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Differential efficacy of three cycles of CMF followed by tamoxifen in patients with ER-positive and ER-negative tumors: Long-term follow up on IBCSG Trial IX

Aebi, S. ; Sun, Z. ; Braun, D. ; Price, K. N. ; Castiglione-Gertsch, M. ; Rabaglio, M. ; Gelber, R. D. ; Crivellari, D. ; Lindtner, J. ; Snyder, R. ; Karlsson, P. ; Simoncini, E. ; Gusterson, B. A. ; Viale, G. ; Regan, M. M. ; Coates, A. S. ; Goldhirsch, A.

In: Annals of Oncology, 2011, vol. 22, no. 9, p. 1981-1987

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    Title
    • Differential efficacy of three cycles of CMF followed by tamoxifen in patients with ER-positive and ER-negative tumors: Long-term follow up on IBCSG Trial IX
    Author
    • Aebi, S.. Division of Medical Oncology, Berne University Hospital and Swiss Group for Clinical Cancer research (SAKK), Berne, Switzerland
    • Sun, Z.. IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston
    • Braun, D.. IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston
    • Price, K. N.. IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, USA
    • Castiglione-Gertsch, M.. Medical Onco-Gynecology Unit, Department of Medicine, Geneva University Hospital, Geneva
    • Rabaglio, M.. IBCSG Coordinating Center and Inselspital, Berne, Switzerland
    • Gelber, R. D.. IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Harvard Medical School, Boston, USA
    • Crivellari, D.. Department of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy
    • Lindtner, J.. Department of Surgical Oncology, Institute of Oncology, Ljulbljana, Slovenia
    • Snyder, R.. Department of Medical Oncology, St Vincent's Hospital, Melbourne, Australia
    • Karlsson, P.
    • Simoncini, E.
    • Gusterson, B. A.. IBCSG Pathology Review Office, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK
    • Viale, G.. IBCSG Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, University of Milan, Milan, Italy
    • Regan, M. M.. IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston
    • Coates, A. S.. International Breast Cancer Study Group, Berne, Switzerland
    • Goldhirsch, A.. Department of Medicine, European Institute of Oncology, Milan, Italy
    Document Type
    • Postprint
    Language
    • English
    Published in
    • Annals of Oncology, 2011, vol. 22, no. 9, p. 1981-1987. Oxford University Press
    Other Version
    OAI-PMH Identifier
    • oai:doc.rero.ch:304488
    Summary
    Background: The benefit of adjuvant chemotherapy in postmenopausal patients with estrogen receptor (ER)-positive lymph node-negative breast cancer is being reassessed. Patients and methods: After stratification by ER status, 1669 postmenopausal patients with operable lymph node-negative breast cancer were randomly assigned to three 28-day courses of ‘classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy followed by tamoxifen for 57 months (CMF→tamoxifen) or to tamoxifen alone for 5 years. Results: ERs were positive in 81% of tumors. At a median follow-up of 13.1 years, patients with ER-positive breast cancers did not benefit from CMF [13-year disease-free survival (DFS) 64% CMF→tamoxifen, 66% tamoxifen; P = 0.99], whereas CMF substantially improved the prognosis of patients with ER-negative breast cancer (13-year DFS 73% versus 57%, P = 0.001). Similarly, breast cancer-free interval (BCFI) was identical in the ER-positive cohort but significantly improved by chemotherapy in the ER-negative cohort (13-year BCFI 80% versus 63%, P = 0.001). CMF had no influence on second nonbreast malignancies or deaths from other causes. Conclusion: CMF is not beneficial in postmenopausal patients with node-negative ER-positive breast cancer but is highly effective within the ER-negative cohort. In the future, other markers of chemotherapy response may define a subset of patients with ER-positive tumors who may benefit from adjuvant chemotherapy