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JCO
To the Editor:
On March 20, 2015, the American Society of
Clinical Oncology submitted a letter to the US Food and Drug
Administration, Division
of Dockets Management, to note that next-generation
sequencing (NGS) is increasingly used to identify patients at high risk
for developing cancer. Recently, in Journal of Clinical Oncology, Jagsi et al1 repeatedly stressed the critical need for physicians to discuss with patients the potential results of genetic testing before
it is ordered so that patients can make informed decisions regarding genetic testing.
Although NGS testing is typically
explained to patients as a tool that might identify actionable molecular
abnormalities,
which suggests the potential benefit of a targeted
therapy, NGS also might suggest that the patient harbors a germline
mutation
characteristic of an inherited syndrome.
Furthermore, a mutation first suggested in this context might have a far
different
or unknown penetrance than one identified when the
patient is tested because clinical criteria for the inherited syndrome
is met.
I agree with both the American Society of Clinical Oncology statement that strongly supports additional exploration of NGS
and that of Jagsi et al1
to remind clinicians that, before we order genetic testing with such
profound implications, a thorough discussion is essential.
Before NGS is ordered, the clinician should also
discuss the possibility that the test might imply a germline mutation of
uncertain significance, even if the test is ordered
primarily to identify somatic mutations that might direct therapy.
REFERENCE
- 1.↵
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