Chemotherapy pill causes fewer side effects

By Miriam Falco
CNN Medical Unit

HOUSTON, Texas (CNN) -- Chemotherapy in a pill appears to be more tolerable for patients with advanced colorectal cancer than similar drugs administered intravenously, according to new research published Thursday.

Although patients taking chemotherapy orally do not live longer than those receiving drugs intravenously, they have a better quality of life because they suffer fewer side effects and are hospitalized less often, the study showed.

Since its approval in 1962, the intravenous chemotherapy drug 5-fluorouracil (5-FU), alone or in combination with other drugs, has been the standard treatment for advanced colon cancer.

"It's the most widely used chemotherapy in the world," said Dr. Robert A. Wolff, assistant professor of medicine at the University of Texas, MD Anderson Cancer Center in Houston.

The drug causes tumors to shrink, but is absorbed erratically and causes many side effects.

Capecitabine, also known by the brand name Xeloda, was approved as an oral chemotherapy drug for breast cancer in 1998. Once it's absorbed, it converts to 5-FU and causes tumors to shrink.

Researchers at the cancer center, studying capecitabine for colon cancer, enrolled 605 patients in clinical trial sites throughout the United States and Canada. Patients were randomly selected to receive chemotherapy intravenously or in pill form.

Those who were in the IV regimen received a daily dose of 5-fluorouracil (5-FU) combined with leukovorin (LV) for five days, in a four-week cycle. Those selected for the oral chemotherapy treatment were given capecitabine. They took the pills twice a day for two weeks, didn't take the drug for a week, then started the cycle again.

Researchers pleased with results

"The nice thing is that there was a greater chance of tumor shrinking with the pill and survivability was the same," explained Dr. Paulo Hoff, the study's lead author.

Wolff called it an advance for treatment of colon cancer. "Toxicity was substantially less with pills. The risk of hospitalization was 20 percent with the IV drug; 11 percent with the pill. Nausea, hair loss and diarrhea were lessened by the pill, too." He added that the treatment is more convenient and less toxic than intravenous chemotherapy.

"The only side effect that was higher among patients taking the pill was foot and hand problems -- soreness and redness -- which are not life-threatening and do not require hospitalization," Hoff explained.

The research appears in the April 15 issue of the Journal of Clinical Oncology.

Since the study was launched, there has been a new standard for treating colon cancer, according to Hoff. Last year the combination of 5-FU/LV and the drug camptosar was determined to be slightly better chemotherapy. The latest trial does not provide a comparison to the current "gold standard," but "researchers are planning to study combinations of the pill and camptosar as well," said Hoff.

Colon cancer is the third leading cause of cancer death in the United States. More than 135,000 people will be diagnosed with colon cancer this year and nearly 57,000 will die, according to the American Cancer Society.

"Capecitabine potentially could simplify cancer treatment," said Dr. Charles Staley, assistant professor at Emory School of Medicine in Atlanta, who called it "a huge deal." "It's very attractive from a biologic and a financial perspective, because the costs of administering chemotherapy intravenously are quite high, when you figure in the all the personnel required to inject and monitor the IV every time a patient has to come in for a treatment. It is a lot easier and cheaper if the patient can take a pill instead," Staley explained.

"The question is, will capecitabine and camptosar become the next gold standard?"

Wolff cautioned that patients need to be "informed, motivated and compliant" if they undergo chemotherapy with pills. Patients could be at risk if they don't stick to the proper dosage regimen.

"It literally puts the treatment in the hands of the patient. It's a consideration that physicians must acknowledge when devising a treatment plan," said Wolff.

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American Cancer Society: Colon and Rectum Cancer Resource Center
M. D. Anderson Cancer Center
Colon Cancer Alliance

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