Phase III clinical trial evaluating survival benefits of sequential versus concurrent docetaxel in doxorubicin-based chemotherapy in node-positive breast cancer patients

This phase III clinical trial evaluated the survival benefits after the addition of docetaxel into doxorubicin-based chemotherapy in node-positive breast cancer patients.

Node-positive breast cancer means that the cancer has spread to the lymph nodes near the breast such as under the arm or above the collarbone. Women diagnosed with this stage of breast cancer often need surgery and chemotherapy for an effective treatment. The most common chemotherapy agents used for breast cancer are CMF (cyclophosphamide or C, methotrexate, 5-fluorouracil), doxorubincine (Adriamycin or A) and docetaxel (Taxotere or T). This 8-year long phase III clinical trial attempted to find out the effect of including T into A/CMF-based chemotherapy on survival.

Overall, 2887 women with node-positive breast cancer participated in this study. Apart from the classic 3 cycles of CMF, patients were randomly assigned to one of four treatment options: first group (group A), four cycles of A followed by CMF, second group (group AC) – four cycles of A plus C followed by CMF, third group (group A-T or sequential T) – three cycles of A followed by T, followed by CMF and the forth group (group TA or concurrent T) – four cycles of T plus A followed by CMF. The main parameters measured were disease free survival (defined as the percentage of patients who were cured of the disease) and overall survival (defined as the percentage of patients who have survived for a certain period of time). 

After approximately 8 years of follow up, patients treated with sequential T had a 19% improvement in disease free survival compared to patients in the A group. Also, sequential T was better than concurrent T, patients in the sequential T group having a 16% higher disease free survival and 21% higher overall survival compared to patients in the concurrent T group.  

In summary, the addition of T after A therapy significantly improved survival rates when compared to simultaneous dosing of both drugs in node-positive breast cancer patients.

This study was funded by Sanofi-Aventis, the manufacturer of Taxotere.