Are there clinical utility data published?
Herein, the clinical utility of the Oncotype DX® assay, a vital component for coverage and reimbursement by managed care and public payers, is summarized. Clinical utility refers to (1) whether decisions were changed by knowledge of the test’s findings and (2) whether patients benefit from changes in decisions resulting from the test.
Experience from several university- and community-based groups has shown that the Oncotype DX assay aids in making clinical decisions concerning adjuvant chemotherapy. The Oncotype DX results are likely to most affect women re-classified as low risk who may opt to forego chemotherapy. The Oncotype DX assay can also affect a relatively smaller percentage of women not intending to undergo adjuvant chemotherapy but who are re-classified as high risk (previously thought to be at a lower risk of recurrence) and for whom chemotherapy would be strongly recommended. On average, studies indicate that, despite the widespread use of Adjuvant!Online (Adjuvant, Inc), guidelines and other tools which integrate traditional measures to aid treatment decisions, women and clinicians are impacted by Oncotype DX assay results and change treatment decisions resulting in a net reduction in the use of adjuvant chemotherapy by 17%–36% (see Tables 1–2 below).
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Table 1. Net Change in Treatment Decisions From CHT to HT
Table 2. Net Change in Treatment Decisions From HT to CHT
CHT – combination chemotherapy and hormonal therapy; HT – hormonal therapy