Prognosis and Prediction: why both matter

The Oncotype DX Breast Recurrence Score^® test offers prognosis and prediction

Data shows that the majority of HR+, HER2-, early-stage breast cancer patients do not benefit from chemotherapy.¹ Despite this fact, a significant number of patients were receiving chemotherapy, often based on prognostic clinical-pathological features.^2,3  The developers of the Oncotype DX^® test felt there could be a better way to select which patients need chemotherapy. With this question in mind, the Oncotype DX test was uniquely designed to help identify patients who need chemotherapy.⁴ 

The Oncotype DX test offers two important pieces of information:

• Prognosis – how likely is it that the cancer will return⁴ 
• Prediction – can chemotherapy help reduce the risk of the cancer returning⁵ 

Prognosis vs Prediction

What is a prognostic test?

Prognosis relates to the natural disease progression. A prognostic biomarker informs about a likely cancer outcome (e.g., disease recurrence, disease progression or death) independent of treatment received.⁶ 

What is a predictive test?

A biomarker is predictive if the treatment effect (experimental compared with control) is different for biomarker-positive patients compared with biomarker-negative patients.⁶ 

In order to be classed as a predictive test, a multigene assay must be trialed in a two-arm study designed to show an interaction between the biomarker and the treatment groups, and the interaction must be statistically significant to show a positive outcome.⁶ 

Only the Oncotype DX test has been proven to be predictive

Other multigene assays in early-stage breast cancer were designed to answer different questions and have not been proven to predict chemotherapy benefit. Clinical-pathological factors, whilst playing an important role in a patient’s diagnosis, are only proven to be prognostic.⁷ 

Only the Oncotype DX Breast Recurrence Score test was designed to be both prognostic and predictive, meaning it can help identify which patients need chemotherapy. Therefore, when ordering a genomic test to guide chemotherapy decisions for your patients with HR+, HER2-, early-stage breast cancer, only the Oncotype DX test provides a reliable, actionable answer. The test is backed by over 120,000 patients’ worth of data^4,5,8-15 and recommended by all major guidelines^16-23.