May 14, 2001 (San Francisco) -- Exciting results from a new cancer study might just change the way some people with bladder cancer are treated -- and double their odds of survival.
Bladder cancer is the sixth most common cancer in the U.S. More than 50,000 new cases of the disease will be diagnosed this year, according to the American Cancer Society, and just over 12,000 people will die from it. Most of those diagnosed are men.
Early bladder cancer affects just the delicate interior surface of the bladder. But as the cancer spreads it invades the muscle that surrounds the bladder. At this stage it usually can be detected by the presence of blood in the urine, says cancer researcher and study leader Ronald B. Natale, MD.
Currently, most people with this stage of bladder cancer, called locally advanced disease, undergo total removal of the bladder, a procedure called radical medical cystectomy. Unfortunately, many of these people go on to have recurrence of the cancer because they harbor an undetectable amount of cancer cells in their blood.
In this study, about 300 patients with locally advanced bladder cancer received three cycles of chemotherapy with four drugs -- methotrexate, vinblastine, doxorubicin, and cisplatin (or MVAC for short) -- before their surgery. The treatment took about three months, and then the patients were allowed to recuperate for about 2 to 3 weeks before undergoing bladder removal.
The chemotherapy appears to have cured almost 40% of the patients, Natale tells WebMD, according to tests performed on the bladders that were removed.
"These patients had no evidence of cancer at the time of surgery," says Natale, who is acting director of Cedars-Sinai Comprehensive Cancer Center in Los Angeles. The pathologists who examined the bladders after surgery confirmed that the cancer was indeed gone, he says.
The researchers tracked the patients for more than seven years. Eighty-five percent lived five years or longer -- which is nearly twice the survival rate of patients who undergo surgery alone.
"[This is] a real breakthrough in the magnitude of survival," says Deborah A. Kuban, MD. "A difference of over two years is really significant for treatment of any cancer."
Kuban, a professor of oncology at M.D. Anderson Cancer Center in Houston, was not involved in this study but commented on the findings for WebMD.
Although the results from this trial are very promising, Natale says, cancer doctors may want to see them repeated in future studies before recommending this strategy to their patients. Although they're encouraging, these results come on the heels of seven studies that failed to find a chemotherapy regimen that improves survival in people with bladder cancer.
Those trials used other chemotherapy regimens before surgery, he notes.
Another problem with this regimen are its side effects: MVAC therapy is considered to be among the most difficult chemotherapy regimens to tolerate. Some small preliminary studies of a different, less toxic combination -- cisplatin and gemcitabine -- suggest that it, too, may be useful for locally advanced bladder cancer.
Also, Natale says, with only 317 patients examined, other researchers may feel the study is too small for the findings to be generalized. He says that one study should not change clinical practice.
Nonetheless, the survival difference is very impressive. And some patients could be treated with bladder-sparing surgery. He says that after chemotherapy, the bladder could be examined using a cystoscope, a tiny tube with a lens on it that can be threaded through the urethra so the doctor can examine the inner surface of the bladder.
"Several biopsies can be taken using the cystoscope, and then the urine and blood can be checked for [any evidence of cancer]," he says. If those tests are negative, the patient might avoid surgery but would need to be followed closely for at least two years, Natale says. "That would mean following every three months," he says.
Kuban says some institutions are already routinely doing bladder-sparing therapies using chemotherapy combined with radiation therapy.
"They are doing this at Massachusetts General [Hospital, in Boston,] and about 40% of the patients are able to keep their bladders," she says.