Laack 2004.
Methods | Randomized multi‐center phase III trial Eligible patients
Exclusion criteria
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Participants | GV arm: 143 participants (ITT population) ‐ median age (range): 60.8 (41 to 75.9) years/16 elderly participants with the following characteristics: stage IIB: 2, and stage IV: 14; male: 14, and female: 2; KPS: 100%: 2, 90%: 3, 80%: 8, and 70%: 3 GVP arm: 144 participants (ITT population) ‐ median age (range): 61.1 (40.6 to 75.9)/27 elderly participants with the following characteristics: stage IIIB: 2, and stage IV: 26; male: 22, and female: 5; KPS: 100%: 4, 90%: 10, 80%: 8, and 70%: 5 |
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Interventions | GV arm: gemcitabine 1000 mg/m2 over 30‐minute i.v. infusion and vinorelbine 25 mg/m2 over 15‐minute i.v. infusion on days 1 and 8, every 3 weeks GVP arm: gemcitabine 1000 mg/m2 over 30‐minute i.v. infusion and vinorelbine 25 mg/m2 over 15‐minute i.v. infusion on days 1 and 8 and cisplatin 75 mg/m2 on day 2 over 1‐hour infusion with standard pre‐hydration and post‐hydration, every 3 weeks Obs: prophylaxis for febrile neutropenia with use of granulocyte‐colony stimulating factor at physician's decision on an individual basis |
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Outcomes | Primary outcome
Secondary outcomes
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Notes | Elderly subgroup analysis not planned in the original protocol. Unpublished post hoc analysis of participants older than 70 years obtained upon direct request to study author | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomly assigned to receive either GV or GVP. Before random assignment, patients were stratified according to participating centre. Randomization (stratified block randomisation with enclosed block length) was performed centrally by the Department of Biostatistics of the German Cancer Research Center (Heidelberg, Germany) using facsimile forms" |
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 | Open‐label study considered to have unclear impact on mortality outcomes |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | Open‐label study |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Thirteen randomly assigned patients (4.3%) did not fulfil the eligibility criteria and were excluded from the full analysis set. Four patients had a stage IIIB disease without malignant pleural effusion, one patient was staged as stage IIIA disease, two patients had brain metastases, two patients did not have NSCLC (one patient had small cell lung cancer and one patient a malignant melanoma), two patients revealed a Karnofsky performance status of lower than 70%, one patient did not fulfil the eligibility criteria concerning tumor size, and one patient refused treatment after randomisation" No further details on attrition bias provided for elderly subgroup |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting bias |
Other bias | High risk | Study designed for the general population; elderly subgroup analysis not planned. Unpublished post hoc elderly subgroup analysis obtained upon direct request to study authors |