Xeloda (chemical name: capecitabine) is a chemotherapy medicine used to treat advanced (metastatic) breast cancer. The study reviewed here found that a combination of Xeloda and Avastin (chemical name: bevacizumab), a targeted therapy medicine, stopped breast cancer from growing longer than treatment with only Xeloda in women diagnosed with metastatic disease.
Avastin is approved by the U.S. Food and Drug Administration (FDA) to be used in combination with Taxol (chemical name: paclitaxel) to treat people with metastatic HER2-negative breast cancer who haven't received chemotherapy yet. Avastin also is used to treat other advanced cancers, including lung, colon, and kidney cancer.
Taxol alone or Xeloda alone is used to treat metastatic breast cancer. Doctors wanted to know if adding Avastin to one or the other of these chemotherapy medicines could offer more benefits. The RIBBON-1 study was designed to answer this question. More than 1,200 women being treated for metastatic breast cancer participated in the study. Some of the women received either a combination of Taxol and Avastin or a combination of Xeloda and Avastin. Other women received Taxol or Xeloda combined with a placebo (dummy) treatment.
Early results from the RIBBON-1 study showed that the combination of Avastin and Taxol increased the time before the cancer began growing by 5 1/2 months compared to Taxol alone. Based on those results, the FDA approved the combination of Avastin and Taxol as a treatment option for some women diagnosed with metastatic breast cancer. The new results reviewed here show that the combination of Avastin and Xeloda offers similar benefits. Still, neither combination -- Avastin and Taxol or Avastin and Xeloda -- was shown to increase overall survival.
If you're being treated for metastatic breast cancer, you and your doctor will consider a number of treatment options that might make sense for you. A combination of Avastin with a chemotherapy medicine is one choice that you might try. Your doctor's recommendation will be based on published research, your doctor's experience using Avastin to treat other people diagnosed with breast cancer, and YOUR unique situation. Together, you and you doctor can make the best treatment choices for YOU.
BASEL, Switzerland, Nov. 24 (MedPage Today) -- The maker of capecitabine (Xeloda) said today that a phase III study showed adding bevacizumab (Avastin) to chemotherapy can increase progression-free survival in women with metastatic breast cancer.
The Roche announcement was based on the RIBBON-1 trial, which studied Avastin in combination with anthracycline- and taxane-based chemotherapies.
The announcement, however, did not confirm an overall survival advantage for the combination.
Earlier this year, the FDA approved bevacizumab in combination with paclitaxel (Taxol) for chemotherapy-naïve patients with metastatic HER2-negative breast cancer. (See: FDA approves Avastin for breast cancer)
But that approval, which came despite an advisory committee's opposition, was based on a finding that the combination increased progression-free survival by an average of 5.5 months but did not increase overall survival. (See: US panel rejects Avastin for use in breast cancer)
In a press release, Roche said "RIBBON-1 met its primary endpoint of increasing the time women with breast cancer lived without their disease advancing (known as progression-free survival) compared to chemotherapy alone, as determined by the treating physicians."
RIBBON-1 randomized 1,237 chemotherapy-naïve patients to bevacizumab plus taxane, anthracycline-based chemotherapy, or capecitabine or to standard chemotherapy plus placebo.
The primary objective of the study was to demonstrate superiority in progression-free survival of the treatment-containing arms compared with the control arm.
Secondary endpoints for the study included response rate, duration of response, time to treatment failure, overall survival, quality of life, safety, and tolerability.
Roche said full results of the study will be "submitted for presentation at a future medical meeting." The only remaining large breast cancer meeting this year is next month's San Antonio Breast Cancer Symposium.
Bevacizumab, which is made by Genentech, is also approved for colon cancer and lung cancer.
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