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Oncotype DX is a multi-gene expression test that physicians currently useto predict the likelihood of chemotherapy benefit as well as the likelihood ofrecurrence for women with early stage breast cancer. In this prospectively-designed study, researchers used Oncotype DX to analyze tumor samples from1,231 patients in the ATAC (Arimidex(R), Tamoxifen, Alone or in Combination)trial, a landmark study that established the wide use of aromatase inhibitorsfor adjuvant treatment of postmenopausal women with hormone receptor-positivebreast cancer.
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"Our multivariate analysis confirms that along with other standardmeasures such as tumor size, Oncotype DX contributes independently toproviding a more complete picture of prognosis," said Mitch Dowsett, Ph.D.,Royal Marsden Hospital and Team Leader at the Breakthrough Breast CancerResearch Centre in London. "Physicians can take this information into accountwhen making chemotherapy treatment decisions for both node-negative and node-positive early stage breast cancer patients planned for either anastrozole ortamoxifen treatment."
The study assessed 9-year distant recurrence for women in the anastrozoleand tamoxifen monotherapy arms of the ATAC trial, including patients withdisease that had spread to the lymph nodes (0 nodes, 1-3 nodes and more than 4nodes). Researchers, with support from the UK's leading breast cancercharity, Breakthrough Breast Cancer, and AstraZeneca, collected tumor blocks,mainly from patients in the United Kingdom, and tested the significance ofadding the Recurrence Score result to a clinical model consisting of age,tumor size, grade and treatment, as well as the Adjuvant! Online riskassessment tool.
The study indicated that the Oncotype DX Recurrence Score (RS) resultshowed statistically significant prognostic value beyond that provided byAdjuvant! Online in both node-negative (p<0.001) and node-positive (p=0.003)patients. The greater efficacy of anastrozole observed in the parent ATACtrial and the similar hazard ratios for the RS in both treatment arms fromthis study suggests a lower risk of recurrence in patients treated witharomatase inhibitors. In addition, for any RS result, the likelihood ofdistant recurrence increases with the number of positive nodes.
"This study is the largest that Genomic Health has conducted to date,reinforcing our commitment to continue adding value to the Oncotype DX breastcancer assay by studying additional patient populations and treatment regimensrelevant to current clinical practice," said Steven Shak, M.D., chief medicalofficer of Genomic Health. "These results, combined with the suite ofclinical evidence that we and our clinical partners generated over the pastfive years, reinforce our belief that Oncotype DX is an indispensable toolwhen making treatment decisions for node-negative patients and in certainnode-positive patients."
Earlier this week, Genomic Health and research collaborators presentedthree additional studies. Highlights include:
About Oncotype DX(R)
Oncotype DX is the first and only multi-gene expression test commerciallyavailable that has clinical evidence validating its ability to predict thelikelihood of chemotherapy benefit as well as recurrence in early-stage breastcancer. Additionally, the test report provides quantitative scores forcertain individual genes. Oncotype DX has been extensively evaluated in elevenclinical studies involving more than 4,000 breast cancer patients, including alarge validation study published in The New England Journal of Medicine and achemotherapy benefit study published in the Journal of Clinical Oncology. Todate, 7,500 physicians have ordered more than 75,000 tests, and both Medicareand private health plans covering approximately 90 percent of U.S. insuredlives provide reimbursement for Oncotype DX through contracts, agreements orpolicy decisions. Both the American Society of Clinical Oncology (ASCO) andthe National Comprehensive Cancer Network recommend the use of Oncotype DX forpatients with node- negative breast cancer that is estrogen-receptor positiveand/or progesterone- receptor positive. For more information about OncotypeDX, please visit http://www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. (Nasdaq: GHDX) is a life science company focused onthe development and commercialization of genomic-based clinical laboratoryservices for cancer that allow physicians and patients to make individualizedtreatment decisions. In 2004, Genomic Health launched its first test,Oncotype DX(R), which has been shown to predict the likelihood of breastcancer recurrence and the likelihood of chemotherapy benefit in a largeportion of early-stage breast cancer patients. The company was founded in2000 and is located in Redwood City, California. For more information, pleasevisit http://www.genomichealth.com.
