Node-Negative Early Stage Breast Cancer Patients Benefit From Taxotere-Based Chemotherapy

June 5, 2008

Sanofi-aventis and GEICAM (Grupo Espanol de Investigacion en Cancer de Mama) announced that for women with high-risk node-negative early stage breast cancer adjuvant treatment (post surgery) with Taxotere(R) (docetaxel) Injection Concentrate as part of the TAC regimen (Taxotere(R), doxorubicin, cyclophosphamide) was associated with a significant improvement in Disease Free Survival (DFS) compared to a standard FAC regimen (5-Fluorouracil, doxorubicin, cyclophosphamide) in the GEICAM 9805/Target-0 study.

The results will be presented at the 2008 annual meeting of the American Society of Clinical Oncology, ASCO, in Chicago (Monday June 2, 2008, 2-6 pm, poster number 1D, abstract 542).

In Europe and North America, most breast cancer patients are diagnosed at an early stage, before the tumor has spread to the lymph nodes. However, few clinical trials in the past were dedicated exclusively to this population of patients. GEICAM 9805/Target-0 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. High risk patients were defined as having at least one of the following St Gallen 1998 criteria: patient's age 2 cm, or hormone-receptor (estrogen and/or progesterone receptor) negative tumor.

The 1059 women enrolled in this multicenter, phase III study were randomized to receive either TAC (nS9) or FAC (nR0) after surgical resection of their tumor. Therapy was given every three weeks for a total of 6 cycles. The primary end point was Disease Free Survival (DFS) and secondary end points included overall survival (OS), safety, and quality of life.

Analysis of efficacy, determined by DFS, was performed after a minimum of 5-years of follow up. The study showed a significant improvement in 5-year DFS that was demonstrated in the TAC arm over the FAC arm, with 91% and 86% patients, respectively, alive and disease free (HR 0.66, 95% CI 0.46-0.94, p=0.0202). The OS data are immature; estimated 5-year OS is 97% for TAC and 95% for FAC (HR 0.72, 95% CI 0.40-1.30, p=0.2677). The safety results have been already published (Martin et al (2006), Ann Oncol 17: 1205-12) TAC produced significantly more hematological adverse reactions than FAC. Primary prophylaxis with G-CSF reduced the rate of neutropenic fever. No toxic deaths were reported.

"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 GEICAM Chair and principal investigator of the 9805 study, Prof. Miguel Martin.

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