REDWOOD CITY, Calif.,
Dec. 9, 2016 /PRNewswire/ -- Genomic
Health, Inc. (NASDAQ: GHDX) today announced results from multiple
studies demonstrating the unparalleled value of the Oncotype
DX® test in individualizing breast cancer treatment
decisions for patients with various stages of the disease.
Presentations included two overviews of prospective outcomes data
and clinical evidence supporting use of the test in early-stage
breast cancer patients with node-positive and node-negative
disease. Data also included new results from the Surveillance,
Epidemiology, and End Results (SEER) Registry program of the
National Cancer Institute (NCI) analyzing outcomes and clinical
utility of the Breast Recurrence Score™ (RS) in patients with
high-grade tumors, and findings from a clinical evaluation of the
Breast DCIS Score™ in patients with ductal carcinoma in situ
(DCIS).
"The clinical evidence generated by independent researchers and
Genomic Health is paramount, highlighting the accuracy of Oncotype
DX in predicting clinical outcomes and its unique value in
providing physicians with critical genomic intelligence to enhance
breast cancer treatment decisions and patient benefit," said
Steven Shak, M.D., chief scientific
officer, Genomic Health. "These latest Oncotype DX
presentations further our understanding of breast cancer biology
across the continuum of the disease, as well as our ability to
fulfill the promise of precision medicine for breast cancer
patients by providing rigorously studied, standard-of-care genomic
testing."
Extensive summary of unprecedented body of clinical
evidence reconfirms unsurpassed clinical validity and utility of
Oncotype DX in breast cancer
The original clinical
validation studies of the Oncotype DX Breast Recurrence Score were
prospectively designed using archived tissue from legacy trials
that had long-term outcomes (NSABP B-14 and B-20, TransATAC, and
SWOG 8814). With more than 700,000 patients tested to date, an
overview of clinical outcomes evidence confirms the original
clinical validation results. The recently presented prospective
outcomes data from four large independent studies – the SEER
Registry in the United States,
Clalit Health Services in Israel,
the international Trial Assigning
IndividuaLized Options for Treatment
(Rx), or TAILORx, and the West German Study Group "Plan B"
trial – indicate that patients with node-negative and node-positive
disease and low RS results (less than 18) can be effectively
treated with hormonal therapy alone and spared the toxicity of
chemotherapy.
"These data, drawn from outcomes of tens of thousands of
patients from around the globe, show that the Recurrence Score has
successfully transitioned genomic testing in breast cancer from
academic research into an intervention with an impact on public
health, sparing thousands of women around the world from
unnecessary chemotherapy each year," said Harold J. Burstein, M.D., Ph.D., Dana-Farber
Cancer Institute and Harvard Medical
School. "They also extend the usefulness of genomics into
populations such as women with node-positive breast cancers or
high-grade tumors – situations where we have historically used
chemotherapy, but where we may now rethink the need for that
treatment."
SEER study of breast cancer-specific survival (BCSS) in
patients with high-grade tumors treated based on Oncotype DX
results shows many patients have excellent outcomes without
chemotherapy
An analysis of clinical outcomes in 9,201
patients with node-negative and node-positive disease and poorly
differentiated tumors demonstrated a wide distribution of the
Oncotype DX Breast Recurrence Score results and showed the test was
a strong predictor of BCSS (p<0.001). Of these patients, those
with RS less than 18 had excellent five-year BCSS (>99 percent)
regardless of tumor size and nodal status. Although patients with
poorly differentiated tumors are well known to have worse prognosis
on average, the test identified a sizable proportion of patients
who can expect favorable five-year BCSS.
Comprehensive review of clinical evidence confirms
Oncotype DX accurately predicts clinical outcomes in node-positive
breast cancer patients, supporting use of the test by physicians
and patients, inclusion in guidelines and recognition by
payors
A systematic review was
conducted across seven studies including more than 8,000
patients with node-positive disease. These studies consistently
identified patients with a low number of positive nodes and low RS
results who had good clinical outcomes without chemotherapy. The
use of Oncotype DX in node-positive breast cancer significantly
decreased the frequency of adjuvant chemotherapy recommendations
and was found to be a cost-effective and/or cost-saving approach
worldwide.
Multi-center study demonstrates Oncotype DX predicts
neoadjuvant chemotherapy benefit
A prospective
multi-center study of 64 patients with early-stage invasive breast
cancer not suitable for breast-conserving surgery showed that
patients with a RS less than 11 had a high clinical response rate
with neoadjuvant hormone therapy, and 75 percent were able to get
breast-conserving surgery. Patients with a RS between 11 and 25 who
received neoadjuvant hormonal therapy also had a high rate of
successful breast-conserving surgery. Conversely, patients with a
RS over 25 benefited from neoadjuvant chemotherapy and had
excellent results. These results reinforce the unmatched utility of
Oncotype DX in predicting chemotherapy benefit for early-stage
invasive breast cancer.
Independently conducted comparison of clinical factors and
Oncotype DX shows Breast DCIS Score is substantially discordant
from clinical prognostic tools
A study in 91 patients
with DCIS compared the use of commonly available clinical
prognostic tools and physician estimates with the Oncotype DX
Breast DCIS Score to determine ipsilateral breast event risks
post-lumpectomy. Results showed that ipsilateral breast event risk
estimates varied significantly (more than 30 percent) among the
commonly available clinical predictive tools and individual
physician estimates, and none reliably replicated the Breast DCIS
Score. These results underscore the unique value of the Breast DCIS
Score.
Additional Oncotype DX presentations at the 2016 SABCS included
the following:
- A prospective multi-center decision impact study of 603
patients from France demonstrated
that the use of the Oncotype DX test changed treatment decisions in
70 percent of patients and reduced the use of chemotherapy,
resulting in an estimated cost savings of 570 euros per patient. These results, based on
real-world clinical practice in France, indicate that molecular testing
provides additional clinically meaningful information for a
significant proportion of patients and support its use and public
reimbursement.
- A gene discovery study conducted in collaboration with SWOG, an
NCI cooperative group, identified new genes and pathways that may
serve important roles in determining the prognosis of late breast
cancer-specific events (BCSE) in patients taking tamoxifen alone.
The study showed that the biology of late recurrence is very
different from the biology of early recurrence – an important
finding for liquid biopsy tests, which may be better suited to
predict late recurrence based on evolution of the tumor.
- Two trial designs were presented, including one for an ongoing
study in 150 patients with a diagnosis of ER-positive,
HER2-negative primary metastatic breast cancer. The study is
evaluating the association of Oncotype DX Breast Recurrence Score
results with time to progression and overall survival.
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 more than 700,000 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 or
www.MyBreastCancerTreatment.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 700,000 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
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, 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.
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SOURCE Genomic Health, Inc.