Keep God Weird

First Phase three survey performed solely in high hazard node-negative
population to demo important improvement in Disease Free Survival (DFS) BRIDGEWATER, N.J., May 27 /PRNewswire-FirstCall/ -- Sanofi-aventis and
GEICAM (Grupo Espanol Delaware Investigacion en Cancer Delaware Mama) announced today
that for women with high-risk node-negative early phase breast cancer
adjuvant treatment (post surgery) with Taxotere(R) (docetaxel) Injection
Concentrate as portion of the TAC regimen (Taxotere(R), doxorubicin,
cyclophosphamide) was associated with a important improvement in Disease
Free Survival (DFS) compared to a criterion FAC regimen (5-Fluorouracil,
doxorubicin, cyclophosphamide) in the GEICAM 9805/Target-0 study. The consequences will be presented at the 2008 yearly meeting of the
American Society of Clinical Oncology, ASCO, in Windy City (Monday June 2,
2008, 2-6 pm, posting figure 1D, abstract 542). In Europe and North America, most breast malignant neoplastic disease patients are diagnosed
at an early stage, before the tumour have distribute 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 inscribe women with node-negative early phase breast
cancer considered to be at high hazard for recurrence. High hazard patients
were defined as having at least one of the followers St Gallen 1998
criteria: patient's age 2 cm, or hormone-receptor (estrogen and/or Lipo-Lutin receptor)
negative tumor. The 1059 women enrolled in this multicenter, form three survey were
randomized to have either TAC (n=539) or FAC (n=520) after surgical
resection of their tumor. Therapy was given every three hebdomads for a total
of 6 cycles. The primary end point was Disease Free Survival (DFS) and
secondary end points included overall endurance (OS), safety, and quality of
life. Analysis of efficacy, determined by DFS, was performed after a minimum
of 5-years of follow up. The survey showed a important 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 information are immature; estimated 5-year os is 97%
for TAC and 95% for FAC (HR 0.72, 95% curie 0.40-1.30, p=0.2677). The safety
results have got been already published (Martin et aluminum (2006), Ann Oncol 17:
1205-12) TAC produced significantly more than hematological harmful reactions
than FAC. Primary prophylaxis with G-CSF reduced the charge per unit of neutropenic
fever. No toxic deceases were reported. "First of all, I would wish to compliment the patients and my fellow
investigators for having the courageousness to take part in this innovative
trial in a purely node-negative patient population. This survey showed that
the TAC regimen betters 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 complemental study
to BCIRG 001/TAX 316, a survey 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 malignant neoplastic disease and at least one high-risk St Gallen 1998
criterion (patient age 2 cm, or
hormone-receptor negative tumor) were enrolled in the study; 1047 patients
were eligible. Patients from Kingdom Of Spain as well as Federal Republic Of Germany and Republic Of Poland were
stratified by establishment and menopausal position and randomized after
surgery to have either TAC (docetaxel 75 mg/m2, doxorubicin 50 mg/m2,
cyclophosphamide Five Hundred mg/m2) or FAC (5-fluorouracil 500 mg/m2, doxorubicin
50 mg/m2, cyclophosphamide 500 mg/m2) every 3 hebdomads for 6 cycles. Radiotherapy was compulsory after conservative surgery and recommended for
patients with tumours > 5 cm; estrogen antagonist was given for 5 old age to all
patients with endocrine antiphonal tumors. A survey amendment initiated
during registration mandated the usage of G-CSF with the first rhythm of TAC, in
order to cut down the relative incidence and badness of hematological toxicities and
febrile neutropenia. The primary end-point was DFS with analysis planned after a minimum
follow-up of 5 years. The full safety analysis have 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 terrible event
(24.6%) reported with the TAC regimen. The relative incidence of febrile neutropenia
decreased to 6.5% with the usage of G-CSF from the first rhythm of TAC. The
incidence of febrile neutropenia among patients treated with FAC was 2.3%. Class 2-4 anaemia was higher in the TAC regimen (47.4%) volts FAC (7.5%). The
incidence of anaemia TAC decreased (27.5%) with the usage of G-CSF. No toxic
deaths were reported. About Breast Cancer According to the American Cancer Society, worldwide, breast malignant neoplastic disease is
the most common malignant neoplastic disease in women and the 2nd most common after lung
cancer in both genders. More than one million new lawsuits of breast cancer
are reported worldwide annually and more than than 400,000 women decease each year
from the disease. In Europe, breast malignant neoplastic disease is responsible for 27.3% of all new cancer
cases among women and 20.22% of malignant neoplastic disease deaths. The International Agency for
Research in Cancer estimations that in 2004 there were 360,749 new breast
cancer lawsuits diagnosed while the figure of deceases was 129,013. According to the American Cancer Society, inch general, breast cancer
rates have got risen about 30% in the past 25 old age in western countries. In
addition, the relative incidence is highest in western countries. This looks to be
due to increased showing which detects breast malignant neoplastic disease in earlier stages. About GEICAM GEICAM (Grupo Espanol Delaware Investigacion en Cancer Delaware Mama) is a Spanish
non-profit scientific co-op grouping fully devoted to breast cancer. GEICAM is comprised of oncologists who belong to the Spanish Society of
Medical Oncology (SEOM) and of other wellness people related to breast
cancer research and treatment. The chief GEICAM aims are to promote
basic, epidemiological and clinical research, and to supply instruction to
doctors and patients and airing of information in the field of
breast malignant neoplastic disease to the Spanish full general population. About sanofi-aventis Sanofi-aventis, somes prima planetary pharmaceutical company, discovers,
develops and administers curative solutions to better the lives of
everyone. Sanofi-aventis is listed in City Of Light (EURONEXT PARIS: SAN) and in
New House Of York (NYSE: ). Forward Looking Statements This fourth estate release incorporates forward-looking statements as defined in
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reflected in such as forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to
various hazards and uncertainties, many of which are hard to foretell and
generally beyond the control of sanofi-aventis, that could do actual
results and developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements. These hazards and uncertainnesses include those discussed or identified in the
public filings with the second and the AMF made by sanofi-aventis, including
those listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in sanofi-aventis' yearly study on Form 20-F
for the twelvemonth ended December 31, 2007. Other than as needed by applicable
law, sanofi-aventis makes not set about any duty to update or revise
any forward-looking information or statements. Contact: Stephanie Stamatakou, sanofi-aventis U.S., 908-981-6127,
Stephanie.stamatakou@sanofi-aventis.com Abstract # 542