What Is patientINFORM?

Summary: The pill capecitabine (sold as Xeloda) works just as well as standard intravenous chemotherapy after surgery for stage III colon cancer, a group of international researchers reported in this week's issue of the New England Journal of Medicine. Before they were even published, the study results prompted the US Food and Drug Administration to approve Xeloda for this group of patients.

Why it's important: Some 30,000 people in the US are diagnosed with colon cancer that has spread to nearby lymph nodes (stage III) every year, according to an editorial that accompanies the study. Though surgery is the primary treatment, many of these patients also will be given chemotherapy -- often with 5-fluorouracil/leucovorin (5FU/LV) -- to improve their chances of survival. Xeloda offers them another option for that treatment, and may be especially attractive for patients who can't tolerate intensive intravenous chemotherapy.

What's already known: Xeloda is already used to treat colon cancer that has spread to other parts of the body (metastatic disease). Studies in patients with advanced disease showed that the pill was just as effective as traditional chemotherapy injected into a vein. Until this latest study, though, it wasn't certain that the pill would be equally effective for patients with earlier-stage colon cancer.

How this study was done: Nearly 2,000 study participants were recruited from medical centers across Europe and in the US, Canada, South America, Thailand, Israel, and Australia. All of them had recently recovered from surgery for stage III colon cancer and were randomly assigned to further treatment with either capecitabine tablets or standard intravenous chemotherapy with 5-FU/LV. The researchers tracked their progress for 3 years, measuring how long it took for the cancer to return and keeping track of side effects. The study was designed and sponsored by Hoffman-La Roche, the company that makes Xeloda.

What was found: The study found that Xeloda is at least as effective as traditional chemotherapy in keeping colon cancer from returning after surgery. Patients who took Xeloda remained cancer-free for about the same amount of time as patients given 5-FU/LV. But the side effects of treatment were different in the two groups. Diarrhea, nausea, mouth sores, hair loss, and low white blood cell count were significantly more common among people who got traditional chemotherapy. People who took Xeloda were significantly more likely to experience hand-foot syndrome, a collection of strange sensations in the hands and feet such as tingling, pain, or numbness. They also had more cases of jaundice (yellowing of the skin and eyes).

Study limitations: The study did not explore the cost difference between the regimens, which may be significant. The starting dose of Xeloda used in the study is higher than that used by many doctors in the US. It's not clear if the lower starting doses sometimes used would be as effective. While this study compared Xeloda to 5-FU/LV, recent studies have shown that adding oxaliplatin to 5-FU/LV (a regimen called FOLFOX) seems to prevent more recurrences that 5-FU/LV alone. It’s not yet clear if Xeloda will work equally as well when combined with other drugs.

The bottom line: The study showed that the chemotherapy pill capecitabine (Xeloda) is just as effective as traditional chemotherapy with 5-FU/LV in patients who have already had surgery for stage III colon cancer. It may provide a more convenient and less intensive (although more expensive) option for some patients. More studies will need to be done to see how capecitabine compares to traditional chemotherapy when newer drugs like oxaliplatin and irinotecan are added to treatment.

Citations: "Capecitabine as Adjuvant Treatment for Stage III Colon Cancer." Published in the New England Journal of Medicine (Vol. 352, No. 26: 2696-2704). First author: Chris Twelves, MD, of the University of Bradford, United Kingdom.

"Adjuvant Therapy for Colon Cancer -- The Pace Quickens." Published in the New England Journal of Medicine (Vol. 352, No. 26: 2746-2748). First author: Carmen Allegra, MD, of Network for Medical Communication and Research, North Potomac, Maryland.