Docetaxel-based regimen improves survival and disease-free survival, data show.

2004 JAN 1 - (NewsRx.com & NewsRx.net) -- A docetaxel (Taxotere)-based regimen reduced the relative risk of death in women with early stage breast cancer by 30% and lowered the relative risk of the cancer returning by 28% when compared to a standard adjuvant (post-surgery) regimen after 55-month follow-up, data show.

The results of BCIRG 001, the first Phase III study evaluating Taxotere after breast surgery, were presented at the San Antonio Breast Cancer Symposium (SABCS) by the Breast Cancer International Research Group (BCIRG) on December 5, 2003.

"Taxotere continues to demonstrate its effectiveness across various stages of breast cancer, and this study indicates that women with early stage breast cancer and their physicians should seriously consider a Taxotere-based treatment, like the TAC regimen tested in the BCIRG 001 trial, to significantly prolong disease-free survival and survival," said Miguel Martin MD, from the Medical Oncology Department, Hospital Universitario San Carlos, Madrid, Spain, chairman of GEICAM.

The BCIRG 001 study was designed to determine if Taxotere, one of the most active agents in advanced breast cancer, would also have benefits for women with early stage disease. Study participants received either a post-surgery regimen of Taxotere, doxorubicin (Adriamycin), and cyclophosphamide (Cytoxan), known as TAC, or the widely used standard regimen of 5-fluorouracil, doxorubicin, and cyclophosphamide, known as FAC. BCIRG 001 enrolled 1,491 pre- and postmenopausal women with early breast cancer at 111 sites in 20 countries; 745 patients were randomized to receive TAC and 746 to receive FAC.

The study was designed to perform analyses on subgroups of women based on hormonal receptor status (hormone-receptor-positive or hormone-receptor-negative tumors) and nodal involvement (1-3 or 4+ axillary lymph nodes). Tumor samples were prospectively collected for 95% of the patients. Hormonal receptor status, Her2neu amplification (FISH), as well as other tumor characteristics were centrally reviewed by an independent pathologist.

At 5 years' follow-up, 75% of patients on TAC and 68% of patients on FAC were disease-free. This corresponds to a 28% reduction in the relative risk of recurrence (p=0.0010). This also resulted in a survival advantage for patients treated with TAC. Eighty-seven percent of patients on TAC and 81% of patients on FAC were alive, which represents a 30% reduction in relative risk of mortality (p=0.0080) in favor of TAC patients.

The significant benefits in favor of the Taxotere arm were observed in both hormone-receptor-positive (HR+) and hormone-receptor-negative (HR-) patients, with a reduction in the recurrence of disease of 27% and 34%, respectively. A significant disease-free survival benefit was also observed independent of Her2neu expression.