REDWOOD CITY, Calif.,
Oct. 10, 2016 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced results
from eight Oncotype DX® Breast Recurrence Score™ (RS)
presentations at the European Society for Medical Oncology (ESMO)
2016 Congress in Copenhagen,
Denmark, highlighting superior clinical evidence in
identifying which patients with node-negative and node-positive
invasive breast cancer should be treated with chemotherapy.
Specifically, prospective clinical outcomes in more than 7,400
patients with node-positive invasive breast cancer from two
independent studies show excellent survival in women with RS
results less than 18.
"The ESMO presentations continue to reinforce that Oncotype DX
provides unique and unsurpassed value beyond tumor size and tumor
grade for invasive breast cancer patients with node-negative and
certain patients with node-positive disease," said Steven Shak, M.D., chief scientific officer,
Genomic Health. "With our level 1 evidence for predicting
chemotherapy benefit and prospective outcomes now in over 63,000
patients from the TAILORx, Clalit, PlanB and SEER studies, it is
clear that Oncotype DX is the only genomic test that can provide
doctors with confidence that their patients will receive the
quality care they deserve."
New data confirm Oncotype DX accurately predicts clinical
outcomes in node-positive breast cancer patients
Two
independent studies in more than 7,400 patients from the United States and Israel provide further evidence that Oncotype
DX accurately predicts outcomes in patients with early-stage,
node-positive invasive breast cancer. Specifically, an updated
analysis of the National Cancer Institute's (NCI) Surveillance,
Epidemiology, and End Results (SEER) Registry results from 6,768
patients who were treated based on RS results showed that in 3,919
patients with a RS of less than 18, breast cancer specific survival
was excellent. Specifically, it was greater than 97 percent in
patients with micrometastases, one, or two positive lymph
nodes.
Similarly, results from a prospective study of more than 700
patients tested with Oncotype DX within Clalit Health Services, the
largest health maintenance organization in Israel, showed that patients with
micrometastases or one to three positive lymph nodes and a RS less
than 18, the vast majority (92.9 percent) of whom were treated with
hormonal therapy alone, had very good outcomes with low rates of
distant recurrence (3.2 percent) and excellent breast cancer
survival (>99 percent) at five years.
"These two important updates add significantly to the growing
body of evidence that Oncotype DX accurately predicts outcomes and
aids treatment decision making in women with early-stage,
node-positive breast cancer. Just as we have learned in
node-negative disease, it is now increasingly evident that women
with one to three positive nodes and the lower scores do extremely
well without chemotherapy," said Kathy S.
Albain, MD, FACP, FASCO, professor of medicine, Loyola University Chicago, Cardinal Bernardin
Cancer Center, Maywood, IL. "While
we are now completing accrual of the RxPONDER trial looking at
whether chemotherapy adds to standard endocrine therapy in this
group, getting the results will take several years. In the
meantime, these data along with previously published results,
provide extremely strong evidence to justify use of Oncotype DX in
1-3 node-positive disease. If the patient's tumor biology is that
of a low Recurrence Score, chemotherapy simply does not add
benefit, and its risks and costs can be avoided."
In addition, exploratory analyses of patients with RS results of
18 to 30 showed that the rate of distant recurrence were generally
closer to lower risk patients with a RS less than 18. The group of
patients with mid-range Recurrence Score results is also being
studied in the Trial Assigning IndividuaLized Options for Treatment
(Rx), or TAILORx, and the RxPONDER trial.
Oral presentation of additional SEER analysis reveals
large disparities in survival and Oncotype DX testing in older
patients
Following up on the results of the
multinational TEAM study, which reported worse outcomes for older
patients with hormone-receptor-positive (HR+) breast cancer, this
study examined RS results in patients 70 years and older versus
those under 70 years. The results showed that mortality was indeed
much higher in older patients who were either not tested with
Oncotype DX or had a RS result greater than 18. Patients age 70 or
older also had lower reported chemotherapy use, supporting
continued examination of the often reported issue of
under-treatment of the elderly.
Oncotype DX reduces overtreatment of breast cancer and
increases confidence in treatment decisions
globally
Results from multiple international studies
conducted in Canada, the
Czech Republic, Italy and Spain reinforce the findings of more than 20
previous decision impact studies from around the world.
Collectively, the results demonstrated that the RS increases
confidence in treatment decisions and changes approximately 30
percent of treatment recommendations, resulting in a 22-24 percent
reduction in use of chemotherapy in patients, including in those
with node-positive disease.
About Oncotype DX®
The Oncotype
DX® portfolio of breast, colon and prostate cancer
tests applies advanced genomic science to reveal the unique biology
of a tumor in order to optimize cancer treatment decisions. With
more than 600,000 patients tested in more than 90 countries, the
Oncotype DX tests have redefined personalized medicine by making
genomics a critical part of cancer diagnosis and treatment. To
learn more about Oncotype DX tests, visit www.OncotypeDX.com,
www.mybreastcancertreatment.org
and www.myprostatecancertreatment.org.
About Genomic Health
Genomic Health, Inc.
(NASDAQ: GHDX) is the world's leading provider of genomic-based
diagnostic tests that help optimize cancer care by addressing the
overtreatment of the disease, one of the greatest issues in
healthcare today. With its Oncotype IQ™ Genomic Intelligence
Platform, the company is applying its world-class scientific and
commercial expertise and infrastructure to lead the translation of
clinical and genomic big data into actionable results for
treatment planning throughout the cancer patient journey, from
diagnosis to treatment selection and monitoring. The Oncotype
IQ portfolio of genomic tests and services currently consists of
the company's flagship line of Oncotype DX gene expression tests
that have been used to guide treatment decisions for more than
600,000 cancer patients worldwide. Genomic Health is
expanding its test portfolio to include additional liquid- and
tissue-based tests, including the recently launched Oncotype SEQ™
Liquid Select assay. The company is based in Redwood
City, California, with international headquarters
in Geneva, Switzerland. For more information, please
visit, www.GenomicHealth.com and follow the company on
Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. 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: our business model; the applicability of clinical
study results to actual outcomes; our ability to develop and
commercialize new tests and expand into new markets domestically
and internationally; unanticipated costs or delays in research and
development efforts; and the other risks and uncertainties 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 quarter ended June 30, 2016.
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,
Recurrence Score, DCIS Score, Oncotype SEQ and Oncotype IQ are
trademarks or registered trademarks of Genomic Health, Inc. All
other trademarks and service marks are the property of their
respective owners.
GHDX-B
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SOURCE Genomic Health, Inc.