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. 2015 Oct 20;2015(10):CD010463. doi: 10.1002/14651858.CD010463.pub2

Chen 2008.

Methods Randomized phase II trial
Eligible patients
  • Histologically or cytologically confirmed NSCLC

  • Stage IIIB (including patients with malignant pleural effusion) or IV disease

  • ≥ 70 years of age

  • Bi‐dimensionally measurable disease

  • No previous chemotherapy or immunotherapy

  • PS 0 to 2 (WHO scale)

  • Adequate bone marrow function


Exclusion criteria
  • Signs or symptoms of brain metastases

  • Inadequate liver function (bilirubin > 1.5 times and ALT/AST > 3 times upper normal limit)

  • Inadequate renal function with creatinine > 2.0 mg/dL

  • Second primary malignancies, except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, excluded from the study

Participants V arm: 31 elderly participants ‐ median age (range): 76.5 (70 to 82) years/PS 2: 16/stage IV: 29
CV arm: 35 elderly participants ‐ median age (range): 75.6 (70 to 83) years/PS 2:16/stage IV: 27
Interventions V arm: vinorelbine 25 mg/m2 over 10‐minute i.v. infusion on days 1 and 8, every 3 weeks
CV: cisplatin 50 mg/m2 over 6‐hour i.v. infusion on day 1 and vinorelbine 22.5 mg/m2 over 10‐minute i.v. infusion on days 1 and 8, every 3 weeks
Planned maximum number of cycles: 6 for responding participants and 4 for those with stable disease
Outcomes Primary outcome
  • Response rate (according to RECIST) ‐ Study designed to accrue ≥ 28 qualified participants in each arm, assuming 10% better response for best treatment


Secondary outcomes
  • Toxicity (according to NCI‐CTC version 2)

  • Time‐to‐tumor progression (defined as time from randomization to disease progression or death)

  • Overall survival (defined as time from randomization to death from any cause)

  • Quality of life according to Lung Cancer Symptom Scale ‐ recorded before every cycle of chemotherapy when participant completed and went off the study

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomised into the vinorelbine (V) or vinorelbine plus cisplatin (VP) treatment arm by an outside centre not involved in the study" ‐ no further information regarding randomization process
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 Low risk No evidence of attrition bias
Selective reporting (reporting bias) Low risk No evidence of reporting bias
Other bias Unclear risk Small phase II trial, designed to evaluate differences in response rate between treatment arms