BOSTON (Reuters) - Older breast cancer patients who got Roche AG’s drug Xeloda all by itself were almost twice as likely to relapse and die than women who got standard chemotherapy, U.S. researchers reported on Wednesday.
Although the drug works well against breast cancer that has spread, it did not prevent spread in women with early-stage breast cancer, the researchers reported in Thursday’s New England Journal of Medicine.
The drug, whose generic name is capecitabine, can be taken as a pill and would be more convenient and less toxic than infusions of chemotherapy. But the trial showed it was not nearly as effective.
“Patients who were randomly assigned to capecitabine were twice as likely to have a relapse and almost twice as likely to die as patients who were randomly assigned to standard chemotherapy,” Dr. Hyman Muss of the University of Vermont and colleagues wrote.
“The study was designed to show it was just as good” as standard treatment for early-stage breast cancer, Muss said in a telephone interview. “It didn’t work out.”
Xeloda did particularly poorly in hormone-receptor-negative tumors — which also cannot be treated with pills such as tamoxifen.
The study is one of the few to look at the effectiveness of breast cancer chemotherapy in older women. Most tests look at younger patients, even though the majority of the 40,000 breast cancer deaths in the U.S. occur in women age 65 and older.
Three years after beginning treatment, 91 percent of the 326 women getting the more aggressive — and more toxic — conventional chemotherapy were alive compared to 86 percent of the 307 who were taking Xeloda tablets.
In the Xeloda group, nearly half the deaths were caused by the breast cancer itself. In the conventional-therapy group, heart disease or other types of cancer were the most common causes.
Editing by Maggie Fox and Cynthia Osterman