- Real-world evidence reinforces TAILORx treatment paradigm
and standard of care use for Oncotype
DX® test
- Importance of tailoring chemotherapy use and differences
between tests acknowledged by leading international breast cancer
specialists
GENEVA, March 25, 2019 /PRNewswire/ -- New data
recently presented at the 16th St. Gallen International Breast
Cancer Conference further support the utility of Oncotype DX Breast
Recurrence Score® test to optimise chemotherapy
recommendations in patients with early-stage breast cancer with or
without lymph node involvement.
An updated analysis1 of the Clalit Health Services
registry, the largest health services organisation in Israel, examined medical records of more than
1,300 patients with node negative breast cancer applying the
Recurrence Score cut point determined by the landmark TAILORx
study2. The findings showed that use of chemotherapy was
aligned with Recurrence Score results and that patients with
Recurrence Score results up to 25, the vast majority of whom were
treated with hormonal therapy alone, had excellent outcomes at ten
years with low rates of distant recurrence.
"This important analysis with long-term follow up is based on
our experience with the Oncotype DX® test in
routine clinical practice and is consistent with findings from
multiple clinical trials, including the TAILORx study", said Prof.
Salomon Stemmer, lead investigator
of the study, Department of Oncology, Davidoff Center, Rabin
Medical Center affiliated to Tel Aviv
University, Israel. "These
results continue to show the unique value of adding genomic
information provided by the test to better target chemotherapy."
Another piece of research presented at the congress is
real-world evidence3 from a study in more than 80,000
patients, based on an analysis of data from the Surveillance,
Epidemiology, and End Results (SEER) registry programme of the
National Cancer Institute (NCI). The findings confirmed that the
Oncotype DX Breast Recurrence Score® result is
predictive of chemotherapy benefit in patients with node-negative
disease (p=0.009), with no chemotherapy benefit in patients with
Recurrence Score results up to 25. In patients with node-negative
disease and Recurrence Score results up to 25 not treated with
chemotherapy, the Breast Cancer Specific Survival (BCSS) was
greater than 96 percent at nine years. In patients with
node-positive disease not treated with chemotherapy and Recurrence
Score results less than 18, BCSS was greater than 97 percent at
nine years.
Importantly, the new real-world evidence reinforces the paradigm
established by the TAILORx study, which provided definitive
information on how to treat women with node-negative early-stage
breast cancer based on their Oncotype DX Breast Recurrence Score
results. TAILORx - the largest randomised adjuvant breast cancer
treatment trial ever conducted - identified the vast majority of
women (approximately 80 percent with Recurrence Score result up to
25) who receive no substantial benefit from chemotherapy, as well
as the important minority (Recurrence Score result 26-100) for whom
chemotherapy can be life-saving.
The important role of genomic testing to optimise patient
outcomes in early-stage breast cancer was discussed in a
debate4 between leading international breast cancer
specialists during the recent St. Gallen International Breast
Cancer Conference. The experts presented several case studies
showing that genomic testing adds value beyond clinical
pathological factors and agreed that there are substantial
differences between the available tests.
Prof. Joseph Gligorov from the
Breast Cancer Expert Center of the APHP-Tenon Hospital in
Paris, who participated in the
panel discussion, commented: "Only a test such as Oncotype DX that
has been specifically developed to be predictive of chemotherapy
benefit can identify the right treatment for the right patient. The
practice-changing precision made possible by such a test can lead
to improved quality of care and breast cancer survival, as well as
reduced waste of healthcare resources by directing chemotherapy
only to patients who have a high likelihood of deriving substantial
benefit."
Additional real-life data highlight value of Oncotype DX
to personalise and improve the quality of clinical
decisions
Also presented at the congress, results of two decision impact
studies from the UK and the Czech
Republic:
- UK clinical practice results5 from 582 patients with
node-positive disease (one to three positive lymph nodes) showed
that chemotherapy recommendations changed in a significant
proportion of patients following testing with Oncotype DX. In
particular, the test allowed more than 60 percent of patients to be
spared chemotherapy and its associated short and long-term
side-effects. Conversely, it identified 23 patients who were
initially advised to undergo only endocrine therapy, but whose
treatment was changed to add chemotherapy based on their Recurrence
Score result. Without testing, these patients would not have
received potentially life-saving chemotherapy treatment.
- A study from Czech medical centers6 which looked at
test utilisation in real-life clinical practice in 432 patients,
including those with high-risk disease by traditional parameters.
Results showed that testing with Oncotype DX led to a 78.4 percent
reduction of chemotherapy recommendations, indicating a significant
potential for overtreatment with chemotherapy when decisions are
based on clinical pathological parameters alone.
About early-stage breast cancer and the Oncotype DX
test
Oncotype DX is the only genomic test validated for its ability
to predict the likelihood of chemotherapy benefit as well as risk
of recurrence in early-stage breast cancer. Breast cancer is the
most common cancer in European women7 and affects many
of them during their years dedicated to working and raising a
family. While chemotherapy is routinely offered, research shows
that only a minority of patients with early-stage breast cancer
actually benefit from it.8,9 The Oncotype DX test is
designed to facilitate personalised clinical decisions by providing
information about the biology of an individual breast cancer, with
the potential to deliver financial benefits for healthcare
systems.
To learn more about the Oncotype DX test, visit:
www.OncotypeIQ.com
About Genomic Health
Genomic Health, Inc. is the world's leading provider of
genomic-based diagnostic tests that help optimise cancer care. With
its Oncotype IQ® Genomic Intelligence Platform, the
company is applying its state-of-the-art scientific and commercial
expertise and infrastructure to translate significant 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 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 one million cancer
patients worldwide. Genomic Health is expanding its test
portfolio to include additional liquid- and tissue-based tests,
including the recently launched Oncotype DX® AR-V7
Nucleus Detect™ 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 belief that the Oncotype
DX Breast Cancer test is unique in its ability to predict
chemotherapy benefit in early-stage breast cancer; the company's
belief that the Oncotype DX Breast Cancer test is cost effective
and can reduce the cost of treatment in the United Kingdom and in various other health
systems around the world; the applicability of study results to
actual outcomes; and the ability of the company's tests to impact
clinical practice. 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 company's ability to increase
usage of its tests; the company's ability to successfully
commercialize its tests outside of the
United States; the company's ability to compete against
third parties; 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 and
uncertainties associated with regulation of the company's tests;
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 September
30, 2018. 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, Breast
Recurrence Score, DCIS Score, Genomic Prostate Score, 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.
1 Stemmer et al. Poster: P249, St. Gallen
International Breast Cancer Conference. March 2019
2 Sparano et al. New Engl J Med. 2018
3 Winer et al. Poster: P246, St. Gallen International
Breast Cancer Conference. March
2019
4 Genomic Health Satellite Symposium: Optimising
outcomes in early-stage breast cancer by tailoring the use of
chemotherapy, St. Gallen International Breast Cancer Conference
5 Battisti et al. Poster: P007, St. Gallen International
Breast Cancer Conference
6 Petrakova et al. Poster: P004, St. Gallen
International Breast Cancer Conference
7 Ferlay J et al, Eur J Cancer. 2013
8 Paik et al. J Clin Oncol. 2006
9 Early Breast Cancer Trialists' Collaborative Group
(EBCTCG) et al. Lancet. 2012
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