Roche breast cancer pill fails to help older women
CHICAGO (Reuters) - Swiss drugmaker Roche Holding AG's oral chemotherapy drug Xeloda, or capecitabine, proved inferior to standard chemotherapy in treating older women with early stage breast cancer, a study released on Saturday at a major meeting of oncology specialists found.
Researchers had thought the oral pill, if effective, could be a gentler alternative to standard chemotherapy after surgery in women older than 65 - an age group typically underrepresented in clinical trials.
"What we found was standard therapy was superior," said the study's lead author, Dr. Hyman Muss of the University of Vermont's College of Medicine. "These were rather surprising numbers."
The data were released at the American Society of Clinical Oncology in Chicago.
The study of 633 early stage breast cancer patients who had already undergone surgery to remove their tumors failed to meet its goal of non-inferiority to standard chemotherapy. The investigators found that patients receiving Xeloda were 2.4 times more likely to suffer a relapse after two years and 2.1 times more likely to die than those receiving standard treatment.
Xeloda is approved to treat metastatic breast cancer, in which the disease has recurred after other treatments, in combination with other chemotherapy drugs. It is also being studied in other trials as a post-surgery treatment for early stage breast cancer, either alone or in combination with other agents.
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Roche breast cancer pill fails to help older women
Xeloda (chemical name: capecitabine) is a chemotherapy medicine that has been shown to be a good treatment for metastatic breast cancer. Xeloda is a pill taken by mouth.
The study reviewed here compared Xeloda to traditional intravenous (IV) chemotherapy to see which one was better at reducing the risk of the breast cancer coming back after surgery in women older than 65 diagnosed with early-stage or locally advanced breast cancer (cancer that hadn't metastasized).
Chemotherapy medicine that can be taken by mouth is easier to take than chemotherapy medicine that has to be given through an IV. The researchers were hoping that Xeloda would be at least as good as traditional IV chemotherapy in lowering the risk of breast cancer coming back.
Half of the more than 600 women in this study were treated with IV chemotherapy after surgery. The other half were treated with Xeloda. Most of the women in the study didn't have breast cancer come back, no matter which type of chemotherapy they got after surgery. Women who got Xeloda were more than twice as likely to have breast cancer come back nearly 2 1/2 years after diagnosis compared to women who got IV chemotherapy. Women who got Xeloda also were more than twice as likely to die from breast cancer.
These differences were greatest in women diagnosed with hormone-receptor-negative breast cancer, which is usually more aggressive than hormone-receptor-positive breast cancer.
Because the differences were so large, the study was stopped early. The researchers concluded that Xeloda was NOT as good as traditional IV chemotherapy medicines at reducing the risk of breast cancer coming back.
If you've been diagnosed with breast cancer that hasn't spread away from the breast area, your doctor may recommend chemotherapy after surgery to lower the risk of the cancer coming back. Taking Xeloda by mouth may seem like a better option than getting chemotherapy through an IV, but this research suggests that Xeloda isn't as good as traditional IV chemotherapy at lowering the risk of the cancer coming back. Your doctor will consider all the chemotherapy options that make the most sense for your unique situation, weighing both the benefits and the potential risks of each approach. Together you and your doctor can decide on the best treatment plan for you.