REDWOOD CITY, Calif.,
Dec. 15, 2015 /PRNewswire/ -- Genomic
Health, Inc. (Nasdaq: GHDX) today announced results from multiple
Oncotype DX® breast cancer test studies at the
38th CTRC-AACR San Antonio Breast Cancer Symposium
(SABCS) reconfirming that Oncotype DX accurately predicts clinical
outcomes – including risk of recurrence and breast cancer survival
– in early-stage patients with invasive breast cancer. Data include
results from the Surveillance, Epidemiology, and End Results (SEER)
program of the National Cancer Institute (NCI); complete results
from a multi-center study from Clalit Health Services, the largest
Health Maintenance Organization in Israel; and additional analysis from the
Trial Assigning IndividuaLized
Options for Treatment (Rx), or TAILORx, led by the
ECOG-ACRIN Cancer Research Group.
"We now have an unprecedented amount of data from four large,
independently run, international studies demonstrating that
Oncotype DX transforms both treatment decisions and prospective
patient outcomes," said Steven Shak,
M.D., chief scientific officer, Genomic Health. "These results
provide unequivocal evidence supporting the expert-derived clinical
practice guidelines on the clinical utility of Oncotype DX in
node-negative and node-positive disease, and demonstrate that
patients and their physicians can make much better informed
decisions based on the Recurrence Score result."
Evidence in Over 44,500 Patients Shows that Oncotype DX
Accurately Predicts Patient Outcomes; Patients with Recurrence
Score® Less than 18 Have Excellent Breast Cancer
Survival at Five Years
SEER is the premier source of cancer statistics in the United States, collecting incidence and
cancer survival data for 30 percent of all U.S. cancer
patients.
A large population-based observational study based on the SEER
registry of more than 40,000 node-negative and 4,500 node-positive
patients showed Breast Cancer Specific Mortality (BCSM) at five
years was less than half a percent in node-negative disease and one
percent in node-positive disease (up to three positive nodes) when
the Recurrence Score results were less than 18.
Another important finding was that mortality increased with
increasing Recurrence Score results (p<0.001), underscoring the
accuracy of Oncotype DX in predicting patient outcomes. BCSM
increased slightly among patients with intermediate Recurrence
Score results of 18-30, and more than tenfold in patients with high
Recurrence Score results equal to or greater than 31. Analyses that
included patient age, tumor size and grade showed that the
Recurrence Score provided information beyond those standard
measures (p<0.001).
The SEER program and Genomic Health are collaborating to gain
important clinical insights from patients who have been treated and
tracked through the comprehensive NCI-affiliated registry to help
improve the diagnosis and treatment of breast cancer.
SEER Results Reveal Disparities in Oncotype DX Testing and
Outcomes Dependent on Patient Age and Geographic
Location
Based on the most recent analysis of patient information from
the year 2012, on average, 41 percent of patients with
node-negative, hormone-positive, HER2-negative breast cancer had
the Oncotype DX test performed. The use of Oncotype DX and
chemotherapy varied greatly based on patient age or geographical
location. Patients 70 years of age or older with node-negative
breast cancer – a subgroup that showed significantly worse breast
cancer survival and lower chemotherapy use across all of SEER
registry – were more than three times less likely to be tested on
average than patients younger than age 70. In addition, a
significant variability in testing was observed among the 12 states
included in the SEER database, with much lower rates of Oncotype DX
testing performed in 2012 in California (32 percent) and Washington (33 percent).
"Electronically supplementing the SEER registry with the Genomic
Health breast cancer test results provides helpful information
on the use of this test to enhance our understanding
of breast cancer diagnosis, treatment and outcomes," said
Lynne Penberthy, M.D., M.P.H.,
associate director of the Surveillance Research Program,
NCI's Division of Cancer Control and Population Sciences.
