Genomic Health Announces Results of Clinical Survey Showing Use of Oncotype DX Changes Treatment Recommendations for Women With Lymph Node-Positive Breast Cancer, Leading to Overall Reduction in Chemotherapy
- Results from Survey of Current Practice by 160 U.S. Oncologists Presented at CTRC-AACR San Antonio Breast Cancer Symposium -
SAN ANTONIO, Dec. 11 /PRNewswire-FirstCall/ -- Genomic Health,
Inc. (NASDAQ:GHDX) today announced results from a
clinical survey evaluating the impact of the Oncotype DX®
Recurrence Score® result on physicians' adjuvant treatment
recommendations for patients with node-positive, hormone
receptor-positive breast cancer. The findings, presented as a
poster at the 32nd Annual CTRC-AACR San Antonio Breast Cancer
Symposium (Abstract # 2031), demonstrated that physicians
frequently changed treatment recommendations for breast cancer
patients with 1-3 positive nodes after integrating Recurrence Score
results.
Oncotype DX is a multi-gene expression test that physicians
currently use to predict the likelihood of chemotherapy benefit and
recurrence risk for patients with early-stage breast cancer. This
survey of 160 medical oncologists about their clinical experience
with Oncotype DX in node-positive breast cancer was conducted
through a voluntary web-based questionnaire, and found that
treatment recommendations changed for half of the patients after
obtaining a Recurrence Score result.
Specifically, in the 138 cases where the physician had a
specific treatment recommendation before obtaining the Recurrence
Score, recommended treatment changed from hormonal therapy plus
chemotherapy to hormonal therapy alone in 46 patients (33 percent),
and from hormonal therapy alone to hormonal therapy plus
chemotherapy in 13 patients (9 percent). Other regimen changes such
as treatment intensity were reported in 11 patients (8 percent). In
these patients with node-positive disease, 72 (52 percent) of
patients analyzed had a low Recurrence Score result (<18), 53
(38 percent) had an intermediate Recurrence Score result (18-30)
and 13 (9 percent) had a high Recurrence Score result (greater than
or equal to 31). Recommendations based on the Recurrence Score
results led to an overall reduction in chemotherapy.
"The clinical experiences of these physicians underscore the
value of using Oncotype DX for node-positive breast cancer patients
as demonstrated in five previous studies including one published
yesterday in the online version of The Lancet Oncology," said Ruth
Oratz, M.D., Clinical Associate Professor of Medicine, New York
University School of Medicine, and lead author of the study. "As
someone who has used Oncotype DX for treatment planning with both
node-negative and node-positive breast cancer patients, I believe
this test is becoming standard practice for individualizing
treatment in early stage breast cancer."
In this survey of 160 patients with node-positive disease,
median age was 61 years and 79 percent of patients were
postmenopausal. Patients had either stage T1 (62 percent), T2 (35
percent) or T3 (3 percent) disease. One, two, three or four or more
positive lymph nodes were reported in 69 percent, 18 percent, 6
percent and 3 percent of patients, respectively. Therefore,
physicians reported use of the Oncotype DX Recurrence Score®
result to plan treatment for node-positive disease most often in
patients with 1-3 positive nodes and stage T1 or T2 disease.
"Results from this survey of current practice patterns indicate
that oncologists who order Oncotype DX for patients with
node-positive breast cancer use the results in a similar manner as
they do for node-negative patients," said Steven Shak, M.D., Chief
Medical Officer of Genomic Health.
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 November 2009, more than 8,000 physicians
have ordered more than 120,000 tests in over 50 countries, 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 is preparing
to launch its Oncotype DX colon cancer test in the first quarter of
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 clinical
experiences of physicians surveyed underscores the value of using
Oncotype DX for node-positive breast cancer patients, the belief
Oncotype DX is becoming standard practice for individualizing
treatment in early stage breast cancer, the ability of the Oncotype
DX breast cancer test to change clinical outcomes, the company's
plans to commercialize a test for colon cancer and the proposed
timing of such commercialization, 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
potential delays associated with commercialization of a new test;
the risks and uncertainties associated with the regulation of the
company's tests; the applicability of clinical study results to
actual outcomes; the availability of reimbursement coverage for the
company's test in specific disease populations; 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, +1-415-595-9407,
media@genomichealth.com, both
of Genomic Health
Web Site: http://www.genomichealth.com/
http://www.oncotypedx.com/
Posted: December 2009
