Manegold 1998.
Methods | Two randomized phase II trials conducted in Europe and Taiwan Eligible patients for the 2 trials ‐ almost identical
Exclusion criteria
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Participants | G arm (Europe): 71 participants (ITT population) ‐ median age (range): 59 (32 to 80) years/elderly participants not reported G arm (Taiwan): 27 participants (ITT population) ‐ median age (range): 63 (36 to 75) years/elderly participants not reported EP arm (Europe): 75 participants (ITT population) ‐ median age (range): 59 (33 to 78) years/elderly participants not reported EP arm (Taiwan): 26 participants (ITT population) ‐ median age (range): 60 (35 to 75) years/elderly participants not reported |
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Interventions | G arm: gemcitabine 1000 mg/m2 over 30‐minute i.v. infusion on days 1, 8, and 15 every 4 weeks (Europe)/gemcitabine 1250 mg/m2 over 30‐minute i.v. infusion on days 1, 8, and 15, every 4 weeks (Taiwan) EP arm: cisplatin 100 mg/m2 i.v. infusion on day 1 and etoposide 100 mg/m2 i.v. infusion on days 1, 2, and 3, every 4 weeks (Europe)/cisplatin 80 mg/m2 i.v. infusion on day 1 and etoposide 80 mg/m2 i.v. infusion on days 1, 2, and 3, every 4 weeks (Taiwan) |
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Outcomes | Neither primary nor secondary outcomes reported | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomise to receive either..." No further information on randomization process provided |
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 of outcome assessment |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | No information on blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of attrition bias |
Selective reporting (reporting bias) | Low risk | No evidence of reporting bias |
Other bias | Unclear risk | No separate elderly subgroup analysis |