About The Royal Marsden Hospital
The Royal Marsden Hospital was the first hospital in the world dedicatedto cancer treatment and research into the causes of cancer. Today thehospital, which is based in London and in Sutton, sees over 40,000 patientsfrom the UK and abroad each year. A world leader in research, drug trialingand diagnostics, The Royal Marsden provides inpatient, day care and outpatientservices for all areas of cancer treatment.
About Breakthrough Breast Cancer
Breakthrough Breast Cancer is the UK's leading breast cancer charitycommitted to fighting breast cancer through research, campaigning andeducation. In 1999 Breakthrough established the UK's first dedicated breastcancer research centre. The Breakthrough Toby Robins Breast Cancer ResearchCentre is housed in the Mary-Jean Mitchell Green building at The Institute ofCancer Research and was set up in association with the Royal Marsden Hospitalin London. The centre is led by Professor Alan Ashworth FRS. For moreinformation about Breakthrough Breast Cancer, please visithttp://www.breakthrough.org.uk.
Forward-looking Statements
This press release contains forward-looking statements within the meaningof the Private Securities Litigation Reform Act of 1995, including statementsrelating to the company's belief that conducting studies in additional patientpopulations and treatment regimens adds value to the Oncotype DX breastcancer assay, the company's belief that clinical evidence and the results ofthe study reinforce that Oncotype DX is an indispensable tool when makingtreatment decisions for node-negative and certain node-positive breast cancerpatients, and the conclusions from studies needing additional trials orresearch and the ability of the company to conduct such studies or research .These risks and uncertainties include, but are not limited to: the results ofadditional clinical studies; the applicability of clinical study results toactual outcomes; the risk that the company may not obtain sufficient levels ofreimbursement for any future tests it may develop; the company's ability todevelop and commercialize new products; the risks and uncertainties associatedwith the regulation of the company's tests by FDA; the company's ability toobtain capital when needed; the company's history of operating losses and theother risks set forth in its filings with the Securities and ExchangeCommission, including the risks set forth in the company's Quarterly Report onForm 10-Q for the three-month period ended September 30, 2008. These forward-looking statements speak only as of the date hereof. Genomic Health disclaimsany obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX and Recurrence Scoreare trademarks or registered trademarks of Genomic Health, Inc. All othertrademarks and service marks are the property of their respective owners.* An oral presentation on Thursday, December 11 suggested that GRB7-dependent pathways are potential therapeutic targets for triple-negative breast cancer, a subtype that does not express genes for estrogen receptor (ER), progesterone receptor (PR) or HER2. Triple negative breast cancer is considered to be more aggressive and difficult to treat than hormone receptor-positive or HER2- positive breast cancers. These results need to be confirmed with future trials. * On Friday, December 12 researchers from Genomic Health presented results from a study that demonstrated quantitative RT-PCR analysis is possible in ductal carcinoma in situ (DCIS) that is adjacent to invasive ductal carcinoma (IDC). Of the 30 ER-positive breast cancer tumor samples that were identified, 90 percent had sufficient RNA for Oncotype DX analysis, after separating the DCIS and IDC tissues. While DCIS adjacent to invasive breast cancer demonstrated similar quantitative biology for the genes evaluated in the Oncotype DX assay, future studies to evaluate Oncotype DX and recurrence rates in DCIS are needed. * A separate study, also presented on Friday, December 12, found that multiple single nucleotide polymorphisms (SNPs) in the genes that encode ER were not associated with the level of ER expression in breast cancer, suggesting that differences in ER expression between individual tumors are likely a result of factors other than inherited gene mutations.
SOURCE Genomic Health, Inc.
