RT Journal Article
T1 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer.
A1 Kalinsky, Kevin
A1 Barlow, William E
A1 Gralow, Julie R
A1 Meric-Bernstam, Funda
A1 Albain, Kathy S
A1 Hayes, Daniel F
A1 Lin, Nancy U
A1 Perez, Edith A
A1 Goldstein, Lori J
A1 Chia, Stephen K L
A1 Dhesy-Thind, Sukhbinder
A1 Rastogi, Priya
A1 Alba, Emilio
A1 Delaloge, Suzette
A1 Martin, Miguel
A1 Kelly, Catherine M
A1 Ruiz-Borrego, Manuel
A1 Gil-Gil, Miguel
A1 Arce-Salinas, Claudia H
A1 Brain, Etienne G C
A1 Lee, Eun-Sook
A1 Pierga, Jean-Yves
A1 Bermejo, Begoña
A1 Ramos-Vazquez, Manuel
A1 Jung, Kyung-Hae
A1 Ferrero, Jean-Marc
A1 Schott, Anne F
A1 Shak, Steven
A1 Sharma, Priyanka
A1 Lew, Danika L
A1 Miao, Jieling
A1 Tripathy, Debasish
A1 Pusztai, Lajos
A1 Hortobagyi, Gabriel N
K1 Antineoplastic Agents, Hormonal
K1 Disease-Free Survival
K1 Lymphatic Metastasis
K1 Premenopause
K1 Receptor, ErbB-2
K1 Reverse Transcriptase Polymerase Chain Reaction
AB The recurrence score based on the 21-gene breast-cancer assay has been clinically useful in predicting a chemotherapy benefit in hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary lymph-node-negative breast cancer. In women with positive lymph-node disease, the role of the recurrence score with respect to predicting a benefit of adjuvant chemotherapy is unclear. In a prospective trial, we randomly assigned women with hormone-receptor-positive, HER2-negative breast cancer, one to three positive axillary lymph nodes, and a recurrence score of 25 or lower (scores range from 0 to 100, with higher scores indicating a worse prognosis) to endocrine therapy only or to chemotherapy plus endocrine (chemoendocrine) therapy. The primary objective was to determine the effect of chemotherapy on invasive disease-free survival and whether the effect was influenced by the recurrence score. Secondary end points included distant relapse-free survival. A total of 5083 women (33.2% premenopausal and 66.8% postmenopausal) underwent randomization, and 5018 participated in the trial. At the prespecified third interim analysis, the chemotherapy benefit with respect to increasing invasive disease-free survival differed according to menopausal status (P = 0.008 for the comparison of chemotherapy benefit in premenopausal and postmenopausal participants), and separate prespecified analyses were conducted. 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). 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), with a similar increase in distant relapse-free survival (hazard ratio, 0.58; 95% CI, 0.39 to 0.87; P = 0.009). The relative chemotherapy benefit did not increase as the recurrence score increased. Among premenopausal women with one to three positive lymph nodes and a recurrence score of 25 or lower, those who received chemoendocrine therapy had longer invasive disease-free survival and distant relapse-free survival than those who received endocrine-only therapy, whereas postmenopausal women with similar characteristics did not benefit from adjuvant chemotherapy. (Funded by the National Cancer Institute and others; RxPONDER ClinicalTrials.gov number, NCT01272037.).
PB Massachusetts Medical Society
YR 2021
FD 2021-12-16
LK https://hdl.handle.net/10668/27721
UL https://hdl.handle.net/10668/27721
LA en
NO Kalinsky K, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, et al.  21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. N Engl J Med. 2021 Dec 16;385(25):2336-2347
DS RISalud
RD Apr 12, 2025