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Chemotherapy Regimen Shows Promise in Early Stage Breast Cancer Patients (dateline March 21, 2004)

The drug docetaxel (brand name, Taxotere) may be a more effective chemotherapy drug for women with early stage breast cancer than a commonly used regimen, according to results of a study presented in December at the San Antonio Breast Cancer Symposium. In the study, women who were treated with a docetaxel-based chemotherapy regimen (TAC) were less likely experience a recurrence of breast cancer or die than women treated with a fluorouracil regimen (FAC). Aventis, the maker of Taxotere, plans to apply for FDA approval in early 2004 to use docetaxel in early stage breast cancer patients whose cancer has spread to the nearby lymph nodes

Chemotherapy involves using anticancer drugs to help control or prevent the growth of cancerous tumors. Chemotherapy is often used as an adjuvant (supplemental) therapy in addition to other treatments, such as surgery or radiation therapy, which are designed to achieve local (breast/chest) control of the cancer.

In the study, researcher John Mackey, M.D., Chair of the Northern Alberta Breast Cancer Program at the Cross Cancer Institute in Edmonton, Canada, and colleagues compared the combination of Taxotere, doxorubicin (brand name, Adriamycin) and cyclophosphamide (brand name, Cytoxan), (TAC), with the standard regimen of 5-fluorouracil, doxorubicin and cyclophosphamide, (FAC).

Between June 1997 and June 1999, the researchers enrolled 1,491 pre-menopausal and post-menopausal women with early-stage breast cancer from 112 centers in 20 countries. After being treated with surgery, each woman was randomly assigned to receive chemotherapy with either the TAC or FAC regimen.

The results of the study showed that, five years after treatment, the women treated with the docetaxel regimen (TAC) had a 28% lower risk of a breast cancer recurrence than the women treated with the fluorouracil regimen (FAC). Furthermore, the researchers found a 30% reduction in the risk of death among the women treated with the Taxotere-based regimen.

"The results of this study suggest that we may be able to cure more women with early-stage disease by providing them a highly effective adjuvant chemotherapy regimen," said Dr. Mackey, in an Aventis news release.

Breast cancer patients who undergo chemotherapy may be given one drug or a combination of two or more drugs during treatment. Most physicians believe that combination chemotherapy (administering two or more drugs) is most effective for breast cancer patients because combination therapy has been shown to provide better cancer cell control with lower doses of individual drugs. With combination chemotherapy, better results may be achieved while causing fewer of the side effects associated with higher doses of an individual drug. At this time, there are over 90 chemotherapy drugs used to treat different types of cancer.

The current study did not unveil any new safety concerns with docetaxel. Possible side effects of docetaxel include:

  • Decrease in white blood cells (leukopenia)
  • Fever (often a warning sign of infection)
  • Fluid retention
  • Allergic reactions
  • Hair loss

A chemotherapy regimen is usually tailored specifically to the breast cancer patient.

Additional Resources and References

  • The December 5, 2003 news release by Aventis, "Second Interim Analysis to Support U.S. and EU Registrational Submissions for Adjuvant Breast Cancer," is available at
  • The study, "TAC Improves Disease Free Survival and Overall Survival Over FAC in Node Positive Early Breast Cancer Patients, BCIRG 001: 55 Months Follow-Up," was presented at the December 2003 San Antonio Breast Cancer Symposium,
  • To learn more about chemotherapy, please visit