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21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer
Kalinsky K, Barlow WE, Gralow JR, Meric-Bernstam F, et al. (2021). New England Journal of Medicine. PubMed 34914339 · DOI 10.1056/NEJMoa2108873 · PubMed record
What kind of source: Randomized trial (RxPONDER), one to three positive nodes, scores 0 to 25. Where it sits in the summary: Established. Back to the summary
What it says, in plain language
For women with one to three positive lymph nodes and a score of 25 or lower, the result split by menopausal status. No added chemotherapy benefit was observed in postmenopausal women. Premenopausal women did benefit, and the benefit did not grow with a higher score.
Source access: the full text was read as a PubMed Central author manuscript. It is linked rather than reproduced because redistribution is not permitted for this copy. Open the PubMed record and follow its PMC link.
The exact words we relied on
“Among postmenopausal women, invasive disease-free survival at 5 years was 91.9% in the endocrine-only group and 91.3% in the chemoendocrine group, with no chemotherapy benefit (hazard ratio for invasive disease recurrence, new primary cancer [breast cancer or another type], or death, 1.02; 95% confidence interval [CI], 0.82 to 1.26; P = 0.89).” — PMID:34914339, Abstract, Results
“Among premenopausal women, invasive disease-free survival at 5 years was 89.0% with endocrine-only therapy and 93.9% with chemoendocrine therapy (hazard ratio, 0.60; 95% CI, 0.43 to 0.83; P = 0.002)” — PMID:34914339, Abstract, Results
“The relative chemotherapy benefit did not increase as the recurrence score increased.” — PMID:34914339, Abstract, Results
“We found that postmenopausal women with one to three positive axillary lymph nodes and a recurrence score of 0 to 25 were able to safely forgo adjuvant chemotherapy without compromising invasive disease–free survival and distant relapse–free survival.” — PMID:34914339, Discussion (PMC author manuscript)
“Whether a chemotherapy benefit in premenopausal women is due to both direct cytocidal effects and treatment-induced menopause remains unclear.” — PMID:34914339, Discussion (PMC author manuscript)
How these quotes were checked
Follow the passage links above to the included paper or public source record.
Full text, author manuscript. The publicly available PMC author manuscript was retrieved on 2026-09-08 and read. Abstract quotes were checked against the cached PubMed record; body-text quotes were checked by exact string match against that manuscript. An author manuscript can differ in wording from the final journal version.
Limits of this source
Five-year results at a planned interim analysis; follow-up continues. Scores above 25 were not randomized. Applies to one to three positive nodes, not four or more.
Review
Reviewed by Sarah Kiselycznyk · September 10, 2026. Review scope and verification method: How we researched this.