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 1 cm) and 18% had no surgery We obtained updated, unpublished survival data (August 2013) from the investigators for this review |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 |