Results From a Large-Scale Prospective Study
Investigating Long-Term Anti-Estrogen Therapy Recommendations
Published in JNCCN — Journal of the National Comprehensive Cancer
Network
Hologic, Inc. (Nasdaq: HOLX) and its subsidiary,
Biotheranostics, Inc., today announced newly published study
results revealing that use of the Breast Cancer Index® (BCI) test
led to physicians changing their long-term anti-estrogen treatment
recommendations for 40% of patients with early-stage hormone
receptor-positive (HR+) breast cancer.1 The results, which suggest
that many women may be over- or undertreated without the
incorporation of BCI, reflect real-world data from the largest
prospective study assessing the impact of the BCI test on treatment
decisions. The study was published in the March issue of the JNCCN
— Journal of the National Comprehensive Cancer Network.
Previous studies have demonstrated that while some women with
early-stage HR+ breast cancer may reduce their risk of recurrence
with longer anti-estrogen therapy (10 vs. 5 years), most women do
not benefit.2-7 The BCI test is the only genomic test recognized by
multiple national oncology guidelines to predict which women are
likely to benefit from continuing anti-estrogen therapy beyond five
years, helping optimize the duration of treatment.
The key results from the JNCCN-published study underscore the
value of BCI in helping to avoid:
- Overtreatment: Of the physician treatment decisions that
changed, 63% changed from a YES to a NO recommendation for extended
anti-estrogen therapy. This finding suggests a critical role of BCI
in helping identify women whose treatment may be discontinued after
the first five years to avoid potential side effects and toxicities
associated with longer anti-estrogen therapy.
- Undertreatment: The remaining 37% of changes in
treatment decisions by physicians were from a NO to a YES
recommendation for extended anti-estrogen therapy. This result
highlights an equally important use of BCI: to identify women who
may benefit from longer treatment to help avoid a potentially
life-threatening metastatic recurrence when extended therapy may
not have been previously recommended based on clinical and
pathologic risk features alone.
“These results further reinforce the impact of the Breast Cancer
Index test in clinical practice. For many physicians, the test
results changed their recommendations for prescribing or not
prescribing extended anti-estrogen therapy for patients based on
the predictive benefit,” said Tara Sanft, M.D., the study’s primary
author, Associate Professor of Medicine at Yale School of Medicine
and Chief Patient Experience Officer at Smilow Cancer Hospital. “As
clinicians, we always strive to give our patients the best clinical
advice possible. The Breast Cancer Index helps us prevent over- and
undertreatment for extended anti-estrogen therapy and is an
incredibly helpful tool, giving us more confidence in our treatment
decisions for breast cancer patients.”
Patients and physicians included in this study are participants
in the BCI Registry Study. The BCI Registry Study is a prospective,
large-scale, multi-center study that investigates long-term
clinical outcomes, decision impact and medication adherence in
patients with early-stage HR+ breast cancer receiving BCI testing
as part of routine clinical care. The study concluded with the
enrollment of over 3,000 patients who will continue to be followed
until 10 years from diagnosis. The current publication reports
results assessing the impact of BCI on clinical decision-making
regarding extended anti-estrogen therapy in the first 1,000
patients enrolled in the BCI Registry Study.
Cancer patients look to their oncology care teams as experts for
guidance in recommending the most appropriate treatment plan
tailored to their individual health and needs. Ultimately, the
newly published findings reveal that when incorporated into routine
clinical care, BCI has the potential to provide clinicians with
greater confidence in their treatment recommendations, with 39% of
providers saying they felt more confident in their recommendation
for extended anti-estrogen therapy following BCI testing.
Additionally, BCI testing led to 41% of patients feeling more
comfortable with their treatment decisions and 45% changing their
preference regarding an additional five years of anti-estrogen
therapy.
“For over 35 years, Hologic has been developing diagnostic
solutions that are rooted in science and backed by robust clinical
data. Alongside our portfolio of Breast and Skeletal Health
Solutions, I’m proud of how Hologic’s Diagnostic Solutions
division, through Biotheranostics, continues to transform the
breast cancer care continuum for women and providers,” said
Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at
Hologic. “As more research is published, I’m thrilled to see the
continued, impressive utility of the Breast Cancer Index test. As
seen in the results of this study, for women with early-stage
hormone receptor-positive breast cancer, this test has the
potential to reinforce the importance of the medication they are
taking — or to allow them to discontinue treatment without fear of
reoccurrence.”
About the Breast Cancer Index Test
The Breast Cancer Index test is a molecular, gene
expression-based test uniquely positioned to provide information to
help physicians individualize treatment decisions for patients with
early-stage HR+ breast cancer. This breakthrough test helps
oncologists and patients navigate the difficult trade-offs between
taking steps to prevent recurrence of their disease and facing
significant side effects and safety challenges related to
unnecessary treatment. The Breast Cancer Index test has guideline
designation from the American Joint Committee on Cancer (AJCC) for
cancer staging based on molecular profile. The American Society of
Clinical Oncology (ASCO), the European Group on Tumor Markers
(EGTM) and the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) acknowledge the Breast Cancer Index test as a
biomarker to inform the extended endocrine treatment decision; and
ASCO, EGTM and St. Gallen acknowledge the Breast Cancer Index test
as a biomarker to inform the chemotherapy decision.8 BCI is the
only validated, commercially available test that predicts the
benefit from extended endocrine therapy.
