Pill called an effective alternative to chemotherapy

Roche's Xeloda eases side effects after surgery for colon cancer

Health & Fitness

July 01, 2005|By Michelle Fay Cortez | Michelle Fay Cortez,BLOOMBERG NEWS

The cancer pill Xeloda, made by Roche Holding AG, has fewer side effects and yet is as effective as standard intravenous chemotherapy for colon cancer patients after surgery, a company- funded study in The New England Journal of Medicine found.

Xeloda is an alternative to generic intravenous drugs, allowing at-home care with less-severe diarrhea, nausea, fever, hair loss and drops in infection-fighting white blood-cell levels.

"It's another option, and it's nice to have more drugs at our disposal," said Nancy Kemeny, an oncologist at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Cornell Medical College in New York.

"Certainly an oral drug is easier than an IV drug," she said in a telephone interview.

Roche, the world's biggest maker of cancer medicines and diagnostic tests, used the results to win regulatory approval last month of Xeloda for colon cancer treatment following tumor removal in the United States. Publication of the findings may help Roche expand sales of the pill, which generates about $420 million each year for treatment of breast cancer and spreading colon cancer.

Xeloda or Sanofi-Aventis SA's Eloxatin should be considered for colon cancer patients getting drug therapy, said the researchers led by Chris Twelves, an oncologist at the University of Glasgow.

Elderly patients might benefit most because they may have more trouble tolerating chemotherapy's side effects and often have shrunken blood vessels that make it hard to start IV therapy.

Almost 1 million people worldwide are diagnosed with colon cancer, including 105,000 in the United States, according to international reports and the American Cancer Society. While earlier diagnosis and new treatments are prolonging survival, about half of patients still die from the disease.

The 1,987-patient international study in yesterday's issue of The New England Journal of Medicine compared Xeloda to fluorouracil and leucovorin given as a rapid intravenous dose, common in Europe, rather than the slower IV administration used in the United States.

Many U.S. oncologists use smaller starting doses, wrote Carmen Allegra from the Network for Medical Communication and Research in Potomac and Daniel J. Sargent from the Mayo Clinic Cancer Center in Rochester, Minn., in an editorial accompanying the study.

"On the basis of convenience, efficacy and favorable rates of toxic effects, [Xeloda] is an excellent choice when single- agent therapy is desired, provided that the treating physician is comfortable using the starting dose reported," they wrote.

Three years after treatment, 64.2 percent of patients getting Xeloda were still alive with no cancer, compared with 60.6 percent of those getting the two generic drugs that have been the standard of care since the 1990s. Overall survival after three years, including those still battling colon cancer, was 81.3 percent for those on Xeloda and 77.6 percent for patients getting fluorouracil and leucovorin.

An earlier study showed Sanofi's Eloxatin boosted the effectiveness and lengthened disease-free survival in colon cancer patients getting the intravenous treatment known as 5FU/LV. Many doctors consider Eloxatin plus 5FU/LV the best treatment after surgery for colon cancer, Kemeny said.

"The three-year disease-free survival with Eloxatin, 5FU/LV was better than what is seen in this study," she said.

"Many doctors are suggesting using [Eloxatin] as the first-line treatment" after surgery, said Kemeny, who wasn't involved in the study.

Eloxatin, however, can have serious side effects, including temporary nerve toxicity, Kemeny said. Many colon cancer patients are older and can't tolerate the complications, she said.

"It's certainly a much tougher treatment than Xeloda" or 5FU/LV alone, Kemeny said. "If we have a young patient who has a long life ahead of them, most of us would suggest taking the Eloxatin, 5FU/LV combination," she said.

While Xeloda has fewer side effects, they can be devastating if the patients don't stop taking the medication immediately when problems arise, Kemeny said. Many patients think that because Xeloda is a pill, it has fewer dangers than other chemo- therapy drugs, she said.

"If a patient develops diarrhea, for example, on Xeloda and doesn't stop taking it, it can get quite bad," she said. "For older patients, if they are motivated to report toxicity regularly, this is a much easier regimen."

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