REDWOOD CITY, Calif.,
Dec. 11, 2017 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) today
announced results of 10 studies that reinforce the unmatched value
of the Oncotype DX Breast Recurrence Score® test and
Oncotype DX® DCIS Score™ test in optimizing
patient treatment across the breast cancer disease continuum. The
data were recently presented at the 2017 San Antonio Breast Cancer
Symposium (SABCS).
"Over the past 14 years, we have collaborated with clinical and
academic thought leaders to present data at SABCS that has
transformed breast cancer care. As this world-leading breast cancer
conference marks its 40th anniversary, we are proud to
contribute important new information that supports the use of
Oncotype DX in both the adjuvant and neoadjuvant settings," said
Steven Shak, M.D., chief scientific
officer, Genomic Health. "With more than 800,000 patients served to
date and outcomes data from more than 60,000 women, we have
unparalleled data that facilitates a deeper understanding of the
practice-changing impact of Oncotype DX testing."
Validation Shows Oncotype DX Breast Recurrence Score Test
Predicts Clinical Response to Neoadjuvant Hormonal Therapy to
Improve Surgical Outcomes
Neoadjuvant systemic therapy
prior to surgery, such as chemotherapy and/or hormonal therapy, can
shrink tumor size and allow breast conserving surgery (BCS) in
patients who may otherwise receive a full mastectomy. However,
chemotherapy can be toxic and, in some patients, does not provide
improved surgical outcomes over hormonal therapy. Core needle
biopsy samples from 294 postmenopausal patients enrolled in the
Phase 3 NEOS neoadjuvant (treatment before surgery) study of
estrogen-receptor positive breast cancer and tumor size ≥2
centimeters were analyzed to determine clinical response to
neoadjuvant hormonal therapy. The analysis demonstrated that
Recurrence Score® (RS) results significantly predicted
the likelihood of clinical response to neoadjuvant therapy
(p<0.001). Specifically, the findings suggest that, for patients
with a RS result below 18, treatment with neoadjuvant hormonal
therapy alone could be an effective treatment strategy, resulting
in BCS in 79 percent of cases.
"This important clinical validation study demonstrates that
analyzing tumor biology with Oncotype DX in the neoadjuvant setting
can help guide important treatment decisions," said Prof.
Hiroji Iwata, principal study
investigator, Department of Breast Oncology, Aichi Cancer Center
Hospital, Nagoya, Japan. "In
particular, patients with a low Recurrence Score result tend to
have higher clinical response rates with neoadjuvant hormonal
therapy, which makes it possible to shrink the tumor size and
achieve breast conserving surgery leading to better cosmetic
outcomes while limiting the impact of treatment side effects on
their quality of life."
Many Node-positive Breast Cancer Patients Can Avoid
Chemotherapy Based on Recurrence Score Result
Consistent
with previously published findings, an analysis from the National
Cancer Institute's (NCI) Surveillance, Epidemiology, and End
Results (SEER) Registry reconfirms that breast cancer patients with
node-positive disease, limited nodal involvement and RS results
less than 18 have extremely low (less than 2 percent) five-year
breast-cancer specific mortality (BCSM). Importantly, in patients
with low RS results, five-year BCSM was low regardless of
chemotherapy use. This indicates that certain node-positive
patients with low RS results can forego chemotherapy and emphasizes
the value of the Oncotype DX Breast Recurrence Score test in a
patient population that is generally treated aggressively based on
traditional clinical factors.
SEER Registry Analysis Supports New AJCC Staging Criteria,
Confirming Many Patients with Poor Prognostic Factors May Be
Downstaged to Stage 1A Disease Based on Their Oncotype DX Breast
Recurrence Score Result
Effective January 2018, the new American Joint Committee on
Cancer (AJCC) Prognostic Stage Groups will add the Oncotype DX
Breast Recurrence Score, hormonal status (ER, PR) and HER2 status
to nodal status, tumor size and tumor grade for staging breast
cancer. For patients with node-negative disease or micrometastases
in the nodes, a low Oncotype DX Breast Recurrence Score result (RS
<11) classifies a patient as having the most favorable
Prognostic Stage, regardless of tumor grade or tumor size (up to
five centimeters). In an analysis of the SEER Registry, age, tumor
size and tumor grade ranged widely in patients with a RS <11.
Importantly, the 9,000 patients with a RS <11 who were treated
with hormonal therapy alone had excellent prognosis, with a
five-year breast cancer-specific survival of 99.6 percent, strongly
supporting the new AJCC staging criteria.
"Genomic testing has transformed the way we treat early-stage
invasive breast cancer, and there is now unequivocal evidence
demonstrating that Oncotype DX can consistently and accurately
predict chemotherapy benefit and the risk of distant recurrence
across patient populations, including those with node-positive
disease," said Kevin R. Fox, M.D.,
director, Rena Rowan Breast Center,
Penn Medicine. "By using the Recurrence Score and
information based on the biology of each patient's tumor, we are
able to optimally manage their disease, avoiding over- and
under-treatment and ultimately reducing the burden of chemotherapy
on patients and the healthcare system."
Additional Oncotype DX Presentations Reinforce Unmatched
Value of Tests in Multiple Patient Populations
- Prospective 10-year, long-term clinical outcomes from a
registry of more than 1,500 patients tested with Oncotype DX within
Clalit Health Services, the largest health maintenance organization
in Israel, demonstrated that
patients with low RS results treated with hormonal therapy alone
showed low 10-year distant recurrence rates. Specifically, the
findings showed that use of chemotherapy was aligned with RS
results, and that node-negative patients with RS results less than
18 -- the vast majority (98.2 percent) of whom were treated with
hormonal therapy alone -- had excellent outcomes, with a 10-year
distant recurrence risk of 4 percent.
- A new analysis revealed distinctive biological features for
breast cancer in men compared with women, and confirmed that
genomic profiling with Oncotype DX testing also provides clinical
value for guiding treatment decisions in men regardless of nodal
status.
- New data from the prospective West German Study Group's (WSG)
PlanB study, one of the largest contemporary adjuvant breast cancer
trials in Europe, reinforce the
value of utilizing the Oncotype DX Breast Recurrence Score test to
evaluate tumor biology in older women. The results demonstrated
that patients age 70 or older, whose performance status allows them
to be candidates for chemotherapy and have high Recurrence Score
results, do as well as younger patients. The researchers suggest
that elderly patients should receive genomic testing to determine
their breast cancer risk and, if they are determined to be high
risk, should receive chemotherapy to optimize outcomes.
- Two new analyses evaluating the results from women with ductal
carcinoma in situ (DCIS) confirmed the ability of the Oncotype DX
DCIS Score test to provide estimates of recurrence risk.
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 September 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, Liquid Select, Genomic
Prostate Score, GPS Oncotype DX AR-V7 Nucleus Detect 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.
GHDX-B
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SOURCE Genomic Health, Inc.