Oncotype DX Recurrence Score results were provided to SEER as
mandated by registry operations. There are plans to broaden this
collaboration on data sharing and to continue to supplement the
SEER registry with Oncotype DX testing information on an annual
basis. SEER and Genomic Health intend to publish this study's
findings and to further analyze results regarding the use of
Oncotype DX within the NCCN-recommended patient criteria and in
broader patient groups. Genomic Health's reporting of the SEER
registry data on Oncotype DX is self-funded, and there is no
financial relationship between the NCI and Genomic Health.
Three Additional Large International Studies Reinforce
Ability of Oncotype DX to Predict Clinical Outcomes, Reconfirming
Worldwide Value of the Test in Guiding Treatment
A study from Clalit Health Services analyzed medical records of
2,028 patients with node-negative and node-positive disease with
micrometastases across nine medical centers. Oncotype DX was used
in clinical practice in all of the patients to assign treatment
with or without chemotherapy. Results showed that the 996 women
with low Recurrence Score results less than 18 who were largely
treated with hormonal therapy alone (98 percent) had excellent
outcomes with less than one percent chance of distant recurrence or
breast cancer specific mortality at five years. In addition, the
812 patients with intermediate Recurrence Score results of 18 to
30, who were treated 28 percent of the time with chemotherapy, had
only slightly higher rates of distant recurrence (3.2 percent) and
breast cancer specific mortality (1.1 percent) at five years.
Separately, results of the initial analysis of TAILORx, which
were recently published in The New England Journal of
Medicine, were presented at SABCS along with an additional
analysis of the correlation of the Oncotype DX single gene scores
with clinicopathological measures. Key findings, previously
reported, demonstrated that trial participants with Recurrence
Score results of less than 11 who received hormonal therapy alone
had less than a one percent chance of distant recurrence at five
years. Similar findings regarding prospective outcomes for Oncotype
DX-tested patients were recently reported at the European Cancer
Congress by the Women's Healthcare Study Group. This separate study
across more than 90 centers in Germany analyzed outcomes in more than 2,500
patients from one of Europe's
largest contemporary adjuvant breast cancer trials.
"Consistent with results from the prospective-retrospective
NSABP and SWOG clinical validation studies of Oncotype DX, the new
multiple prospective outcomes studies provide additional strong
evidence of the test's ability to accurately predict prospective
outcomes regardless of age, tumor size or grade," said Norman Wolmark, M.D., chairman of the National
Surgical Adjuvant Breast and Bowel Project (NSABP). "This is a
significant milestone in genomics and reconfirms, for the first
time, the undeniable clinical value of Oncotype DX in selecting
patients for chemotherapy treatment."
Next-generation Sequencing (NGS) Study Showcases Genomic
Health's Scientific Leadership in Generating and Analyzing "Big
Data"
A gene discovery study conducted by the NCI cooperative group,
SWOG, identified a number of new genes and pathways that may be
important in early breast cancer recurrence or response to
chemotherapy. The study also showed that the biology of late
recurrence was very different from the biology for early
recurrence. This is a particularly important finding because it
provides an opportunity for a new technology such as liquid biopsy
– which may be better suited to predict late recurrence based on
evolution of the tumor – to help guide duration of hormonal therapy
and to track cancer progression and drug resistance.
Also presented at the 2015 SABCS was a second decision impact
study of Oncotype DX in DCIS (ductal carcinoma in situ) across 13
centers in the United States.
Results demonstrated that the test significantly changes treatment
decisions, reinforcing previously published results and providing
further confidence to physicians and their patients as they include
the test in treatment decision-making.
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 over half a million 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 early-stage cancer, one of the greatest issues in
healthcare today. The company is applying its world-class
scientific and commercial expertise and infrastructure to lead the
translation of massive amounts of genomic data into
clinically-actionable results for treatment planning throughout the
cancer patient's journey, from diagnosis to treatment selection and
monitoring. 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 or outcomes; 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; 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, delays or other challenges in research and
development efforts including for new products; 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, 2015. 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.
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SOURCE Genomic Health, Inc.