BACKGROUND: The authors evaluated the long-term efficacy and side effects in 
patients with nonmetastatic, unilateral, inflammatory breast cancer (IBC) who 
received homogeneous treatment with intensive induction chemotherapy followed by 
a maintenance regimen.
METHODS: One hundred twenty patients were randomized to receive high-dose 
fluorouracil, epirubicin, and cyclophosphamide (FEC-HD) (fluorouracil 750 
mg/m(2) on Days 1 to 4, epirubicin 35 mg/m(2) on Days 2 to 4, and 
cyclophosphamide 400 mg/m(2) on Days 2 to 4 for 4 cycles every 21 days) with or 
without lenograstim. Locoregional treatment consisted of surgery and/or 
radiotherapy. Maintenance chemotherapy was FEC 75 (fluorouracil 500 mg/m(2), 
epirubicin 75 mg/m(2), and cyclophosphamide 500 mg/m(2) on Day 1 every 21 days 
for 4 cycles). No hormone treatment was allowed.
RESULTS: The safety of the FEC-HD regimen was described previously. Among 102 
patients who underwent surgery, a pathologic complete response (pCR) was 
achieved by 23.5% of patients with breast tumors and by 31.4% of patients with 
involved axillary lymph nodes. The overall pCR rate was 14.7%. One hundred nine 
patients received FEC 75. After a median 10 years of follow-up, the disease-free 
survival (DFS) and overall survival (OS) rates were 35.7% and 41.2%, 
respectively. The median DFS was 39 months (95% confidence interval [95% CI], 
25-53 months), and the median survival was 61 months (95% CI, 43-79 months). 
Five patients developed a temporary decrease in left ventricular ejection 
fraction without congestive heart failure. In the lenograstim group, 1 patient 
developed acute myeloblastic leukemia M2, and 1 patient developed 
myelodysplastic syndrome.
CONCLUSIONS: FEC-HD induction chemotherapy followed by FEC 75 maintenance 
regimen had moderate and acute long-term toxicities and lead to high DFS and OS 
rates in patients with IBC.