One of the first of a series of trials to investigate the use of sorafenib - a targeted anti-cancer drug - for the treatment of advanced breast cancer has found that if it is combined with the chemotherapy drug, capecitabine, it makes a significant difference to the time women live without their disease worsening.
Principal investigator of the study, Professor José Baselga told Europe's largest cancer congress, ECCO 15 - ESMO 34, in Berlin today (Wednesday 23 September): "This is the first, large, randomised study that demonstrates significant clinical activity of sorafenib in breast cancer when given in combination with chemotherapy. Our results showed that patients who received sorafenib plus capecitabine had a 74% percent improvement in the time they lived without their disease worsening compared to those who received the chemotherapy alone. This is a very positive study and the magnitude of the benefit is such that it suggests that this agent will be an important addition to our therapeutic armoury in breast cancer."
Sorafenib (Nexavar®) is a potent multi-kinase inhibitor, which works by interfering with the growth of cancer cells and slowing the growth of new blood vessels within the tumour. Until now, it has only been used in the treatment of kidney and liver cancer.
Prof Baselga, who is head of the oncology department at Vall d'Hebron University Hospital (Barcelona, Spain), president of ESMO (European Society for Medical Oncology) and a member of the ECCO (European CanCer Organisation) executive committee, and his colleagues in Spain, France and Brazil enrolled 229 patients with locally advanced or metastatic breast cancer in the double-blind, randomised phase II clinical trial between June 2007 and December 2008. They randomised the patients to receive capecitabine (1000 mg/m2 pill taken twice daily for 14 of every 21 days) and a placebo (114 women), or capecitabine and sorafenib (400 mg pill taken twice daily continuously) for 115 women.