Faslodex

In April 2002, the first ERD, called Faslodex (chemical name: fulvestrant), was approved by FDA. It is currently the only ERD available. Faslodex is approved as a "second-line" hormonal treatment for post-menopausal women with advanced hormone-receptor-positive breast cancer. Women who have already taken another "first-line" treatment, such as aromatase inhibitors or tamoxifen and are no longer responding to it can take Faslodex next.

The FDA's approval of Faslodex was based on two large clinical trials in Europe and North America.

Clinical trial results

In the two trials, 851 women were divided into two groups. One group had a monthly injection of Faslodex; the other took a daily tablet of Arimidex (chemical name: anastrozole), an aromatase inhibitor. All of the women were post-menopausal and had metastatic cancers that had grown even though the women had taken tamoxifen. The researchers wanted to see whether Faslodex would be more beneficial to these women than an aromatase inhibitor as their next hormonal treatment.

Here's what the researchers found:

• In the North American trial, Faslodex and Arimidex worked equally well at stopping or slowing cancer growth. Seventeen percent of women treated with Faslodex and 17% of those treated with Arimidex had their cancers either grow more slowly or stop growing.
• In the European trial, Faslodex worked somewhat better than Arimidex at stopping or slowing cancer growth. Twenty percent of women treated with Faslodex responded partly or completely to treatment, as opposed to 15% of those treated with Arimidex.
• In the North American trial, Faslodex did significantly better than Arimidex at delaying the time it took for the cancers to begin to grow again — an average of 5.4 months with Faslodex, compared to 3.4 months with Arimidex.
• In the European trial, Faslodex did slightly better than Arimidex at delaying the time it took for the cancers to begin to grow again — an average of 5.5 months with Faslodex and 5.1 months with Arimidex.
• All the women who had side effects experienced similar ones whether they took Faslodex or Arimidex. About a quarter of all the women had nausea. Those who took Faslodex also had some mild pain and redness at the place where they were injected.

How you take Faslodex

Faslodex is given as an injection (shot) into the muscle of the buttock (backside). You get it once a month in the doctor's office. Faslodex can be given as a single 5-milliliter injection or two 2.5-milliliter injections. These options work equally well, but may cause different reactions (including mild pain and swelling) in different women at the injection site.

Is Faslodex right for you?

If you have advanced hormone-receptor-positive breast cancer that's stopped responding to tamoxifen or an aromatase inhibitor, Faslodex is another option for you.

Be sure to discuss all the options for hormonal treatments with your doctor. Schedule regular visits to talk about side effects and how well the treatment is working. Together, you and your doctor can better decide whether to stick with your current treatment or switch to something else.