21-gene assay to inform chemotherapy benefit in node-positive breast cancer
New England Journal of Medicine Dec 07, 2021
Kalinsky K, Barlow WE, Gralow JR, et al. - In this study, chemoendocrine therapy for breast cancer conferred longer invasive disease–free survival and distant relapse–free survival, vs endocrine-only therapy, in premenopausal women with one to three positive lymph nodes and a recurrence score of 25 or lower. Adjuvant chemotherapy failed to be beneficial for postmenopausal women with similar characteristics.
A prospective trial wherein 5,083 women (33.2% premenopausal and 66.8% postmenopausal) with hormone-receptor–positive, human epidermal growth factor receptor 2-negative breast cancer, one to three positive axillary lymph nodes, and a recurrence score of 25 or lower were included.
They were randomized to endocrine therapy only or to chemotherapy plus endocrine (chemoendocrine) therapy.
In interim analysis, difference in chemotherapy benefit, in terms of increasing invasive disease–free survival, was evident by menopausal status (P=0.008 for the comparison of chemotherapy benefit in premenopausal and postmenopausal participants).
At 5 years, postmenopausal women in the endocrine-only group showed an invasive disease–free survival of 91.9%, and those from the chemoendocrine group 91.3%, with no chemotherapy benefit (hazard ratio for invasive disease recurrence, new primary cancer, or death, 1.02).
In premenopausal group, endocrine-only therapy conferred an invasive disease–free survival of 89.0% vs 93.9% with chemoendocrine therapy, at 5 years (hazard ratio, 0.60), with a similar increase in distant relapse–free survival (hazard ratio, 0.58).
With increasing recurrence score, no increase was seen in the relative chemotherapy benefit.
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