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.

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


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

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Abstract Disclosures


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.