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

Rosso 1988.

Methods Randomized multi‐center trial
Eligible patients
  • Cytologically or histologically confirmed NSCLC

  • Stage III considered unresectable or stage IV

  • ECOG PS: 0 to 2

  • ≤ 75 years of age

  • No previous chemotherapy


Exclusion criteria
  • Brain metastasis

Participants E arm: 113 participants (ITT population) ‐ median age (range): not reported/56 participants > 60 years of age/elderly population not reported
EP arm: 103 participants (ITT population) ‐ median age (range): not reported/59 participants > 60 years of age/elderly population not reported
Interventions E arm: etoposide 120 mg/m2 i.v. infusion on days 1, 2, and 3, every 3 weeks
EP am: cisplatin 60 mg/m2 on days 1 and 2 plus etoposide 120 mg/m2 i.v. infusion on days 1, 2, and 3, every 3 weeks for maximum of 6 cycles
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 randomised to be treated...." No further information no random sequence generation
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
Blinding of outcome assessment (detection bias) 
 Other outcomes High risk No information on blinding
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk "Of 216 patients accrued into the study, 23 were not evaluable..."
Selective reporting (reporting bias) Low risk No evidence of reporting bias
Other bias Unclear risk No separate elderly subgroup analysis