American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Now Includes Breast Cancer Index™ to Guide Decisions about Extended Endocrine Therapy
April 25 2022 - 7:08AM
Business Wire
Guideline inclusion further validates the need
to incorporate Breast Cancer Index into standard of care
Hologic, Inc. (Nasdaq: HOLX) announced today that the American
Society of Clinical Oncology (ASCO) has published an update which
expands the utility of Breast Cancer Index™ (BCI) within its
Clinical Practice Guideline: “Biomarkers for Adjuvant Endocrine and
Chemotherapy in Early-Stage Breast Cancer.” Specifically, ASCO now
recognizes BCI as the only genomic test to help guide extended
endocrine therapy decisions in early-stage, HR+ breast cancer
patients with node negative or node positive (one-three positive
nodes) disease when treated with five years of primary endocrine
therapy without evidence of recurrence. A special article
highlighting the new ASCO guidelines was recently published in the
Journal of Clinical Oncology on this subject.1
“The clinical decision to either extend or end adjuvant
endocrine therapy after five years is a challenging decision for
healthcare providers and their patients. I am pleased to see
updated guidelines from ASCO affirming the use of a data-driven
biomarker like Breast Cancer Index to predict likelihood of benefit
from extended endocrine therapy, helping to better inform
decision-making processes around treatment plans,” said Mark
Pegram, MD, Chief Medical Consultant for Breast Oncology at
Biotheranostics, a subsidiary of Hologic. “There is an extensive
body of clinical evidence consistently proving the utility of BCI,
and its addition to major oncology clinical guidelines like those
from ASCO further underscores the test’s potential in clinical
decision-making regarding extended adjuvant endocrine therapy.”
BCI is a proprietary molecular gene expression-based test that
is uniquely positioned to provide information to help physicians
individualize treatment plans beyond five years. It is also the
only test to be recognized by other major clinical practice
guidelines for prediction of which early-stage, HR+ breast cancer
patients are likely to benefit from extended endocrine therapy.2
Extended endocrine therapy has been demonstrated to help reduce the
risk of recurrence in some women with early-stage, HR+ breast
cancer. However, for breast cancer patients on extended endocrine
therapy, the potential side effects and toxicities of treatment
often have significant negative effects on health and quality of
life, such as osteoporosis, bone fractures and joint pain.3-6 As a
result, it’s important to know if a patient is unlikely to benefit
from extended endocrine therapy to help reduce these challenging
side effects and health consequences.
“We are pleased to see that ASCO updated its clinical practice
guidelines to include BCI as the only genomic test to predict the
value of extended endocrine therapy, reaffirming other guidelines
within clinical oncology,” said Kevin Thornal, Hologic’s president,
Diagnostic Solutions Division. “We look forward to continuing to
improve women’s health by giving healthcare providers the
information they need to make the best treatment decisions for
their patients.”
According to the ASCO Guideline Update, the purpose was to
“update recommendations on appropriate use of breast cancer
biomarker assay results to guide adjuvant endocrine and
chemotherapy decisions in early-stage breast cancer.1” An updated
literature search identified 24 randomized clinical trials and
prospective-retrospective studies published from January 2016 to
October 2021, which were evaluated by an Expert Panel to develop
evidence-based recommendations.
About Breast Cancer Index Breast
Cancer Index™ 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. Breast Cancer
Index has guideline designation from the American Joint Committee
on Cancer for cancer staging based on molecular profile. ASCO, the
European Society for Medical Oncology (ESMO), the European Group on
Tumor Markers (EGTM) and St. Gallen acknowledge Breast Cancer Index
as a biomarker to inform the chemotherapy decision; and ASCO and
EGTM acknowledge BCI as a biomarker to inform the extended
endocrine treatment decision. It is the only validated,
commercially available test that predicts benefit from extended
endocrine therapy. Breast Cancer Index 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 and is not required to be cleared or approved
by the US Food and Drug administration. For more information, visit
www.breastcancerindex.com.
About Hologic Hologic, Inc. is an
innovative medical technology company primarily focused on
improving women’s health and well-being through early detection and
treatment. For more information on Hologic, visit
www.hologic.com.
Forward-Looking Statements This
press release may contain forward-looking information that involves
risks and uncertainties, including statements about the use of the
Breast Cancer Index test. There can be no assurance this test will
achieve the benefits described herein or that such benefits will be
replicated in any particular manner with respect to an individual
patient. The actual effect of the use of the test can only be
determined on a case-by-case basis depending on the particular
circumstances and patient in question. In addition, there can be no
assurance that this test will be commercially successful or achieve
any expected level of sales based on the updated ASCO clinical
practice guideline. 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 statements are based.
Hologic, Breast Cancer Index and The Science of Sure are
trademarks and/or registered trademarks of Hologic, Inc. in the
United States and/or other countries.
References
- https://ascopubs.org/doi/full/10.1200/JCO.22.00069. Accessed
April 21, 2022.
-
https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
Accessed April 21, 2022.
- Femara Full Prescribing Information And Side Effects:
https://www.breastcancer.org/treatment/hormonal-therapy/femara.
- Armimidex Full Prescribing Information And Side Effects:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de.
- Aromasin Full Prescribing Information And Side Effects:
http://labeling.pfizer.com/ShowLabeling.aspx?id=523.
- Tamoxifen Full Prescribing Information And Side Effects:
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682414.html.
SOURCE: Hologic, Inc.
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