A clinical trial showed that post-surgery treatment with docetaxel injection concentrate as part of the TAC (Taxotere, anthracycline, cyclophosphamide) treatment regimen improves the disease-free survival of women with high-risk, node-negative, early-stage breast cancer compared to the standard treatment of FAC regimen (5-fluorouracil, anthracycline, cyclophosphamide).
The trial, GEICAM (Grupo Espanol de Investigacionen Cancer de Mama) 9805/Target-0 which begun in 2003, is the first taxane-based study to exclusively enroll women with node-negative, early-stage breast cancer considered to be at high risk for recurrence.
It enrolled 1,059 women who were randomized to receive either TAC or FAC after surgical resection of their tumors.
Analysis of efficacy, determined by disease free survival, was performed after a minimum five years of follow-up.
The study showed that more women were alive and disease-free with TAC (91 percent) compared to FAC (86 percent).
This result was presented during the 2008 annual American Association of Clinical Oncology conference held in Chicago recently.
“First of all, I would like to congratulate the patients and my fellow investigators for having the courage to participate in this innovative trial in a purely node-negative patient population. This study showed that the TAC regimen improves disease-free survival in women with high-risk, node-negative breast cancer,” said Prof. Miguel Martin, GEICAM chairman and principal investigator of the 9805 study.
The result of this study will significantly improve the treatment of breast cancer, which is the most common cancer among women and the second most common after lung cancer in both genders.
More than one million new cases of breast cancer are reported worldwide annually and more than 400,000 women die each year from the disease.
It is estimated that worldwide more than 300,000 women per year will be diagnosed with early-stage breast cancer.