US Oncology Research Network Presents Clinical Studies at San Antonio Breast Cancer Symposium
researchers affiliated with US Oncology Research gave oral presentations at
the 2008 San Antonio Breast Cancer Symposium. Three others presented their
research in poster presentations during the conference, which ran
cancer research committee, presented findings on the largest of the three
major trials comparing efficacy of an aromatase inhibitor/inactivatorversus
tamoxifen as initial endocrine therapy. One objective of the study, titled
“Results of the first planned analysis of the TEAM (tamoxifen exemestane
adjuvant multicenter) prospective randomized Phase III trial in hormone
sensitive postmenopausal early breast cancer,” was to evaluate exemestane (E)
compared to tamoxifen (T) as initial adjuvant endocrine therapy.
The analysis represents the first of two co-primary endpoints that will be
reported from this trial. The first co-primary endpoint compares early events
by measuring disease-free survival (DFS: disease progression or death) at 2.75
years in 9,775 patients randomized to initial therapy with either tamoxifen or
The analysis of DFS at 2.75 years demonstrated an 11 percent reduction in
the risk of DFS events in favor of AROMASIN (HR=0.89; 95% CI, 0.77-1.03).
Relapse free survival and time to distant metastases, which are breast cancer
endpoints, were statistically significant. A second planned analysis of DFS
after five years of therapy is expected in late 2009. Results from TEAM trial
sub-studies were also presented at the CTRC-AACR San Antonio Breast Cancer
“The TEAM trial is the largest aromatase inhibitor study ever to be done.
The overall results are positive with an improvement in outcome measured by
several parameters and a favorable safety profile for exemestane relative to a
worldwide standard, tamoxifen,” said Dr. Jones. “This very large study is a
treasure trove of substudies providing valuable scientific information for
women with breast cancer. The final endpoint of the study should be available
next year, and that is a comparison of the switch strategy of tamoxifen
switching to exemestane versus 5 years of exemestane. We await those results
The second oral presentation, “A Phase II study of Trastuzumab-DM1 (T-DM1),
a HER2 antibody-drug Conjugate, in patients with HER2-positive metastatic
breast cancer (MBC): Interim Results,” was given by Dr.
This was a follow-up to a Phase I study previously given to patients with
MBC who had progressed on or within 60 days of receiving trastuzumab-based
therapy. Phase II was undertaken to assess the objective response rate of
T-DM1 in patients who progressed, while receiving HER2-directed therapy and
chemotherapy for HER2-positive MBC.
The study’s investigators concluded that T-DM1 has single agent activity
in patients with previously-treated HER2-positive MBC and appears to have
anti-tumor activity in trastuzumab and lapatinib-pretreated patients. T-DM1
also appears to be well tolerated at the dose and schedule tested. T-DM1
continues to be investigated in patients.
“This is an exciting study for patients with HER2-positive disease who
have failed prior HER2-directed therapy. This novel antibody drug conjugate
represents another option for this group of patients. We are very pleased with
the results and tolerability of the drug,” said Dr. Vukelja.
In addition, US Oncology affiliated physicians presented the following
of US Oncology’s Breast Committee, presented “Phase II study of pegylated
liposomal doxorubicin (PLD) and carboplatin (Cb) can be administered with
trastuzumab (H) in patients with metastatic breast cancer.”
— Dr. Jones presented “Preliminary toxicity results of a Phase II trial
of adjuvant docetaxel/cyclophosphamde plus trastuzumab in HER2+ early stage
breast cancer patients.”
— Dr. Jones’ study, “Docetexal plus cyclophosphamide is cost-effective
compared to doxorubicin plus cyclophosphamide, based on an economic analysis
of US Oncology Trial 9735: Additional rational to avoid anthracyclines in the
adjuvant treatment of operable breast cancer,” was presented by Dr. Verma.
About US Oncology Research
The US Oncology Research network is an established community-based
research operation specializing in comprehensive Phase I-IV trials and
translational Phase I research. The research network is currently enrolling
patients at 109 research sites, and is involved in 63 open trials.
Supported by US Oncology, the network has played a pivotal role in 24 of
the last 30 cancer drugs approved by the Food and Drug Administration and more
than 32,000 patients have participated in clinical trials. For more
information, visit the “Research” section under “Our Services” on the
company’s Web site, http://www.usoncology.com.
About US Oncology
US Oncology, headquartered in
manufacturers and payers to identify and deliver innovative services that
enhance patient access to advanced cancer care. US Oncology supports one of
the nation’s foremost cancer treatment and research networks, accelerating the
availability and use of evidence-based medicine and shared best practices.
US Oncology’s expertise in supporting every aspect of the cancer care
delivery system — from drug development to treatment and outcomes measurement
– enables the company to help increase the efficiency and safety of cancer
care. According to the company’s last quarterly earnings report, US Oncology
is affiliated with 1,227 physicians operating in 485 locations, including 92
radiation oncology facilities in 39 states. For more information, visit the
company’s Web site, http://www.usoncology.com.
SOURCE The US Oncology Research Network