Transcript Use of Biomarkers to Guide Decisions on Adjuvant Systemic

Use of Biomarkers to Guide Decisions on Adjuvant Systemic
Therapy for Women With Early-Stage Invasive Breast Cancer:
American Society of Clinical Oncology Clinical Practice
Guideline
www.asco.org/guidelines/adjuvantbreastmakers ©American Society of Clinical Oncology 2016. All rights reserved.
Introduction
• The purpose of this guideline is to provide evidence-based
recommendations on appropriate use of breast tumor biomarker assay
results to guide decisions on adjuvant systemic therapy for women with
early-stage invasive breast cancer with known hormone receptor status.
•
In an era of great interest in personalized, precision medicine, the role of
tumor biomarker assays in guiding clinical care has taken on even greater
importance than in the past.
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
ASCO Guideline
Development Methodology
The ASCO Clinical Practice Guidelines Committee guideline process includes:
• a systematic literature review by ASCO guidelines staff
• an expert panel provides critical review and evidence interpretation to
inform guideline recommendations
• final guideline approval by ASCO CPGC
The full ASCO Guideline methodology supplement can be found at:
www.asco.org/guidelines/adjuvantbreastmarkers
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Clinical Questions
For women with early-stage invasive breast cancer and with
known ER/PgR and HER2 status, which additional biomarkers
have demonstrated clinical utility to
1. Guide decisions regarding the need for adjuvant systemic
therapy?
2. Guide the choice of specific drugs or regimens for adjuvant
systemic therapy?
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Target Population and Audience
Target Population
Women with early-stage invasive breast cancer being considered
for adjuvant systemic therapy
Target Audience
Medical, surgical, and radiation oncologists; oncology nurses and
physician assistants; pathologists; general practitioners; and
patients
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©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
CLINICAL QUESTION 1
For women with early-stage invasive breast cancer and with known ER/PgR and HER2 status,
which other biomarkers have demonstrated clinical utility to guide decisions on the need for
adjuvant systemic therapy?
Recommendation 1.1
If a patient has ER/PgR-positive, HER2-negative (node-negative) breast cancer, the clinician may
use 21-gene recurrence score (21-gene RS; Oncotype DX; Genomic Health, Redwood, CA) to
guide decisions for adjuvant systemic chemotherapy (Type: Evidence based; Evidence quality:
High; Strength of recommendation: Strong).
Recommendation 1.2
If a patient has ER/PgR-positive, HER2-negative (node-positive) breast cancer, the clinician should
not use the 21-gene RS to guide decisions for adjuvant systemic chemotherapy (Type: Evidence
based; Evidence quality: Intermediate; Strength of recommendation: Moderate).
Recommendation 1.3
If a patient has HER2-positive breast cancer or TN breast cancer, the clinician should not use the
21-gene RS (Oncotype DX) to guide decisions for adjuvant systemic therapy (Type: Informal
consensus; Evidence quality: Insufficient; Strength of recommendation: Strong).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 1.4
If a patient has ER/PgR-positive, HER2-negative (node-negative) breast cancer, the
clinician may use the 12-gene risk score (EndoPredict; Sividon Diagnostics, Köln,
Germany) to guide decisions for adjuvant systemic chemotherapy (Type: Evidence
based; Evidence quality: Intermediate; Strength of recommendation: Moderate).
Recommendation 1.5
If a patient has ER/PgR-positive, HER2-negative (node-positive) breast cancer, the
clinician should not use the 12-gene risk score (EndoPredict) to guide decisions for
adjuvant systemic chemotherapy (Type: Evidence based; Evidence quality:
Insufficient; Strength of recommendation: Moderate).
Recommendation 1.6
If a patient has HER2-positive breast cancer or TN breast cancer, the clinician
should not use 12-gene risk score (EndoPredict) to guide decisions for adjuvant
systemic therapy (Type: Informal consensus; Evidence quality: Insufficient;
Strength of recommendation: Strong).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 1.7
If a patient has ER/PgR-positive, HER2-negative (node-positive or node-negative)
breast cancer, the clinician should not use 70-gene assay (MammaPrint; Agendia,
Irvine CA) to guide decisions for adjuvant systemic chemotherapy (Type: Evidence
based; Evidence quality: Intermediate; Strength of recommendation: Moderate).
