NCCN: New Genetic Risk Assessment Recommendations for Breast, Ovarian and Pancreatic Cancers
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Describe the changes in the December 2019 NCCN guidelines for breast, ovarian and pancreatic genetic cancer testing 2. State the concerns regarding the use of direct-to-consumer genetic cancer testing
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from 1/15/2020 through 07/15/2022, participants must read the learning objectives and faculty disclosures and study the educational activity.
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Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
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Continuing Nursing Education
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NCCN has updated their guidelines (December 2019) on screening for those who may be at high risk for breast, ovarian or pancreatic cancers. There are some important changes addressed in these new recommendations, including the following
Pancreatic cancer has been included in the title of the document with a separate section
The document, as in previous iterations, focuses on BRCA1/2
However, in addition, other high and moderate penetrance genes are now included
Individuals of Ashkenazi Jewish (AJ) heritage can be considered for genetic testing even if unaffected and in the absence of family history
4-10% of individuals with pancreatic cancer can be carriers of pathogenic variants in genes that confer high or moderate risk
A pathogenic mutation may be present even in the absence of the typical clues such as early age at diagnosis or strong family history
As a result of the above, NCCN recommends that genetic counseling and testing be offered to
All individuals with exocrine pancreatic cancer
First degree relatives of individuals diagnosed with exocrine pancreatic cancer
Genes that will likely be ordered include BRCA1/2, as well as ATM, CDKN2A, STK11, TP53 and most Lynch syndrome genes
Other benefits of testing include
Information and knowledge that could be of importance to other family members
New medications, specifically PARP (poly ADP-ribose polymerase) inhibitors, may be selected based on identification of mutations in the BRCA genes
Breast Cancer and AJ Population
2.5% (1/40) individuals of Ashkenazi Jewish heritage (unselected – i.e. do not need high risk family history) will have one of the 3 founder BRCA1/2 variants vs 0.1% in the general population
90% of pathogenic BRCA1/2 pathogenic variants belong to one of the 3 founder mutations
Previously, NCCN recommended offering genetic testing to AJ individuals if there was personal or family history
New guidance states testing may be considered in unaffected AJ individuals
The recommendation refers to the 3 founder mutations only
Ideally, testing should be offered in the context of longitudinal studies | If studies are not available, testing can be considered providing that pre-test education and access to post-test management is available
Testing for high-penetrance breast and/or ovarian cancer susceptibility genes can also be considered
For women with bilateral breast cancer, first diagnosed between 50 and 65 years of age
Unaffected women who don’t meet the NCCN guidelines for personal or family history but have a probability of 2.5 to 5% of carrying a BRCA1/2 pathogenic variant (using validated calculators such as Tyrer-Cuzick | Prior to testing for variants in other high penetrance genes aside from BRCA1/2, NCCN recommends counseling and assessing patient preference, risk for VUS and cost/insurance
Note: High penetrance genes will usually include BRCA1/2, CDH1, PALB2, PTEN and TP53 with other genes included on some genetic testing panels as well
There is a low probability (<2.5%) of clinically useful findings on genetic testing if a patient has breast cancer
After age 65 and
No close relatives (first, second or third degree relatives on the same side of the family) with breast, ovarian, pancreatic or prostate cancer
NCCN continues to caution about the use of direct-to-consumer (DTC) genetic tests
DTC tests are not necessarily validated for clinical use
Comprehensive risk assessment is not provided because DTC tests usually do not include gross deletion or duplication analyses
Research on DTC tests have revealed false positive results as well as variant classification errors
Confirmatory germline testing by a certified clinical laboratory is recommended
Medical management based only on a DTC test is not recommended
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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