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Node-Negative Early Stage Breast Cancer Patients Benefit from Taxotere(R)-Based Chemotherapy
Date:5/27/2008

s 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.

About the Study

The GEICAM 9805/Target-0 trial was initiated as a complementary study to BCIRG 001/TAX 316, a study that enrolled women with node-positive early stage breast cancer.

From December 2001 to March 2003, 1059 patients aged 18-71, with T1-T3, N0, M0 operable breast cancer and at least one high-risk St Gallen 1998 criterion (patient age <35 years, tumor grade II/III, tumor size >2 cm, or hormone-receptor negative tumor) were enrolled in the study; 1047 patients were eligible. Patients from Spain as well as Germany and Poland were stratified by institution and menopausal status and randomized after surgery to receive either TAC (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2) or FAC (5-fluorouracil 500 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2) every 3 weeks for 6 cycles. Radiotherapy was mandatory after conservative surgery and recommended for patients with tu
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SOURCE sanofi-aventis
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