Sorafenib significantly improves progression-free survival in advanced breast cancer when given in combination with capecitabine
Results from first, large randomized trial are in
One of the first of a series of trials to investigate the use of sorafenib for the treatment of advanced breast cancer has found that if it is combined with capecitabine, it makes a significant difference to progression-free survival (PFS).
Principal investigator of the study, Prof. José Baselga, presented the results at Europe’s largest cancer congress, ECCO 15 – ESMO 34, in Berlin on Wednesday 23 September 2009. This is the first, large, randomized study that demonstrates significant clinical activity of sorafenib in breast cancer when given in combination with chemotherapy. Study results showed that patients who received sorafenib plus capecitabine had a 74% improvement in PFS compared with those who received chemotherapy alone. This is a very positive result and the magnitude of the benefit is such that it suggests that this agent will be an important addition to the therapeutic armory in breast cancer.
Sorafenib 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 tumor. Until now, it has only been used in the treatment of kidney and liver cancer.
Prof. Baselga and colleagues in Spain, France, and Brazil enrolled 229 patients with locally advanced or metastatic breast cancer in the double-blind, randomized phase II clinical trial between June 2007 and December 2008. They randomized the patients to receive capecitabine (1000 mg/m2 p.o. taken twice daily for 14 of every 21 days) and a placebo (114 women), or capecitabine and sorafenib (400 mg p.o. taken twice daily continuously) for 115 women.
The first results from the trial show that the average PFS was 6.4 months for women on capecitabine and sorafenib compared with 4.1 months for women taking the placebo. It is too early for data on overall survival to be available. The only death that occurred was in the placebo arm of the trial, attributed to the effect of capecitabine. The number of patients discontinuing treatment because of adverse side-effects was 9 (8%) in the placebo arm and 15 (13.4%) in the sorafenib arm. The regimen was tolerable and side-effects were mostly manageable. No new or unexpected side-effects were observed with this combination. The fact that this treatment could be taken orally may represent a unique and convenient treatment option for patients with breast cancer.
This trial is an example of a good academic and industry partnership. It was designed and conducted by the Spanish breast co-operative group SOLTI, with the participation of Brazilian and French groups. The trial was fully supported by Onyx and Bayer. Based on the encouraging data from this trial so far, Onyx and Bayer are evaluating various strategies for sorafenib in breast cancer. This trial is the first in a series of randomized phase II studies with sorafenib that are currently underway in breast cancer.
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