Role of Oncotype DX in Guiding Adjuvant Chemotherapy Decisions

Clinical Validity and Utility

The National Institute for Health and Care Excellence (NICE) recommends Oncotype DX for patients assessed as being at intermediate risk where the biological information would help predict disease course and guide chemotherapy decisions 1
Oncotype DX provides a Recurrence Score (RS) that stratifies patients into risk categories for distant recurrence, with established clinical validity in both node-negative and node-positive disease 3, 2
The test has been shown to predict benefit from chemotherapy in both lymph node-negative and lymph node-positive disease through retrospective analyses of prospective trials 4

The National Comprehensive Cancer Network (NCCN) considers RT-PCR analysis (e.g., Oncotype DX) to refine risk stratification for adjuvant chemotherapy in node-negative, ER-positive, HER2-negative breast cancers larger than 0.5 cm (category 2B recommendation) 7
Oncotype DX is most appropriate for patients with hormone receptor-positive, HER2-negative breast cancer where the benefit of adding chemotherapy to endocrine therapy is uncertain 1, 6

Oncotype DX provides prognostic information independent of that derived from the Adjuvant! algorithm 4
Combining RS with clinicopathological features may provide improved risk assessment over RS alone 4

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient direct evidence that Oncotype DX testing leads to improved clinical outcomes, despite its established clinical validity 3, 2
Cost-effectiveness studies suggest Oncotype DX may be cost-effective or cost-saving, but these are based on assumptions about clinical utility that require confirmation 5

Identify patients with early-stage (I-II), hormone receptor-positive, HER2-negative breast cancer 1, 7
Consider Oncotype DX testing for node-negative patients with tumors >0.5 cm where chemotherapy benefit is uncertain 7, 6