| Methods |
Multicentre RCT
2 arms
Quality score: B |
| Participants |
n = 72
Median age: 58 years
ECOG 2‐3: 22% |
| Interventions |
5‐FU/Lv: Lv 100 mg/m²; 5‐FU 370 mg/m² d 1‐5, repeated at d 29
versus
EEP‐L: epirubicine 30 mg/m² d,1,5; etoposide 100 mg/m² d 1, 3, 5; cisplatin
30 mg/m² d 2,4 and lonidamide 150 mg/d, repeated at d 29 |
| Outcomes |
Median survival
1and 2‐year survival rates
Response rates
Symptom control
Toxicity |
| Notes |
No standard error can be assessed for TTP |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Patients were randomised by a sealed envelope method, using random permutated blocks unknown to the clinicians, to receive either the 5‐FU/6S‐LV (Study A) or EEP‐L combination (Study B). Patients also were stratified into four groups based on a resected or nonresected primary tumor and an ECOG PS ≤ 1 or > 1. |
| Allocation concealment (selection bias) |
Low risk |
Sealed envelope method, using random permutated blocks unknown to the clinicians |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
One patient refused further treatment after the first cycle and was excluded from the response analysis, but not from the tolerance and survival analysis. Two patients refused chemotherapy after randomisation and were excluded completely from the analysis. |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
One patient refused further treatment after the first cycle and was excluded from the response analysis, but not from the tolerance and survival analysis. Two patients refused chemotherapy after randomisation and were excluded completely from the analysis. |
| Selective reporting (reporting bias) |
Low risk |
Report includes all expected outcomes |
| Other bias |
High risk |
1 participant who died after the second cycle of therapy has not been included in the survival analysis = no ITT |
| Blinded review of CT/MRI‐scans? |
High risk |
High risk. Likely unblinded |
