Cascinu 2011.
Methods | Multicentre RCT 2 arms Quality score: A | |
Participants | n = 78 Median age: 63 years ECOG 2‐3: 6.3% Metastatic disease: 89.7% |
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Interventions | Arm A (LdCF): 5‐FU (400 mg/m2 bolus +600 mg/m2 22 h continuous infusion d 1‐2) + cisplatin (50 mg/m2 d 1) + pegylated liposomal doxorubicin (20 mg/m2 d1), repeated at d 14 versus Arm B (MCF) : 5‐FU (400 mg/m2 bolus +600 mg/m2 22 h continuous infusion d 1‐2) + cisplatin (50 mg/m2 d 1, repeated at d 15) + mitomycin‐C (7 mg/m2, repeated at d 42) |
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Outcomes | Response rates Time to progression Overall survival Toxicity |
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Notes | second‐line treatment in 38.5% and 25.6 % of patients | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random sequence generated by a computer programme |
Allocation concealment (selection bias) | Low risk | Central allocation |
Incomplete outcome data (attrition bias) efficacy | Low risk | Seventy‐seven of 78 patients were assessable for response; one patient in arm B was not assessable but was included in the ITT analysis and kept in the denominator of the response rate. |
Incomplete outcome data (attrition bias) safety | Low risk | Seventy‐seven of 78 patients were assessable for response; one patient in arm B was not assessable but was included in the ITT analysis and kept in the denominator of the response rate. |
Selective reporting (reporting bias) | Low risk | Expected endpoints reported |
Other bias | Low risk | Patients characteristics resulted well balanced between the treatment groups |
Blinded review of CT/MRI‐scans? | Low risk | Tumour response was assessed by an independent radiologist as central reviewer. |