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December 01, 2021
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Premenopausal women may benefit from chemotherapy for node-positive breast cancer

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Premenopausal women with node-positive breast cancer and low recurrence scores benefited from adjuvant chemotherapy, whereas postmenopausal women did not, according to results of a study published in The New England Journal of Medicine.

The goal of treatment for breast cancer is to move away from a ‘one-size-fits-all’ approach and to determine who benefits from adjuvant chemotherapy and who does not,” Kevin Kalinsky, MD, MS, director of Glenn Family Breast Center at Winship Cancer Institute of Emory University, told Healio.

5-year invasive DFS.
Data derived from Kalinsky K, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2108873.

As Healio previously reported, the prospective SWOG S1007 RxPONDER trial included 5,018 adult women (median age, 57.5 years) with stage II or stage III hormone receptor-positive, HER2-negative breast cancer with one to three positive lymph nodes and no contraindications to anthracycline- and/or taxane-based chemotherapy.

All women had recurrence scores of 25 or less as determined by the Oncotype Dx test (Exact Sciences), which provides individualized risk assessments for patients with early-stage invasive breast cancer based on evaluation of 16 cancer-related genes and five reference genes.

Researchers randomly assigned women 1:1 to endocrine therapy with or without chemotherapy, stratifying by recurrence score (0-13 vs. 14-25), menopausal status, and axillary nodal dissection vs. sentinel node biopsy.

The effect of chemotherapy on invasive DFS — as well as whether that effect varied based on recurrence score — served as the primary objective. Distant RFS and OS served as secondary objectives.

Two-thirds of women were postmenopausal and one-third were premenopausal.

At the median follow-up of 5.3 years, 481 invasive DFS events occurred (58% of expected).

Results showed a 5-year invasive DFS rate of 91.3% for postmenopausal women assigned chemotherapy vs. 91.9% for those who were not (HR = 1.02; 95% CI, 0.82-1.26). Conversely, researchers observed a benefit of chemotherapy among premenopausal women, with 5-year invasive DFS rates of 93.9% with chemotherapy and 89% without (HR = 0.6; 95% CI, 0.43-0.83). Researchers observed similar improvements in distant RFS (HR = 0.58; 95% CI, 0.39-0.87).

Kevin Kalinsky
Kevin Kalinsky

“Premenopausal women with one to three positive axillary lymph nodes and recurrence scores of 25 or less have improved invasive DFS and distant RFS with chemoendocrine therapy compared with endocrine therapy alone, whereas postmenopausal women with similar characteristics can forego adjuvant chemotherapy,” Kalinsky said. “It is important to also consider other clinical and pathologic features when individualizing the conversation with the patient about the selection of systemic therapeutics.”

Future research includes a translational medicine effort to evaluate tumor tissue, as well as patient-reported outcomes and utilization and outcomes with radiation therapy, he added.

“We are also collecting blood samples in patients without a recurrence up to 8 years post-randomization to identify predictors of late recurrence. This is an ongoing effort, and we are collecting these samples at this time to address this important issue,” Kalinsky said.

For more information:

Kevin Kalinsky, MD, MS, can be reached at Emory University, 1365 Clifton Road, Atlanta, GA 30322; email: kevin.michael.kalinsky@emory.edu.