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21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer
Kevin Kalinsky1, William E Barlow1, Julie R Gralow1
1From the Winship Cancer Institute at Emory University, Atlanta (K.K.); Southwest Oncology Group Statistics and Data Management Center (W.E.B., D.L.L., J.M.) and the University of Washington School of Medicine-Seattle Cancer Care Alliance (J.R.G.) - both in Seattle; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B., D.T., G.N.H.); Loyola University Chicago, Maywood, IL (K.S.A.); the University of Michigan, Ann Arbor (D.F.H., A.F.S.); Dana-Farber Cancer Institute, Boston (N.U.L.); Mayo Clinic, Jacksonville, FL (E.A.P.); Fox Chase Cancer Center, Philadelphia (L.J.G.), and the University of Pittsburgh, Pittsburgh (P.R.) - both in Pennsylvania; BC Cancer-Vancouver Cancer Centre, Vancouver (S.K.L.C.), and Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (S.D.-T.) - both in Canada; UGCI Medical Oncology Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (E.A.), Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Cáncer-Instituto de Salud Carlos III, Universidad Complutense, Madrid (M.M.), Hospital Universitario Virgen del Rocío, Seville (M.R.-B.), Institut Català d'Oncologia, Barcelona (M.G.-G.), Hospital Clínico Universitario de Valencia, Biomedical Research Institute Investigación del Hospital Clínico de la Comunidad Valenciana, Valencia (B.B.), and Centro Oncológico de Galicia, A Coruña (M.R.-V.) - all in Spain; Institut Gustave Roussy (S.D.) and Institut Curie (J.-Y.P.), Paris, Institut Curie-Centre Réné Huguenin, Saint-Cloud (E.G.C.B.), and Centre Antoine Lacassagne, Nice (J.-M.F.) - all in France; Mater Misericordiae University Hospital, Dublin (C.M.K.); Instituto Nacional de Cancerología de México, Mexico City (C.H.A.-S.); the National Cancer Center Korea, Goyang-si (E.-S.L.), and Asa Medical Center, University of Ulsan College of Medicine, Seoul (K.-H.J.) - both in South Korea; Exact Sciences, Redwood City, CA (S.S.); the University of Kansas Medical Center, Kansas City (P.S.); and Yale University, New Haven, CT (L.P.).
Premenopausal women with lymph-node-positive breast cancer benefit from chemotherapy, unlike postmenopausal women. The 21-gene recurrence score did not predict chemotherapy benefit in this study.
Area of Science:
- Oncology
- Genomics
- Clinical Trials
Background:
- The 21-gene recurrence score predicts chemotherapy benefit in early-stage, lymph-node-negative breast cancer.
- Its utility in lymph-node-positive breast cancer remains unclear.
Purpose of the Study:
- To evaluate the chemotherapy benefit in hormone-receptor-positive, HER2-negative breast cancer with 1-3 positive lymph nodes and a low recurrence score (≤25).
- To determine if menopausal status influences chemotherapy benefit.
Main Methods:
- Prospective randomized trial comparing endocrine therapy alone versus chemoendocrine therapy.
- Participants: 5018 women with 1-3 positive lymph nodes and recurrence score ≤25.
- Primary endpoint: invasive disease-free survival.
Main Results:
- Chemotherapy benefit varied by menopausal status (P=0.008).
- Postmenopausal women showed no significant invasive disease-free survival benefit (HR 1.02, P=0.89).
- Premenopausal women had improved invasive disease-free survival (HR 0.60, P=0.002) and distant relapse-free survival (HR 0.58, P=0.009) with chemoendocrine therapy.
Conclusions:
- Premenopausal women with 1-3 positive lymph nodes and low recurrence score benefit from adjuvant chemotherapy.
- Postmenopausal women with similar characteristics do not benefit from adjuvant chemotherapy.
- Chemotherapy benefit was not influenced by the recurrence score in this population.
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