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Dr. Stephen Jones, US Oncology medical director and co-chair of its breastcancer research committee, presented findings on the largest of the threemajor trials comparing efficacy of an aromatase inhibitor/inactivatorversustamoxifen as initial endocrine therapy. One objective of the study, titled"Results of the first planned analysis of the TEAM (tamoxifen exemestaneadjuvant multicenter) prospective randomized Phase III trial in hormonesensitive postmenopausal early breast cancer," was to evaluate exemestane (E)compared to tamoxifen (T) as initial adjuvant endocrine therapy.
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The analysis represents the first of two co-primary endpoints that will bereported from this trial. The first co-primary endpoint compares early eventsby measuring disease-free survival (DFS: disease progression or death) at 2.75years in 9,775 patients randomized to initial therapy with either tamoxifen orAROMASIN.
The analysis of DFS at 2.75 years demonstrated an 11 percent reduction inthe 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 cancerendpoints, were statistically significant. A second planned analysis of DFSafter five years of therapy is expected in late 2009. Results from TEAM trialsub-studies were also presented at the CTRC-AACR San Antonio Breast CancerSymposium.
"The TEAM trial is the largest aromatase inhibitor study ever to be done.The overall results are positive with an improvement in outcome measured byseveral parameters and a favorable safety profile for exemestane relative to aworldwide standard, tamoxifen," said Dr. Jones. "This very large study is atreasure trove of substudies providing valuable scientific information forwomen with breast cancer. The final endpoint of the study should be availablenext year, and that is a comparison of the switch strategy of tamoxifenswitching to exemestane versus 5 years of exemestane. We await those resultswith interest."
The second oral presentation, "A Phase II study of Trastuzumab-DM1 (T-DM1),a HER2 antibody-drug Conjugate, in patients with HER2-positive metastaticbreast cancer (MBC): Interim Results," was given by Dr. Sasha J. Vukelja ofTexas Oncology.
This was a follow-up to a Phase I study previously given to patients withMBC who had progressed on or within 60 days of receiving trastuzumab-basedtherapy. Phase II was undertaken to assess the objective response rate ofT-DM1 in patients who progressed, while receiving HER2-directed therapy andchemotherapy for HER2-positive MBC.
The study's investigators concluded that T-DM1 has single agent activityin patients with previously-treated HER2-positive MBC and appears to haveanti-tumor activity in trastuzumab and lapatinib-pretreated patients. T-DM1also appears to be well tolerated at the dose and schedule tested. T-DM1continues to be investigated in patients.
"This is an exciting study for patients with HER2-positive disease whohave failed prior HER2-directed therapy. This novel antibody drug conjugaterepresents another option for this group of patients. We are very pleased withthe results and tolerability of the drug," said Dr. Vukelja.
In addition, US Oncology affiliated physicians presented the followingposter sessions:
-- Dr. Rufus Collea, who is with New York Oncology Hematology and a memberof US Oncology's Breast Committee, presented "Phase II study of pegylatedliposomal doxorubicin (PLD) and carboplatin (Cb) can be administered withtrastuzumab (H) in patients with metastatic breast cancer."
-- Dr. Jones presented "Preliminary toxicity results of a Phase II trialof adjuvant docetaxel/cyclophosphamde plus trastuzumab in HER2+ early stagebreast cancer patients."
-- Dr. Jones' study, "Docetexal plus cyclophosphamide is cost-effectivecompared to doxorubicin plus cyclophosphamide, based on an economic analysisof US Oncology Trial 9735: Additional rational to avoid anthracyclines in theadjuvant treatment of operable breast cancer," was presented by Dr. Verma.
About US Oncology Research
The US Oncology Research network is an established community-basedresearch operation specializing in comprehensive Phase I-IV trials andtranslational Phase I research. The research network is currently enrollingpatients at 109 research sites, and is involved in 63 open trials.
Supported by US Oncology, the network has played a pivotal role in 24 ofthe last 30 cancer drugs approved by the Food and Drug Administration and morethan 32,000 patients have participated in clinical trials. For moreinformation, visit the "Research" section under "Our Services" on thecompany's Web site, http://www.usoncology.com.
About US Oncology
US Oncology, headquartered in Houston, works closely with physicians,manufacturers and payers to identify and deliver innovative services thatenhance patient access to advanced cancer care. US Oncology supports one ofthe nation's foremost cancer treatment and research networks, accelerating theavailability and use of evidence-based medicine and shared best practices.
US Oncology's expertise in supporting every aspect of the cancer caredelivery system -- from drug development to treatment and outcomes measurement-- enables the company to help increase the efficiency and safety of cancercare. According to the company's last quarterly earnings report, US Oncologyis affiliated with 1,227 physicians operating in 485 locations, including 92radiation oncology facilities in 39 states. For more information, visit thecompany's Web site, http://www.usoncology.com.
SOURCE The US Oncology Research Network
