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. 2013 Jun 6;2013(6):CD009620. doi: 10.1002/14651858.CD009620.pub2

Hall 2004.

Methods Randomised controlled trial
Trial duration: 7 years and 5 months, from February 1990 to July 1997
Trial location: 14 centres across the United Kingdom
Participants Number of participants: 300 randomised (interferon‐149, control‐151)
Inclusion criteria:
Patients had histologically proven epithelial ovarian cancer that showed no evidence of disease progression after post‐operative chemotherapy.
The percentage of participants with FIGO stage I, II, III and IV ovarian cancer in the interferon group was 7%, 22%, 63% and 15% while in the chemotherapy group was 8%, 13%, 64% and 15% respectively
Exclusion criteria: not specified
Interventions Intervention:
Interferon‐alpha: INF‐α 2a (Roferon‐A, Roche) (4.5 mega‐units subcutaneously 3 days per week). Interferon was continued until disease progression or in response to toxicity or patient request
Control:
No maintenance treatment
Outcomes
  • Overall survival (OS)

  • Progression free survival (PFS), definition was not given

  • Toxicity/adverse event (flu‐like symptoms, fatigue, nausea/vomiting, neurological, dyspnoea, depression/anxiety, skin change/rash, alopecia, arthralgia/arthritis, insomnia, haematological, hepatic, injection site reaction, other, not stated)

Notes Ethics approval: study was approved by the Local Research Ethics Commitee of each participating centre
Informed consent: written informed consent was obtained from patients prior to randomisation
Funding: not mentioned
Correspondence with authors: g.hall@leeds.ac.uk on date on 3rd July 2012
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described how randomisation was done
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not described if participants were blinded to the treatment assigned. Control group did not receive any treatment
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described if outcome assessors were blinded to treatment assignment but inlikely to have any effect on the outcomes
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intention‐to‐treat (ITT) analysis was done on all the patients. Eight patients (2 interferon and 6 observation) died without any follow‐up visits). 144 of 149 participants in the interferon group received at least one injection
Selective reporting (reporting bias) Unclear risk Protocol was not available
Other bias Low risk No reason to suspect other bias