REDWOOD CITY, Calif.,
March 15, 2018 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) was informed
by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) that the Trial
Assigning IndividuaLized Options for Treatment (Rx), or TAILORx,
has achieved sufficient information to render a conclusion
regarding the effect of chemotherapy in early-stage breast cancer
patients with Recurrence Score® results of 11 to
25. This primary study group represents approximately 100,000
women diagnosed each year in the United
States alone. ECOG-ACRIN will be submitting the results as a
late-breaking abstract for presentation at an upcoming major
medical meeting.
The TAILORx trial was independently designed and conducted by
ECOG-ACRIN under the sponsorship of the National Cancer Institute
(NCI), part of the National Institutes of Health. The primary
objective of TAILORx is to more precisely determine the effect of
chemotherapy, if any, for women with node-negative, hormone
receptor-positive disease and Oncotype DX Breast Recurrence
Score® results of 11 to 25.
TAILORx is the largest adjuvant breast cancer treatment trial
ever conducted, and enrolled 10,273 women with early-stage breast
cancer across approximately 1,200 sites in the United States and five additional
countries. Investigators used the Oncotype DX Breast Recurrence
Score test on every patient to quantify individual risk of
recurrence and assign treatment to determine whether chemotherapy
would be beneficial or not. Based on previous studies, TAILORx
participants with Recurrence Score results less than 11 were
treated with hormonal therapy alone while those with Recurrence
Score results greater than 25 were treated with chemotherapy plus
hormonal therapy.
To more precisely define the effect of chemotherapy for women
considered to be at intermediate risk for recurrence, more than
6,700 women with Oncotype DX Breast Recurrence Score results of 11
to 25, the primary study group, were randomized to receive hormonal
therapy with or without chemotherapy. These randomized patients
comprised 65 percent of all TAILORx patients and were followed for
approximately nine years on average. All five adult cancer research
groups in the NCI's National Clinical Trials Network (NCTN)
enrolled patients in the trial. These groups include ECOG-ACRIN,
the Alliance for Clinical Trials in Oncology, NRG Oncology, SWOG
and the Canadian Cancer Trials Group. Leading breast cancer
advocacy organizations, including the Breast Cancer Research
Foundation, Susan G. Komen and the
National Breast Cancer Coalition, also supported the trial.
"We are proud that the Oncotype DX Breast Recurrence Score test
played a pivotal role in assigning treatment for this pioneering
precision medicine trial. These TAILORx results will more precisely
inform physicians and their patients with Recurrence Score results
of 11 to 25 about who will, or will not, benefit from the addition
of chemotherapy," said Steven Shak,
M.D., chief scientific officer, Genomic Health.
In 2015, results from the TAILORx secondary study group with
Oncotype DX Breast Recurrence Score results less than 11 were
published in The New England Journal of Medicine.
More than 99 percent of the 1,626 women who received hormonal
therapy alone without chemotherapy were free of breast cancer
distant recurrence after five years. These results provided the
highest level of evidence (level 1A) supporting the clinical
utility of Oncotype DX® to identify early-stage breast
cancer patients who can safely avoid chemotherapy treatment.
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
Recurrence Score® test, is the only test that has
been shown to predict the likelihood of chemotherapy benefit as
well as recurrence in invasive breast cancer. Additionally, the
Oncotype DX Breast DCIS Score™ test predicts the likelihood of
recurrence in a pre-invasive form of breast cancer called DCIS. In
prostate cancer, the Oncotype DX Genomic Prostate Score™ test
predicts disease aggressiveness and further clarifies the current
and future risk of the cancer prior to treatment intervention. With
more than 850,000 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.OncotypeIQ.com,
www.MyBreastCancerTreatment.org or
www.MyProstateCancerTreatement.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,
including 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 850,000 cancer patients
worldwide. Genomic Health is expanding its test portfolio
to include additional liquid- and tissue-based tests, including the
recently launched Oncotype DX® AR-V7 Nucleus
Detect™ test. 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 Oncotype
DX Breast Recurrence Score 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 results of clinical studies; the applicability of
clinical study results to actual outcomes; the ability of the test
results to change treatment decisions and improve patient outcomes;
the risks and uncertainties associated with the regulation of the
company's tests; the risk that the company may not obtain or
maintain sufficient levels of reimbursement, domestically or
abroad, for its existing tests and any future tests it may develop;
the risks of competition; unanticipated costs or delays in research
and development efforts; 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 filed
on Form 10-K for the year ended December 31,
2017. 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, Breast
Recurrence Score 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.
GHDX-B
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SOURCE Genomic Health, Inc.