A randomized neoadjuvant chemotherapy (NC) study in advanced breast cancer (BC): AC vs FEC 60

Abstract

832 Background: We designed this study to compare the clinical and pathologic response rates of AC [Doxorubicin (D) and Cyclophosphamide (C)] and FEC [Fluorouracil (F), Epirubicin (E) and Cyclophosphamide] as NC in patients (pts) with BC. Methods: Women (n = 100) with operable primary BC with stage III and age ≤ 70 years old (yo) were randomly assigned to receive four cycles of AC (arm A, n = 51 pts) (D = 60 mg/m2; C = 600 mg/m2) every 21 days or four cycles of FEC (arm B, n = 49 pts) (F = 600 mg/m2; E = 60 mg/m2; C = 600 mg/m2) every 28 days between January 2002 and May 2003. Clinical and pathologic tumor responses were assessed by clinical examination and pathologic analyses. The initial tumor size, stage, age, menopausal status and hormonal receptors status were well balanced in both arms. Results: Median initial tumor size was 9,34 and 8,8 cm, stage IIIa was 50% and 48%, stage IIIb was 50% and 52%, median age was 51 yo (range from 28 –70) and 52 yo (range from 33 –69), menopausal status was 42% and 44%, estrogen receptor positive was 62,2% and 60,4%, progesterone receptor positive was 53% and 56% in the arm A and arm B respectively. After four cycles of NC the results were as follows (arm A first): median pathologic tumor size 3,9 vs 3,12 cm, median clinical size reduction 5,95 vs 5,15 cm, downstaging 49% vs 52%, negative nodes (pN0) 30,7% vs 26,5%, pathologic complete response (pCR) 12,1% vs 10,7%, pathologic partial response 75,3% vs 77,1%, stable disease was 7,3% vs 10,2% and progression 4,3% vs 2%. Conclusions: The FEC 60 neoadjuvant regimen is as effective as AC in this population. Randomized trials report complete pathologic responses ranging from 14% to 31%. However, this study could not found these rates. It is believed due to the large mean tumor size verified in our population. Furthermore, the literature shows better pCR in sequential NC regimens containing anthracycline and taxanes, so FEC with a Taxane can be an approach to these patients. No significant financial relationships to disclose.