French Epi (A) 1991.

Study characteristics
Methods	RCT ‐ Randomisation not described ‐ Stratified on the basis of bone mets/or not Multi centre 13 institutions, France Baseline ‐ More lymph node mets in the FEC50 combination group
Participants	275 women with histologic evidence of breast cancer with recurrent or metastatic disease 100% MBC 100% Firstline Randomised no: 1) n = 140 2) n = 135 Assessable no: 1) n = 132 (median age 53; 26‐70). (n) for effectiveness = 121; toxicity = 125 2) n = 129 (median age 53; 30‐70) (n) for effectiveness = 121; toxicity = 126
Interventions	E vs FEC 50 1) Epirubicin 75 mg/m2 iv 2) FEC 50 Epirubicin 50 mg/m2 iv day 1 X 21 day cycle + 5‐Flurouracil 500 mg/m2 iv + Cyclophosphamide 500 mg/m2 (All treatments repeated every 21 days)
Outcomes	Survival curve ‐ Kaplan‐Meier method ‐ ? from randomisation or? from treatment TTF curve provided however as authors report this as TTP, this has been included OR (CR+PR) 1) 37/121 duration of response = 315 days (range 84‐1107) 2) 54/121 duration of response = 378 days (range 84‐1008) Toxicity Treatment ceased due to cardiac toxicity in 15 patients (7 in the single group;3 in the combination group) Nausea and vomiting and granulopenia reported by percentage of total cycles of chemotherapy Toxic death‐ NR six cases of cardiac failure ‐ all controlled by symptomatic treatment
Notes	F/U survival min 8mths (based on cycles) ‐ max ‐ 40mths (1200 days reported from curves) F/U TTP min 4mths ‐ max 40mths based on curve
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data well balanced between the groups
Selective reporting (reporting bias)	Low risk	All expected outcomes reported