Avastin delays progression Breakthrough therapy offers women with metastatic breast cancer a chance to live without progression twice longer than those treated with paclitaxel alone
Roche announced that its innovative cancer drug bevacizumab (Avastin) has been approved in Europe for the treatment of women with metastatic breast cancer. The European Commission has approved Roche's bevacizumab (Avastin) for the first-line treatment of women with metastatic breast cancer in combination with standard chemotherapy paclitaxel. The approval is based on pivotal phase-III-trial data (E2100) which showed that women with metastatic breast cancer treated with bevacizumab plus paclitaxel have the chance to live twice longer without their cancer progressing than those treated with paclitaxel alone. David Cameron, medical oncologist from Lothian University Hospitals NHS Trust and clinical lead for the South East Scotland Cancer Research Network, said: "It is devastating for a woman to be diagnosed with advanced breast cancer. Despite all the improvements in treatment that have already been made, the remarkable effect of bevacizumab in prolonging the time to progression of metastatic breast cancer will be welcomed by patients-this time gained is very precious." Each year, more than a million new cases of breast cancer are diagnosed worldwide, resulting in over 400,000 deaths per year. Metastatic breast cancer is the number-one cause of cancer death worldwide in women under the age of 55. Additional phase-III trials are ongoing to explore bevacizumab in the first-line treatment of metastatic breast cancer in combination with docetaxel (AVADO) and other commonly used chemotherapies including capecitabine (RIBBON-1). Recently, a phase-III, first-line trial (AVEREL) in HER2-positive breast cancer evaluating bevacizumab in combination with docetaxel plus trastuzumab was initiated.
Study E2100 was the first phase-III study set to evaluate Roche's bevacizumab in combination with paclitaxel in comparison with paclitaxel alone for the first-line treatment of patients with locally recurrent or metastatic breast cancer. This randomized, controlled, multicenter study enrolled 722 women. The study was sponsored by the National Cancer Institute (NCI), part of the United States National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). The patients were randomized to receive treatment with paclitaxel with or without bevacizumab. The trial was designed to give bevacizumab at a dose of 10 mg/kg every two weeks until disease progression. The results showed that patients receiving bevacizumab plus paclitaxel had a median progression-free survival (PFS) of more than a year (13.3 months), while patients receiving paclitaxel alone had a median PFS of approximately seven (6.7 months) months. PFS is a measure of the time patients live without their disease progressing. Overall in the trial, patients treated with bevacizumab plus paclitaxel had a 52-percent reduction in the risk of disease progression or death, as expressed by a hazard ratio of 0.48 (1-0.48 = 0.52, or 52 percent), which is also identical to doubling PFS 1/0.48 = ~2). Overall, in the E2100 study, bevacizumab in combination with paclitaxel was generally well tolerated and had a favorable safety profile in patients with locally recurrent or metastatic breast cancer at the recommended dose of 10 mg/kg every two weeks.
Roche's bevacizumab is the first treatment that inhibits angiogenesis-the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Bevacizumab targets a naturally occurring protein called VEGF (vascular endothelial growth factor), a key mediator of angiogenesis, thus choking off the blood supply essential for tumor growth and metastasis. Roche and Genentech are pursuing a comprehensive clinical program investigating the use of bevacizumab in various tumor types (including colorectal, breast, lung, pancreatic and ovarian cancers, renal-cell carcinoma, prostate cancer, and others) and different settings (advanced and adjuvant). The total development program is expected to include over 40,000 patients worldwide. M |
