Women with early-stage breast cancer treated with a docetaxel(Drug information on 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(Drug information on doxorubicin) [Adriamycin], cyclophosphamide(Drug information on 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.
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