STATEMENT OF THE AMERICAN-SOCIETY-OF-CLINICAL-ONCOLOGY - GENETIC TESTING FOR CANCER SUSCEPTIBILITY

As the leading organization of physicians who treat people with cancer , the American Society of Clinical Oncology (ASCO) recognizes that can cer specialists must be fully informed of the range of issues involved in genetic testing for cancer risk. The newly discovered and still de veloping ability to identify individuals at highest risk for cancer ho lds the promise of improved prevention and early detection of cancers. It also poses potential medical, psychological, and other personal ri sks that must be addressed in the context of informed consent for gene tic testing. ASCO firmly believes that any physician who offers geneti c testing should be aware of, and able to communicate, the benefits an d limits of current testing procedures, and the range of prevention an d treatment options available to patients and their families. For thes e reasons, ASCO endorses the following principles: ASCO affirms the ro le of clinical oncologists in documenting a family history of cancer i n their patients, providing counseling regarding familial cancer risk and options for prevention and early detection, and recognizing those families for which genetic testing may serve as an aid in counseling. To the greatest extent possible, genetic testing for cancer susceptibi lity should be performed in the setting of longterm outcome studies. A SCO endorses the formulation and implementation of a notional cooperat ive study/registry with appropriate confidentiality to define the clin ical significance of mutations in known cancer susceptibility genes. A SCO is committed to providing educational opportunities for physicians concerning methods of quantitative cancer risk assessment, genetic te sting, and pre- and post-test genetic counseling so that oncologists m ay more responsibly integrate genetic counseling and testing into the practice of clinical and preventive oncology. Oncologists must assure that informed consent has been given by the patient as an integral par t of the process of genetic predisposition testing, whether such testi ng is offered on a clinical or research basis. ASCO recommends that ca ncer predisposition testing be offered only when: 1) the person has a strong family history of cancer or very early age of onset of disease; 2) the test can be adequately interpreted; and 3) the results will in fluence the medical management of the patient or family member. As cli nical testing becomes more widely available, the Society encourages on cologists to utilize laboratories committed to the validation of testi ng methodologies, and to facilitate families' participation in long-te rm outcome studies. ASCO recommends that oncologists include in pre- a nd post-test counseling discussion of possible risks and benefits of c ancer early detection and prevention modalities, which have presumed b ut unproven efficacy for individuals at the highest hereditary risk fo r cancer. ASCO endorses efforts to strengthen regulatory authority ove r laboratories that provide cancer predisposition tests that will be u tilized to inform clinical decisions. These regulatory requirements sh ould include appropriate oversight of the products used in genetic tes ting, interlaboratory comparisons of reference samples, as well as qua lity control mechanisms. ASCO endorses all efforts including legislati on to prohibit discrimination by insurance companies or employers base d on an individual's inherited susceptibility to cancer. All individua ls at hereditary risk for cancer should have access to appropriate gen etic testing and associated medical care, which should be covered by p ublic and private third-party payers. ASCO endorses continued support of patient-oriented research to analyze the psychological impact of ge netic testing of at-risk populations.