RIBBON-2 is an international, multicentre, randomised, double-blind, placebo-controlled clinical study that enrolled 684 patients with previously treated metastatic HER2-negative breast cancer. The trial evaluated the addition of either Avastin or placebo to an investigator's choice of chemotherapy. The following chemotherapy regimens were used in the study:
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Taxanes: paclitaxel, protein-bound paclitaxel or docetaxel
Gemcitabine
Capecitabine
Vinorelbine
Avastin is an antibody that specifically binds and blocks VEGF (vascular endothelial growth factor). VEGF is the key driver of tumour angiogenesis - an essential process of development and maintenance of blood vessels which is required for a tumour to grow and to spread (metastasize) to other parts of the body. Avastin's precise mode of action helps control tumour growth and metastases with only a limited impact on side effects of chemotherapy. Avastin has proven survival benefits across multiple tumour types. Avastin is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer. These types of cancer collectively cause over 2.5 million deaths each year.(3,4,5) In the US, Avastin was the first anti-angiogenesis therapy approved by the FDA and is now approved for the treatment of five tumour types: colorectal cancer, non-small cell lung cancer, breast cancer, brain (glioblastoma) and kidney (renal cell carcinoma). More than 500,000 patients have been treated with Avastin so far. A comprehensive clinical programme with over 450 clinical trials is investigating the use of Avastin in various tumour types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian, prostate and others) and different settings (advanced or early stage disease). About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80’000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com. 1. Boyle P et al. World Cancer Report 2008 IARCPress, Lyon, 2008
2. Ferlay J et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5. version 2.0, IARCPress, Lyon, 2004
3. Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American Cancer Society, 2007
4. WHO Cancer Factsheet N°297 – updated July 2008. Last accessed 24 March 2009 at http://www.who.int/mediacentre/factsheets/fs297/en/index.html.
5. Parkin DM et al. CA Cancer J Clin 2005; 55: 74-108