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

Bonomi 1985.

Methods Randomised Phase II trial
Participants 581 women with squamous cell carcinoma of the cervix considered incurable with surgery or radiation
Interventions Arm 1: cisplatin 50 mg/m2 iv q21
Arm 2: cisplatin 100 mg/m2 q21
Arm 3: cisplatin 20 mg/m2 iv daily d1‐5 q21
All arms to a maximum dose of 400 mg/m2
Outcomes Response rates
Toxicity
OS
PFS
Notes 54 excluded (5 no histological confirmation of tumour, 32 wrong cell type, 3 inadequate renal function, 8 second or wrong primary tumour, 2 inadequate performance status, 4 improper pre‐protocol treatment). There were a further 30 women who could not be evaluated (8 inadequate pathological material, 3 improper randomisation, 2 clerical error, 11 never received cisplatin, 1 removed by investigator, 5 inadequate data). ITT analysis 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 54 excluded. There were a further 30 women who could not be evaluated. ITT analysis not performed
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Low risk No hint at any other possible biases