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www.fdanews.com/articles/83031-two-types-of-breast-cancer-treatments-show-benefit

TWO TYPES OF BREAST CANCER TREATMENTS SHOW BENEFIT

December 9, 2005

Results from a clinical trial comparing the effectiveness of the drugs paclitaxel and docetaxel, delivered over two different dosing schedules, showed that both drugs -- regardless of the dosing schedules tested in this trial -- provided similar benefits for women with Stage II or III, operable breast cancer. However, more women treated with docetaxel than with paclitaxel experienced serious side effects from their treatment.

The trial was led by the Eastern Cooperative Oncology Group in Boston, Mass.

Paclitaxel and docetaxel are members of a class of drugs called taxanes, and both are approved for the treatment of patients with breast cancer that has spread to the lymph nodes. Although these drugs have been shown to be beneficial in treating breast cancer, this is the first time they have been directly compared and the first time that a weekly dosing schedule has been compared with a standard every three-week dosing schedule in the treatment of early-stage breast cancer.

A total of 4,988 women were enrolled in the trial between 1999 and 2002. All of the women had axillary lymph node (a lymph node in the armpit region that drains lymph channels from the breast) positive or high-risk (their tumor was at least 2 cm in size) node-negative breast cancer. All of the women were first treated with doxorubicin and cyclophosphamide, a standard treatment protocol referred to as AC (representing the drugs doxorubicin and cyclophosphamide). Following AC chemotherapy, patients were randomly assigned to groups that received either paclitaxel or docetaxel, administered weekly for 12 weeks or every third week over a 12-week period.