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Taxotere and Herceptin Reduces Recurrence of Early-Stage Breast Cancer
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Taxotere and Herceptin Reduces Recurrence of Early-Stage Breast Cancer
This study supports the benefits of Herceptin for women with early-stage, HER2-positive cancer that have been seen in earlier studies. When compared to chemotherapy alone, Herceptin plus chemotherapy lowers the risk of the cancer coming back for women with early-stage, HER2-positive breast cancer after surgery.But there are also several questions about the study.
Why these drugs? The drug regimens used in this study are not standard in the United States. So even though these new regimens seem to benefit women with early-stage breast cancer, the researchers didn't compare the new regimens to the current standard of care.
In the United States and other parts of Europe, Herceptin is usually given AFTER chemotherapy, every three weeks for one year. In this study, Herceptin was given after Taxotere or Navelbine, but BEFORE the FEC combination, and only for nine weeks.
Several things were being studied for the first time. This is the first time Navelbine and Taxotere were compared for their effectiveness in treating women with early-stage breast cancer. This is also the first time Herceptin was given for only nine weeks. And it's also the first time Herceptin was given before chemotherapy (the FEC combination). So it's hard to know which one of all these changes made the biggest difference.
Herceptin may cause heart problems. In this study, there were no heart problems in the women who took Herceptin. But this may be because Herceptin was given for only nine weeks, and the women were only followed for three years. Longer follow-up is needed to see if any heart side effects happen later.
Until research directly compares the difference in benefits between giving Herceptin for a short time, as was done in this study, and the longer standard dose, we don't know if risks and benefits are equal for both.
The FDA is reviewing the results of all the studies on Herceptin, carefully weighing the benefits of Herceptin against the side effects in deciding whether to approve Herceptin for women with early-stage breast cancer.
Finding an effective treatment for HER2-positive breast cancer is especially important because this kind of cancer tends to be more aggressive than HER2-negative disease. Still, while the results on Herceptin are very positive and encouraging, it's important to keep in mind that these are early results. The researchers plan to follow the women for much longer to look at their long-term survival and risk of recurrence.
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.
Reviewed study: "Taxotere and Herceptin Reduces Recurrence of Early-Stage Breast Cancer" by Heikki Joensuu and others, The New England Journal of Medicine, February 23, 2006
Is this for me? If you have been diagnosed with early-stage, HER2-positive breast cancer and will need chemotherapy after surgery, you might want to read this article.
Background and importance of the study: Herceptin (chemical name: trastuzumab) is approved by the U.S. Food and Drug Administration (FDA) to treat women with metastatic (advanced), HER2-positive breast cancer. Herceptin has a solid track record in helping women with advanced disease. So researchers are interested in exploring the possible benefits of Herceptin for other women: those with early-stage, HER2-positive breast cancer.
Taxotere (chemical name: docetaxel) is a commonly used drug for women with breast cancer. Taxotere can be more effective than other chemotherapy drugs, with fewer serious side effects.
Taxotere is approved by the FDA for use by women with lymph node-positive breast cancer after initial surgery. Navelbine (chemical name: vinorelbine) is a chemotherapy drug that is used to treat breast cancer that has returned or spread. Both Taxotere and Navelbine have been used in combination with Herceptin to treat women with advanced, HER2-positive breast cancer.
In 2005, several studies demonstrated that Herceptin plus chemotherapy was able to reduce the risk of recurrence (the cancer coming back) by about 50% in women with early-stage, HER2-positive breast cancer.
In the study reviewed here, researchers wanted to see if Taxotere or Navelbine would lengthen disease-free survival (the length of time without the cancer coming back) for women with EARLY-STAGE breast cancer. They also wanted to see if Herceptin given after either Taxotere or Navelbine would lengthen disease-free survival for women who had HER2-positive cancer. And they also wanted to see if side effects were different for the different drug combinations.
Study design: This study looked at 1,010 women, ages 25 to 65, who were diagnosed with early-stage breast cancer with either positive lymph nodes or negative lymph nodes that measured at least 20 millimeters (just under an inch). Some women had mastectomy, and others had lumpectomy. The women were separated into two groups according to their HER2 status:
- 778 women had HER2-negative cancer, and
- 232 women had HER2-positive cancer.
The women with HER2-negative cancer were randomly assigned to one of two groups:
- About half the women received Taxotere for three cycles, followed by three cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC).
- The other half received Navelbine for three cycles, followed by three cycles of FEC.
The women with HER2-positive cancer were randomly assigned to one of four groups, with about a quarter receiving:
- Taxotere for three cycles, then three cycles of FEC, or
- Taxotere for three cycles, then Herceptin for nine weeks, then three cycles of FEC, or
- Navelbine for three cycles, then three cycles of FEC, or
- Navelbine for three cycles, then Herceptin for nine weeks, then three cycles of FEC.
The study began in 2000 and ended in 2003. In 2002, an independent committee monitoring the study recommended reducing the amount of Taxotere given to the women because 40% of the women receiving Taxotere had been diagnosed with neutropenic fever. This type of fever is due to a low white blood cell count, which was caused by Taxotere.
The women who had lumpectomy received radiation after chemotherapy. Women who had hormone-receptor-positive cancer received tamoxifen for five years.
The women were followed for about three years after their initial treatment.
The study was funded by the Finnish Breast Cancer Group and is known as the Fin/Her study.
Results: The researchers found that in women with early-stage breast cancer, Taxotere significantly improved disease-free survival, compared to Navelbine. This means the difference is likely due to Taxotere and not just to chance. Women who received Taxotere also had significantly fewer distant metastases (the cancer coming back in a different part of the body) than women who received Navelbine. But overall survival was not significantly different between the two groups—both groups of women lived equally as long.
Compared to women with HER2-positive cancer who did not receive Herceptin, those who did:
- had significantly improved disease-free survival,
- had significantly fewer distant metastases, and
- had better overall survival (but this difference was not significant, so the difference could have been due to chance).
Women who received Taxotere had more neutropenia (low white blood cell count), allergic reactions, neuropathy (tingling and numbness in the nerves), and swelling. Women who received Navelbine had more blood clots. Women who also took Herceptin did not have significantly more adverse effects than those who did not. None of the women who received Herceptin had heart problems during the time of the study. (Earlier studies have suggested that Herceptin is associated with cardiac problems.)
Conclusions: The researchers concluded that Taxotere improved disease-free survival (the length of time until the cancer comes back) in women with early-stage breast cancer, compared to Navelbine. But Taxotere caused more severe side effects than Navelbine and did not improve overall survival (how long women live, with or without disease).
In women with early-stage, HER2-positive breast cancer, Herceptin improved disease-free survival. Herceptin did not cause any heart problems during the time of the. But follow-up was short, so conclusions are early and preliminary.