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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Jul 11;7:CD007102. doi: 10.1002/14651858.CD007102.pub3
Study Reason for exclusion
Abrao 2008 Not an RCT. In this case-control study, 108 women were treated with 5-day MTX (42 women) or 5-day DACT (42 women) or MTX/DACT combined (24 women). The combined intervention was stopped due to high rates of toxicity
Berkowitz 1979 Not an RCT. The study may have high-risk patients.
It was not clear if patients were balanced for demographic variables
It was not clear if all patients between 1976 to 1978 were treated with MTX @ 6mg/kg or if the decision to use this dose was left to attending physician
Gleeson 1993 Not an RCT. High risk of selection bias “ the choice of treatment was at the discretion of the attending oncologist” Follow-up period not clear.
Kohorn 1996 Not an RCT. In this case-control study, women were treated with a 5-day DACT regimen (43 women) or a pulsed DACT regimen (18 women)
Matsui 1998 High risk of selection bias; patients were not matched for the potential confounding variables in the different treatment groups
Included in subsequent publication.
Matsui 2005 High risk of selection bias; study did not provide information about patient characteristics and if they were matched for the potential confounding variables in the different treatment groups
Petrilli 1980 High risk of selection bias: study did not provide information about the characteristics of patients and if they were matched for potential confounding variables in the treatment groups
Roberts 1996 Case series rather than case-control study; 61 patients received MTX, 4 ACT and 5 MACT
Risk of selection bias; patients were not matched for the potential confounding variables
Smith 1982 Not an RCT. In this case-control study, 39 women received MTX and 29 women received MTX-FA
Wong 1985 Not an RCT. In this case-control study, 33 women received MTX and 68 women received MTX-FA

DACT = Dactinomycin or Actinomycin D; MTX = Methotrexate; MTX-FA = methotrexate-folinic acid; RCT = randomised controlled trial