Monk 2008.
| Methods | Randomised Phase III trial 2003 to 2007 |
|
| 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 |
|
| Outcomes | OS PFS Response rates Toxicity (WHO) QoL |
|
| 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 |