Methods |
Multicentre RCT
3 arms
Quality score: B |
Participants |
n = 165
Median age: 60 years
Metastatic disease: 63%
ECOG 2‐3: 27% |
Interventions |
5‐FU: 5‐FU 500 mg/m² d 1‐5 repeated at d 29
versus
E: epirubicin 90 mg/m² d 1, repeated at d 29 versus
5‐FU+E: 5‐FU 400 mg/m² d 1‐5; epirubicin 90 mg/m² d 1, repeated at d 29 |
Outcomes |
Median survival
Toxicity |
Notes |
— |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random number tables |
Allocation concealment (selection bias) |
Low risk |
Central allocation |
Incomplete outcome data (attrition bias)
efficacy |
High risk |
Analysis for all randomised and screened patients |
Incomplete outcome data (attrition bias)
safety |
Unclear risk |
Analysis for all randomised, screened and treated patients |
Selective reporting (reporting bias) |
High risk |
No response rates are given |
Other bias |
Low risk |
N/A |
Blinded review of CT/MRI‐scans? |
High risk |
High risk |