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

Lou 2010.

Methods Randomized trial
Eligible patients
  • Confirmed stage III or IV NSCLC

  • ≥ 70 years of age

  • Measurable or evaluable disease

  • No prior chemotherapy

  • ECOG PS: 0 to 2

  • Life expectancy ≥ 3 months

  • Adequate bone marrow, renal, and hepatic function


No exclusion criteria reported
Participants G arm: 34 participants ‐ median age (range): 72 (70 to 80) years; 3 participants with PS of 0, 28 with PS of 1, and 3 with PS of 2
CG arm: 34 participants ‐ median age (range): 72 (70 to 77) years; 1 participant with PS of 0, 30 with PS of 1, and 3 with PS of 2
Interventions G arm: gemcitabine 1000 mg/m2 i.v. infusion on days 1 and 8, every 3 weeks
CG arm: carboplatin AUC5 i.v. infusion on day 2 and gemcitabine 1000 mg/m2 i.v. infusion on days 1 and 8, every 3 weeks
Outcomes Outcomes
  • Overall survival

  • Response rate

  • Toxicity according to WHO criteria

  • QoL assessed by LCSS

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information on 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 of outcome assessors for OS and 1yOS. Study considered to have unclear impact on mortality outcomes
Blinding of outcome assessment (detection bias) 
 Other outcomes High risk No information on blinding of outcome assessors for other outcomes
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No evidence of attrition bias. No loss to follow‐up
Selective reporting (reporting bias) Low risk No evidence of selective reporting bias
Other bias Low risk No evidence of other bias