Oral Presentation of the US Oncology Adjuvant Trial 9735 at 2007 San
Antonio Breast Cancer Symposium Showed Taxotere(R) and Cyclophosphamide
Improved Overall Survival Versus An Anthracycline Combination
SAN ANTONIO, Dec. 13 /PRNewswire-FirstCall/ -- Results presented at the
30th annual San Antonio Breast Cancer Symposium (SABCS) showed that for
women with early stage breast cancer who have had surgery, treatment with
the investigational chemotherapy combination of Taxotere(R) (docetaxel)
Injection Concentrate and cyclophosphamide significantly improved overall
survival compared to standard chemotherapy. The presentation reports
results with a median follow-up of seven years and has been updated since
the last report was published with 5.5 years median follow-up [Jones S et
al. J Clin Oncol, 2006, 24:5381-7]. This latest report has also been
updated from the abstract submitted to SABCS 2007.
In the updated analysis, overall survival at seven years was
statistically higher among women treated with Taxotere(R) and
cyclophosphamide (TC) versus those treated with doxorubicin and
cyclophosphamide (AC): 87% versus 82% (HR: 0.69, [95% CI, 0.50, 0.97]). The
31% reduction in the risk of death was statistically significant (p=0.032).
At seven years, the disease-free survival (DFS) was also statistically
greater among women treated with TC than those treated with AC: 81% versus
75% (HR: 0.74, [95% CI, 0.56, 0.98]). The 26% reduction in the risk of
cancer recurrence among women treated with TC was statistically significant
(p=0.033). The disease-free survival benefit seen in the elderly patients
(aged 65 years or older; 31% risk reduction of recurrence) is consistent
with that in the overall patient population.
Principal study investigator Dr. Stephen Jones, medical director and
co-chair, breast cancer research committee of US Oncology, helped develop
the regimen combining the anthracycline doxorubicin with cyclophosphamide,
which became a foundation of breast cancer chemotherapy for more than 30
years.
"The investigational Taxotere(R) combination significantly increased
the percentage of women living with no signs of cancer at seven years, as
compared to the anthracycline combination," said Dr. Jones.
US Oncology Adjuvant Trial 9735 Protocol
USO Adjuvant Trial 9735 was designed primarily to evaluate disease-free
survival among women with node-positive and node-negative early breast
cancer. Node-positive indicates that the cancer has spread to the lymph
nodes under the arm, while node-negative breast cancer means that the lymph
nodes are clear of cancer. Secondary endpoints included overall survival
and safety. The investigators also explored the efficacy and safety of the
treatments based on the age of patients and the biologic characteristics of
their tumors.
All patients taking part in the study had received surgery for Stage
I-III invasive breast cancer, meaning that the cancer was either localized
to the breast or had spread to the lymph nodes under the adjacent arm.
A total of 1016 patients were randomized between June 1997 and December
1999; 48% of patients had node-negative disease and 16% were age 65 years
or older. After surgery, patients were randomized to receive four cycles of
either standard-dose of anthracycline doxorubicin 60 mg/m2 and
cyclophosphamide 600/mg/m2 (n=510) or Taxotere(R) 75 mg/m2 and
cyclophosphamide 600mg/m2 (n=506), administered by intravenous infusion
every three weeks. After chemotherapy was completed, patients were treated
with radiation therapy if indicated. Patients with hormone receptor
positive disease also received hormonal therapy (tamoxifen).
In the TC group, there were 88 DFS events (17%) and 58 deaths (12%).
The AC group had 118 DFS events (23%) and 84 deaths (17%). Exploratory
analyses showed benefit of TC irrespective of age, hormonal status or Her2
status.
Grade 3-4 neutropenia occurred in 60% of younger (<65 years) and 52% of
older (greater than or equal to 65 years) women in the TC group, and in 54%
and 59% of younger and older women, respectively, in the AC group. Among
younger patients, the frequencies of Grade 3-4 febrile neutropenia were
4.4% with TC and 2.3% with AC, while in older patients the frequencies were
7.7% and 3.7% for TC and AC, respectively. Grade 3-4 nausea was less common
among women in both age groups treated with TC (<65: 2%, greater than or
equal to 65: 3%) than those given AC (<65: 7%, greater than or equal to 65:
5%). In the TC group, additional Grade 3-4 adverse events reported among
women <65 and greater than or equal to 65 were fever in 4% and 6% and
infection in 7% and 6%, respectively, while in the AC arm the rates of
Grade 3-4 fever were 3% and 4% and Grade 3-4 infections were 10% and 2% for
younger and older women, respectively.
Breast Cancer, the Most Common Cancer in Women
Breast cancer is the most frequently diagnosed cancer in women
throughout the world. The American Cancer Society estimates that one in
eight women will develop breast cancer within their lifetime. By the end of
2007, more than 178,000 American women will have learned they have invasive
breast cancer. In the European Union, more than 429,900 new cases were
diagnosed in 2006. Age is the biggest risk factor, and one in 26 women over
70 will have breast cancer in her lifetime.
In the U.S., breast cancer is the third-leading cause of cancer death
in women. More than 40,000 women in the U.S. will die of breast cancer this
year; more than half are 65 or older. In the EU, breast cancer is the
leading cause of cancer death among women; an estimated 132,000 died from
breast cancer in 2006.
About US Oncology, Inc.
US Oncology, headquartered in Houston, Texas, supports one of the
nation's largest cancer treatment and research networks. US Oncology
provides extensive services and support to its affiliated cancer care sites
nationwide to help them expand their offering of the most advanced
treatments and technologies, build integrated community-based cancer care
centers, improve their therapeutic drug management programs, and
participate in many of the new cancer-related clinical research studies. US
Oncology also provides a broad range of services to pharmaceutical
manufacturers, including product distribution and informational services
such as data reporting and analysis.
According to the company's last quarterly earnings report, US Oncology
is affiliated with 1,164 physicians operating in 443 locations, including
91 radiation oncology facilities in 39 states.
About US Oncology Research Network
The US Oncology Research Network is an established community-based
research operation specializing in all phases of cancer clinical trials.
The research network currently has 500 physicians actively enrolling
patients, 77 research sites, and is currently involved in more than 60 open
research trials. The network has contributed to the development of 24 of 30
of the latest cancer-fighting drugs approved by the Food and Drug
Administration for use. Since 1993, more than 32,000 patients have
participated in clinical trials managed by US Oncology network practices.
For more information, visit the "Research" section under "Our Services" on
the company's Web site, http://www.usoncology.com.
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: SAN) and in New York
(NYSE: SNY).
Contact: Noelle Boyd
sanofi-aventis
908-981-6489
noelle.boyd@sanofi-aventis.com
Kimberly Rutherford
832-601-6193
kimberly.rutherford@usoncology.com
Elizabeth Vocke
Hill and Knowlton,
813-775-6206
elizabeth.vocke@hillandknowlton.com
SOURCE sanofi-aventis
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Related links:
http://www.sanofi-aventis.us/
http://www.prnewswire.com/comp/232375.html/
CONTACT:
Noelle Boyd of sanofi-aventis,
+1-908-981-6489, noelle.boyd@sanofi-aventis.com; or Kimberly
Rutherford of US Oncology, +1-832-601-6193,
kimberly.rutherford@usoncology.com; or Elizabeth Vocke of Hill
and Knowlton, +1-813-775-6206,
elizabeth.vocke@hillandknowlton.com
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