Adjuvant FEC Versus EP in Breast Cancer (MIG5)
Adjuvant FEC Versus EP in Breast Cancer (MIG5)
In this multicenter, randomized phase III trial, node positive early breast cancer patients
 are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin
 60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP
 (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary
 study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free
 survival (EFS).
At the time the Gruppo Oncologico Nord-Ovest- Mammella Intergruppo trial 5 (GONO-MIG5) was
 designed in 1996, paclitaxel was known to have efficacy in patients with advanced breast
 cancer, but its role was still to be established in the adjuvant setting. Therefore the
 GONO-MIG5 trial was designed to compare a standard anthracycline-containing chemotherapy
 regimen, i.e. 5fluorouracil, epirubicin, ciclophosphamide (FEC), given for 6 cycles to a new
 regimen containing both epirubicin and paclitaxel (EP), given concurrently, for 4 cycles.
 This latter regimen was chosen on the basis of the results obtained in metastatic breast
 cancer patients, where the combination of doxorubicin and paclitaxel was associated with more
 than 90% of objective response . Only four cycles of the new regimen were planned since the
 expected toxicity, particularly the cardiotoxicity, was high, and a short treatment duration
 was hoped to be the best strategy to obtain a favourable balance between the toxicity and the
 expected high efficacy.
Inclusion Criteria:

 -  Women with histologically confirmed breast cancer who had undergone radical mastectomy
 or breast-conserving surgery in addition to full ipsilateral axillary lymph node
 dissection

 -  Lymph node-positive disease with less than 10 involved axillary lymph nodes

 -  Surgery performed not more than 5 weeks before randomization

 -  ECOG performance status 0

 -  Absolute neutrophil count ≥ 2,000/mm³

 -  WBC ≥ 3,000/mm³

 -  Platelet count ≥ 100,000/mm³

 -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

 -  AST and ALT ≤ 1.5 times ULN

 -  Postoperative regional radiotherapy limited to the remaining breast admitted for
 patients who received breast-conserving surgery

 -  Written informed consent

 Exclusion Criteria:

 -  Prior or concurrent ipsilateral or contralateral invasive breast carcinoma within the
 last 10 years

 -  Metastatic disease, including metastasis in the ipsilateral supraclavicular lymph
 nodes

 -  Prior chemotherapy or prior cytotoxic regimens or prior hormonal therapy

 -  Pregnant or nursing

 -  Other serious medical illness requiring medication, uncontrolled infections

 -  Other malignancy except adequately treated, cone-biopsied in situ carcinoma of the
 cervix or basal cell or squamous cell carcinoma of the skin

 -  Recent myocardial infarction, congestive heart failure, or serious arrhythmia