Avastin® (bevacizumab) in combination with chemotherapy does not extend overall survival in patients with inoperable, advanced or metastatic stomach cancer, according to the results of a phase III trial released by Roche.[i]
Stomach cancer, also known as gastric cancer, has limited treatment options. Approximately 21,000 people are diagnosed with the disease in the United States each year and nearly 11,000 people die from the disease.
Avastin is a targeted therapy that blocks a protein known as VEGF. VEGF plays a key role in the development of new blood vessels. By blocking VEGF, Avastin deprives the cancer of nutrients and oxygen and inhibits its growth. Avastin’s effects on blood vessels may also improve the delivery of chemotherapy to the tumor. Avastin has been approved for the treatment of selected patients with several types of cancer, including lung, colon, and breast cancers.
AVAGAST is a multi-center, randomized, double-blind, placebo-controlled, phase III study designed to evaluate the use of Avastin plus Xeloda (capecitabine) or fluorouracil and cisplatin chemotherapy compared to Xeloda or fluorouracil and cisplatin chemotherapy alone. The study included 774 patients with inoperable, locally advanced or metastatic stomach cancer who had received no prior treatment. The primary endpoint of the study is overall survival and the secondary endpoints include progression-free survival, time to progression, overall response rate, duration of response, disease control rate, and safety.
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According to Roche, Avastin failed to meet the target of extending overall survival. The results of the study will be submitted for presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in June. At that point, data will be available regarding the secondary endpoints of the study.
[i] Media Release: Phase III study of Avastin plus chemotherapy in advanced stomach cancer did not meet primary endpoint. February 23, 2010. roche.com/media/media_releases/med-cor-2010-02-23.htm