- The Washington Times - Monday, June 14, 2004

A pill with fewer side effects than chemotherapy could replace the traditional intravenous treatment used for colon cancer patients, according to an international study presented last week.

In an analysis of patients whose cancer had spread from the colon to the lymph nodes after surgery, physicians say the survival rates for those taking the pill Xeloda is “at least equivalent” to those using intravenous chemotherapy, known as the Mayo Clinic Regimen.

A second analysis found the pill “superior,” said a spokesman for Roche, the Swiss drugmaker that developed Xeloda.

The study was presented at a conference of the American Society for Clinical Oncology, which met last week in New Orleans.

The use of Xeloda decreased the risk of disease relapse by 14 percent, when compared with the standard intravenous therapy, according to the study. It also caused significantly fewer serious side effects, especially low blood counts and inflammation of the mouth.

“With Xeloda, we found no problem with hair loss, very little damage to blood counts and only rare incidents of patients being hospitalized,” said Dr. Howard Burris, an oncologist at the Sarah Cannon Cancer Center in Nashville.

A complication called hand-foot syndrome, which involves redness, pain and swelling of the hands and feet, was more common in patients treated with Xeloda. However, this condition is “effectively managed” through patient education, treatment interruption and, if necessary, dose reduction, researchers said.

Dr. Burris helped conduct the Xeloda trials, led by researchers in the United Kingdom.

The studies evaluated nearly 2,000 patients who received either Xeloda or standard chemotherapy. The three-year relapse-free survival rate was 65.5 percent for those on Xeloda and 61.9 percent for patients on standard chemotherapy.

Though the Mayo Clinic Regimen typically requires at least 30 clinic visits during the 24 weeks of treatment, patients receiving Xeloda might require no more than eight visits, the researchers said at the conference.

Xeloda already is approved for use in the United States for patients with later-stage colon or breast cancer, or those whose disease has spread to other parts of the body.

However, the new data “show the significant potential of Xeloda to treat more patients with early-stage colon cancer,” said Dr. Jim Cassidy, chairman of medical oncology at the Beatson Oncology Center in Glasgow, who presented the research at the conference.

“These findings … show that a convenient oral regimen can be used in place of hours of cumbersome chemotherapy. … This study will flip the standard of care, so that Xeloda will now be the preferred treatment,” Dr. Burris said.

He stressed the importance of being able to target and destroy cancer cells once they spread to the lymph nodes. “There are hundreds of lymph nodes in the body, and there’s always a chance of cancer cells hanging out” in that tissue, he said.

Colorectal cancer, cancer of the colon or rectum, is the second deadliest malignancy in the United States behind lung cancer. About 57,000 Americans die of this cancer yearly, according to the American Cancer Society.

Roche officials said the favorable research results will be submitted to the U.S. Food and Drug Administration to support use of Xeloda for patients who have had their colon tumors surgically removed.

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