Inflammatory breast cancer outcome with epirubicin-based induction and maintenance chemotherapy: ten-year results from the French Adjuvant Study Group GETIS 02 Trial.

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.

• Authors: Corinne Veyret, Christelle Levy, Philippe Chollet, Yacine Merrouche, Henri Roche, Pierre Kerbrat, Pierre Fumoleau, Pierre Fargeot, Pierre Clavere, Bernard Chevallier
• Journal: Cancer (Cancer) Vol. 107 Issue 11 Pg. 2535-44 (Dec 01 2006) ISSN: 0008-543X [Print] United States
• PMID: 17054108 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: (c) 2006 American Cancer Society.

Chemical References

• Placebos
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Epirubicin
• Lenograstim
• Cyclophosphamide
• Fluorouracil

Topics

• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, pathology, radiotherapy, surgery)
• Chemotherapy, Adjuvant
• Cyclophosphamide (administration & dosage, adverse effects)
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Epirubicin (administration & dosage, adverse effects)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects)
• Humans
• Inflammation
• Lenograstim
• Placebos
• Recombinant Proteins (administration & dosage, adverse effects)
• Remission Induction
• Survival Rate