Depierre 1994.
Methods | Randomized phase III trial, multi‐center Eligibility criteria
Exclusion criteria
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Participants | PV arm: 121 ITT population ‐ median age (range): 59.2 years (not reported)/number of elderly participants not reported V arm: 119 ITT population ‐ median age (range): 58.8 years (not reported)/number of elderly participants not reported |
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Interventions | PV arm: cisplatin 80 mg/m2 i.v. infusion every 3 weeks and vinorelbine 30 mg/m2 weekly. Hydration with 2000 mL of 5% dextrose solution administered 30 minutes before cisplatin infusion. Administration of methylprednisolone (120 mg) and of metoclopramide recommended to prevent nausea and vomiting V arm: vinorelbine 30 mg/m2 i.v. infusion, weekly |
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Outcomes | Overall survival (OS) defined as interval from randomization to death from any cause Time‐to‐progression (TTP) defined as interval from randomization to progressive disease Response rate Toxicity according to WHO criteria |
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Notes | No planned elderly subgroup analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | No evidence of selection bias. "Randomization was performed through a centralized blind telephone assignment procedure, with stratification by centre and stage" |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment analysis |
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome | Unclear risk | No information on blinding of assessors |
Blinding of outcome assessment (detection bias) Other outcomes | Unclear risk | No information on blinding of assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on judgment of attrition bias for the elderly |
Selective reporting (reporting bias) | Low risk | No evidence of reporting bias |
Other bias | Unclear risk | Study designed for general adult population; no elderly subgroup analysis planned |