Abstract S6-03: DBCG 07-READ: A randomized phase III trial comparing six cycles of docetaxel and cyclophosphamide (DC) to three cycles of epirubicin and cyclophosphamide followed by three cycles of docetaxel (EC-D) in patients with early breast cancer
| العنوان: | Abstract S6-03: DBCG 07-READ: A randomized phase III trial comparing six cycles of docetaxel and cyclophosphamide (DC) to three cycles of epirubicin and cyclophosphamide followed by three cycles of docetaxel (EC-D) in patients with early breast cancer |
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| المؤلفون: | Martin Andersson, Dorte Nielsen, Peter Michael Vestlev, I Hoejris, D Carlsen, Marianne Ewertz, E Maae, Erik Jakobsen, H. T. Mouridsen, J Kenholm, Hanne Melgaard Nielsen, M.B. Jensen, AS Knoop, Bent Ejlertsen, Malgorzata K Tuxen, S. Cold, Eva Balslev, T Bechmann |
| المصدر: | Cancer Research. 77:S6-03 |
| بيانات النشر: | American Association for Cancer Research (AACR), 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Oncology, Cancer Research, medicine.medical_specialty, Chemotherapy, Anthracycline, Cyclophosphamide, business.industry, medicine.medical_treatment, Cancer, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Docetaxel, 030220 oncology & carcinogenesis, Internal medicine, medicine, Breast-conserving surgery, 030212 general & internal medicine, business, medicine.drug, Epirubicin |
| الوصف: | Background: DBCG 07-READ was designed to compare sequential EC followed by D with DC in patients with early, TOP2A normal breast cancer as a retrospective evaluation of the DBCG 89D trial suggested that these patients would not benefit from an anthracycline. Methods: This is a multicenter open-label randomized phase III trial. Three groups of women were eligible following completely resected unilateral invasive TOP2A normal (TOP2A gene to centromere 17 ratio of 0.8 to 2.0) breast cancer by mastectomy or breast conserving surgery in combination with axillary clearance or a negative sentinel node biopsy; 1: Age 18 to 39 years; 2: Age 40 to 75 years and estrogen receptor (ER) negative ( 20 mm. Eligible patients were required to have a Charlson Comorbidity (CC) Index < 2 and to be without signs of distant metastasis. Patients were randomized to receive 6 cycles of DC (docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2) every 3 weeks or 3 cycles of EC (epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2) followed by 3 cycles of D (docetaxel 100 mg/m2) every 3 weeks. In case of a CC Index of 1 or 2 chemotherapy was administered at a reduced dose-intensity. Adjuvant endocrine treatment, trastuzumab and radiotherapy were administered according to the guidelines of the DBCG. The primary endpoint was disease-free survival (DFS), and secondary endpoints were overall survival (OS) and distant disease-free survival (DDFS). Results: Between July 2008 and December 2012 we (12 DBCG centers) randomly assigned 2006 eligible patients to DC (N=1008) or EC-D (N=998). Patient and tumor characteristics were balanced by treatment groups. The median estimated potential follow-up is 5.4 years and the 5-year DFS was 88.0%; 95% CI 85.8 to 90.0 in the EC-D arm and 87.9%; 95% CI 85.7 to 89.9 in the DC arm. No significant difference in the risk of DFS events HR=1.03; 95% CI 0.80 to 1.32; p=0.84 or mortality HR=1.11; 95% 0.79 to 1.56; p=0.55 was observed in the intent to treat analysis. Patient-reported toxicity will be compared for the two chemotherapy regimens. Conclusion: The READ trial gives evidence to support no outcome benefit from anthracycline in patients with TOP2A normal ealy breast cancer. Citation Format: Ejlertsen B, Tuxen MK, Jakobsen EH, Jensen M-B, Knoop AS, Hoejris I, Ewertz M, Balslev E, Vestlev PM, Kenholm J, Nielsen DL, Bechmann T, Andersson M, Cold S, Nielsen HM, Maae E, Carlsen D, Mouridsen HT. DBCG 07-READ: A randomized phase III trial comparing six cycles of docetaxel and cyclophosphamide (DC) to three cycles of epirubicin and cyclophosphamide followed by three cycles of docetaxel (EC-D) in patients with early breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr S6-03. |
| تدمد: | 1538-7445 0008-5472 |
| DOI: | 10.1158/1538-7445.sabcs16-s6-03 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::6d4a1c8351f73b733b54bbc32524adb5 https://doi.org/10.1158/1538-7445.sabcs16-s6-03 |
| رقم الانضمام: | edsair.doi...........6d4a1c8351f73b733b54bbc32524adb5 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15387445 00085472 |
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| DOI: | 10.1158/1538-7445.sabcs16-s6-03 |