TAILORx Results: Can a Gene-Expression Test Help Determine if Some Women with Breast Cancer Can Safely Avoid Chemotherapy?
BACKGROUND AND PURPOSE:
There is a gene-expression assay that includes 21 genes with a score system (from 1-100) that predicts chemotherapy benefit
High: ≥31 (or some studies ≥26) is associated with a high risk of recurrence
Low: 0-10 predicts only 2% recurrence at 10 years, regardless of chemotherapy
Mid-range: 11-25, with limited data
Sparano et al. (NEJM, 2018) examined the benefits of chemotherapy when the recurrence score falls in the mid-range
Prospective randomized controlled trial (RCT)
Trial Assigning Individualized Options for Treatment (TAILORx) study
Human epidermal growth factor receptor 2 (HER2)–negative
Axillary node–negative breast cancer
Women assigned to
Recurrence score of ≤10: Endocrine therapy only
Score of ≥26: Chemotherapy plus endocrine (chemoendocrine) therapy
Score of 11-25 were randomized to the following arms
Endocrine therapy alone
Freedom from invasive disease recurrence
Second primary cancer
Freedom from recurrence of breast cancer at a distant site
Freedom from recurrence of breast cancer at a distant or local–regional site
6,711 women had a midrange recurrence score (16-25)
Primary outcomes: Endocrine therapy was noninferior to chemoendocrine therapy
Hazard Ratio (HR) 1.08; 95% CI, 0.94 to 1.24; P=0.26
9 years of follow up, groups had similar rates for the following
Invasive disease free survival
Freedom from disease recurrence at a distant site
Distant or local-regional site
There was some benefit of chemotherapy found in women ≤50 years of age with a recurrence score of 16 to 25
Chemoendocrine therapy and endocrine therapy alone had similar effects for in women hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer and a midrange 21-gene recurrence score
Age did play a factor in benefits of chemotherapy, with younger women demonstrating some benefit
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