Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update

Published online ahead of print April 19, 2022. DOI: 10.1200/JCO.22.00069
Fabrice Andre, Nofisat Ismaila, Kimberly H. Allison, William E. Barlow, Deborah E. Collyar, Senthil Damodaran, N. Lynn Henry, Komal Jhaveri, Kevin Kalinsky, Nicole M. Kuderer, Anya Litvak. Erica L. Mayer, Lajos Pusztai, Rachel Raab, Antonio C. Wolf and Vered Stearns.


To update recommendations on appropriate use of breast cancer biomarker assay results to guide adjuvant endocrine and chemotherapy decisions in early-stage breast cancer


An updated literature search identified randomized clinical trials and prospective-retrospective studies published from January 2016 to October 2021. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert Panel members used informal consensus to develop evidencebased recommendations


The search identified 24 studies informing the evidence base


Clinicians may use Oncotype DX, MammaPrint, Breast Cancer Index (BCI), and EndoPredict to guide adjuvant endocrine and chemotherapy in patients who are postmenopausal or age . 50 years with early-stage estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative (ER1 and HER2–) breast cancer that is node-negative or with 1-3 positive nodes. Prosigna and BCI may be used in postmenopausal patients with node-negative ER1 and HER2– breast cancer. In premenopausal patients, clinicians may use Oncotype in patients with node-negative ER1 and HER2– breast cancer. Current data suggest that premenopausal patients with 1-3 positive nodes benefit from chemotherapy regardless of genomic assay result. There are no data on use of genomic tests to guide adjuvant chemotherapy in patients with either $ 4 positive nodes. Ki67 combined with other parameters or immunohistochemistry 4 score may be used in postmenopausal patients without access to genomic tests to guide adjuvant therapy decisions. BCI may be offered to patients with 0-3 positive nodes who received 5 years of endocrine therapy without evidence of recurrence to guide decisions about extended endocrine therapy. None of the assays are recommended for treatment guidance in individuals with HER2-positive or triple-negative breast cancer. Treatment decisions should also consider disease stage, comorbidities, and patient preferences.

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