REDWOOD CITY, Calif.,
May 25, 2016 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced that
the Journal of Clinical Oncology, the official journal of
the American Society of Clinical Oncology (ASCO), published results
from a large study confirming the ability of the Oncotype
DX® Breast Recurrence Score™, in combination
with quantitative estrogen-receptor (ER) expression, to accurately
predict after five years of tamoxifen therapy the risk of late
distant recurrence up to 15 years in patients with early-stage,
hormone receptor-positive breast cancer. These findings suggest
that Oncotype DX may help identify which patients are most likely
to benefit from extended hormonal treatment with tamoxifen.
"Extending tamoxifen treatment for 10 years has been shown to be
associated with better outcomes, but not all patients have the
same risk of late distant recurrence – meaning cancer coming back
after five years – and it is important to know a patient's risk in
order to better understand who will benefit the most from extended
hormonal treatment," said Norman
Wolmark, M.D., chairman of the National Surgical Adjuvant
Breast and Bowel Project (NSABP) Foundation, the organization
that carried out the study in conjunction with Genomic Health. "The
results of this large study confirm that Oncotype DX
helps better define who is at greatest risk of a late distant
recurrence and who would likely derive the greatest benefit from
extended tamoxifen therapy."
The study analyzed the results of two clinical trials: NSABP
B-14 (668 patients) and B-28 (1,065 patients). Patients were
followed up on for a median of 13.9 years (B-14) and 11.2 years
(B-28). The results reconfirm earlier findings from validation
studies of Oncotype DX which demonstrated that Breast Recurrence
Score results were strongly associated with distant recurrence up
to 15 years for patients with node-positive and node-negative
disease. The new study also showed that in patients with greater ER
expression, the association of the continuous Breast Recurrence
Score with distant recurrence was significant after adjustment for
age, grade and tumor size.
The results suggest that extending tamoxifen beyond five years
may provide greater benefit in patients with high and intermediate
Breast Recurrence Score results who also show high ER expression.
Conversely, patients with low Breast Recurrence Score results have
a much lower risk of late distant recurrence and would be expected
to have less benefit from extended tamoxifen beyond five years.
Findings from a separate study of Oncotype DX were also recently
published in the Journal of Clinical Oncology. That study
evaluated the ability of the Breast Recurrence Score to provide
information on breast cancer progression and survival in newly
diagnosed stage IV breast cancer patients. About five percent of
patients are diagnosed with stage IV disease, and there is limited
molecular information on the impact of tumor biology on patient
outcomes. Results showed that the Breast Recurrence Score
independently predicted both time to progression and two-year
overall survival in patients with ER-positive, HER2-negative
metastatic breast cancer, indicating that biology is the major
determinant of outcome, not only for patients diagnosed with
node-negative and node-positive breast cancer, but also for
patients diagnosed with stage IV disease.
"The publication of these two studies in the Journal of
Clinical Oncology further demonstrates our leadership in
the area of breast cancer precision medicine and our ongoing
commitment to evaluate our genomic tests in a wide range of cancer
patients," said Frederick Baehner,
M.D., vice president, Pathology, Genomic Health. "The impressive
amount of evidence that we have generated over the last decade has
helped us better understand the biology of breast and other types
of cancer throughout the disease continuum – from early-stage to
advanced metastatic disease – and continues to inform our liquid
biopsy development efforts focused on late-stage solid tumor
cancers."
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 quarterly report on Form 10-Q for the
quarter ended March 31, 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, 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.
GHDX-B
Logo -
http://photos.prnewswire.com/prnh/20130425/SF01493LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/genomic-health-announces-publication-in-journal-of-clinical-oncology-demonstrating-oncotype-dx-predicts-late-distant-recurrence-in-breast-cancer-300274494.html
SOURCE Genomic Health, Inc.