Cullinan 1994.
Methods | Multicentre RCT 4 arms Quality score: D | |
Participants | n = 252 Median age: 62 years ECOG 2‐3: 30% | |
Interventions | FAMe: 5‐FU 325 mg/m² d1‐5; adriamycin 40 mg/m² d 1, repeated at d 36; methyl‐CCNU 110 mg/m² p.o. d 1, repeated at d 71 versus FAMe+Tzt: 5‐FU 325 mg/m², d 1‐5; adriamycin 40 mg/m² d 1, repeated at d 36; triazinate 250 mg/m² d 36‐38, repeated at d 57; methyl‐CCNU 110 mg/m² p.o. d 1, repeated at d 71 versus FAP: 5‐FU 300 mg/m² d 1‐5; adriamycin 40 mg/m² d 1; cisplatin 60 mg/m² d 1, repeated at d 36 versus FU: 5‐FU 500 mg/m² d 1‐5 repeated at d 36 | |
Outcomes | Median survival Toxicity Effects on performance status and weight gain | |
Notes | Three combination chemotherapy arms combined in the analysis. The single‐agent 5‐FU arm was opened after 56 participants were randomised. FAMe and FAP were closed after a planned interim analysis because of slightly higher death rate. | |
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 | Low attrition rate with long follow‐up (only 7 of 252 patients remain alive at the time of analysis) |
Incomplete outcome data (attrition bias) safety | Low risk | n = 69 + 51 + 53 + 79 |
Selective reporting (reporting bias) | Unclear risk | Missing response rates only a small minority of patients had measurable disease so regression rate was not used as a study endpoint |
Other bias | High risk | Missing information to type and follow‐up in the treatment groups, combination of 3 combination treatment arms in the analysis, 2 arms were closed after a planned interim analysis |
Blinded review of CT/MRI‐scans? | Unclear risk | Not stated |