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 This is an original JCO publication from 2015. Please visit the JCO website to access the full article.


Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

 

 Authors

Catherine Van Poznak, Mark R. Somerfield, Robert C. Bast, Massimo Cristofanilli, Matthew P. Goetz, Ana M. Gonzalez-Angulo, David G. Hicks, Elizabeth G. Hill, Minetta C. Liu, Wanda Lucas, Ingrid A. Mayer, Robert G. Mennel, William F. Symmans, Daniel F. Hayes, and Lyndsay N. Harris

THE BOTTOM LINE

Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: ASCO Clinical Practice Guideline

Guideline Questions

1. Should metastases be biopsied or otherwise sampled to test for changes from the primary tumor with respect to ER, PR, or HER2 status?

2. For women with metastatic breast cancer and with known ER, PR, and HER2 status, which additional tumor markers have demonstrated clinical utility to initiate systemic therapy or direct selection of a new systemic therapy regimen?

3. For women with metastatic breast cancer and with known ER, PR, and HER2 status, which additional tumor markers have demonstrated clinical utility to guide decisions on switching to a different drug or regimen or discontinuing treatment?

4. For biomarkers shown to have clinical utility to guide decisions on systemic therapy for metastatic disease in questions 2 and 3, what are the appropriate assays, timing, and frequency of measurement?

Target Population

Women with metastatic breast cancer being considered for systemic therapy or for changes in the drug or regimen they are receiving

Target Audience

Any physician caring for patients with breast cancer, including medical, surgical, and radiation oncologists; oncology nurses and physician assistants, pathologists, and patients.

Methods

An Expert Panel was convened to develop clinical practice guideline recommendations based on a systematic review of the medical literature.

Key Points

See Summary of Recommendations Table below.

SUMMARY OF RECOMMENDATIONS

Use of Biomarkers to Guide Decisions on Systemic Therapy For Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

Clinical QuestionRecommendationEvidence Rating
Under what circumstances (i.e., for which patients) should metastases be biopsied or otherwise sampled to test for changes from the primary tumor with respect to endocrine receptor or HER2 status?Patients with accessible, newly diagnosed metastases from primary breast cancer should be offered biopsy for confirmation of disease process and testing of ER, PR, and HER2 status. They should also be informed that if discordances are found, evidence is lacking to determine whether outcomes are better with treatment regimens based on receptor status in the metastases or the primary tumor. With discordance of results between primary and metastatic tissues, the panel consensus is to preferentially use the ER, PR, and HER2 status from the metastasis to direct therapy if supported by the clinical scenario and the patient’s goals for care.

Type: Evidence-based for biomarker change from primary to metastasis, but no evidence to demonstrate that systemic therapy choices affect health outcomes when biomarker change occurs.

Evidence quality: Insufficient

Strength of recommendation: Moderate

For women with metastatic breast cancer and with known endocrine receptor and HER2 status, which additional tumor markers have demonstrated clinical utility to guide initiation of systemic therapy or direct selection of a new systemic therapy regimen?Decisions on initiating systemic therapy for metastatic breast cancer should be based on clinical evaluation, judgment, and patient preferences. There is no evidence at this time that initiating therapy solely on the basis of biomarker results beyond that of ER, PR, and HER2 improves health outcomes.

Type: Evidence-based

Evidence quality: Low

Strength of recommendation: Moderate

For women with metastatic breast cancer and with known estrogen receptor (ER), progesterone receptor (PR), and HER2 status, which additional tumor markers have demonstrated clinical utility to guide decisions on whether to switch to a different drug or regimen or discontinue treatment?Recommendations for tissue biomarkers: In patients who are already receiving systemic therapy for metastatic breast cancer, decisions on changing to a new drug or regimen or discontinuing treatment should be based on the patient’s goals for care and clinical evaluation and judgment of disease progression or response, given that there is no evidence at this time that changing therapy solely on the basis of biomarker results beyond ER, PR, and HER2 improves health outcomes, quality of life, or cost-effectiveness.

Type: Evidence-based

Evidence quality: Low

Strength of recommendation: Moderate

Recommendations for circulating tumor markers: In patients already receiving systemic therapy for metastatic breast cancer, decisions on changing to a new drug or regimen or discontinuing treatment should be based on clinical evaluation, judgment of disease progression or response, and the patient’s goals for care. There is no evidence at this time that changing therapy based solely on circulating biomarker results improves health outcomes, quality of life, or cost-effectiveness.

Type: Evidence-based

Evidence quality: Intermediate

Strength of recommendation: Moderate

CEA, CA 15-3, and CA 27.29 may be used as adjunctive assessments to contribute to decisions regarding therapy for metastatic breast cancer. Data are insufficient to recommend use of CEA, CA 15-3, and CA 27.29 alone for monitoring response to treatment. The recommendation for use is based on clinical experience and Panel informal consensus in the absence of studies designed to evaluate the clinical utility of the markers. As such, it is also reasonable for clinicians to not use these markers as adjunctive assessments

Type: Informal consensus

Evidence quality: Insufficient

Strength of recommendation: Moderate

For each tumor biomarker shown to have clinical utility for guiding decisions on systemic therapy for metastatic disease in questions 2 or 3, what are the appropriate assays, timing, and frequency of measurement?Decisions for systemic therapy should be influenced by ER, PR, and HER2. To date, clinical utility has not been demonstrated for any additional biomarkers.

Type: Informal consensus

Evidence quality: Low

Strength of recommendation: Strong

 

 

 

 

ASCO Guideline Disclaimer: The clinical practice guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc. (“ASCO”) to assist practitioners in clinical decision making. The information therein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients. Recommendations reflect high, moderate or low confidence that the recommendation reflects the net effect of a given course of action.  The use of words like “must,” “must not,” “should,” and “should not” indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating physician in the context of treating the individual patient. Use of the information is voluntary.  ASCO provides this information on an “as is” basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions.


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