AMSTERDAM, March 11, 2016 /PRNewswire/ -- Genomic
Health, Inc. (Nasdaq: GHDX) today announced new five-year clinical
outcomes results from a large PlanB study, which was highlighted as
an oral presentation at the 10th European Breast Cancer
Conference (EBCC-10)1 in Amsterdam, Netherlands. The study, conducted
by the West German Study Group (WSG), showed that 94 percent of
early-stage breast cancer patients with Oncotype
DX® Recurrence Score® results of 11 or
less, who were treated with hormonal therapy alone, were
disease-free five years after diagnosis.
These new PlanB study results with five-year outcomes provide
information beyond the three-year outcomes published recently in
the Journal of Clinical Oncology. The results add to the
unprecedented amount of clinical outcomes data on Oncotype DX and
are consistent with conclusions of the Trial
Assigning IndividuaLized Options for
Treatment (Rx), or TAILORx, recently published in The New
England Journal of Medicine, and results from the
Surveillance, Epidemiology, and End Results (SEER) program of the
National Cancer Institute (NCI), recently presented at the San
Antonio Breast Cancer Symposium.
"Our study shows the unique value of adding biologic information
provided by the Oncotype DX test in order to identify low-risk
breast cancer patients - among patients with 0-3 involved lymph
nodes - who can safely be spared the toxicity and side effects of
chemotherapy without compromising outcomes," said Prof.
Nadia Harbeck, WSG scientific
director and head of the breast center at University of
Munich (LMU). "This is especially
important for patients who would be considered as intermediate to
high risk of recurrence based on traditional clinical parameters.
These results confirm previous retrospective studies with Oncotype
DX, as well as the prospective TAILORx trial, which already
provided results for the node-negative population."
The study, conducted at 93 centers across Germany enrolled more than 3,100 patients with
estrogen-receptor positive, HER2-negative, early-stage breast
cancer, including those with node-positive disease (up to three
nodes) who were considered candidates for chemotherapy by
traditional parameters. The Oncotype DX test was used on all
patients to identify those who could be spared adjuvant
chemotherapy despite being considered as having high clinical risk
disease 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.
In women with Recurrence Score results of 11 or less who were
treated with hormonal therapy alone, five-year disease free
survival (DFS) was estimated as 94 percent. Patients with
Recurrence Score results of 12 to 25 who were treated with adjuvant
chemotherapy also had high DFS rates of 94 percent, while in
patients with Recurrence Score results above 25 who had also
received chemotherapy, DFS rates were 84 percent.
"The compelling suite of new global prospective outcomes data
generated in the last six months supports our prior validation work
and all of the guidelines worldwide that include Oncotype DX to
select patients for chemotherapy treatment, while providing
physicians and patients with the highest level of evidence
supporting the Recurrence Score as standard of care," said
Steven Shak, M.D., chief scientific
officer, Genomic Health.
Most recently, the German Association of Gynecological
Oncology's (AGO's) treatment guidelines distinguished Oncotype
DX as the first and only multi-gene breast cancer test with the
highest 1A level of evidence, following publication of multiple
large prospective outcomes studies. The AGO guidelines also
reconfirmed Oncotype DX as the only multi-gene expression test
validated to provide predictive information on the likelihood of
chemotherapy benefit for women with early-stage, hormone-receptor
positive, HER2-negative invasive breast cancer.
"Value in health care depends on results and outcomes, which is
vital to the patient. Results from this study clearly show the
value benefit of a personalized approach to breast cancer
treatment," said Denis Horgan,
executive director of the European Alliance for Personalized
Medicine. "We hope to see more healthcare systems across
Europe provide access to molecular
diagnostics that are supported by a high level of scientific
evidence and proven clinical utility."
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 annual report on Form 10-K for the year
ended December 31, 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.
1Abstract no: 8 LBA. "Prospective WSG Phase III PlanB
trial: Clinical outcome at 5-year follow up and impact of 21 Gene
Recurrence Score result, central/local-pathological review of
grade, ER, PR and Ki67 in HR+/HER2- high risk node-negative and
–positive breast cancer", Friday, Plenary session: oral and late
breaking abstracts, 09.45-11.15 hrs, Elicium.
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SOURCE Genomic Health, Inc.