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%
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)
Outcomes	Response rates Time to progression Overall survival Toxicity
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.