Avastin (bevacizumab), an angiogenesis inhibitor targeting vascular endothelial growth factor (VEGF) which supports the growth of new blood vessels needed for cancers to develop, has been launched in Europe for the first line treatment of women with metastatic breast cancer.

The launch follows approval earlier this year by the European Commission of Avastin for the first line treatment of women with metastatic breast cancer in combination with paclitaxel, a standard chemotherapy. This was based on results from a pivotal Phase III trial (E2100) showing a doubling of disease-free survival in women with metastatic breast cancer treated with Avastin plus paclitaxel compared to those given paclitaxel alone.

Kathy Miller, Associate Professor at the Indiana University School of Medicine and lead investigator of the E2100 trial, reported that 722 women with previously untreated, metastatic breast cancer were randomised to treatment with paclitaxel with or without Avastin (10mg/kg every two weeks until disease progression). The results showed that patients receiving Avastin plus paclitaxel had a median progression-free survival of more than one year (13.3 months) compared to 6.7 months for those given paclitaxel alone, giving a 52% reduction in the risk of disease progression or death (hazard ratio 0.48; p

David Cameron, Director of English National Cancer Research Networks and Professor of Oncology at the University of Leeds UK, said: “Despite all the improvements in treatment that have already been made, more than 400 000 women die of breast cancer each year. The remarkable effect of Avastin in prolonging the time to progression of metastatic breast cancer will be welcomed by patients – this time gained is very precious.”

Professor Cameron explained new developments were needed in metastatic breast cancer because previously available chemotherapy agents had reached a plateau of prolonging survival by about nine months. “Half of the women with advanced breast cancer will find their disease is getting worse again before one year.” He suggested that angiogenesis was an ideal target for cancer therapy because nearly all facets of cancer cell growth, including unlimited cell growth, reduced sensitivity to apoptosis and limitless replication potential require a blood supply to deliver required oxygen and nutrients.

Professor Cameron outlined the ongoing clinical trials with Avastin in breast cancer. These include further trials in metastatic breast cancer in combination with a range of drugs, in addition to studies in early breast cancer. AVADO and RIBBON1 are investigating Avastin with single agent taxane, including docetaxel, which is used more than paclitaxel in Europe. AVEREL will combine Avastin with Herceptin (trastuzumab) plus chemotherapy.

In early breast cancer, E5103 is investigating adding Avastin to standard chemotherapy in women with HER2-negative disease. BEATRICE will study Avastin in women with triple negative breast cancer (negative for oestrogen, progesterone and HER2 receptors). “Around 10-15% of women with breast cancer have this type of breast cancer, which is not helped by any of the newer treatments,” Professor Cameron explained.

National regulatory authorities throughout Europe are now considering licensing of Avastin in metastatic breast cancer, with Germany being the first country to approve this indication. In the UK, more than 85% of private medical insurance companies have already agreed to fund treatment in at least some patients in this setting.

www.avastin.com

Written by: Susan Mayor PhD
Susan Mayor is a freelance medical journalist, UK
susan@mayor.dircon.co.uk