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. |
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| Outcomes | Primary: OS Secondary: PFS, ORR, SAE |
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| 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. |
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| 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. |