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 |
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| Participants | Female Age range: 26‐77 years (median 57.5 years) MBC First‐line chemotherapy |
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| Interventions | Arm I: EP versus E→P Arm I (EP) epirubicin + paclitaxel Arm II (E→P) epirubicin followed by paclitaxel (dose dense) |
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| 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 |
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| 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 |
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| 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 |