Long-term results of International Breast Cancer Study Group Trial VIII: adjuvant chemotherapy plus goserelin compared with either therapy alone for premenopausal patients with node-negative breast cancer |
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| Institution: | 1. Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden;2. IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute and Department of Biostatistics, Harvard School of Public Health;3. IBCSG Statistical Center, Frontier Science and Technology Research Foundation, Boston, USA;4. Unité de Onco-Gynécologie Médicale Departement de Médecine Hôpitaux Universitaires de Genève, Genève;5. IBCSG Coordinating Center and Department of Medical Oncology, Inselspital, Bern, Switzerland;6. IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute and Frontier Science and Technology Research Foundation, Harvard School of Public Health, Harvard Medical School, Boston, USA;7. Department of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy;8. Department of Surgery, The Royal Melbourne Hospital, Melbourne, Australia;9. Department of Radiation Oncology, Groote Shuur Hospital, University of Cape Town, Cape Town, South Africa;10. Department of Medical Oncology, Centre Hospitalier Universitaire Vaudois, Centre du Cancer Lausanne, Lausanne and Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland;11. Department of Medicine, Research Unit in Medical Senology, European Institute of Oncology, Milan, Italy;12. IBCSG Pathology Review Office, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK;13. IBCSG Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, University of Milan, Milan, Italy;14. International Breast Cancer Study Group, Bern, Switzerland;15. School of Public Health, University of Sydney, Sydney, Australia;16. Department of Medicine, European Institute of Oncology, Milan, Italy;17. Oncology Institute of Southern Switzerland, Bellinzona, Switzerland |
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| Abstract: | BackgroundThe International Breast Cancer Study Group Trial VIII compared long-term efficacy of endocrine therapy (goserelin), chemotherapy cyclophosphamide, methotrexate and fluorouracil (CMF)], and chemoendocrine therapy (CMF followed by goserelin) for pre/perimenopausal women with lymph-node-negative breast cancer.Patients and methodsFrom 1990 to 1999, 1063 patients were randomized to receive (i) goserelin for 24 months (n = 346), (ii) six courses of ‘classical’ CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy (n = 360), or (iii) six courses of CMF plus 18 months goserelin (CMF→ goserelin; n = 357). Tumors were classified as estrogen receptor (ER) negative (19%), ER positive (80%), or ER unknown (1%); 19% of patients were younger than 40. Median follow-up was 12.1 years.ResultsFor the ER-positive cohort, sequential therapy provided a statistically significant benefit in disease-free survival (DFS) (12-year DFS = 77%) compared with CMF alone (69%) and goserelin alone (68%) (P = 0.04 for each comparison), due largely to the effect in younger patients. Patients with ER-negative tumors whose treatment included CMF had similar DFS (12-year DFS CMF = 67%; 12-year DFS CMF→ goserelin = 69%) compared with goserelin alone (12-year DFS = 61%, P= NS).ConclusionsFor pre/perimenopausal women with lymph-node-negative ER-positive breast cancer, CMF followed by goserelin improved DFS in comparison with either modality alone. The improvement was the most pronounced in those aged below 40, suggesting an endocrine effect of prolonged CMF-induced amenorrhea. |
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