In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 1081-1081
Abstract:
1081 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 FEC 120 . We prospectively compared a sequential epirubicin-docetaxel chemotherapy regimen to FEC 120 . 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 (E 90 C–D: 4 cycles epirubicin [E] 90 mg/m 2 plus cyclophosphamide [C] 600 mg/m 2 q21d followed by 4 cycles docetaxel [D] 100mg/m 2 q21d) compared to dose-intensive anthracycline-containing polychemotherapy (FE 120 C: 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 E 90 C–D arm and in 8.0% in the FE 120 C arm due to toxicity (p=0.0009). Antibiotic treatment was given in 10.4% (E 90 C–D) vs. 19.7% (FE 120 C), 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.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.1081
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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