| Methods |
RCT
2 arms
Quality score: B |
| Participants |
n = 41
Metastatic disease: 71 % |
| Interventions |
FEMTX: methotrexate 1500 mg/m² d 1, 5‐FU 1500 mg/m² d 1, Lv 30 mg p.o. every 6 hours d 1, 2, epirubicin 60 mg/m² d 15, repeated at d 29
versus
BSC |
| Outcomes |
Median survival
1‐and 2‐year survival rates
Response rates
Toxicity
Palliative measures |
| Notes |
Study terminated after 6 years when 41 participants were randomised because of slow patient accrual and "conspicuous difference in survival" |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random permutated blocks (length 10) were used. The block was not known by clinicians. |
| Allocation concealment (selection bias) |
Low risk |
Sealed envelopes, Random permutated blocks (length 10) were used. The block was not known by clinicians. |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
Only 1 patient in treatment group did not receive at least one course of chemo |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
Only 1 patient in treatment group did not receive at least one course of chemo |
| Selective reporting (reporting bias) |
Low risk |
Report includes all expected outcomes |
| Other bias |
High risk |
Early termination of the study |
| Blinded review of CT/MRI‐scans? |
High risk |
High risk |
