Nexavar (chemical name: sorafenib) is a targeted therapy medicine that blocks proteins that make cancers grow and spread. Nexavar is already approved by the U.S. Food and Drug Administration (FDA) to treat advanced-stage liver and kidney cancer. Doctors wanted to know if adding Nexavar to chemotherapy to treat advanced-stage breast cancer could improve response to treatment.
The results from a series of studies suggest that some women diagnosed with advanced-stage breast cancer benefit more from chemotherapy and Nexavar compared to chemotherapy and placebo (a sugar pill).
The results were presented at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO).
In the TIES series of studies, 160 women diagnosed with either locally advanced or metastatic HER2-negative breast cancer were not candidates for surgery to remove the cancer. Locally advanced breast cancer has spread to the chest wall below or the skin above the breast. Metastatic breast cancer has spread to a part of the body away from the breast, such as to the bones, the liver, or the brain. Targeted therapies such as Herceptin (chemical name: trastuzumab) and Tykerb (chemical name: lapatinib) aren't effective against HER2-negative breast cancer.
All the women had received breast cancer treatment before joining one of the TIES studies. One of those earlier treatments was the targeted therapy Avastin (chemical name: bevacizumab).
In the TIES studies, all the women were treated with one of two chemotherapy medicines: Gemzar (chemical name: gemcitabine) or Xeloda (chemical name: capecitabine). Half the women were randomly chosen to get Nexavar with the chemotherapy. Nexavar is a pill taken by mouth. The other women were given a placebo pill that looked exactly the same as the Nexavar pill. The researchers recorded how the women did during and after treatment.
The average time of progression-free survival was 3.4 months for women who got Nexavar with chemotherapy compared to 2.7 months for women who got only chemotherapy. Progression-free survival is the amount of time the women lived without the cancer growing.
The women who got Nexavar and chemotherapy had a better and longer response to treatment:
- 63% of women who got Nexavar and chemotherapy had some response to treatment compared to 55% of women who got only chemotherapy.
- Average response time was longer in women who got Nexavar -- 4.8 months compared to 3.1 months in women got only chemotherapy.
All the women had some side effects. Still, side effects were more likely to appear in women who got Nexavar. The side effects included:
- hand-foot syndrome (57% with Nexavar, 18% with placebo)
- tiredness (61% versus 47%)
- mouth sores (27% versus 7%)
- diarrhea (35% versus 22%)
- low red blood cell counts (14% versus 8%)
- high blood pressure (20% versus 9%)
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.
Some women seemed to benefit from Nexavar much more than others. Doctors think that more and larger studies on using Nexavar to treat advanced-stage breast cancer should be done, but genetic or other testing should be done first to help doctors figure out which women are most likely to benefit from Nexavar.
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.