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Oral Chemotherapy Drug an Option for Colon Cancer

Study finds it's effective and well-tolerated among those with advanced disease

WEDNESDAY, June 29, 2005 (HealthDay News) -- People with advanced colon cancer now have an additional chemotherapy option: the oral medication capecitabine.

A team of international researchers reports that capecitabine slightly improves the chances of relapse-free survival, is as effective for overall survival and is better tolerated than what was a commonly used chemotherapy combination, intravenously administered fluorouracil and leucovorin.

The findings appear in the June 30 issue of the New England Journal of Medicine.

Since this study was undertaken, however, a new medication called oxaliplatin has been added to the two-drug combination and boosted survival rates. The current study didn't look at the oxaliplatin, fluorouracil and leucovorin combination.

"This study very clearly shows that capecitabine is at least as effective as fluorouracil plus leucovorin, which was the standard of care for colon cancer" at the time this study began, said Dr. Carmen Allegra, chief medical officer for the Network for Medical Communication and Research in North Potomac, Md. Allegra wrote an accompanying editorial in the same issue of the journal.

Dr. Jay Brooks, chairman of hematology and oncology at the Ochsner Clinic Foundation Hospital in Baton Rouge, La., said that while capecitabine isn't his first choice for chemotherapy, it may be a good option for people who live far from a cancer care center, or for those who don't want to receive intravenous treatments.

In his editorial, Allegra noted that 30,000 people in the United States are diagnosed with stage III colon cancer every year. That means that in addition to being in the colon, the cancer has spread to the lymph nodes. Treatment for this stage of disease generally includes surgery to remove as much of the cancer as possible, followed by chemotherapy to destroy any remaining cancer cells. Allegra explained that surgery alone is about 50 percent to 60 percent effective in curing this stage of colon cancer. With the addition of chemotherapy, the four-year survival rate rises to about 80 percent, he said.

Capecitabine was approved in 2001 for use in treating colon cancer that had spread to other sites in the body, and several large studies found it to be as effective as other treatments for metastatic disease. However, the question remained: Would it be as effective as standard treatments for stage III colon cancer?

To answer that question, researchers from the United States, Australia, Canada and Europe recruited 1,987 people for this study who had stage III colon cancer and had already had surgery to remove the tumor.

Over 24 weeks, the study volunteers received either oral capecitabine (1,004 people) or intravenous fluorouracil and leucovorin (983 people). For the first two years following chemotherapy, the study participants were assessed every six months. After that, they were checked annually.

The differences in overall survival rates were not statistically significant, which means that capecitabine was as effective as the fluorouracil and leucovorin combination. Capecitabine did offer a slight advantage in relapse-free survival; those on capecitabine were 14 percent less likely to have a relapse than those on the combination therapy.

Capecitabine's real advantage, besides being orally administered, is that it's generally better tolerated than the fluorouracil/leucovorin combination treatment, causing less diarrhea and nausea, and leaving people less susceptible to infection, according to the study.

However, one side effect of chemotherapy -- hand-foot syndrome -- was significantly more common in people on capecitabine. Hand-foot syndrome causes redness on the palms of the hands and soles of the feet, and eventually can severely damage the skin in those areas if the medication dosage isn't adjusted, according to Allegra.

"The very best available therapy is multi-agent therapy including oxaliplatin, but multi-agent therapy is definitely more toxic. If you don't want to or can't take the oxaliplatin combination, then capecitabine may be best for you," said Allegra.

Added Brooks: "For a patient who wants to have chemotherapy, but doesn't want to take it by vein or have such an intense regimen, capecitabine is a reasonable alternative. It's not my first recommendation, and just because it's oral doesn't mean it's without side effects, however."

Allegra said that when someone has to come to a cancer center for intravenous chemotherapy, the nurses and doctors have a chance to see the patient and look for any serious side effects. And, they can immediately adjust the dosage if necessary.

So, if you choose capecitabine, be sure you know what side effects to watch for, and report them immediately to your doctor.

More information

To learn more about colon cancer treatment options, visit the American Cancer Society.

SOURCES: Carmen Allegra, M.D., chief medical officer, Network for Medical Communication and Research, North Potomac, Md.; Jay Brooks, M.D., chairman, hematology/oncology, Ochsner Clinic Foundation Hospital, Baton Rouge, La.; June 30, 2005, New England Journal of Medicine
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