REDWOOD CITY, Calif.,
Sept. 11, 2017 /PRNewswire/ --
Genomic Health, Inc. (Nasdaq: GHDX) today announced the
presentation of new data that provide additional evidence of the
unmatched value of the Oncotype DX Breast Recurrence
Score® test in accurately predicting outcomes in
early-stage breast cancer patients. The data were presented at the
2017 European Society for Medical Oncology (ESMO) Congress in
Madrid.
Results from a first-of-its-kind analysis including over 6,000
patients younger than age 40 from the National Cancer Institute's
Surveillance, Epidemiology, and End Results (SEER) Registry program
showed that of the 1,767 women tested with Oncotype DX those with a
low Recurrence Score® (RS) result (<18) experienced
excellent outcomes with 100 percent breast cancer-specific survival
(BCSS) at five years, despite the vast majority of them foregoing
chemotherapy. Additionally, results from the West German Study
Group's (WSG) PlanB study, one of the largest contemporary adjuvant
breast cancer trials in Europe,
showed very low rates of distant recurrence in clinically high-risk
patients with node-positive or node-negative breast cancer who had
low RS results (0-11) following five years of hormone therapy
alone.
"The data presented at the 2017 ESMO Congress reinforce the
value of the Oncotype DX Breast Recurrence Score test in providing
clinicians with critical information to personalize and improve
treatment decisions for early-stage breast cancer patients
regardless of their age," said Phil
Febbo, M.D., chief medical officer, Genomic Health. "These
two separate studies once again support the ability of the Oncotype
DX test to accurately identify patients who do not benefit from
chemotherapy despite being considered high risk based on age or
other traditional clinical factors, demonstrating the important
role of genomic testing in these populations."
New SEER Registry Analysis Shows Excellent Survival in
Breast Cancer Patients Younger than 40 with Low Recurrence Score
Results
Breast cancer at a young age is generally
associated with a poor prognosis and more aggressive treatment.
This large, population-based study analyzed data from the SEER
Registry program of BCSS in 1,767 patients younger than age 40 with
node-negative, hormone receptor-positive, HER2-negative breast
cancer who were treated based on their RS result. Results showed
the five-year BCSS rate was 100 percent in the 821 patients with a
RS result less than 18 – of whom 83 percent did not receive
chemotherapy. Among those with a RS result less than 18, BCSS was
also excellent for a large subgroup of patients with no or unknown
chemotherapy use and for smaller subgroups of patients younger than
age 30 and between 30 and 34 years of age. Similarly, patients with
a RS result of 25 or less also had a favorable five-year BCSS. Poor
outcomes were observed with high Recurrence Score results despite
frequent reported use of chemotherapy. (Abstract #1451P)
"Findings from this SEER analysis provide important outcome
information for young women with breast cancer – who often face the
most difficult decisions regarding optimal treatment," said
Hope S. Rugo, M.D., professor of
medicine; director, University of California
San Francisco Helen Diller Family Comprehensive Cancer
Center. "The results of this analysis indicate that not all
young breast cancer patients have aggressive tumor biology and a
poor prognosis. In fact, patients with a low Recurrence Score
result had excellent survival even without chemotherapy. Based on
these findings, women with breast cancer for which there is
uncertainty about the benefit from chemotherapy and regardless of
age should consider genomic testing to help determine the best way
to treat their disease."
Analysis from Prospective PlanB Study Shows Very Low Rates
of Distant Recurrence in Clinically High-risk Patients with Low
Recurrence Score Results and No Chemotherapy
Distant
recurrence results from the PlanB trial were presented for the
first time, showing that patients with low RS results treated with
hormonal therapy alone had very low rates of distant recurrence
(distant disease-free survival or DDFS) after a median follow-up of
60 months. Five-year DDFS rates were comparable in patients with
node-positive (up to three nodes) disease (97.9 percent) and in
those with clinically high-risk node-negative disease (97.7
percent). The RS result was found to be the strongest independent
predictor for DDFS in multivariable analysis (p<0.001),
providing the greatest impact on prognosis and outperforming all
other factors, including the traditional criteria of tumor size and
tumor grade (Abstract #LBA11). These distant recurrence results
provide information beyond the five-year PlanB outcomes published
recently in Breast Cancer Research and Treatment, which
include disease-free survival and overall survival.
"These new study results show the unique value of adding
biological information provided by the Oncotype DX test in order to
identify low-risk breast cancer patients -- those with 0-3 involved
lymph nodes -- who can safely be spared the toxicity and side
effects of chemotherapy without compromising outcomes," said Dr.
Oleg Gluz, scientific coordinator of
the West German Study Group that conducted the PlanB study. "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."
Additional Oncotype DX® Presentations Confirm
Genomic Tests Are Not Interchangeable and Reinforce Unique Value of
Recurrence Score Result in Identifying Minority of Patients Who
Benefit from Chemotherapy
Results of a head-to-head comparison confirmed that the most
common genomic tests in clinical use for early breast cancer
(Oncotype DX, MammaPrint®, EndoPredict®,
Prosigna® and Breast Cancer IndexSM)
risk-stratify patients differently, and thus are not
interchangeable. These findings have implications for the potential
use of adjuvant chemotherapy. (Abstract #187P)
Findings from an analysis of more than 600,000 RS results collected globally
demonstrated highly similar distributions of RS results
geographically, with more than half of patients classified as low
risk (i.e., with a RS result less than 18). These findings mirror
observations from prospective registry studies, including SEER and
Clalit, as well as the TAILORx and PlanB prospective clinical
trials, and suggest that tumor biology as characterized by RS
results does not vary by geography. These findings support the
generalizability of outcomes-study results across geographic
regions. (Abstract #192P)
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, 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 800,000 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.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, 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 800,000 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™ 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 results of clinical
studies; the impact of clinical studies on reimbursement and test
adoption; the applicability of clinical study results to actual
outcomes; the commercial performance of the company's tests; and
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 risk that the company may not obtain or maintain
adequate levels of reimbursement, domestically or abroad, for its
existing tests and any future tests it may develop; the ability of
the company to achieve expanded coverage of reimbursement for its
existing tests and the ability of any such expanded coverage to
result in additional revenue; the ability of test results to change
treatment decisions; the risks of competition; the risks and
uncertainties associated with the regulation of the company's
tests; the results of clinical studies; the applicability of
clinical study results to actual outcomes and the ability to
demonstrate sufficient clinical utility; 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 our most recent report on Form 10-Q for the
quarter ended June 30, 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,
Recurrence Score, DCIS Score, Oncotype SEQ, Oncotype DX Genomic
Prostate Score, Oncotype DX AR-V7 Nucleus Detect, Liquid Select 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.