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. 2013 Oct 21;2013(10):CD010482. doi: 10.1002/14651858.CD010482.pub2

MITO‐2 2011.

Methods Open‐label, multi‐centre phase III RCT (Italy, Portugal, Turkey). Accrual dates January 2003 to November 2007, with median follow‐up time of 40 months
Participants 820 women with cytological or histological diagnosis of EOC (stage Ic to IV FIGO). Included if < 75 years, Eastern Cooperative Oncology Group performance status ≤ 2, life expectancy ≥ 3 months and adequate bone marrow, kidney and liver function
Interventions Standard arm: Carbo AUC 5 and PAC 175 mg/m²
Experimental arm: Carbo AUC 5 and PLD 30 mg/m² (diluted in 250 mL 5% glucose and infused over 60 minutes, after completion of Carbo treatment)
Outcomes Primary: PFS
Secondary: OS, treatment activity, toxicity (according to National Cancer Institute Common Toxicity Criteria version 2.0), QoL (EORTC QLQ‐C30 questionnaire)
Notes Included stage Ic and II. Overall, approximately 46% had suboptimal cytoreduction (residual disease > 1 cm) and 18% had no surgery
We obtained updated, unpublished survival data (August 2013) from the investigators for this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated minimisation method
Allocation concealment (selection bias) Low risk Central telephone assignment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open label
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Independent evaluation not described
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Low attrition except for QoL data
Selective reporting (reporting bias) Low risk Prespecified and expected outcomes were reported
Other bias Low risk Baseline characteristics of groups were similar