| Methods |
Single‐centre RCT
2 arms
Quality score: D |
| Participants |
n = 122
Median age: 55 years
Metastatic disease: 67%
ECOG 2‐3: 48% |
| Interventions |
FE: 5‐FU 1000 mg/m² CI d 1‐5, repeated at d 29; epirubicin 120 mg/m² d 1, repeated at d 29
versus
FEP: 5‐FU 1000 mg/m² CI d 1‐5, repeated at d 29, epirubicin 120 mg/m² d 1, repeated at d 29, P 30 mg/m² d 2, 4, repeated at d 29 |
| Outcomes |
Median survival
Response rates
Toxicity |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
110/122 received treatment and were assessable |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
110/122 received treatment and were assessable |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes available |
| Other bias |
Unclear risk |
No information about type and schedule of follow‐up |
| Blinded review of CT/MRI‐scans? |
High risk |
High risk |
