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BRIDGEWATER, N.J. (Map) -
The results will be presented at the 2008 annual meeting of the American
Society of Clinical Oncology, ASCO, in
In
The 1059 women enrolled in this multicenter, phase III study were randomized to receive either TAC (n=539) or FAC (n=520) 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.
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
The primary end-point was DFS with analysis planned after a minimum follow-up of 5 years.
The full safety analysis has previously been published (Martin et al (2006), Ann Oncol 17: 1205-12). The analysis demonstrated that febrile neutropenia (grade 4) was the most common and clinically severe event (24.6%) reported with the TAC regimen. The incidence of febrile neutropenia decreased to 6.5% with the use of G-CSF from the first cycle of TAC. The incidence of febrile neutropenia among patients treated with FAC was 2.3%. Grade 2-4 anemia was higher in the TAC regimen (47.4%) vs FAC (7.5%). The incidence of anemia TAC decreased (27.5%) with the use of G-CSF. No toxic deaths were reported.
About Breast Cancer
According to the American Cancer Society, worldwide, breast cancer is the most common cancer in 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.
In
According to the American Cancer Society, in general, breast cancer rates have risen about 30% in the past 25 years in western countries. In addition, the incidence is highest in western countries. This appears to be due to increased screening which detects breast cancer in earlier stages.
About GEICAM
GEICAM (Grupo Espanol de Investigacion en Cancer de Mama) is a Spanish non-profit scientific cooperative group fully devoted to breast cancer. GEICAM is comprised of oncologists who belong to the Spanish Society of Medical Oncology (SEOM) and of other health professionals related to breast cancer research and treatment. The main GEICAM objectives are to promote basic, epidemiological and clinical research, and to provide education to doctors and patients and dissemination of information in the field of breast cancer to the Spanish general population.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in
Forward Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include financial projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations with
respect to future events, operations, products and services, and statements
regarding future performance. Forward-looking statements are generally
identified by the words "expects," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions. Although sanofi-aventis'
management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties,
many of which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include those discussed or identified in the public filings with the SEC and
the AMF made by sanofi-aventis, including those listed under "Risk Factors"
and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended
Contact: Stephanie Stamatakou, sanofi-aventis U.S., 908-981-6127, Stephanie.stamatakou@sanofi-aventis.com Abstract # 542
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