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. 2013 Jul 9;2013(7):CD006910. doi: 10.1002/14651858.CD006910.pub2

Colombo 2012.

Methods Phase III open‐label RCT conducted in 22 countries; accrual between Nov 2005 and Mar 2009 ID: NCT00262990
Participants 829 women with PR ROC following ≤ 3 platinum‐taxane based regimens. Measurable and non‐measurable disease (but CA125 elevated at baseline); ovarian, fallopian and primary peritoneal cancer included. Excluded if peripheral neuropathy, unresolved bowel obstruction or diarrhoea had within 7 days of start of treatment.
Interventions Arm 1: PAT (10 mg/m²) IVI q3wk
Arm 2: PLD (50 mg/m²) IVI q4wk
No routine premedication was given to either arm.
Outcomes Primary: OS
Secondary: PFS, ORR, SAE
Notes Women were assessed 8‐weekly; median follow‐up was 27 months.
Arms received a median of 4.5 and 3 cycles for PAT and PLD respectively.
Median TTP was 15.9 weeks for both arms.
Median time to death was 56.6 weeks versus 54.4 weeks in favour of PAT.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Central randomisation.
Allocation concealment (selection bias) Low risk Allocation via an interactive voice response system.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinded central review of results.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Very few women lost to follow‐up and low attrition (< 20%) in most analyses. As with other studies, QoL data suffered from high attrition rates and therefore we could not use it in the meta‐analyses.
Selective reporting (reporting bias) Low risk All expected outcomes were reported.
Other bias Low risk Baseline characteristics were similar.