Nexavar Offers No Benefits in Treating Advanced-Stage Disease

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Nexavar (chemical name: sorafenib) is a targeted therapy medicine that blocks proteins that make cancers grow and spread. Doctors call Nexavar a multi-kinase inhibitor. Nexavar already is approved by the U.S. Food and Drug Administration (FDA) to treat advanced-stage liver and kidney cancer. Nexavar is a pill taken by mouth. Doctors have been studying whether Nexavar could improve advanced-stage breast cancer's response to standard treatment.

Results from one of a series of small, early studies called TIES (Trials to Investigate the Efficacy of Sorafenib) found that Nexavar offered no benefits to women diagnosed with advanced-stage breast cancer who were getting a standard treatment regimen of chemotherapy and/or hormonal therapy.

The results were presented at the September 2011 European Multidisciplinary Cancer Conference (ECCO-ESMO).

All the 218 women in the study had been diagnosed with either locally advanced or metastatic HER2-negative breast cancer. Surgery wasn't a treatment option. Locally advanced breast cancer is cancer that has spread to the chest wall below or the skin above the breast. Metastatic breast cancer is cancer that has spread to a part of the body away from the breast, such as the bones, the liver, or the brain. Targeted therapies such as Herceptin (chemical name: trastuzumab) and Tykerb (chemical name: lapatinib) don't work against HER2-negative breast cancer.

All the women had received other breast cancer treatments, including the targeted therapy medicine Avastin (chemical name: bevacizumab), before joining the TIES study.

During the study, all the women diagnosed with hormone-receptor negative cancer were treated with the chemotherapy medicine Taxotere (chemical name: docetaxel). Women diagnosed with hormone-receptor-positive cancer with visceral metastases (cancer that has spread to organs such as the liver, the brain, or the lungs) were treated with Taxotere and the hormonal therapy medicine Femara (chemical name: letrozole). Women diagnosed with hormone-receptor-positive cancer that was either locally advanced or had only spread to the bones were treated only with Femara.

No matter which standard treatment they got, half the women also were treated with Nexavar. The other women were given a placebo pill that looked exactly the same as the Nexavar pill.

The average length of progression-free survival was 8.4 months for both women who got Nexavar and women who didn't. Progression-free survival is the amount of time the women lived without the cancer growing. The likelihood of responding to treatment (called response rate) was also the same for both groups.

All the women had some side effects from treatment. Still, severe side effects (grade 3) were more likely in women who got Nexavar. These severe side effects included hand-foot syndrome, rash, and low white blood cell counts (neutropenia, leukopenia). Hand-foot syndrome is a skin reaction that occurs when a small amount of medicine leaks out of capillaries (small blood vessels), usually into the palms of the hands and soles of the feet. The leaked medicine can damage the surrounding tissue. This may cause severe pain and make it hard to use your hands or walk.

Although this study suggests that Nexavar doesn't offer any benefits for advanced-stage breast cancer treatment, results from some of the other TIES studies will be reported in the future.

If you're being treated for advanced-stage breast cancer, you and your doctor may be considering a number of options, especially if the cancer has stopped responding to standard treatments. Treatment with a regimen that includes Nexavar may be an option if you're willing to participate in a clinical trial. Ask your doctor if there are any clinical trials that might be a good fit for you and your unique situation. Visit the Breastcancer.org Clinical Trials pages for more information.

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