Freedman 1980.
Methods | Randomised Phase II trial 1975 |
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Participants | 59 women with recurrent squamous cell cervical cancer | |
Interventions | Arm 1: sequential cyclophosphamide 8 mg/kg iv d1‐5 q28 then adriamycin 80 mg/m2 iv d1 q28 then hexamethylmelamine 8 mg/kg po daily continuously Arm 2: sequential adriamycin 80 mg/m2 iv d1 q28 then cyclophosphamide 8 mg/kg iv d1‐5 q28 then hexamethylmelamine 8 mg/kg po daily continuously Arm 3: sequential hexamethylmelamine 8 mg/kg po daily continuously then cyclophosphamide 8 mg/kg iv d1‐5 q28 then adriamycin 80 mg/m2 iv d1 q28 Not stated prospectively what criteria would be for switching treatment (i.e. number of cycles versus progressive disease) |
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Outcomes | Response rates Survival time after chemotherapy start Survival from time of treatment change |
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Notes | 1 patient excluded (died prior to starting chemotherapy). No ITT analysis performed. Cross‐over between arms allowed. Reasons for switching chemotherapy agents varied and included disease progression, toxicity and cumulative doxorubicin dose | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stratified by ease of disease evaluation then randomised |
Allocation concealment (selection bias) | Unclear risk | Not documented |
Blinding (performance bias and detection bias) All outcomes | Low risk | Not documented, but OS unlikely to be affected by blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
Other bias | High risk | Patients allowed to switch between arms for variety of reasons including toxicity, cumulative doxorubicin dose and disease progression |