Metastatic Breast Cancer Often Treated with Medicines Used “Off-Label”

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When a medication is approved by the U.S. Food and Drug Administration (FDA) for use in one way, it is generally understood that research and experience may eventually guide doctors to other uses of that medication. This is especially true with advanced cancer treatments, when it might be necessary to exhaust all reasonable options to fight the cancer. The term "off-label use" refers to the use of a drug in a way that has not been officially approved by the FDA. Doctors will usually choose to use a medication off-label to treat specific cancer situations only when there is some good evidence from research and clinical experience that the medication can be used effectively in that situation. Off-label use in this manner is considered acceptable and appropriate.

A study found that about one-third of women being treated for metastatic breast cancer received a cancer medicine used in an off-label way. Most of the time the off-label use was considered appropriate to the situation. The results were presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting.

The researchers reviewed the treatment histories of over 2,000 women age 65 and older who were diagnosed with and treated for metastatic breast cancer.

The results:

  • Over one-third of the women had received an off-label treatment at some point in their overall treatment plan.
  • Among the women studied, the younger they were, the more likely they were to have received an off-label treatment.
  • In over 93% of cases when treatments were used off-label, the use was considered appropriate. This means that the treatment choice was reasonable based on research evidence and clinical experience. Only 6.7% of the women received off-label treatments that were considered medically inappropriate.
  • Drugs that were commonly used off-label, but appropriately, included:
    • vinorelbine (brand name: Navelbine)
    • gemcitabine (brand name: Gemzar)
    • carboplatin (brand name: Paraplatin)
    • mitoxantrone (brand name: Novantrone)

If you are being treated for breast cancer and are taking time to learn about the medications in your treatment plan, you may discover that one or more of your treatments were never approved by the FDA for use in someone with your specific situation. Even though a treatment may be off-label, it is very likely that your doctor has recommended it to you based on sound evidence and experience from use of that treatment in patients with situations similar to your own. Still, it is a good idea to talk with your doctor about the role of any off-label treatments in your overall treatment plan, and why an off-label treatment might make sense for you and your unique situation.

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