Oncotype DX Score, TailorX Trial, and the Role of Oncotype DX Score in Breast Cancer Management

On this episode of SO Files, Alston, Brad and Linda take a closer look at the recently published TAILORx Clinical Trial Published in NEJM by Sparano and colleagues. The study expands the existing clinical application of the Oncotype DX score. If that score sounds familiar its because it has been quickly making its way into clinical practice over the past few years (see our last episode on the new AJCC guidelines!). We explain the origin of the score, how it has been incorporated into clinical practice thus far, and how this trial addresses a large gap in the existing literature.

Relevant Reading:

TAILORx Trial

Sparano et. al., NEJM 2018

A randomized controlled trial, designed to assess the utility of the Oncotype DX Score in predicting the need for chemotherapy, in addition to anti endocrine therapy, for hormone receptor +, Her2 -, node negative breast cancer. Bottom Line: Patients with an intermediate Oncotype DX Score of 11-25 can forgo chemotherapy, especially those patients >50 y/o.

NSABP B14 Study

Fisher et al. NEJM 1989

Overview of study layout in 1980’s – establishes adjuvant tamoxifen > no adjuvant therapy in ER+/Node negative patients.

NSABP B20 Study

Fisher et al. JNCI 1997

Overview of study layout in 1990’s – establishes chemo + endocrine for ER+/Node negative patients = decreased recurrence. 

Oncotype Dx Study

Paik et al. NEJM 2004

First description of OncotypeDx use and correlation with outcomes. Patients can now be stratified into low, intermediate, high risk of recurrence.

Oncotype DX applied study

Paik et al. J Clin Onc 2006

Same group shows that the score can be used to predict benefit from chemotherapy in individual patients.

ASCO 2007 Update

Harris et al. JCO 2007

ASCO first updates their guidelines to recommend use of gene assays in clinical care.