O'Byrne 2002.

Methods	Phase III multicentre RCT. Accrual May 1997 to April 2000. (ID: NCT00653952)
Participants	438 women with ROC (PS or PR) that had 1 prior course of platinum‐based non‐taxane containing chemotherapy and evaluable disease. Prior therapy with PLD or PAC was an exclusion criterion.
Interventions	Arm 1: PLD 50 mg/m² IVI over 60 min q4wk (D) Arm 2: Paclitaxel 175 mg/m² over 3 hours q3wk (P)
Outcomes	OS, PFS and SAE
Notes	This study is listed as 'Terminated' on the NCT registry after enrolling 220 women. The only published report is an ASCO 2002 abstract which had no data that could be included in our meta‐analyses. Results were reported as follows: 'A preliminary analysis indicates that the overall progression‐free survival rates are similar between the two arms (D: 21.7 versus P: 22.4 weeks; P value 0.15). The overall response rates for D and P are 17.8% and 22.4%, respectively (P value 0.34). Median overall survival times are 45.7 weeks for D and 56.1 weeks for P (P value 0.44). No significant difference was seen in median progression‐free or overall survival for platinum sensitive or refractory patients in either treatment arm. The overall number of adverse events was equivalent in either arm. Nausea and vomiting, stomatitis and plantar‐palmar erythrodysesthesia were seen more frequently with D whereas alopecia, myalgia, arthralgia and paraesthesiae occurred more commonly with P. These findings clearly indicate that D has comparable efficacy to P in taxane naive patients with ROC. D may be particularly suitable for those patients with musculoskeletal disorders or for whom the prospect of alopecia has a significant adverse psychological effect.'
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described. Stratified prospectively for platinum sensitivity and bulky disease.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Assessor blinding not described.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient information given to assess this risk.
Selective reporting (reporting bias)	Unclear risk	Very limited results were reported; see notes section above. Baseline characteristics stated as 'well‐matched'.
Other bias	High risk	214 women were enrolled and yet the study was terminated. The reason for termination was 'poor accrual' and the final results for the 214 women were, to our knowledge, never published. Janssen Oncology emailed on 29/11/12 for more data (no response).