REDWOOD CITY, Calif.,
March 1, 2016 /PRNewswire/ -- Genomic
Health, Inc. (Nasdaq: GHDX) today announced that the
Journal of Clinical Oncology published clinical outcomes
results from PlanB, one of Europe's largest adjuvant studies that
utilized the Oncotype DX® breast cancer test to assign
treatment. Led by the Women's Healthcare Study Group (WSG) in
Germany, results from the PlanB
study showed that women with Oncotype DX Recurrence
Score® results of 11 or less had excellent outcomes with
98 percent disease-free survival rates at three years, despite
having high-risk disease by traditional parameters. This finding is
consistent with conclusions of the Trial Assigning
IndividuaLized Options for Treatment
(Rx), or TAILORx, recently published in The New England
Journal of Medicine, adding to the unprecedented body of
evidence demonstrating that Oncotype DX accurately predicts
outcomes, including breast cancer recurrence and survival, in data
collected from more than 50,000 patients.
"The compelling suite of new global prospective outcomes data
generated in the last six months proves that tens of thousands of
patients worldwide can forgo chemotherapy and its harmful side
effects based on a low Recurrence Score," said Steven Shak, M.D., chief scientific officer,
Genomic Health. "Not only do these collective results support our
prior validation work and all of the guidelines worldwide that
include Oncotype DX to select patients for chemotherapy treatment,
they also provide physicians with the highest level of evidence to
support using the test as standard of care."
This large study, conducted in 93 centers across Germany, enrolled more than 3,100 patients
with high-risk, estrogen-receptor positive, HER2-negative
early-stage breast cancer, including those with node-positive
disease who were considered candidates for chemotherapy by
traditional parameters. Oncotype DX Recurrence Score results were
used to identify patients who would be spared adjuvant chemotherapy
despite being considered as having high clinical risk by
traditional parameters. Participants with Recurrence Score results
of 12 or higher were randomized to different chemotherapy regimens,
and patients with Recurrence Score results of 11 or less were
treated with hormonal therapy alone.
The study showed that women with Recurrence Score results of 11
or less had excellent outcomes at three years despite having
high-risk disease by traditional parameters, such as nodal status.
The results indicate that chemotherapy can safely be spared in
patients with high clinical risk of recurrence – including
node-positive disease – if the Recurrence Score result is 11 or
less.
"Our study results show that a low Recurrence Score result
identifies patients who can be safely spared chemotherapy without
compromising outcomes. These results confirm previous retrospective
studies as well as the prospective TAILORx trial," said Prof.
Nadia Harbeck, WSG Scientific
Director and Head of the breast cancer unit at University of
Munich, Germany.
Findings from the PlanB study also suggest there may be
overtreatment in a substantial subset of patients who have
Recurrence Score results between 12 and 25, as patients in this
range also had excellent outcomes with disease-free survival of 98
percent at three years. These findings add to a recent study from
Clalit Health Services, the largest Health Maintenance Organization
in Israel, that showed that women
with Recurrence Score results of less than 18 who were largely
treated with hormonal therapy alone had excellent outcomes with
less than a one percent chance of distant recurrence or breast
cancer-specific mortality at five years.
"Patients should only get chemotherapy with all its side effects
if they are going to benefit substantially. Gene expression tests
often play an important role in making this decision," said
Renate Haidinger, president of the
German Breast Cancer Association, the leading national patient
advocacy organization in Germany.
"Based on the latest study results, we hope that patients can get
broad access to this test."
Five-year results from PlanB will be highlighted in the official
European Breast Cancer Conference (EBCC-10) press program on
Thursday, March 10, followed by the
oral presentation on Friday, March
11, at a plenary session.
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. The
company's flagship product, the Oncotype DX breast cancer test, has
been shown to predict the likelihood of chemotherapy benefit as
well as recurrence in invasive breast cancer. Additionally, the
test predicts the likelihood of recurrence in a pre-invasive form
of breast cancer called DCIS. With 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 breast
cancer tests, visit: www.OncotypeDX.com or
www.mybreastcancertreatment.org.
About Genomic Health
Genomic Health, Inc. (NASDAQ:
GHDX) is the world's leading provider of genomic-based diagnostic
tests that address both the overtreatment and optimal treatment of
cancer, 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. 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, including statements relating to the benefits of the test to
physicians, patients and payors. 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 ability of test
results to change treatment decisions; the results of clinical
studies; 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 yearly report on Form 10-Q for the
quarter ended Sept, 30, 2015. 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, and DCIS Score are trademarks or registered
trademarks of Genomic Health, Inc. All other trademarks and service
marks are the property of their respective owners.
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SOURCE Genomic Health, Inc.