1. Inflammatory breast cancer outcome with epirubicin-based induction and maintenance chemotherapy: ten-year results from the French Adjuvant Study Group GETIS 02 Trial.
- Author
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Veyret C, Levy C, Chollet P, Merrouche Y, Roche H, Kerbrat P, Fumoleau P, Fargeot P, Clavere P, and Chevallier B
- Subjects
- Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms pathology, Breast Neoplasms radiotherapy, Breast Neoplasms surgery, Chemotherapy, Adjuvant, Cyclophosphamide administration & dosage, Cyclophosphamide adverse effects, Disease-Free Survival, Dose-Response Relationship, Drug, Epirubicin administration & dosage, Epirubicin adverse effects, Female, Fluorouracil administration & dosage, Fluorouracil adverse effects, Granulocyte Colony-Stimulating Factor administration & dosage, Granulocyte Colony-Stimulating Factor adverse effects, Humans, Inflammation, Lenograstim, Placebos, Recombinant Proteins administration & dosage, Recombinant Proteins adverse effects, Remission Induction, Survival Rate, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy
- Abstract
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., ((c) 2006 American Cancer Society.)
- Published
- 2006
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