Alberts 2008.

Methods	This was a multicentre, open‐label, two‐arm phase III randomised controlled trial Trial duration: enrolment from January 29, 2002 to March 31, 2004. Trial duration not specified Trial location: Europe, North and South America
Participants	Number of participants: 847 participants (426 intervention, 421 control), 774 ovarian cancer (OC), 73 primary peritoneal carcinoma (PPC) Inclusion criteria: Previously untreated females with histologically confirmed epithelial ovarian cancer or PPC and FIGO Stage III or IV with either optimal or suboptimal residual disease following initial surgery The majority of patients were Stage III O.C patients with 76.5% and 76.7% in the experimental group and comparison groups respectively. Stage IV 23.5% and 23.3% respectively Randomisation within 12 weeks after initial surgery Seven days or less between randomisation and first treatment dose Adequate bone marrow, hepatic and renal function Eastern Cooperative Oncology Group performance score of 0‐2 Exclusion criteria: not stated
Interventions	Intervention: Chemotherapy plus interferon‐gamma 1b (IFN‐γ 1b) Chemotherapy included paclitaxel (175 mg/m2 over 3 hours) followed by carboplatin (AUC 6) every 3 weeks. A total of 6 cycles of chemotherapy were given unless disease progression or dose‐limiting toxicity occurred or patients refused further treatment Interferon therapy included 100μg administered subcutaneously, 3 times weekly (every other day; no more than 3 days in a 7‐day period) continuously (including the 3 weeks following the last dose of chemotherapy) Control: Chemotherapy alone consisting of Paclitaxel (175 mg/m2 over 3 hours) followed by carboplatin (AUC 6) every 3 weeks. A total of 6 cycles of chemotherapy were given unless disease progression or dose‐limiting toxicity occurred or patients refused further treatment
Outcomes	Overall survival (OS): time (days) from the time of randomisation until death Progression free survival (PFS): time (days) from randomisation until the earliest date of disease progression, death, or censoring Treatment‐failure free survival (TFFS): time (days) from randomisation until the earliest date of progressive disease, death, or the start of non‐protocol carcinoma treatment for any reason Adverse events (any, skin, blood, gastrointestinal, general, nervous system, musculoskeletal, infectious, psychiatric, metabolism, immune, investigations)
Notes	Ethics approval: this was not reported on Informed consent: patients provided informed consent between January 29, 2002 and March 31, 2004 Funding: this was not reported on Correspondence with authors: dalberts@azcc.arizona.edu on 3rd July 2012
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not mentioned how randomisation was carried out
Allocation concealment (selection bias)	Unclear risk	Not reported on
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Open‐label trial but unlikely to affect outcomes. Control group received chemotherapy alone
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Disease progression was assessed by an endpoint review committee blinded to the treatment assignment using serial CT scans, MRIs, physical exams, and CA‐125 levels
Incomplete outcome data (attrition bias) All outcomes	High risk	ITT analysis was done 79% of participants adhered to treatment (i.e, undertook at least 5 out of 6 courses) in the treatment arm and 86% adhered in the control arm. 34% of adherent participants died in the intervention arm while 28% died in the control arm. 61% of non‐adherent participants died in the intervention arm while 45% of non‐adherent participants died in the control arm.
Selective reporting (reporting bias)	Unclear risk	Protocol was not available
Other bias	Unclear risk	Study stopped early due to DSMB (data and safety monitoring board) recommendation ‐ this was due to the study finding a statistically significant difference between treatment groups that crossed the pre‐specified boundaries for inferiority and futility.