Abstract
The present study was performed to evaluate the significance of biologic subtype and 21-gene recurrence score relative to local recurrence and local–regional recurrence after breast conservation treatment with radiation. Eastern Cooperative Oncology Group E2197 was a prospective randomized clinical trial that compared two adjuvant systemic chemotherapy regimens for patients with operable breast carcinoma with 1–3 positive lymph nodes or negative lymph nodes with tumor size >1.0 cm. The study population was a subset of 388 patients with known 21-gene recurrence score and treated with breast conservation surgery, systemic chemotherapy, and definitive radiation treatment. Median follow-up was 9.7 years (range = 3.7–11.6 years). The 10-year rates of local recurrence and local–regional recurrence were 5.4 % and 6.6 %, respectively. Neither biologic subtype nor 21-gene Recurrence Score was associated with local recurrence or local–regional recurrence on univariate or multivariate analyses (all P ≥ 0.12). The 10-year rates of local recurrence were 4.9 % for hormone receptor positive, HER2-negative tumors, 6.0 % for triple negative tumors, and 6.4 % for HER2-positive tumors (P = 0.76), and the 10-year rates of local–regional recurrence were 6.3, 6.9, and 7.2 %, respectively (P = 0.79). For hormone receptor-positive tumors, the 10-year rates of local recurrence were 3.2, 2.9, and 10.1 % for low, intermediate, and high 21-gene recurrence score, respectively (P = 0.17), and the 10-year rates of local–regional recurrence were 3.8, 5.1, and 12.0 %, respectively (P = 0.12). For hormone receptor-positive tumors, the 21-gene recurrence score evaluated as a continuous variable was significant for local–regional recurrence (hazard ratio 2.66; P = 0.03). The 10-year rates of local recurrence and local–regional recurrence were reasonably low in all subsets of patients. Neither biologic subtype nor 21-gene recurrence score should preclude breast conservation treatment with radiation.
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Acknowledgments
This study was coordinated by the Eastern Cooperative Oncology Group (Robert L. Comis, M.D., Chair), and supported in part by the Public Health Service Grants CA23318, CA66636, CA21115, CA14958, CA80775, CA49883, CA39229, CA27525, CA25224, CA32102, CA45389, the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services. Other supporting grants include Sanofi-Aventis and The Breast Cancer Research Foundation. The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute. Biospecimens were provided by the ECOG Pathology Coordinating Office and Reference Laboratory.
Conflict of interest
Compensated Robert Gray: Research Funding, Genomic Health, Inc.; Lori J. Goldstein: Member, Advisory Board, Genomic Health, Inc.; Frederick L. Baehner: Employee, Genomic Health, Inc., also with stock ownership; Steven Shak: Employee, Genomic Health, Inc., also with stock ownership; Sunil Badve: Other remuneration, Genomic Health, Inc.
Not Compensated Lawrence J. Solin: (a) Member, Advisory Board, Genomic Health, Inc.; (b) Principal Investigator, Biomarkers in Tissue Samples from Patients with Ductal Breast Carcinoma in situ NCT01132560 at ClinicalTrials.gov
Other co-authors have no conflict of interest.
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Solin, L.J., Gray, R., Goldstein, L.J. et al. Prognostic value of biologic subtype and the 21-gene recurrence score relative to local recurrence after breast conservation treatment with radiation for early stage breast carcinoma: results from the Eastern Cooperative Oncology Group E2197 study. Breast Cancer Res Treat 134, 683–692 (2012). https://doi.org/10.1007/s10549-012-2072-y
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DOI: https://doi.org/10.1007/s10549-012-2072-y