Women with early-stage breast cancer treated with a
docetaxel (Taxotere)-based regimen after surgery had a 32% less chance of
developing disease recurrence than did women receiving one of the most effective
adjuvant treatments currently available. Results from the Breast Cancer
International Research Group (BCIRG) trial 001, the first phase III trial to
evaluate docetaxel after breast surgery, were presented at the recent annual
meeting of the American Society of Clinical Oncology (ASCO) by the BCIRG.

Benefits Favor One Group

In the analysis of the study, women were divided into two groups—those with
one to three positive lymph nodes and those with four or more. The most
significant benefit from the use of docetaxel was seen in women with one to
three positive lymph nodes. Among these women, treatment with docetaxel reduced
the risk of relapse by 50% and the mortality rate by 54%. Women with one to
three positive lymph nodes account for 60% to 70% of all women worldwide with
node-positive early-stage breast cancer.

"The superior results observed with the docetaxel-based regimen indicate
that it can potentially cure more women than one of the best chemotherapies we
have," said Jean-Marc Nabholtz, MD, chairman of the BCIRG, study chairman,
professor of medicine at the University of California at Los Angeles (UCLA), and
director of the Cancer Therapy Development Program at the Jonsson Comprehensive
Cancer Center at UCLA. "Although early, these results should be considered
when choosing therapy for a large number of women with early breast
cancer."

Study Demographics

The BCIRG 001 study was designed to determine whether docetaxel would also
benefit women with early-stage disease. After surgery, study participants
received either the TAC regimen (docetaxel, doxorubicin [Adriamycin],
cyclophosphamide [Cytoxan, Neosar]) or the standard FAC regimen (fluorouracil,
doxorubicin, cyclophosphamide). Of the 1,491 women enrolled in the study, 745
were randomized to the TAC arm and 746 to the FAC arm.

Nearly 3 years after treatment, study results show that 82% of patients in
the TAC arm and 74% in the FAC arm were alive and disease-free. For those
treated with TAC, this represents a significant improvement in disease-free
survival and a 32% reduction in the risk of recurrence (P = .0011)
compared to those treated with FAC. In addition, women in the TAC arm had nearly
a 50% less chance of developing a metastatic relapse.