Recommendation 1.8
If a patient has HER2-positive breast cancer, the clinician should not use the 70gene assay (MammaPrint) to guide decisions regarding adjuvant systemic therapy
(Type: Informal consensus; Evidence quality: Low; Strength of recommendation:
Moderate).
Recommendation 1.9
If a patient has TN breast cancer, the clinician should not use the 70-gene assay
(MammaPrint) to guide decisions about adjuvant systemic therapy (Type: Informal
consensus; Evidence quality: Insufficient; Strength of recommendation: Strong).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 1.10
If a patient has ER/PgR-positive, HER2-negative (node-negative) breast cancer, the
clinician may use the PAM50 risk of recurrence score (PAM50-ROR; Prosigna Breast
Cancer Prognostic Gene Signature Assay), in conjunction with other clinicopathologic
variables, to guide decisions about adjuvant systemic therapy (Type: Evidence based;
Evidence quality: High; Strength of recommendation: Strong).
Recommendation 1.11
If a patient has ER/PgR-positive, HER2-negative (node-positive) breast cancer, the
clinician should not use the PAM50 Risk of Recurrence (ROR) score (PAM50-ROR;
Prosigna Breast Cancer Prognostic Gene Signature Assay; NanoString Technologies,
Seattle, WA) to guide decisions about adjuvant systemic therapy (Type: Evidence
based; Evidence quality: Intermediate; Strength of recommendation: Moderate).
Recommendation 1.12
If a patient has HER2-positive breast cancer, the clinician should not use the PAM50ROR to guide decisions regarding adjuvant systemic therapy (Type: Informal
consensus; Evidence quality: Insufficient; Strength of recommendation: Strong).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 1.13
If a patient has TN breast cancer, the clinician should not use the PAM50-ROR to
guide decisions for adjuvant systemic therapy (Type: Informal consensus; Evidence
quality: Insufficient; Strength of recommendation: Strong).
Recommendation 1.14
If a patient has ER/PgR-positive, HER2-negative, node-negative breast cancer, the
clinician may use the Breast Cancer Index to guide decisions for adjuvant systemic
therapy (Type: Evidence based; Evidence quality: Intermediate; Strength of
recommendation: Moderate).
Recommendation 1.15
If a patient has ER/PgR-positive, HER2-negative, node-positive breast cancer, the
clinician should not use the Breast Cancer Index (bioTheranostics, San Diego, CA)
to guide decisions about adjuvant systemic therapy (Type: Informal consensus;
Evidence quality: Insufficient; Strength of recommendation: Strong).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 1.16
If a patient has HER2-positive breast cancer or TN breast cancer, the clinician
should not use the Breast Cancer Index to guide decisions for adjuvant systemic
therapy (Type: Informal consensus; Evidence quality: Insufficient; Strength of
recommendation: Strong).
Recommendation 1.17
If a patient has ER/PgR-positive, HER2-negative (node-positive or node-negative)
breast cancer, the clinician should not use the five-protein assay Mammostrat (GE
Healthcare, Aliso Viejo, CA) to guide decisions about adjuvant systemic therapy
(Type: Evidence based; Evidence quality: Intermediate; Strength of
recommendation: Moderate).
Recommendation 1.18
If a patient has HER2-positive breast cancer or TN breast cancer, the clinician
should not use five-protein assay Mammostrat to guide decisions about adjuvant
systemic therapy (Type: Informal consensus; Evidence quality: Insufficient;
Strength of recommendation: Strong).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 1.19
If a patient has ER/PgR-positive, HER2-negative (node-positive or node-negative)
breast cancer, the clinician should not use immunohistochemistry-4 (IHC-4) to
guide decisions about adjuvant systemic chemotherapy (Type: Evidence based;
Evidence quality: Intermediate; Strength of recommendation: Moderate).
