Chen 2006.
Methods |
Inclusion: Eligible participants had to meet following criteria:
Exclusion: Patients were ineligible if they had:
|
|
Participants | Arm I: 40 people Arm II: 41 people |
|
Interventions | Arm I: paclitaxel (160 mg/m2) iv over 3 hours on day 1 and carboplatin (AUC 6 mg/mL X minutes) iv over 1 hour on day 1, every 3 weeks Arm II: paclitaxel (160 mg/m2) iv over 3 hours on day 1 and cisplatin (60 mg/m2) iv over 1 hour on day 1, every 3 weeks | |
Outcomes | Primary outcome: response rate Secondary outcomes: time to progression; toxicity; overall survival |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were stratified according staging and PS. |
Allocation concealment (selection bias) | Low risk | Participants were randomised into the paclitaxel plus carboplatin or paclitaxel plus cisplatin treatment arm by an outside centre not involved in the study. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information about blinding process |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information about blinding process |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of incomplete outcome |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting bias |
Other bias | High risk | Phase II trial and a study of elderly people, so could be associated with higher response rate |