Popov 2008.
Methods | RCT 2 arms Quality score: D | |
Participants | n = 72 Median age: 56 years ECOG 2‐3: 29% | |
Interventions | LV5‐FU2 oxaliplatin: oxaliplatin 85 mg/m² d 1+ folinic acid 200 mglm², as 2‐hour infusion, d 1‐2 + 5‐FU 400 mg/m², Lv. bolus d 1‐2, repeated at d 15 versus LV5‐FU2‐CDDP: cisplatin 50 mg/m², d1+ folinic acid 200 mg/m², as 2‐hour infusion, d 1‐2 + 5‐FU 400 mg/m², Lv. bolus d1‐2 + 5‐FU 600 mg/m² , 22‐hour continuous infusion d 1‐2, repeated at d 15 The maximum number of cycles foreseen was 12 |
|
Outcomes | Median overall survival Median time to progression Tumour 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 | High risk | Patients receiving 4 or more cycles were evaluable for efficacy |
Incomplete outcome data (attrition bias) safety | Low risk | Patients receiving 1 cycle were evaluable for toxicity |
Selective reporting (reporting bias) | Low risk | Report includes all expected outcomes |
Other bias | Unclear risk | N/A |
Blinded review of CT/MRI‐scans? | Low risk | "Independent response review was performed by members (surgeon, medical oncologist, radiologist and pathologist) of the joint interdisciplinary committee for gastrointestinal tumors of the Institute and the University Clinic for gastrointestinal diseases. The committee members were not involved in the study" |