ASCO integrated the results from the TAILORx trial into the ASCO Clinical Practice Guideline, recommending that Oncotype DX recurrence score be used to guide treatment decisions in patients with hormone receptor–positive, HER2-negative, axillary node–negative breast cancer. The details were recently published as a special article in the Journal of Clinical Oncology.1
The “trial assigning individualized options for treatment (Rx)” or TAILORx had a noninferiority design and included 6711 patients with hormone receptor–positive, HER2-negative, axillary node–negative breast cancer and an Oncotype DX recurrence score the fell between the range of 11 and 25. Patients were randomly assigned to receive adjuvant treatment with chemoendocrine therapy or endocrine therapy alone, and the trial showed that endocrine therapy was noninferior to chemoendocrine therapy (hazard ratio, 1.08; 95% CI, 0.94-1.24; P =.26), suggesting patients with a certain Oncotype DX recurrence score can forgo chemotherapy and be treated with endocrine therapy alone.
On the basis of the TAILORx trial results, ASCO’s updated recommendations specified that “there is little to no benefit from chemotherapy” for breast cancer patients with hormone receptor–positive, HER2-negative, axillary node–negative disease and an Oncotype DX recurrence score below 26, “especially” for patients older than 50 years. For patients older than 50 years, endocrine therapy alone can be offered, and for patients aged 50 years or younger, chemoendocrine therapy can be offered if the patient’s Oncotype DX recurrence score is between 16 and 25.
The recommendations stated that patients who have an OncotypeDX recurrence score above 30 “should be considered candidates” for chemoendocrine therapy. Also, chemoendocrine therapy can be offered to patients with an Oncotype DX recurrence score between 26 and 30.
Andre F, Ismaila N, Henry NL, et al. Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early stage invasive breast cancer: ASCO Clinical Practice Guideline Update—integration of results from TAILORx [published online May 31, 2019]. J Clin Oncol. doi: 10.1200/JCO.19.00945