TAILORx Trial: Predicting Benefit From Chemotherapy in Early Breast Cancer
Posted: Monday, August 26, 2019
For postmenopausal women diagnosed with breast cancer, clinical risk stratification may provide “prognostic information that, when added to the 21-gene recurrence score, could be used to identify premenopausal women who could benefit from more effective therapy,” according to the authors of the TAILORx trial, Joseph A. Sparano, MD, of the Albert Einstein College of Medicine and the Montefiore Medical Center, Bronx, New York, and colleagues. These findings, which were also presented at the 2019 American Society of Clinical Oncology Annual Meeting (Abstract 503) and covered by JNCCN 360, were published in The New England Journal of Medicine.
“Binary clinical risk stratification based on tumor size and histologic grade added prognostic information to the 21-gene recurrence score, but not prediction of a large chemotherapy benefit,” the trial investigators concluded. “The integration of genomic and clinical information may provide a more accurate estimation of prognosis for individual patients than could be provided by either the genomic or clinical information alone.”
In this prospective trial, the authors focused on 9,427 women diagnosed with hormone receptor–positive, HER2-negative, axillary node–negative breast cancer. All patients had previously undergone an assay of 21 genes, and the clinical risk of the recurrence of breast for the women was classified as low or high based on the tumor size and histologic grade.
The investigators reported that the level of clinical risk was prognostic of distant recurrence in women with an intermediate 21-gene recurrence score of 11 to 25 who were randomly assigned to endocrine therapy (hazard ratio = 2.73), for women assigned to chemotherapy plus endocrine therapy (hazard ratio = 2.41), as well as for women with a high risk of recurrence—26 to 100—assigned to chemotherapy and endocrine therapy (hazard ratio = 3.17). For women up to 50 years old who were treated with endocrine therapy alone, the estimated rate of distant recurrence at 9 years was less than 5% with a low recurrence score. “In this age group, the estimated distant recurrence at 9 years exceeded 10% among women with a high clinical risk and an intermediate recurrence score who received endocrine therapy alone and among those with a high recurrence score who received chemoendocrine therapy,” they stated.
Disclosure: The study authors’ disclosure information may be found at nejm.org.