Cheaper, more accurate test for bladder cancer unveiled

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By Miriam Falco
CNN Senior Medical Producer

ATLANTA, Georgia (CNN) -- Researchers at Yale University School of Medicine have developed a urine test that identifies a protein found in bladder cancer cells. The test could lead to an easier, less invasive way to detect the disease, which kills more than 12,000 people each year.

"Right now, there is no simple approved test for bladder cancer," said researcher Dr. Dario Altieri.

The current detection method combines cytology -- looking for malignant cells in the urine -- and a cystoscopy, where a scope is passed through the urethra into the bladder to examine the bladder walls. Experts agreed that it's a painful, invasive and expensive procedure.

"The hope is that a urine test for bladder cancer could become as routine as other regular check-ups, such as PSA tests for prostate cancer," explained Altieri.

The Yale scientists examined urine samples from 158 volunteers for traces of the protein survivin. The volunteers were divided into groups of healthy people, people with bladder diseases other than cancer, people with new or recurrent bladder cancer, and people with other types of cancer.

"All patients with new or recurring bladder cancer tested positive for survivin. All healthy patients tested negative for the protein. None of the patients with kidney, prostate, cervical or vaginal cancer tested positive for survivin either," said Altieri.

Of the 60 patients with known bladder disease other than cancer, three did test positive for survivin. After testing those patients with the standard, invasive test, one was found to have cancer, one was diagnosed six months after the test and the other is still being monitored for possible cancer, according to Altieri. The study is published in this week's Journal of the American Medical Association (JAMA).

Early detection is key to surviving bladder cancer. Symptoms include blood in urine, often combined with frequent urination.

Treatment for bladder cancer varies from chemotherapy, immunotherapy and radiation to surgery. Some early stage tumors can be removed by passing a surgical device through the urethra. In some cases, depending on how far the cancer has spread beyond the bladder walls into the muscle, more radical surgery may be required, including the removal of the entire bladder. In men, the prostate would also be removed -- in women, the uterus, ovaries, fallopian tubes, and part of the vagina are also removed.

According to the American Cancer Society, the five-year survival rate is 93 percent. However, 80 percent of patients will have a recurrence of the disease, according to the study authors. Therefore, once patients are diagnosed and treated for bladder cancer, they must undergo a cystoscopy every three months for two years to ensure that the cancer has not returned. In addition, they must have an annual upper tract study, where the kidneys, urethra and bladder are examined for new tumors.

"This is a very expensive disease from diagnosis to death," said Dr. Thomas Keane, an associate professor of urology at Emory University in Atlanta.

The American Cancer Society estimates that there will be 54,300 new cases of bladder cancer diagnosed in 2001 and about 12,400 deaths this year. People over the age of 40 are at a higher risk and men are at a higher risk than women. Bladder cancer is the fourth most common cancer in men, the eighth most common cancer in women and smokers are at a higher risk than non-smokers.

"Bladder cancer is caused by genetic mutations -- chemicals can cause genetic mutations, but the majority of patients are smokers," explained Dr. Kevin Halling, a pathologist from the Mayo Clinic.

"People who work with aromatic chemicals have a higher rate of bladder cancer -- it could almost be considered an occupational cancer," added Keane. "It is rare to find bladder cancer in a patient who never smoked."

Still, the Yale study is just one part of research into detecting bladder cancer.

"It's very promising, it's novel and the preliminary data is very promising. But more data is required -- this is not an assay (test) ready for widespread use yet," said Dr. H. Barton Grossman, a professor of urology at M.D. Anderson Cancer Center, in Houston, Texas. "This is not the only group doing research on these markers. Nobody's hit the home run yet. Lots of groups are looking into this and hopefully one of these groups will be able to hit that home run and come up with a simple urine test that detects cancer and becomes part of a regular check-up," added Grossman.

Emory's Keane agreed.

"There have been at least four big studies in past few years, looking for a marker to detect bladder cancer without false positives. Up to now telomerase has been the hot new marker. Obviously more work needs to be done. These are small numbers," explained Keane, adding "until they (researchers) get tests which approach 100 percent specificity and sensitivity, one cannot replace cystoscopy as the only method to test for bladder cancer."

The Yale researchers are preparing for further study.

"The next step is to confirm these results in a much larger, multi-center study. We've already applied for the funding," said Altieri.

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American Foundation for Urologic Disease
National Cancer Institute - Bladder Cancer
Journal of the American Medical Association

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