Skip to main content
. 2012 Oct 17;2012(10):CD006469. doi: 10.1002/14651858.CD006469.pub2

Malkasian 1981.

Methods Randomised Phase II trial
Participants 41 women with recurrent and metastatic cervical cancer who had had as much surgery as was possible and radiotherapy where appropriate
Interventions Arm 1: 5‐fluorouracil 450 mg/m2 iv d1‐5 and vincristine 1.5 mg/m2 d1 and d5 q35
Arm 2: doxorubicin 60 mg/m2 iv d1 q21
Outcomes Response rates
Toxicity
OS
Time to treatment failure
Notes 2 patients excluded (1 refused treatment after randomisation, 1 immediately lost to follow‐up). ITT analysis was not performed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not documented
Allocation concealment (selection bias) Unclear risk Not documented
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not documented but OS unlikely to be affected by blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 patients excluded. No missing outcome data
Selective reporting (reporting bias) Low risk Published report included all pre‐specified outcomes
Other bias Low risk No hint at any other possible biases