sequentially."

The DRIFT device would be filled with docetaxel and placed in the bladder along with the dose of gemcitabine. The balloon-like device is designed to float in the bladder while holding the dose of docetaxel. The patient would then be free to leave the clinic and return home. After the patient eliminates the gemcitabine, the DRIFT device would release the dose of docetaxel. The device would then be safely removed by the patient. This means the patient would spend a fraction of the time now required to be in clinic.

"This breakthrough invention should encourage more rapid uptake of gem/doce and other sequenced agents, especially in the community setting,” O’Donnell says.