Smit 2003.
Methods | Randomized multi‐center, phase III trial Eligible patients
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Participants | CP arm: 159 participants (ITT population) ‐ median age (range): 57 (27 to 75) years/elderly participants not reported CG arm: 160 participants (ITT population) ‐ median age (range): 57 (28 to 75) years/elderly participants not reported GP arm: 161 participants (ITT population) ‐ median age (range): 56 (31 to 75) years/elderly participants not reported |
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Interventions | CP arm: cisplatin 80 mg/m2 i.v. infusion on day 1 plus paclitaxel 175 mg/m2 over 3‐hour i.v. infusion on day 1, every 3 weeks CG arm: cisplatin 80 mg/m2 i.v. infusion on day 1 plus gemcitabine 1250 mg/m2 over 30‐minute i.v. infusion on days 1 and 8, every 3 weeks GP arm: paclitaxel 175 mg/m2 over 3‐hour i.v. infusion on day 1 plus gemcitabine 1250 mg/m2 over 30‐minute i.v. infusion on days 1 and 8, every 3 weeks Prophylactic antiemetics during and after cisplatin administration, typically ondansetron and dexamethasone. Responding participants received maximum of 6 cycles |
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Outcomes | Primary outcome
Secondary outcomes
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Notes | No information on inclusion of elderly patients nor on specific subgroup analysis, despite multiple attempts to contact study authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was performed centrally by the EORTC Data Center after stratification for PS (0 to 1 v 2), stage of disease (IIIB v IV), and institute, using the minimization technique" |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment |
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome | Unclear risk | No information on blinding |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | No information on blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No evidence of attrition bias |
Selective reporting (reporting bias) | Low risk | No evidence of reporting bias |
Other bias | Unclear risk | Study designed for the general population; elderly subgroup analysis not planned |