Skip to main content
. 2013 Dec 18;2013(12):CD008792. doi: 10.1002/14651858.CD008792.pub2

Fountzilas 2001.

Study characteristics
Methods Accrual dates: October 1997 to May 1999
Sample size: 183
Number of centres: unknown (Greece)
Randomisation method:done at central office and based on a random number list, stratification
Baseline comparability: no significant imbalance reported
Participants Female
Age range: 26‐77 years (median 57.5 years)
MBC
First‐line chemotherapy
Interventions Arm I: EP versus E→P
Arm I (EP) epirubicin + paclitaxel
Arm II (E→P) epirubicin followed by paclitaxel (dose dense)
Outcomes Overall response rate
Complete response rate (complete disappearance of all clinical symptoms and signs of disease for at least 4 weeks)
Time to progression
Overall survival (from start of chemotherapy to date of death or last follow‐up)
Toxicity
Notes Schema 2
Randomised phase 2
Follow‐up: minimum 6 months, maximum 84.5 months
Median relative dose intensity in both groups was similar (96‐97)
80% completed planned combination therapy, 85% completed planned sequential therapy
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 1‐ adequate
Allocation concealment (selection bias) Unclear risk 2‐ not reported
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk 2‐ not reported
Blinding of outcome assessment (detection bias)
All outcomes Low risk 1‐ all imaging reviewed by 3 independent radiologists at the end of the study
Incomplete outcome data (attrition bias)
All outcomes Low risk 1‐ no missing data
Selective reporting (reporting bias) Low risk 1‐ all pre‐specified outcomes are reported
Other bias Low risk 1‐ treatment groups similar at baseline regarding important prognostic factors
The trial was not stopped early
The analysis was by intention to treat