Presentations Provide New Insights into Treatment Impact, Node-Positive
Breast Cancer, Measuring ER/PR Scores
REDWOOD CITY, Calif., Dec. 17 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from multiple studies reinforcing the clinical utility of the company's Oncotype DX(R), a multi-gene expression test to predict the likelihood of recurrence and the likelihood of chemotherapy benefit for a large portion of early-stage breast cancer patients. This research was presented at the 30th Annual San Antonio Breast Cancer Symposium, December 13-15.
"The extensive body of research on Oncotype DX, including data presented in San Antonio this week, along with its recent inclusion in ASCO treatment guidelines, supports the use of Oncotype DX in treatment planning for women with early-stage estrogen receptor-positive breast cancer," said Lori J. Goldstein, M.D., Director of the Breast Evaluation Center at Fox Chase Cancer Center in Philadelphia, Pennsylvania, and author of two Oncotype DX studies.
Eight studies presented at the San Antonio Breast Cancer Symposium
evaluated Oncotype DX, including its use in estrogen receptor-positive,
node- positive breast cancer; the test's impact on treatment selection and
patient satisfaction; reporting of quantitative ER and PR scores within the
Oncotype DX report; and a comparison between the Oncotype DX Recurrence
Score(TM) and Adjuvant Online, among other presentations.
Positive Results in Node-Positive Disease
* An oral presentation by the Southwest Oncology Group (SWOG) on
Thursday, December 13 reported positive results for the Oncotype DX
Recurrence Score result in early-stage estrogen receptor-positive
breast cancer patients with positive nodes. Researchers analyzed tumor
samples from patients in the SWOG/Breast Cancer Intergroup of North
America trial that evaluated postmenopausal patients with node
positive, hormone receptor-positive breast cancer who were treated with
chemohormonal therapy (cyclophosphamide, doxorubicin, 5-fluorouracil,
followed by tamoxifen) vs. tamoxifen alone. Chemotherapy did not
appear to benefit those with low Oncotype DX Recurrence Score results,
despite the presence of positive nodes. Conversely, a large benefit was
observed with the addition of chemotherapy in patients with high
Oncotype DX Recurrence Score results. These results join a suite of
studies that consistently demonstrate the value of the Oncotype DX
Recurrence Score result for individualized treatment planning, and show
that Oncotype DX may be clinically useful in some patients with hormone
receptor positive, node-positive breast cancer.
Oncotype DX Changes Treatment Decisions
Three studies assessing the impact of Oncotype DX on treatment
decisions concluded that use of the test resulted in less recommendation
for and use of chemotherapy. Collectively, these studies demonstrate the
actionable nature of Oncotype DX in its ability to help reduce unnecessary
use of chemotherapy, lowering both adverse effects and cost for these
patients, while increasing patient confidence in their treatment selection.
* A prospective, multi-institutional study presented Thursday, December
13 by Loyola University Chicago Stritch School of Medicine evaluated 89
patients to determine the psychological impact of Oncotype DX
Recurrence Score results on patients' treatment decision-making and
anxiety. Use of Oncotype DX changed both physician and patient
decisions on adjuvant therapy selection, resulting in less chemotherapy
use, decreased patient anxiety and increased patient confidence
regarding their treatment decision.
* On Friday, December 14 researchers from the University of Pittsburgh
Cancer Institute reported that use of the Oncotype DX assay in patients
with estrogen receptor-positive, node-negative early breast cancer over
three years significantly decreased the recommendation for adjuvant
chemotherapy for patients with low Recurrence Score results, indicating
that the assay is being used as intended among oncologists in an
academic breast cancer program.
