American Society of Clinical Oncology Policy Statement Update: Genetic and Genomic Testing for Cancer Susceptibility

The American Society of Clinical Oncology (ASCO) has long affirmed that the recognition and management of individuals with an inherited susceptibility to cancer are core elements of oncology care. ASCO released its first statement on genetic testing in 1996 and updated that statement in 2003 and 2010 in response to developments in the field. In 2014, the Cancer Prevention and Ethics Committees of ASCO commissioned another update to reflect the impact of advances in this area on oncology practice. In particular, there was an interest in addressing the opportunities and challenges arising from the application of massively parallel sequencing—also known as next-generation sequencing—to cancer susceptibility testing. This technology introduces a new level of complexity into the practice of cancer risk assessment and management, requiring renewed effort on the part of ASCO to ensure that those providing care to patients with cancer receive the necessary education to use this new technology in the most effective, beneficial manner. The purpose of this statement is to explore the challenges of new and emerging technologies in cancer genetics and provide recommendations to ensure their optimal deployment in oncology practice. Specifically, the statement makes recommendations in the following areas: germline implications of somatic mutation profiling, multigene panel testing for cancer susceptibility, quality assurance in genetic testing, education of oncology professionals, and access to cancer genetic services.


Type Guideline
CME Available No
Topic
Cost Free
Note



Genomic Competencies

Experts from the disciplines listed below have tagged this resource as fulfulling genomic competencies.

Nurse

  • Professional Responsibilities
    • PR-4:   Incorporate genetic and genomic technologies and information into practice.
      • PR4-K1:   Technology and information systems
        • PR4-1:   Evaluate genetic and genomic technologies used in client care.
        • PR4-2:   Demonstrate use of genetic and genomic technology and client data for clinical decision-making in providing safe client care.
        • PR4-3:   Identify the credibility, reliability and limitations of genetic and genomic information.
        • PR4-4:   Identify ethical, legal, and social issues associated with genetic/genomic information.
  • Provision of education, care and support
    • PECS-2:   Provide clients with genetic and genomic information and resources for informed decision making
      • PECS2-K1:   Resources for healthcare professionals and lay public
        • PECS2-1:   Evaluate strengths, limitations, and best use of one genetic and/or genomic resource for a client or group of clients.
        • PECS2-2:   Help clients interpret and understand genetic and genomic information.
      • PECS2-K2:   Referral resources for genetic and genomic services within one's community
        • PECS2-1:   Evaluate strengths, limitations, and best use of one genetic and/or genomic resource for a client or group of clients.
        • PECS2-2:   Help clients interpret and understand genetic and genomic information.
      • PECS2-K3:   Roles of genetic/genomic health care professionals
        • PECS2-1:   Evaluate strengths, limitations, and best use of one genetic and/or genomic resource for a client or group of clients.
        • PECS2-2:   Help clients interpret and understand genetic and genomic information.
    • PECS-4:   Use genetic- and genomic-based interventions and information to improve clients' outcomes
      • PECS4-K1:   Pharmacogenetics, pharmacogenomics
        • PECS4-1:   Demonstrate ability to incorporate family history as part of the nursing assessment.
        • PECS4-3:   Intervene when client has an unintended response to genetic/genomic based interventions to ensure client safety.
      • PECS4-K2:   Gene or gene product targeted therapy
        • PECS4-1:   Demonstrate ability to incorporate family history as part of the nursing assessment.
        • PECS4-3:   Intervene when client has an unintended response to genetic/genomic based interventions to ensure client safety.
      • PECS4-K3:   Protein replacement therapy
        • PECS4-1:   Demonstrate ability to incorporate family history as part of the nursing assessment.
        • PECS4-3:   Intervene when client has an unintended response to genetic/genomic based interventions to ensure client safety.
      • PECS4-K4:   Chaperone therapy
        • PECS4-1:   Demonstrate ability to incorporate family history as part of the nursing assessment.
        • PECS4-3:   Intervene when client has an unintended response to genetic/genomic based interventions to ensure client safety.
    • PECS-7:   Performs interventions/treatments appropriate to clients' genetic and genomic healthcare needs.
      • PECS7-K1:   Pharmacogenetics, pharmacogenomics
        • PECS4-3:   Intervene when client has an unintended response to genetic/genomic based interventions to ensure client safety.
      • PECS7-K2:   Gene or gene product targeted therapy
        • PECS4-3:   Intervene when client has an unintended response to genetic/genomic based interventions to ensure client safety.
      • PECS7-K3:   Protein replacement therapy
        • PECS4-3:   Intervene when client has an unintended response to genetic/genomic based interventions to ensure client safety.

