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 (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. 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.
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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 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 tumors > 5 cm; tamoxifen was given for 5 years to all
patients with endocrine responsive tumors. A study amendment initiated
during enrollment mandated the use of G-CSF with the first cycle of TAC, in
order to reduce the incidence and severity 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 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 Europe, breast cancer is recsponsible for 27.3% of all new cancer
cases among women and 20.22% of cancer deaths. The International Agency for
Research in Cancer estimates that in 2004 there were 360,749 new breast
cancer cases diagnosed while the number of deaths was 129,013.
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 Paris (EURONEXT PARIS: SAN) and in
New York (NYSE: SNY).
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