The National Institute for Health and Care Excellence (NICE) Recommends Use of Exact Sciences’ Oncotype DX® Test to Help Guide Chemotherapy Decisions for Node-positive Breast Cancer Patients
2024年5月10日 - 4:00PM
ビジネスワイヤ(英語)
Exact Sciences, a leading provider of cancer screening and
diagnostic tests, today announced that the UK’s National Institute
for Health and Care Excellence (NICE) has recommended the expanded
use of the Oncotype DX Breast Recurrence Score® test to more
effectively target chemotherapy treatment for women who have
hormone receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-), early-stage breast cancer involving up
to three positive nodes and who have been through the menopause.
NICE confirmed that breast cancer patients who are male and trans,
non-binary or intersex may benefit from the test depending on their
hormonal profile. The recommendation has the potential to impact
more than 3000 additional breast-cancer patients in England who
will now have access to the test through the National Health
Service (NHS).1
The new guidance expands upon earlier NICE recommendations for
testing patients without lymph node involvement. Access to genomic
testing for patients with lymph node-positive breast cancer
addresses the issue of overtreatment with chemotherapy, helping
many patients to avoid treatment side effects such as nausea,
fatigue, hair loss and potentially secondary cancer. In addition,
expanded reimbursement has the potential to free up resources and
capacity within NHS breast cancer services.
Dr Caroline Archer, consultant medical oncologist Portsmouth
Hospital NHS Trust said: “This is a practice-changing moment
for node-positive patients and the NHS. There is an urgent need to
target chemotherapy more precisely to those most likely to benefit
from it, so that patients can avoid unnecessary side effects. The
Oncotype DX Breast Recurrence Score result enables us to do this
effectively by providing specific information about an individual’s
response to chemotherapy. This positive recommendation marks a
significant step forward in supporting equitable access to the test
across the country.”
While the majority of patients with lymph node-positive
early-stage breast cancer receive chemotherapy, research shows that
only a minority benefit from the treatment. The Oncotype DX® test
is the only test able to identify around 85% of postmenopausal
patients whose cancer outcomes are not likely improved by
chemotherapy, meaning they can avoid the risk of side
effects.2,3,4
A recent independent UK multi-centre trial led by Prof Holt
involving 680 women with lymph node-positive early breast cancer
confirmed that using the Oncotype DX test to help guide
chemotherapy treatment decisions leads to a substantial reduction
in unnecessary chemotherapy, as well as savings for the NHS.5
Prof Simon Holt, Health and Life Science, Swansea University
& Peony Breast Care Unit, Prince Philip Hospital said:
“This decision to recommend the use of the Oncotype DX test to
guide chemotherapy decisions in early node positive breast cancer
will be of great benefit to our postmenopausal patients and to the
NHS. The use of the test will reduce the suffering and
inconvenience by sparing up to 85% of people unnecessary
chemotherapy, which in turn, then reduces the care demands on
Oncology services. It also reduces significantly the cost of
treatment so that NHS resources can be redistributed to other
medical priorities.
Also, our research has shown that the use of the Oncotype DX
test means both clinicians and their patients will have much
greater confidence in their chemotherapy decisions.”
The test’s efficacy is also supported by the landmark TAILORx6
and RxPONDER7 studies, which demonstrated that most patients with
either node-negative or node-positive early-stage breast cancer do
not benefit from chemotherapy and can be reliably identified using
the Oncotype DX test.
Matt Bull, Head of Northern Europe (UK, Ireland and Nordics)
at Exact Sciences, added: “We are delighted that more patients
with node-positive breast cancer will now also benefit from knowing
their Recurrence Score® result. We are proud of the potential
impact the expanded use of the Oncotype DX test will have — better
patient treatment, improved clinical confidence and less pressure
on the health service.”
About the Oncotype DX Breast Recurrence Score test
The Oncotype DX Breast Recurrence Score 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. The
test was first made available to patients in 2004, and over 1,5
million patients around the world have benefited from it. It is
incorporated in major breast cancer treatment guidelines, including
those of the European Society for Medical Oncology (ESMO) and the
St. Gallen International Breast Cancer Conference, as well as the
American Society of Clinical Oncology (ASCO®) and the National
Comprehensive Cancer Network (NCCN®) in the U.S.
To learn more about the test, visit:
https://www.oncotypeiq.com/en
About Exact Sciences
A leading provider of cancer screening and diagnostic tests,
Exact Sciences gives patients and health care professionals the
clarity needed to take life-changing action earlier. Building on
the success of the Cologuard® and Oncotype® tests, Exact Sciences
is investing in its pipeline to develop innovative solutions for
use before, during, and after a cancer diagnosis. For more
information, visit https://www.exactsciences.com, follow Exact
Sciences on X (formerly known as Twitter) @ExactSciences, or find
Exact Sciences on LinkedIn and Facebook.
NOTE: Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score
and Recurrence Score are trademarks or registered trademarks of
Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences
Corporation. Exact Sciences and Cologuard are trademarks or
registered trademarks of Exact Sciences Corporation. All other
trademarks and service marks are the property of their respective
owners.
1 Tumour profiling tests to guide adjuvant chemotherapy
decisions for lymph node-positive early breast cancer [DG58], NICE
Resource impact tool, May 2024:
https://www.nice.org.uk/guidance/dg58/resources/resource-impact-template-excel-13425543901
2 Bello et al. Ann Surg Oncol. 2018. 3 Zhang et al. Breast
Can Res Treat. 2020. 4 Stemmer et al. npj Breast Cancer.
2017. 5 Holt et al. British Journal of Cancer, 2024 pp.
1-8 6 Sparano et al. N Engl J Med. 2018 7 Kalinsky et
al. New Engl J Med. 2021
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Media: Federico Maiardi +41 79-138-13-26
fmaiardi@exactsciences.com