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.
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.
Fisher et al. NEJM 1989
Overview of study layout in 1980’s – establishes adjuvant tamoxifen > no adjuvant therapy in ER+/Node negative patients.
Fisher et al. JNCI 1997
Overview of study layout in 1990’s – establishes chemo + endocrine for ER+/Node negative patients = decreased recurrence.
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.
Paik et al. J Clin Onc 2006
Same group shows that the score can be used to predict benefit from chemotherapy in individual patients.
Harris et al. JCO 2007
ASCO first updates their guidelines to recommend use of gene assays in clinical care.