Frasci 2001.
Methods | Randomized phase II trial Inclusion criteria
Exclusion criterion
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Participants | V arm: 60/median age of included participants: 74 (range 71 to 81) years; 13% ECOG 2; 16.7% Charlson score > 2 VG arm: 60/median age of included participants: 75 (range 71 to 83) years; 16% ECOG 2; 20% Charlson score > 2 |
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Interventions | V arm: vinorelbine 30 mg/m2 i.v. infusion on days 1 and 8, every 3 weeks for maximum of 6 cycles VG arm: vinorelbine 30 mg/m2 i.v. infusion plus gemcitabine 1200 mg/m2 i.v. infusion on days 1 and 8, every 3 weeks for maximum of 6 cycles All participants received antiemetic prophylaxis consisting of HT3‐receptor antagonist |
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Outcomes | Primary outcomes
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Notes | Study prematurely stopped after first interim analysis showed increased risk of death for participants in V arm Evaluation of co‐morbidities using Charlson score before start of treatment. Quality of life assessment using Lung Cancer Symptom Scale (LCSS) questionnaire at diagnosis, after third and sixth cycles of chemotherapy. Response rate and toxicity classified according to World Health Organization (WHO) criteria |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was performed centrally at the Division of Medical Oncology of the National Tumor Institute of Naples". "(...) procedure that used the centre, stage IIIB vs IV and performance (ECOG 0 or 1 vs 2) as stratifying variables". "Patients were assigned to one of the two arms by computer‐driven minimization" |
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 | Open‐label study considered to have unclear influence on mortality outcomes |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | Open‐label study |
Incomplete outcome data (attrition bias) All outcomes | High risk | Five patients excluded because no information sent to co‐ordination center. After early trial interruption, additional 21 patients included and outcome data not reported |
Selective reporting (reporting bias) | High risk | Study not planned for PFS analysis. Therefore, no data on this outcome. Absence of important outcome associated with reporting bias, despite lack of inclusion in study design |
Other bias | High risk | Study closed prematurely because planned interim analysis showed that magnitude of survival gain achieved by combination therapy met chosen criteria for early discontinuation. However, additional 21 participants included after that and outcome data not reported |