Taxotere Added to Standard Chemotherapy Reduces Risk of Recurrence

Reviewed study: "Taxotere Added to Standard Chemotherapy Reduces Risk of Recurrence" by H. Roche et al., San Antonio Breast Cancer Symposium, December 2004, Abstract #27

Background and importance of the study: Taxotere (chemical name: docetaxel) is an important and commonly used drug for women with breast cancer that has returned or spread after chemotherapy. Taxotere can be more effective than other chemotherapy drugs, with fewer serious side effects.

In August 2004, Taxotere was approved by the U.S. Food and Drug Administration for use by women with node-positive breast cancer after initial surgery.

Before the FDA approval, a number of studies had been underway to examine what role Taxotere might play in combination with other chemotherapies for women with node-positive disease. The study reviewed here addressed the following questions:

• Does adding Taxotere to FEC chemotherapy improve outcome?
• Does adding Taxotere to FEC provide extra benefit to women of any age and the extent of lymph node involvement?

This study looked at how Taxotere used with the FEC chemotherapy regimen (5-fluorouracil, epirubicin, and cyclophosphamide) might lower the risk of recurrence in women with node-positive breast cancer. In this regimen, chemotherapy was given after surgery.

Study design: In this French study of 1,999 women, with node-positive breast cancer, all women received chemotherapy:

• Half received six cycles of FEC.
• Half had three cycles of FEC followed by three cycles of Taxotere.

Other treatments were also given, depending on the woman's particular situation. Women who had lumpectomies received radiation therapy for four weeks following the last chemotherapy cycle. Those women with hormone-receptor-positive breast cancer took tamoxifen for five years.

After five years, the researchers compared the two groups of women in two ways:

• how many women were alive without the cancer coming back (which is called disease-free survival), and
• how many women were alive (which is called overall survival).

Study results: The researchers found that disease-free survival was improved by 5%, and overall survival by 4%, for women who took Taxotere and FEC. These differences were statistically significant, which means they were most likely due to the effect of the chemotherapy regimen and not due to chance. When the researchers looked at the age and lymph node status of the two groups of women, they found that the combination of Taxotere and FEC seemed only to add benefit beyond just FEC in women 50 years or older with fewer than four positive nodes.

The researchers also saw differences in side effects:

• Heart problems were more common in the group of women who took only FEC (13%), compared to the group who took Taxotere and FEC (4%).

Conclusion: Adding Taxotere to FEC treatment appears to further lower the risk of having breast cancer return and improve survival chances. Heart problems were less common among the women who took Taxotere and FEC compared to those who took FEC only.

The researchers tried to figure out if there were other reasons, besides age and lymph node status, why women who took Taxotere and FEC did better than the women who took FEC only. They discovered that there were more women with hormone-receptor-positive disease in the group of women who took Taxotere and FEC. This type of cancer tends to respond less well to chemotherapy than hormone-receptor-negative disease. But overall, women with hormone-receptor- positive disease tend to have a better outcome because these kind of cancers tend to be less aggressive by nature. And these women also took tamoxifen, which adds another layer of protection over time. It's unclear if these differences are enough to explain the better outcome for the women who took Taxotere and FEC. More studies are needed to figure this out.

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