* In a separate study also presented on Friday, December 14, researchers
at the University of Pennsylvania evaluated changing practice patterns
and frequency of chemotherapy use among node-negative, hormone
receptor-positive patients treated in 2003 before the availability of
Oncotype DX compared to those treated in 2005 and 2006 after the test
was used. The recommendation and use of adjuvant chemotherapy declined
significantly from 2003, when it was recommended to 55 percent of
patients, to 25 percent in 2005 after physicians started using Oncotype
"Over the past four years, Oncotype DX has continued to demonstrate
consistent results across multiple clinical trials, from validation to
clinical practice impact," said Steven Shak, M.D., chief medical officer of
Genomic Health. "With this latest research, in addition to updated ASCO
Guidelines recommending Oncotype DX, it is clear the test is becoming
standard practice for physicians and women making important breast cancer
Reporting of Quantitative Estrogen Receptor and Progesterone Expression
with Oncotype DX
* A study presented by Kaiser Permanente researchers on Saturday,
December 15 found estrogen receptor (ER) expression, as determined by
both immunohistochemistry (IHC) and RT-PCR (as measured by Oncotype
DX), was prognostic in a group of ER-positive and ER-negative patients.
RT-PCR results were more continuously distributed with a large dynamic
range than estrogen receptor expression measured by IHC, which was
generally either very high or very low. Among estrogen receptor-
positive, tamoxifen-treated patients, only quantitative RT-PCR using
Oncotype DX allowed for a risk comparison across levels of estrogen
receptor expression, and identified a 2.5-fold increase in survival for
those with the highest quantitative estrogen receptor expression. Based
on these and other results, Genomic Health plans to provide individual
estrogen and progesterone receptor scores as an enhancement to Oncotype
DX Recurrence Score reports beginning in early 2008.
Other Oncotype DX Studies
* An oral presentation on Saturday, December 15 showed Recurrence Score
results were significantly predictive of recurrence in both node
negative disease and node-positive disease, and demonstrated that
Oncotype DX provides additional prognostic information beyond that
developed by Adjuvant Online.
* A separate study presented on Thursday, December 13 by Istituto
Nazionale dei Tumori in Italy demonstrated that Recurrence Score
results from a primary diagnosis of breast cancer are also associated
with survival in the first two years after recurrence. Specifically,
those with low Recurrence Score results experienced longer survival
* Finally, a study presented by Genomic Health on Friday, December 14
reported gene expression profiles as measured by Oncotype DX in
histologically characterized breast cancers including ductal, lobular,
or mixed, as well as in a number of special histologic subtypes. The
study found considerable variation in gene expression both within and
between these rarer special subtypes of estrogen receptor-positive
invasive breast cancer.
About Oncotype DX(R)
Oncotype DX is the first diagnostic multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of breast cancer survival and the likelihood of chemotherapy benefit. Oncotype DX has been extensively evaluated in multiple independent studies involving more than 3,300 breast cancer patients, including a large validation study published in The New England Journal of Medicine and a chemotherapy benefit study published in the Journal of Clinical Oncology. To date, nearly 7,000 physicians have ordered more than 40,000 tests, and health plans covering over 50 percent of U.S. insured lives provide reimbursement for Oncotype DX through contracts, agreements and policy decisions. The American Society of Clinical Oncologists (ASCO) recommends the use of Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive. For more information about Oncotype DX, please visit http://www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. (Nasdaq: GHDX) is a life science company focused on the development and commercialization of genomic-based clinical laboratory services for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched its first test service, Oncotype DX(R), which has been shown to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit in early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit http://www.genomichealth.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that the use of Oncotype DX is indicated in treatment planning for early-stage estrogen receptor positive breast cancer patients, the value provided by using Oncotype DX, the belief that Oncotype DX may be clinically useful in some patients with hormone receptor positive, node positive breast cancer, the ability of Oncotype DX to change treatment decisions, the ability of Oncotype DX to reduce unnecessary chemotherapy and to increase patient confidence in their treatment decisions, the belief that Oncotype DX is becoming standard practice for doctors and patients making treatment decisions, and Genomic Health's plans to provide single gene reporting and the timing of any such product enhancement. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to: the applicability of clinical results to actual outcomes; the ability of our test to continue to impact treatment decisions; our ability to increase usage of our tests; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing tests and any future tests we may develop; the risk of delay in developing new products or product enhancements; the risks and uncertainties associated with the regulation of our test by FDA; our ability to obtain capital when needed; our history of operating losses; the results of clinical studies and the other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the three-month period ended September 30, 2007. These forward- looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: Genomic Health, the Genomic Health logo, Oncotype, Oncotype DX and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
|SOURCE Genomic Health, Inc.|
Copyright©2007 PR Newswire.
All rights reserved