SWOG S0200.

Study characteristics
Methods	Phase III multicentre RCT. Accrual from August 2002 to December 2004. (ID:NCT00043082)
Participants	61 women with PS ROC or peritoneal cancer; a progression‐free and platinum‐free interval of 6 to 24 months according to RECIST or GCIG CA‐125 criteria; progression following first‐line platinum‐based chemotherapy and up to 12 courses of non‐platinum containing consolidation treatment; Zubrod performance status 0‐1.
Interventions	Intervention PLD (30 mg/m²) IV plus carbo IV (AUC = 5 mg/mL/min), every 4 weeks Control Carboplatin IV (AUC = 5 mg/mL/min), every 4 weeks Patients could receive a premed of intravenous dexamethasone (20 mg) plus IV granisetron before carboplatin dose, and further dexamethasone on days 2,3, and 4. G‐CSF was allowed to treat G3 to 4 neutropenia when it occurred, and then subsequently to prevent it.
Outcomes	Primary OS Secondary PFS, ORR, toxicity
Notes	The accrual goal was 900, but study was discontinued due to slow accrual. Unpublished final survival data related to the 2010 publication was received from investigators on 13 December 2012. PFS was significantly improved by the addition of PLD to carboplatin. The final OS was not statistically significantly different between treatment arms, in contrast to the earlier report of 2008 where OS was significantly longer in the PLD/carboplatin arm. Despite using a lower dose of PLD, this trial had a relatively high rate of haematological SAEs (G3 to 4) in the PLD/carboplatin arm compared with the carboplatin alone arm (neutropenia 48% versus 3%; anaemia 16% versus 0%; thrombocytopenia 39% versus 10%). Eight women in the carboplatin arm had allergic reactions (any grade) compared with 0 in the PLD/carbo arm. The HFS rate was 3/31 (10%) in the PLD/carbo arm. The proportion of women in each group who received a dexamethasone premed was not described. Investigators concluded that PLD/carboplatin dosing interval was more convenient than the PAC/carboplatin and GEM/carboplatin alternatives; that PLD was well tolerated with no significant HFS problems; and that "administering PLD with carboplatin appears to substantially reduce the incidence of platinum‐associated hypersensitivity reactions."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Central randomisation.
Allocation concealment (selection bias)	Low risk	Central allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low attrition.
Selective reporting (reporting bias)	Low risk	Final HRs for survival were not published; however, the investigators provided us with these unpublished data.
Other bias	Unclear risk	This study closed early due to insufficient accrual and the final sample size was not powered to detect a survival difference. Conflict of interest: this investigation was supported in part by Ortho Biotech Products, L.P.