96324-114

Sequential treatment with epirubicin/cyclophosphamide, followed by docetaxel versus FEC120 in the adjuvant treatment of node-positive breast cancer patients: Final survival analysis of the German ADEBAR phase III study.

Subcategory: 
Category: 
Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy
Session Type and Session Title: 
General Poster Session, Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy
Abstract Number: 

1081

Citation: 

J Clin Oncol 30, 2012 (suppl; abstr 1081)

Author(s): 

Wolfgang Janni, Nadia Harbeck, Harald Leo Sommer, Brigitte Kathrin Rack, Doris Augustin, Wolfgang Simon, Julia Kathrin Jueckstock, Arthur Wischnik, Katja Annecke, Klaus Friese, Marion Kiechle, SUCCESS Study Group; Universitätsklinikum Düsseldorf, Department of Gynecology and Obstetrics, Duesseldorf, Germany; Breast Center, Dept of OB&GYN, University of Munich, Munich, Germany; Cancer Center of the Ludwig-Maximilian-University, Munich, Germany; Department of Gynecology and Obstetrics, Klinikum der Ludwig-Maximilians-Universität, Munich, Germany; Klinikum Deggendorf, Deggendorf, Germany; Robert-Bosch-Krankenhaus, Stuttgart, Germany; Frauenklinik Innenstadt Munich University, Munich, Germany; Zentraklinikum Augsburg, Augsburg, Germany; Department of Obstetrics and Gynecology, Technical University Munich, Munich, Germany; Department of Obstetrics and Gynecology, Klinikum r.d. Isar Frauenklinik, Technische Universitaet Muenchen, Munich, Germany


Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: Based on meta-analytic evidence, taxane containing adjuvant chemotherapy has been established as standard treatment in breast cancer (BC). However, in the MA-21 study, adriamycin-cyclophosphamide, followed by paclitaxel was significantly inferior FEC120. We prospectively compared a sequential epirubicin-docetaxel chemotherapy regimen to FEC120. Methods: The ADEBAR study was a multicenter phase III trial (n=1502) to evaluate whether pts with > 3 axillary lymph node metastases BC benefit from a sequential anthracycline-docetaxel regimen (E90C–D: 4 cycles epirubicin [E] 90 mg/m2 plus cyclophosphamide [C] 600 mg/m2 q21d followed by 4 cycles docetaxel [D] 100mg/m2 q21d) compared to dose-intensive anthracycline-containing polychemotherapy (FE120C: 6 cycles E 60 mg/m² d 1+8, 5-FU 500mg/m² d 1+8 and C 75 mg/m² d 1-14, q4w). The observation time (median – 95%CI) was 49.5 (47.4 – 51.3) m. Results: Treatment was stopped prematurely in 3.7% of the pts in the E90C–D arm and in 8.0% in the FE120C arm due to toxicity (p=0.0009). Antibiotic treatment was given in 10.4% (E90C–D) vs. 19.7% (FE120C), G-CSF support in 39.2% vs 61.4 % and erythropoietin stimulation in 8.7% vs. 20.0%, respectively (p<0.0001). Haematological toxicity (leucopenia, neutropenic fever, thrombocytopenia, anemia) was significantly higher in the FEC-arm. At the time of the current analysis, 369 events of recurrence, were observed: 166 events in the FE120C group and 193 in the E90C–D group. The unadjusted hazard ratio (HR) was 0.877 (95 percent confidence interval, 0.722 to 1.065; p=0.3819, log-rank test). Overall survival in the two groups was not significantly different: (131 deaths with FEC vs. 134 with E90C–D (HR 0.996, 0.783-1.267, p=0.9691). Subgroup analyses, stratifying for tumor size, lymph node involvement, hormone receptor and HER2-neu status showed no significant difference between the two arms. Conclusions: Different toxicity profiles given, hematological toxicity in the FE120C group was more severe than in the E90C–D. In contrast to AC-P in earlier studies, EC-Doc provides a feasible and effective option to FEC120.