21-Gene Assay Guides Chemotherapy in Node-Positive Breast Cancer

Premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with one to three positive lymph nodes and a recurrence score of 25 or lower benefit from chemoendocrine therapy versus endocrine therapy alone, according to a study published online Dec. 1 in the New England Journal of Medicine.

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HER2-Negative Node-Positive Breast Cancer

Kevin Kalinsky, M.D., from Emory University in Atlanta, and colleagues randomly assigned 5,083 women (33.2 percent premenopausal; 66.8 percent postmenopausal) with hormone receptor-positive, HER-2-negative breast cancer, one to three positive axillary lymph nodes, and a recurrence score of 25 or lower to endocrine therapy or chemotherapy plus endocrine therapy; 5,018 participated in the trial.

The researchers found that at the prespecified third interim analysis, there was a difference in the chemotherapy benefit with respect to increasing invasive disease-free survival according to menopausal status, and consequently, separate prespecified analyses were performed. Invasive disease-free survival at five years was 91.9 and 91.3 percent in the endocrine-only and chemoendocrine groups, respectively, among postmenopausal women (hazard ratio, 1.02; 95 percent confidence interval [CI], 0.82 to 1.26; P = 0.89). Among premenopausal women, the corresponding survival rates were 89.0 and 93.9 percent (hazard ratio, 0.60; 95 percent CI, 0.43 to 0.83; P = 0.002); a similar increase was seen in distant relapse-free survival (hazard ratio, 0.58; 95 percent CI, 0.39 to 0.87; P = 0.009). There was no increase observed in the relative chemotherapy benefit as the recurrence score increased.

“Premenopausal women with one to three positive lymph nodes had a significant benefit from chemotherapy, even with a very low recurrence score,” the authors write.

Several authors disclosed financial ties to the biopharmaceutical industry.

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