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Release: Sept. 25, 2001

Study shows promise of treatment for superficial bladder cancer

IOWA CITY, Iowa -- A non-surgical treatment for an aggressive form of superficial bladder cancer is showing promising clinical results, according to findings published by a University of Iowa Health Care researcher in the October issue of the Journal of Urology. In superficial bladder cancer, the cancer is on the bladder surface but has not yet invaded into the bladder muscles.

The immunotherapy treatment combined interferon-alpha with a bacteria known as bacillus Clamette-Guerin (BCG) to treat patients who had already failed BCG treatment alone. The study showed that 55 percent of patients treated with the combined immunotherapy were disease-free two-and-a-half years after treatment compared to an expected disease-free rate of less than 20 percent for patients treated with another non-surgical (chemotherapy) method.

The findings are believed to be the first to indicate that the combined therapy works for people who previously have failed treatment with BCG alone, said investigator and study author Michael O'Donnell, M.D., UI associate professor of urology, who completed the study while a staff physician at Beth Israel Deaconess Medical Center in Boston. Janice Krohn, nurse practitioner, and William DeWolf, M.D., chief of urology, both at Beth Israel Deaconess, were also members of the research team.

The use of interferon-alpha and BCG together in the therapy does more than simply add the power of each treatment to the other, the study revealed.

"The combined treatment is up to 40 times more effective in stimulating the immune system than the use of either interferon or BCG alone," said O'Donnell, who also is head of the UI Division of Urologic Oncology.

Superficial bladder cancer can be treated with surgery that scrapes the tumors from the surface, followed by chemotherapy to kill off any residual cancerous cells. However, the recurrence rate using these techniques is from 60 to 80 percent. The superficial cancer then can advance to a more invasive bladder cancer that often requires removal of the entire bladder.

Interferon, one of the two main ingredients in the new immunotherapy combination, works only about 15 percent of the time when used alone for people who have failed other treatments. BCG alone works about 50 to 70 percent of the time to kill off cancer but if it fails once, it often fails again when used alone.

O'Donnell said the combination of interferon and BCG seems to overcome some of the weakness of the other therapies and can be used in people who have failed even two treatments with BCG alone. For those individuals, the only other alternative might be to remove the bladder as a preventive measure, before the cancer enters the muscle.

"The combination therapy is injected directly into the bladder cavity and affects the body's own immune system," O'Donnell explained. "The BCG is too weak to cause actual infection, but still can stimulate the immune system to fight cancer cells. The interferon helps by blocking another chemical that would otherwise diminish the desired immune response."

He added that the BCG may help interferon be more effective because the BCG is sticky and thus stays in the bladder longer along with the interferon. If used alone, interferon, which is water-soluble, is more easily lost through normal urination.

Aggressive bladder cancer affects about three times as many men as it does women. Symptoms can include blood in the urine or bladder irritability, which can be misdiagnosed as a urinary traction infection or prostate inflammatory problem. Smoking is the number one cause of aggressive bladder cancer in the United States.

"Bladder cancer caused by smoking has a '20-year fuse,'" O'Donnell said. "What you've done as a smoker, even if you quit, can have an effect 20 years later."

O'Donnell continues to work on superficial bladder cancer investigation through more advanced Phase II and III trials involving hundreds of patients and many other sites in the United States. O'Donnell's current urologic oncology research is part of the efforts at the Holden Comprehensive Cancer Center at the UI.

The Holden Comprehensive Cancer Center is Iowa's only National Cancer Institute (NCI)-designated comprehensive cancer center. NCI-designated comprehensive cancer centers are recognized as the leaders in developing new approaches to cancer prevention and cancer care, conducting leading edge research and educating the public about cancer.

University of Iowa Health Care describes the partnership between the UI College of Medicine and the UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide. Visit UI Health Care online at www.uihealthcare.com.