As alternatives face a global shortage, Frederick Health is one of the first hospitals in the nation to perform a new bladder cancer procedure.
Approved by the Food and Drug Administration in September, Inlexzo is a small flexible device inserted directly into the bladder. Once inside, the device curls into a pretzel shape and remains within the body. It then releases medicine for several weeks, until it is removed.
Bladder cancer is the sixth most common form of cancer, with 80,000 new cases in the US projected for 2025. It also carries one of the highest rates of recurrence, subsequently earning it one of the highest costs for treatment overall.
The primary distinction between the stages of bladder cancer is whether the cancer has progressed into the muscle of the bladder, and even the surrounding organs. Over 75% of cases present as non-muscle invasive and are treatable using the new procedure.
Frederick Health Hospital Dr. Heather Chalfin is the first surgeon in Maryland to have performed the procedure. She says the process is similar to other surgeries, which lends familiarity to those performing it. “Patients with kidney stones need what is called a ureteral stent, which is like a plastic tube that curls in the kidney or curls in the bladder,” Dr. Chalfin explained.
Alternative Procedure
One of the primary forms of treatment for bladder cancer is a medicine called Bacillus Calmette-Guérin, or BCG. The medicine is also administered directly into the bladder, but as a liquid that needs to be held within the body before being expelled some hours later.
BCG works to activate the body’s immune system within the site of the bladder itself, helping to fight the cancer. Dr. Chalfin says many people do not respond to BCG treatment, rendering it ineffective for that patient.
For those individuals, Dr. Chalfin explained, Inlexzo stands as an alternative procedure and a change in method. “That’s also a big benefit to having the chemotherapy active over a three week period versus just an hour,” Dr. Chalfin said.
BCG is facing a world wide shortage, which has resulted in rationing and patient prioritization. The production of BCG is limited by its manufacturing process and further complicated by its use in treating other conditions like tuberculosis.
Extreme Measures
When the cancer progresses to affect the muscles of the bladder, it has reached its second stage, which represents approximately 20% of new cases. This is where bladder preservation occurs, Dr. Chalfin explained.
At this stage, a patient may need systemic chemotherapy which is introduced not into the bladder, but into the vein. This way it spreads throughout the entire body. Other procedures include radiation therapy.
When the cancer spreads to other organs, it is considered advanced, representing 5% of new cases. When this occurs, removal of the bladder may be necessary.
With more options for patients at earlier stages, fewer cases of such extreme measures may be necessary, Dr. Chalfin said. “The fact that we have new treatments, which have been shown to have a lot of good complete responses, and that a significant proportion of patients have kept their bladder multiple years out after these treatments, is a huge benefit,” Dr. Chalfin explained.
Possible Causes
Dr. Chalfin explained smoking is one the biggest risk factors for bladder cancer. She also pointed to industrial dyes as a source as well, explaining it was historically known as the “blue collar cancer,” (1, 2).
While most cancers occur due to "acquired mutations” which people pick up over time from anything like strong sunlight to pollution, some traits are passed down from parent to child. In These cases, Dr. Chalfin, Frederick Health Hospital has ways to identify those risks. “All new patients receive a family cancer history questionnaire,” Dr. Chalfin explained. “If they meet our national cancer guidelines criteria that they should have a blood test to see if they have this gene mutation, we’re able to offer that then and there in our urology clinic.”
While bladder cancer appears most commonly after the age of 55 and usually in men, Dr. Chalfin warns women should be careful too. Commonly, she explained, women are more likely to progress to the later stages due to not being identified as early.
