Genomic Health Announces Publication of Study Using Oncotype DX(R) in Node-Negative and Node-Positive Breast Cancer Patients Treated With Aromatase Inhibitors
REDWOOD CITY, Calif., March 8 /PRNewswire-FirstCall/ -- Genomic
Health, Inc. (NASDAQ:GHDX) today announced the publication of
positive results from a large international study which
demonstrated that the Oncotype DX® breast cancer Recurrence
Score® (RS) result is a significant independent predictor of
distant recurrence in both node-negative and node-positive, hormone
receptor-positive, postmenopausal breast cancer patients who are
treated with either anastrozole or tamoxifen. The study, originally
presented at the San Antonio Breast Cancer Symposium in 2008, was
published online today in the Journal of Clinical Oncology.
The Oncotype DX breast cancer test measures the expression of 21
genes of an individual tumor to generate an RS result that
quantifies the magnitude of chemotherapy benefit and the likelihood
of recurrence for early-stage breast cancer patients. As of
December 2009, more than 8,000 physicians had used more than
135,000 Oncotype DX breast cancer tests for treatment
planning.
"We believe the results of this study reinforce the important
role of Oncotype DX in making individualized treatment decisions
for early stage breast cancer patients with node-negative and
node-positive disease," said Steven Shak, M.D., chief medical
officer of Genomic Health. "Oncotype DX testing allows physicians
and patients to make a more informed decision on whether to add
chemotherapy, yielding a potential savings to the U.S. healthcare
system of approximately $2,000 in direct costs per patient."
The study used Oncotype DX to analyze tumor samples from 1,231
patients involved in the landmark ATAC (Arimidex®, Tamoxifen,
Alone or in Combination) trial, which established the extensive use
of aromatase inhibitors for adjuvant treatment of postmenopausal
women with hormone receptor-positive breast cancer. Nine-year
distant recurrence was assessed for women in the anastrozole and
tamoxifen monotherapy arms of the ATAC trial, including patients
with disease that had spread to the lymph nodes (0 nodes, 1-3 nodes
and 4 or more nodes).
Researchers collected tumor blocks primarily from patients in
the United Kingdom and tested the significance of adding the RS
result to a clinical model consisting of age, tumor size, grade and
treatment, as well Adjuvant! Online, a valid risk assessment tool
that evaluates clinical variables to help physicians and patients
assess the risks and benefits of getting additional therapy after
surgery.
Results indicated that the RS result provided statistically
significant prognostic value beyond that provided by Adjuvant!
Online in node-negative (p<0.001) patients. While the study
confirmed the performance of the RS result in a large contemporary
patient population of postmenopausal hormone receptor-positive
women treated with tamoxifen, it also demonstrated that the
established relationship between the RS and risk of distant
recurrence for tamoxifen may now be applied to anastrozole. The
greater efficacy of anastrozole observed in the parent ATAC trial
and the analysis of the RS results in both treatment arms from this
study suggests a lower risk of recurrence in patients treated with
aromatase inhibitors. Additionally, as consistent with prior
OncotypeDX results in node-positive breast cancer, for any RS
result, the likelihood of distant recurrence increases with the
number of positive nodes.
About Oncotype DX®
The Oncotype DX breast cancer test is the only multigene
expression test commercially available that has clinical evidence
validating its ability to predict the likelihood of chemotherapy
benefit as well as recurrence in early-stage breast cancer.
Additionally, the test report provides quantitative scores for
certain individual genes. The Oncotype DX breast cancer test has
been extensively evaluated in thirteen clinical studies involving
more than 4,000 breast cancer patients worldwide, 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. As of December 2009, more than 8,000 physicians
in over 50 countries had ordered more than 135,000 tests, and both
Medicare and private health plans covering over 90 percent of U.S.
insured lives provide reimbursement for Oncotype DX for patients
with node-negative breast cancer that is estrogen-receptor positive
and/or progesterone-receptor positive through contracts, agreements
or policy decisions. Both the American Society of Clinical Oncology
and the National Comprehensive Cancer Network recommend 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
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 the Oncotype DX® breast cancer test, which has been
shown to predict the likelihood of chemotherapy benefit as well as
recurrence in early-stage breast cancer. In addition to the widely
adopted Oncotype DX breast cancer test, Genomic Health launched its
Oncotype DX colon cancer test in January 2010. The company was
founded in 2000 and is located in Redwood City, California. For
more information, please visit 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 study
data support the clinical utility of our test in postmenopausal
breast cancer patients with node-negative or node-positive, hormone
receptor-positive disease who are treated with either anastrozole
or tamoxifen, the belief that using Oncotype DX for breast cancer
can allow better-informed decisions to avoid the toxicity and
medical costs of chemotherapy, and the amount of the potential cost
savings, the belief that the RS result provided statistically
significant prognostic value beyond that provided by Adjuvant!
Online, and the applicability of clinical study results to actual
outcomes. Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially,
and reported results should not be considered as an indication of
future performance. These risks and uncertainties include, but are
not limited to: the risks and uncertainties associated with the
regulation of the company's tests; the applicability of clinical
study results to actual outcomes; and the other risks set forth in
the company's filings with the Securities and Exchange Commission,
including the risks set forth in the company's Quarterly Report on
Form 10-Q for the quarter ended September 30, 2009. These
forward-looking statements speak only as of the date hereof.
Genomic Health disclaims any obligation to update these
forward-looking statements.
NOTE: 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
CONTACT: Investors, Brad Cole, +1-650-569-2281,
investors@genomichealth.com,
or Media, Emily Faucette, +1-650-569-2824,
media@genomichealth.com, both
of Genomic Health
Web Site: http://www.genomichealth.com/
Posted: March 2010