Recommendation 1.20
If a patient has HER2-positive breast cancer or TN breast cancer, the clinician
should not use IHC-4 to guide decisions about adjuvant systemic therapy (Type:
Informal consensus; Evidence quality: Insufficient; Strength of recommendation:
Strong).
Recommendation 1.21
If a patient has ER/PgR-positive, HER2-negative (node-negative) breast cancer, the
clinician may use the uPA and PAI-1 to guide decisions about adjuvant systemic
therapy (Type: Evidence based; Evidence quality: High; Strength of
recommendation: Weak).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 1.22
If a patient has HER2-positive breast cancer or TN breast cancer, the clinician
should not use the uPA and PAI-1 to guide decisions about adjuvant systemic
therapy (Type: Informal consensus; Evidence quality: Insufficient; Strength of
recommendation: Weak).
Recommendation 1.23
The clinician should not use circulating tumor cells (CTC) to guide decisions for
adjuvant systemic therapy (Type: Evidence based; Evidence quality: Intermediate;
Strength of recommendation: Strong).
Recommendation 1.24
If a patient has ER/PgR-positive, HER2-negative (node-positive or node-negative)
breast cancer, the clinician should not use tumor-infiltrating lymphocytes (TILs) to
guide decisions for adjuvant systemic therapy (Type: Informal consensus; Evidence
quality: Insufficient; Strength of recommendation: Strong).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 1.25
If a patient has HER2-positive breast cancer or TN breast cancer, the clinician
should not use TILs to guide decisions about adjuvant systemic therapy (Type:
Evidence based; Evidence quality: Intermediate; Strength of recommendation:
Strong).
Recommendation 1.26
Ki67 labeling index by immunohistochemistry should not be used to guide choice
of adjuvant chemotherapy (Type: Evidence based; Evidence quality: Intermediate;
Strength of recommendation: Moderate).
Recommendation 1.27
If a patient has ER/PgR-positive, HER2-negative (node-negative) breast cancer,
and has had 5 years of endocrine therapy without evidence of recurrence, the
clinician should not use multiparameter gene expression or protein assays
(Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, or IHC-4) to guide
decisions about extended endocrine therapy (Type: Evidence based; Evidence
quality: Intermediate; Strength of recommendation: Moderate).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
CLINICAL QUESTION 2
For women with early-stage invasive breast cancer and with known ER/PgR and HER2
status, which additional biomarkers have demonstrated clinical utility to guide choice of
specific drugs or regimens for adjuvant systemic therapy?
Recommendation 2.1
The clinician should not use CYP2D6 polymorphisms to guide adjuvant endocrine therapy
selection (Type: Evidence based; Evidence quality: Intermediate; Strength of
recommendation: Moderate).
Recommendation 2.2
The clinician should not use p27 expression by immunohistochemistry to guide adjuvant
endocrine therapy selection (Type: Informal consensus; Evidence quality: low; Strength of
recommendation: Strong).
Recommendation 2.3
The clinician should not use Ki67 labeling index by immunohistochemistry to guide type of
adjuvant endocrine therapy selection (Type: Evidence based; Evidence quality:
Intermediate; Strength of recommendation: Moderate).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 2.4
The clinician should not use MAP-Tau mRNA expression or mRNA expression by
immunohistochemistry to guide selection of type of adjuvant chemotherapy
(Type: Evidence based; Evidence quality: Intermediate; Strength of
recommendation: Moderate).
Recommendation 2.5
The clinician should not use HER1/EGFR expression by immunohistochemistry to
guide selection of type of adjuvant chemotherapy (Type: Evidence based;
Evidence quality: Low; Strength of recommendation: Moderate).
Recommendation 2.6
The clinician should not use TOP2A gene amplification or TOP2A protein
expression by immunohistochemistry to guide selection of type of adjuvant
chemotherapy (Type: Evidence based; Evidence quality: High; Strength of
recommendation: Moderate).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Summary of Guideline
Recommendations
Recommendation 2.7
The clinician should not use HER2 and TOP2A gene co-amplification, CEP17
duplication, TIMP-1, FOXP3, or p53 to guide selection of type of adjuvant
chemotherapy (Type: Evidence based; Evidence quality: Intermediate;
Strength of recommendation: Moderate).
