Monk 2008.
Methods | Randomised Phase III trial 2003 to 2007 |
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Participants | 513 women with advanced, recurrent or persistent squamous cell cervical cancer not suitable for surgery or radiotherapy | |
Interventions | Arm 1: cisplatin 50 mg/m2 d2 plus paclitaxel 135 mg/m2 over 24 h d1 q21 Arm 2: cisplatin 50 mg/m2 d1 plus vinorelbine 30 mg/m2 d1, 8 q21 Arm 3: cisplatin 50 mg/m2 plus gemcitabine 1000 mg/m2 d1, 8 q21 Arm 4: cisplatin 50 mg/m2 plus topotecan 0.75 mg/m2 d1‐3 q21 |
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Outcomes | OS PFS Response rates Toxicity (WHO) QoL |
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Notes | First 41 patients enrolled were excluded from primary analysis. another 38 patients later found to be ineligible. 434 evaluable for efficacy. 9 patients never treated so excluded from toxicity assessment | |
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 | Low risk | Not documented but OS unlikely to be affected by blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | First 41 patients enrolled were excluded from primary analysis. Another 38 patients later found to be ineligible |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
Other bias | Low risk | No hint at any other possible biases |