Physician

  • Genomic Testing
    • P-GT2A:   Patient Care
      • 2A1:   Discuss the indications for genomic testing - specifically the benefits, risks, and alternatives
      • 2A2:   Explain the implications of placing genomic test results in the patient’s medical record
      • 2A3:   Discuss the possibility of incidental findings and how they will be handled
      • 2A5:   Explain to the patient issues of costs and financial coverage of genomic testing
      • 2A6:   Order, interpret, and communicate the results of appropriate genomic tests, within the physician’s scope of practice
      • 2A7:   Provide referral to an appropriate specialist for genomic testing of a condition outside the physician’s scope of practice
      • 2A8:   Respond to the results of an abnormal genetic screening test, such as newborn screening, including immediate management and appropriate referral
    • P-GT2B:   Knowledge for Practice
      • 2B1:   Describe the major forms of genomic variability
      • 2B2:   Explain how different genomic changes may result in different phenotypes
      • 2B3:   Recognize that genomic tests require interpretation with respect to the patient’s clinical status (e.g., pathogenic, likely pathogenic, benign)
      • 2B4:   Explain the concepts of analytic validity, clinical validity, clinical utility as they relate to genomic testing
      • 2B5:   Recognize that medically ’non-actionable’ genomic results can be useful to the patient and family (i.e., personal utility)
    • P-GT2C:   Practice-Based Learning and Improvement
      • 2C1:   Incorporate genomic findings into the health record and patient-care plan
      • 2C2:   Have a method for periodic review of ’new’ genomic interpretation for clinical applications.
    • P-GT2D:   Interpersonal and Communication Skills
      • 2D1:   Ensure that undergoing genomic testing is a joint decision of the patient and the physician
      • 2D2:   Explain and document findings from genomic testing to patient, including implications for other family members
      • 2D3:   Facilitate access to resources to enhance patient learning about the results of genomic testing
      • 2D4:   Address the needs of the patient as an individual as well as the needs of family members
    • P-GT2E:   Professionalism
      • 2E1:   Be aware of and comply with local and federal laws and regulations regarding use of genomic tests
      • 2E2:   Be aware of and responsive to patients’ concerns about genetic discrimination
      • 2E3:   Respect patient’s privacy and need to maintain confidentiality of genomic information
    • P-GT2G:   Interprofessional Collaboration
      • 2G1:   Initiate responsible referrals to specialists or other health professionals
      • 2G2:   Provide support to patients based on recommendations of specialists
      • 2G3:   Maintain a dialog with the clinical laboratory to ensure that the appropriate test(s) are ordered and interpreted in the context of the patient’s clinical status
    • P-GT2H:   Personal and Professional Development
      • 2H1:   Engage in continuing education regarding advances in genomic medicine and changing indications for and interpretation of genomic testing
  • Patient Treatment Based on Genomic Results
    • P-PM3A:   Patient Care
      • 3A1:   Identify medical conditions and drug responses that have a strong genetic component
      • 3A2:   Recognize that variants affecting drug responses found in a patient may also have implications for other family members
      • 3A3:   Discern the potential clinical impact of genetic variation on risk stratification and individualized treatment
    • P-PM3B:   Knowledge for Practice
      • 3B1:   Appreciate the importance of genetic diversity of humans and the abundance of genetic variants in each individual genome
      • 3B2:   Identify single-gene disorders that may be amenable to targeted pharmacological therapy
      • 3B3:   Recognize that genomic test results may guide choice of therapy for multifactorial disorders
      • 3B4:   Recognize that there is variability in the phenotypic expression of genetic variants and in response to therapy
      • 3B5:   Recognize that the effects of some medications are strongly influenced by inherited or somatically acquired genetic variation
    • P-PM3D:   Interpersonal and Communication Skills
      • 3D1:   Discuss benefits, risks, and alternatives of various preventive and therapeutic approaches driven by genomic findings
      • 3D2:   Communicate clearly with other medical professionals involved in the care of the patient about the therapeutic implications of the genetic information garnered about the patient 3D3. Discuss pharmacogenomics implications for future health
      • 3D3:   Discuss pharmacogenomics implications for future health
    • P-PM3H:   Personal and Professional Development
      • 3H1:   Maintain the medical knowledge and clinical competence in genomics required for the provision of therapy
      • 3H2:   Be familiar with the available databases and resources relevant to genetic variation, including ongoing clinical trials involving patients with genetic disorders, pharmacogenomics, and patient-oriented Internet resources from reliable organizations

Genetic Counselor

  • Genetics Expertise and Analysis
    • 1:   Demonstrate and utilize a depth and breadth of understanding and knowledge of genetics and genomics core concepts and principles.
      • 1a:   Demonstrate knowledge of principles of human, medical, and public health genetics and genomics and their related sciences.
      • 1b:   Apply knowledge of genetic principles and understand how they contribute to etiology, clinical features and disease expression, natural history, differential diagnoses, genetic testing and test report interpretation, pathophysiology, recurrence risk, management and prevention, and population screening.
    • 4:   Identify, assess, facilitate, and integrate genetic testing options in genetic counseling practice.
      • 4a:   Investigate the availability, analytic validity, clinical validity, and clinical utility of screening, diagnostic and predictive genetic/genomic tests.
    • 7:   Critically assess genetic/genomic, medical and social science literature and information.
      • 7d:   Incorporate medical and scientific literature into evidenced-based practice recognizing that there are limitations and gaps in knowledge and data.