Ten-year results of intense dose-dense chemotherapy show superior survival compared to a conventional schedule in high-risk primary breast Cancer: final results of AGO phase III iddEPC trial
dose-dense; high-risk early breast cancer; intense dose-dense
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Main Authors: | , , , , , , , , , , , , , , , , , |
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Format: | Article (Journal) |
Language: | English |
Published: |
2018
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In: |
Annals of oncology
Year: 2018, Volume: 29, Issue: 1, Pages: 178-185 |
ISSN: | 1569-8041 |
DOI: | 10.1093/annonc/mdx690 |
Online Access: | Volltext lizenzpflichtig ![]() |
Author Notes: | V. Möbus, C. Jackisch, H.J. Lück, A. du Bois, C. Thomssen, W. Kuhn, U. Nitz, A. Schneeweiss, J. Huober, N. Harbeck, G. von Minckwitz, I.B. Runnebaum, A. Hinke, G.E. Konecny, M. Untch & C. Kurbacher, on behalf of the AGO Breast Study Group (AGO-B) |
Summary: | dose-dense; high-risk early breast cancer; intense dose-dense Background: Primary breast cancer (BC) patients with extensive axillary lymph-node involvement have a limited prognosis. The Arbeitsgemeinschaft fuer Gynaekologische Onkologie (AGO) trial compared intense dose-dense (idd) adjuvant chemotherapy with conventionally scheduled chemotherapy in high-risk BC patients. Here we report the final, 10-year follow-up analysis. - Patients and methods: Enrolment took place between December 1998 and April 2003. A total of 1284 patients with 4 or more involved axillary lymph nodes were randomly assigned to receive 3 courses each of idd sequential epirubicin, paclitaxel and cyclophosphamide (iddEPC) q2w or standard epirubicin/cyclophosphamide followed by paclitaxel (EC → P) q3w. Event-free survival (EFS) was the primary end point. - Results: A total of 658 patients were assigned to receive iddEPC and 626 patients were assigned to receive EC → P. The median duration of follow-up was 122 months. EFS was 47% (95% CI 43% to 52%) in the standard group and 56% (95% CI 52% to 60%) in the iddEPC group [hazard ratio (HR) 0.74, 95% CI 0.63-0.87; log-rank P = 0.00014, one-sided]. This benefit was independent of menopausal, hormone receptor or HER2 status. Ten-year overall survival (OS) was 59% (95% CI 55% to 63%) for patients in the standard group and 69% (95% CI 65% to 73%) for patients in the iddEPC group (HR = 0.72, 95% CI 0.60-0.87; log-rank P = 0.0007, two-sided). Nine versus two cases of secondary myeloid leukemia/myelodysplastic syndrome were observed in the iddEPC and the EC → P arm, respectively. - Conclusion: The previously reported OS benefit of iddEPC in comparison to conventionally dosed EC → P has been further increased and achieved an absolute difference of 10% after 10 years of follow-up. |
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Item Description: | Gesehen am 20.07.2020 |
Physical Description: | Online Resource |
ISSN: | 1569-8041 |
DOI: | 10.1093/annonc/mdx690 |