| Methods |
Multicentre RCT
2 arms
Quality score: A |
| Participants |
n = 130
Metastatic disease: 88%
ECOG 2‐3: 7% |
| Interventions |
FAM: 5‐FU 600 mg/m² d 1, 8, 29, 36; adriamycin 30 mg/m² d 1, 29 and mitomycin 10 mg/m² d 1, repeated at d 57
versus
PELF: cisplatin 40 mg/m² d 1, 5; etoposide 30 mg/m² d 1, 5; Lv 200 mg/m² d 1‐4 + 5‐FU 300 mg/m² d 1‐4, repeated at d 22 |
| Outcomes |
Median survival
Response rates
Time to progression
Toxicity |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Low risk |
Centralised |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
All eligible pts include din survival evaluation |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
All eligible pts included |
| Selective reporting (reporting bias) |
Low risk |
Report includes all expected outcomes |
| Other bias |
Low risk |
Baseline characteristics well‐balanced |
| Blinded review of CT/MRI‐scans? |
Low risk |
Extramural review |
