Pill Helps Colon Cancer Patients

H O U S T O N, April 16, 2001 -- What if cancer chemotherapy came in a pill and didn't make patients feel as sick?

For advanced colon cancer patients, a new study offers hope a pill will do just that.

Traditionally, advanced colon cancer treatment requires patients coming into the hospital to get intravenous delivery of chemotherapy with 5-fluorouracil and leucovorin, two anti-cancer drugs.

But M.D. Anderson Cancer Center researchers in Houston have found that a pill, called Xeloda, manufactured by Hoffman La Roche, has a better side effects profile compared to the standard therapy for advanced colon cancer.

Colorectal cancer is the third most commonly diagnosed malignancy, accounting for 10 percent to 15 percent of newly diagnosed cancer cases in the United States and Europe. An estimated 783,00 new cases are diagnosed annually worldwide.

Up to 30 percent of patients are diagnosed with advanced cancer while 50 percent to 60 percent eventually develop the advanced disease in which the cancer spreads throughout the body.

Approved for Advanced Breast Cancer

Currently, Xeloda is approved for advanced breast cancer patients and the company is seeking approval from the Food and Drug Administration for the treatment of advanced colon cancer patients.

Although the drug is not officially approved for colon cancer, doctors can prescribe it off-label, which means physicians have the authority to use their professional discretion in giving approved drugs for one indication to patients with another.

"We think for patients to be able to take a medication at home, not have to come back and forth to a chemotherapy treatment area, not have to have IV injections, is an advantage," says Dr. Robert Wolff, assistant professor of gastrointestinal oncology at M.D. Anderson and a researcher on the study.

Fewer Side Effects

Xeloda is what is called a "pro-drug," which requires the body to metabolize it into an active form of 5-fluorouracil, which kills cancer cells, explains Wolff. Since not every cell in the body can transform the drug, it has fewer side effects than 5-fluorouracil, which can damage healthy tissue.

Side effects include bone marrow suppression and susceptibility to infections, nausea, vomiting and diarrhea.

The results of the study of 600 patients with advanced colon cancer are published in the April 15 issue of the Journal of Clinical Oncology.

Charles Barnes, a Houston resident, has been taking Xeloda for four months. Before that he took traditional IV-chemotherapy with all its side effects.

"A lot of diarrhea, a lot of exhaustion," says Barnes, talking about the IV chemotherapy. "Could just walk short distances. No energy. But with the pill you really can't tell that you're taking anything."

Survival time was comparable with both types of treatments. Median survival time with the pill was 12.5 months compared to 13.3 months with the intravenous treatment.

ABCNEWS' Christi Myers of KTRK, Houston, and ABCNEWS.com's Robin Eisner contributed to this report.