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Drug Eases Painful Effect of Cancer Therapy

Cuts frequency, duration of common mouth sores

WEDNESDAY, Dec. 15, 2004 (HealthDayNews) -- Doctors may soon be able to offer people undergoing cancer treatment some relief from the painful mouth sores that can accompany certain therapies.

A study finds that a new medication called palifermin, approved by the U.S. Food and Drug Administration on Wednesday, reduced the duration of oral side effects from cancer treatment by 66 percent, as well as decreased the incidence of severe oral complications by more than two-thirds.

The problem arises because to effectively kill cancer cells, cancer treatments often destroy healthy tissue. Doing so leaves behind a wake of unwanted side effects. One such side effect is called oral mucositis.

Oral mucositis affects the lining of the mouth and causes it to swell. In more severe cases, there is also pain, mouth ulcers, trouble swallowing, and difficulty eating.

Oral mucositis is a very common complication from certain types of cancer treatment. As many as 80 percent of all people undergoing bone marrow transplant will experience this side effect, and almost everyone who receives head or neck radiation therapy will have oral mucositis, according to the National Cancer Institute.

Currently, there is no effective treatment for this complication. The pain can be so bad that some people refuse additional treatment because they don't want to endure oral mucositis again, said study co-author Dr. Patrick Stiff, a professor of medicine and pathology at Loyola University Chicago Stritch School of Medicine.

"When you ask patients, two or three to one say that mouth sores were the worst part of the treatment," said Stiff. "From the patients' perspective, it's terrible, and from the doctor's perspective, there's nothing that works."

Of palifermin, he said, "Finally we've come up with the molecule that makes our mucous membrane proliferate. The misery of getting a cure is largely going to be relieved."

Results of the study, which was funded by the drug's maker, the biotech firm Amgen Inc., appear in the Dec. 16 issue of the New England Journal of Medicine.

The study was a phase III clinical trial and included 212 people with cancers of the blood, such as leukemia and lymphoma. All had decided to undergo stem-cell transplantation. Before this procedure can occur, people must undergo high-dose chemotherapy and radiation.

Half of the study participants received palifermin three days before their treatment began, while the other half received a placebo.

The incidence of oral mucositis was 98 percent in the placebo group vs. 63 percent in the treatment group. For the more severe form, the incidence was 62 percent in the placebo group compared to 20 percent for the palifermin group.

The duration of oral mucositis was significantly reduced in the treated group: Those who received palifermin suffered from the oral complications for three days compared to nine days for the untreated group.

The study participants were asked to rate their mouth and throat soreness on a scale of zero to 98, with zero being the least pain. The average score for the placebo group was 46.8 vs. 29 for the palifermin group.

"The fear of getting severe mouth sores in a bone marrow transplant setting is going to finally come to an end. We can take care of patients better with less side effects and less pain," said Stiff.

Palifermin is a man-made version of the normally occurring keratinocyte growth factor. It works by making mucous membrane cells grow more rapidly. So, when it's given before cancer therapy, it causes the lining in the mouth to become thicker, giving people a "head start so the mucous membranes don't thin as quickly," Stiff explained.

"We routinely use growth factors in clinical hematology, so it's not a big step to think that a drug made from growth factor could recover mucosal tissue," said Dr. Perry Cook, a hematologist at New York University Clinical Cancer Care Center.

"This is a promising agent that could be easily integrated into clinical practice," said Cook. "It easily could shorten the average duration of stay by three to five days," Cook said, adding that people often have to stay in the hospital solely because of their mucosal symptoms.

More information

To learn more about the effects that cancer treatment can have on your mouth, visit the National Cancer Institute.

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SOURCES: Patrick Stiff, M.D., professor, medicine and pathology, Loyola University Chicago Stritch School of Medicine, Chicago; Perry Cook, M.D., hematologist, New York University Clinical Cancer Care Center, and associate professor, medicine, New York University School of Medicine, New York City; Dec. 16, 2004, New England Journal of Medicine
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