The Breast Cancer Index test is intended for routine clinical
use and treatment decisions based on results are the responsibility
of the physician. It is a laboratory developed test (LDT) performed
in a single CLIA-certified and CAP-accredited diagnostic
laboratory. For more information, visit
www.breastcancerindex.com.
About Hologic, Inc.
Hologic, Inc. is a global medical technology innovator focused
on improving the health and well-being of women, their families and
communities through early detection and treatment. Its advancements
include invention of the world’s first commercial 3D mammography
system to find breast cancer earlier; leadership in testing for
cervical cancer, sexually transmitted infections and respiratory
illnesses; and minimally invasive surgical technologies for uterine
fibroids and abnormal uterine bleeding.
The company also champions women through the Hologic Global
Women’s Health Index, which provides a science-backed data
framework for improving women’s well-being.
Forward-Looking Statements
This news release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of Hologic products. There can be no assurance these products
will achieve the benefits described herein or that such benefits
will be replicated in any particular manner with respect to an
individual patient, as the actual effect of the use of the products
can only be determined on a case-by-case basis. In addition, there
can be no assurance that these products will be commercially
successful or achieve any expected level of sales. Hologic
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any such statements presented
herein to reflect any change in expectations or any change in
events, conditions or circumstances on which any such data or
statements are based.
Hologic, The Science of Sure and Breast Cancer Index are
trademarks and/or registered trademarks of Hologic, Inc. and/or its
subsidiaries in the United States and/or other countries.
______________________________________ 1Sanft T, Wong J, O’Neal
B, et al. Impact of the Breast Cancer Index for Extended Endocrine
Decision-Making: First Results of the Prospective BCI Registry
Study. Journal of The National Comprehensive Cancer Network.
Published online March 04, 2024. doi:10.6004/jnccn.2023.7087
2Davies C, Pan H, Godwin J, et al. Long-term effects of continuing
adjuvant tamoxifen to 10 years versus stopping at 5 years after
diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a
randomised trial. The Lancet. 2013;381(9869):805-816.
doi:https://doi.org/10.1016/s0140-6736(12)61963-1 3Gray RG, Rea D,
Handley K, et al. aTTom: Long-term effects of continuing adjuvant
tamoxifen to 10 years versus stopping at 5 years in 6,953 women
with early breast cancer. Journal of Clinical Oncology.
2013;31(18_suppl):5-5.
doi:https://doi.org/10.1200/jco.2013.31.18_suppl.5 4Jakesz R, Greil
R, Gnant M, et al. Extended Adjuvant Therapy With Anastrozole Among
Postmenopausal Breast Cancer Patients: Results From the Randomized
Austrian Breast and Colorectal Cancer Study Group Trial 6a. Journal
of the National Cancer Institute. 2007;99(24):1845-1853.
doi:https://doi.org/10.1093/jnci/djm246 5Goss PE, Ingle JN, Martino
S, et al. Randomized Trial of Letrozole Following Tamoxifen as
Extended Adjuvant Therapy in Receptor-Positive Breast Cancer:
Updated Findings from NCIC CTG MA.17. Journal of the National
Cancer Institute. 2005;97(17):1262-1271.
doi:https://doi.org/10.1093/jnci/dji250 6Mamounas EP, Bandos H,
Lembersky BC, et al. A randomized trial of five years of letrozole
versus placebo after aromatase inhibitor-based therapy: NRG
Oncology/NSABP B-42. The Lancet Oncology. 2019;20(1):88-99.
doi:https://doi.org/10.1016/S1470-2045(18)30621-1 7Goss PE, Ingle
JN, Pritchard KI, et al. Extending Aromatase-Inhibitor Adjuvant
Therapy to 10 Years. New England Journal of Medicine.
2016;375(3):209-219. doi:https://doi.org/10.1056/nejmoa1604700
8Referenced with permission from the NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer
V.4.2023.© National Comprehensive Cancer Network, Inc. 2023. All
rights reserved. Accessed December 15, 2023. To view the most
recent and complete version of the guideline, go online to
NCCN.org. NCCN makes no warranties of any kind whatsoever regarding
their content, use or application and disclaims any responsibility
for their application or use in any way.
SOURCE: Hologic, Inc.
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Media Contact Bridget Perry Director, Corporate
Communications +1 508.263.8654 bridget.perry@hologic.com
Investor Contact Ryan M. Simon Vice President, Investor
Relations +1 858.410.8514 ryan.simon@hologic.com
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