A groundbreaking bladder cancer treatment, using a first-of-its-kind technology, is showing promising results for patients with tumors that previously required bladder removal—one of the most complex and invasive procedures in urology.
The treatment, known as TAR-200, involves the insertion of a small device into the bladder using a catheter. According to recent data presented at the American Urological Association’s annual conference, the therapy proved effective in about half of patients with non–muscle-invasive bladder cancer who had not responded to earlier treatments.
“Bladder cancer is relatively common, typically affecting people in their 60s, 70s and even 80s,” said Prof. Shay Golan, Chair of Urology at Rabin Medical Center and head of Urologic Oncology branch of the Israeli Urological Association. “Each year, some 2,000 Israelis are diagnosed with the disease, with smokers facing a five- to six-fold increased risk.”
Golan noted that bladder cancer ranges widely in severity, from cases manageable with localized treatments to aggressive forms with the potential to spread and become fatal. Diagnosis typically involves a urine test to detect cancerous cells, a dedicated CT scan and a cystoscopy, a procedure in which a tiny camera is inserted into the bladder through a catheter.
The most common form of bladder cancer is urothelial carcinoma, which originates in the epithelial cells lining the urinary tract—including the bladder, ureters and kidneys. About 95% of cases are found in the bladder itself. Because these tumors tend to bleed easily, most patients are diagnosed after noticing blood in their urine. Other symptoms can include persistent burning or urgency during urination, in the absence of any detectable infection.
Bladder tumors are classified as either muscle-invasive or non–muscle-invasive. The latter group includes two main types: carcinoma in situ (CIS), a flat but aggressive lesion with high risk of spreading, and papillary tumors, which grow into the bladder cavity like small, shrub-like projections.
“When tumors are non-invasive, the standard treatment involves local endoscopic removal followed by additional bladder instillations,” Prof. Golan explained. These follow-up treatments include localized chemotherapy or immunotherapy using a weakened tuberculosis bacterium called BCG, which stimulates the immune system to attack cancer cells.
Alternative to complex surgery
Despite treatment with BCG, about 30% of bladder cancer patients experience recurrence or disease progression. “In the past, these patients had to undergo bladder removal surgery—a complex procedure that takes several hours, carries a risk of complications and requires the creation of a stoma for urination through the abdominal wall,” said Prof. Golan. “The goal of the surgery was to prevent the cancer from becoming metastatic.”
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Until recently, patients in this situation faced a difficult choice: undergo radical bladder removal to stop the cancer from spreading. In recent years, attempts have been made to develop alternatives that avoid surgery, particularly for patients with carcinoma in situ. The U.S. Food and Drug Administration has prioritized the evaluation of treatments for this group. “Even so, existing therapies have so far helped only about 25% of patients avoid surgery,” Golan said.
Now, however, a breakthrough appears to be on the horizon. “While bladder removal is still considered a standard option when other treatments fail,” Golan explained, “TAR-200 offers an innovative solution: the insertion of a small, ring-shaped device into the bladder in a short, minimally invasive procedure. It continuously releases a chemotherapy drug into the bladder cavity. The device is replaced every three months during routine monitoring, along with cystoscopy to detect any early signs of recurrence.”
Prof. Shay GolanAt this stage, the findings are promising. At the American Urological Association’s annual meeting, new research data was presented on TAR-200’s impact on two patient groups with urothelial carcinoma.
Among patients with carcinoma in situ, the median time to disease progression was 26 months, and about 87% of those who responded to the treatment avoided bladder removal even after one year. In patients with papillary tumors, more than 80% showed no disease progression nine months into treatment, and around 95% remained surgery-free after a median follow-up of more than a year.
Due to its effectiveness, TAR-200 has received accelerated approval from the FDA. “The treatment has shown particularly high efficacy, is quick and simple to administer and has a very low rate of side effects,” Golan said. “Still, it’s critical to maintain close follow-up to catch any recurrence early.”
He concluded, “This is a new era for patients. Through innovative therapies and careful urological monitoring, we are extending the lives of many patients and preserving their quality of life—without the need for drastic surgery.”