Long-Term Results Show Herceptin Offers More Benefits Than Risks for Early-Stage Breast Cancer

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Herceptin (chemical name: trastuzumab) is a targeted therapy medicine used to treat HER2-positive breast cancer.

Large studies have confirmed that adding Herceptin to chemotherapy to treat women diagnosed with early-stage, HER2-positive breast cancer improves overall survival and disease-free survival compared to chemotherapy alone.

Overall survival is how long a woman lives, with or without the cancer growing. Disease-free survival is how long a woman lives without the cancer growing.

Heart problems, including heart muscle damage and heart failure, are possible side effects of Herceptin. So doctors wanted to know if treating early-stage, HER2-positive breast cancer with Herceptin caused long-term heart problems or if the problems went away after women stopped being treated with Herceptin.

A study has found that women diagnosed with early-stage, HER2-positive breast cancer are only slightly more likely to have heart problems if they’re treated with Herceptin and that any heart problems that developed went away in most women.

The study was published online on Sept. 21, 2015 by the Journal of Clinical Oncology. Read the abstract of “Long-Term Cardiac Safety Analysis of NCCTG N9831 (Alliance) Adjuvant Trastuzumab Trial.”

HER2-positive breast cancers make too much of the HER2 protein. The HER2 protein sits on the surface of cancer cells and receives signals that tell the cancer to grow and spread. About one out of every four breast cancers is HER2-positive. HER2-positive breast cancers tend to be more aggressive. Before medicines were developed that targeted the HER2 protein, HER2-positive breast cancers were harder to treat than HER2-negative cancers.

Herceptin works by attaching to the HER2 protein and blocking it from receiving growth signals. Herceptin, which is given intravenously, is approved by the U.S. Food and Drug Administration to:

  • treat advanced-stage, HER2-positive breast cancers
  • be given to women with earlier stages of HER2-positive disease as adjuvant treatment (treatment after initial treatment, such as surgery) either alone or as part of a regimen with chemotherapy

In this study, called the NCCTG N9831 trial, nearly 2,000 women diagnosed with early-stage, HER2-positive breast cancer were treated with the chemotherapy medicines Adriamycin (chemical name: doxorubicin) and Cytoxan (chemical name: cyclophosphamide) after surgery. This chemotherapy combination is called AC. After the AC combination was completed, the women were randomly assigned to receive one of three treatments:

  • Taxol (chemical name: paclitaxel) every week for 12 weeks
  • Taxol every week for 12 weeks followed by Herceptin every week for 1 year
  • Taxol plus Herceptin every week for 12 weeks followed by 40 weeks of Herceptin alone

In 2011, the researchers reported that after 4 years of follow-up:

  • 0.3% of the women treated with Taxol alone after AC chemotherapy had heart problems
  • 2.8% of the women treated with Taxol first then Herceptin had heart problems
  • 3.3% of the women treated with Taxol and Herceptin at the same time had heart problems

In this latest report, the researchers now have about 9 years of follow-up information. They found:

  • 0.6% of the women treated with Taxol alone after AC chemotherapy had heart problems
  • 2.8% of the women treated with Taxol first then Herceptin had heart problems
  • 3.4% of the women treated with Taxol and Herceptin at the same time had heart problems

In the 5 years since the first report, only two more women were diagnosed with chronic heart failure out of more than 1,000 women treated with Herceptin. Most of the women who were diagnosed with heart function problems in the first 4 years recovered.

Women who were 60 or older, who had existing heart function problems, and who took high blood pressure medicine were more likely to have heart problems if they were treated with Herceptin.

If you’ve been diagnosed with early-stage, HER2-positive breast cancer, it’s likely that Herceptin will be part of your treatment plan after surgery. If it is, it’s a good idea to ask your doctor about your personal risk of treatment-related heart problems, especially if you’re older than 60, have been diagnosed with high blood pressure, or have existing heart problems. You also may want to ask your doctor if visiting a cardiologist before treatment starts is a good idea for you. The cardiologist can evaluate your heart function and decide if you’re at high risk for developing heart disease or heart failure from breast cancer treatment. You also may want to ask your oncologist how your heart function will be monitored during treatment.

Together, you can decide on the best treatment plan for your unique situation.

For more information on Herceptin, including what to expect when you’re being treated with it, visit the Breastcancer.org Herceptin pages.



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