FDA Tells Doctors About Potential Heart Problems with Herceptin
Reviewed study: "FDA Tells Doctors About Potential Heart Problems with Herceptin"
A study has shown a significant increase in heart problems in women with early-stage, HER2-positive breast cancer receiving chemotherapy and Herceptin (chemical name: trastuzumab). Because of this, the U.S. Food and Drug Administration (FDA) and Genentech, the company that makes Herceptin, have issued a warning to doctors for their patients. While researchers and doctors already knew about the potential heart problems with Herceptin, the FDA warning is a more formal acknowledgement of the issue.
Breastcancer.org reported on this study, NSABP-B-31, in May 2005. After three years of follow-up, 4.1% of women who received Herceptin and chemotherapy had major heart problems (heart failure). About 0.8% of women who received chemotherapy alone had heart failure. This difference is statistically significant, meaning that it's likely due to Herceptin and not just to chance.
The FDA warning tells doctors about the potential heart problems associated with Herceptin so they can best guide their patients. The warning about heart problems will be included with the medication instructions. It will advise doctors to thoroughly evaluate all of a woman's risk factors for heart disease before giving her Herceptin to treat early-stage breast cancer.
Background on Herceptin: Herceptin is a very effective treatment against HER2-positive breast cancer in women with stage II, III, and IV disease (medium to large cancers or cancers with lymph nodes involved, or metastatic disease). It is given intravenously into the bloodstream once every one to three weeks.
Herceptin is called a targeted therapy because it targets HER2-positive breast cancers—cancers that make too much of the HER2/neu gene or HER2 protein. Herceptin is also called an immune treatment because it is made of an immune system–like antibody that blocks the HER2 protein in cancer cells. Blocking the protein helps stop the growth of HER2-positive cancer cells.
About one out of every four breast cancers is HER2-positive. HER2-positive breast cancers tend to be more aggressive than HER2-negative breast cancers.
Herceptin is only given to women with HER2-positive breast cancer.
The makers of Herceptin plan to ask the FDA to approve its use for women with early-stage breast cancer. The warning about heart problems will be included with the medication instructions. It will advise doctors to thoroughly evaluate all of a woman's risk factors for heart disease before giving her Herceptin to treat early-stage breast cancer
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What breastcancer.org says about this article…
FDA Tells Doctors About Potential Heart Problems with Herceptin
If you have just had surgery for HER2-positive, early-stage breast cancer, you and your doctor now may be considering medicines to reduce your risk of recurrence. It's important for you to discuss the possible role of chemotherapy and Herceptin in your treatment. If you have any heart disease risk factors, make sure you and your doctor talk about them in detail.These are risk factors for heart disease:
- having high cholesterol,
- having high blood pressure,
- smoking cigarettes,
- having diabetes,
- being overweight, and
- having a family history of heart disease.
Before you start chemotherapy and Herceptin, your doctor will test the strength of your heart with a MUGA scan. This test might also be repeated during treatment to make sure your heart is still strong. If weakening of the heart is detected, a change in therapy may be recommended. Usually, the heart can regain its strength once the treatment has been stopped.
Remember that every woman reacts differently to treatment. It's very important to find the right combination that you're comfortable with and that works best for YOU.
Visit Breastcancer.org often to learn about the very latest on Herceptin research.