American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Now Includes Breast Cancer Index™ to Guide Decisions about Extended Endocrine Therapy
Hologic announces that the American Society of Clinical Oncology (ASCO) has updated its guidelines to include Breast Cancer Index™ (BCI) as the only genomic test for determining extended endocrine therapy in early-stage, HR+ breast cancer patients. This guideline aims to help healthcare providers make informed treatment decisions after five years of primary therapy. BCI is recognized for its ability to predict which patients may benefit from continued treatment, mitigating unnecessary side effects associated with extended therapy.
- ASCO guidelines now endorse Breast Cancer Index as the sole genomic test for guiding extended endocrine therapy decisions.
- Recognition by ASCO further validates the utility of BCI in clinical decision-making.
- The updated guidelines are based on extensive clinical evidence, enhancing BCI's credibility.
- Forward-looking statements indicate uncertainty about the test's commercial success and sales reach.
- There is no assurance that the benefits of BCI will be replicated for individual patients.
Guideline inclusion further validates the need to incorporate Breast Cancer Index into standard of care
“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
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
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
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
About Hologic
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
References
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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:
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