Recommendation 2.8
In patients with HER2-positive breast cancer, the clinician should not use
PTEN to guide adjuvant therapy selection (Type: Evidence based; Evidence
quality: Intermediate; Strength of recommendation: Moderate).
Recommendation 2.9
In patients with HER2-positive breast cancer, the clinician should not use
soluble HER2 levels to guide selection of type of adjuvant therapy (Type:
Evidence based; Evidence quality: Low; Strength of recommendation:
Moderate).
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Patient and Clinician Communication
• Clinicians should educate patients, family members, and/or
caregivers about the results of pathology tests and how
clinicians use them to develop a treatment plan tailored to
the biology of their cancers.
• Patients should be given a copy of their pathology report and
ER, PgR, HER2, Oncotype DX, EndoPredict, PROSIGNA, BCI or
uPA/PAI-1 test results, when indicated in a specific situation.
• The clinician should review the individual results with the
patient, discuss any issues with the test interpretation or
performance, and ask the patient if he or she has any
additional questions about the results.
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Health Disparities
• The biomarker distribution of ER/PgR expression and HER2
status can vary across tumors from patients with different
ethnic and racial backgrounds.
• In addition to the biologic variability of ER, PgR, and HER2
expression in breast cancer, there is evidence that disparities
exist in the frequency of biomarker testing in certain
populations and that this is influenced by health insurance
coverage.
• Awareness of these disparities should be considered in the
context of this clinical practice guideline, and health care
providers should strive to deliver the highest level of cancer
care to these vulnerable populations.
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Multiple Chronic Conditions
• As many patients for whom guideline recommendations apply
present with MCC, any treatment plan needs to take into
account the complexity and uncertainty created by the
presence of MCC and highlight the importance of shared
decision-making regarding guideline use and implementation.
• Clinicians should review all other chronic conditions present in
the patient and take those conditions into account when
formulating the treatment and follow-up plan.
• This may mean that some or all of the recommended care
options are modified or not applied, as determined by best
practice in consideration of any MCC.
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Limitations and Future Directions
• Conclusions on prognostic and predictive biomarkers in
early breast cancer are limited by the lack of prospective
confirmatory studies; findings of insufficient clinical utility;
and, in many cases, a lack of data on clinical validity and
reproducibility of assays.
• Extensive research is needed to validate some of the
biomarker candidates described and to identify promising
new biomarkers.
• Research is also needed to better understand the impact of
age, race/ethnicity, and health disparities on prognostic
and predictive value of biomarker candidates.
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
Additional Resources
More information, including a Data Supplement, a
Methodology Supplement, slide sets, and clinical tools
and resources, is available at
www.asco.org/adjuvantbreastmarkers
Patient information is available at www.cancer.net
www.asco.org/guidelines/adjuvantbreastmakers
©American Society of Clinical Oncology 2016. All rights reserved.
ASCO Guideline Panel Members
Member
Lyndsay N. Harris (Chair)
Affiliation
University Hospitals Seidman Cancer Center, Case Western Reserve University,
Cleveland, OH
Fabrice Andre
Institute Gustave Roussy, Paris, France
Robert C. Bast
The University of Texas MD Anderson Cancer Center, Houston, TX
Deborah E. Collyar
Patient Advocates in Research
Elizabeth H. Hammond
University of Utah & Intermountain Health Care, Salt Lake City, UT
Daniel F. Hayes
University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
Nicole M. Kuderer
University of Washington Medical Center, Seattle, WA
Cathy van Poznak
University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
Minetta C. Liu
Mayo Clinic College of Medicine, Rochester, MN
Lisa M. McShane
National Cancer Institute, Bethesda, MD
Robert G. Mennel
Baylor University Medical Center, Texas Oncology PA, Dallas, TX
Ana Maria Gonzalez Angulo
The University of Texas MD Anderson Cancer Center, Houston, TX
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©American Society of Clinical Oncology 2016. All rights reserved.
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