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

Rijavec 2010.

Methods Randomized phase II trial
Eligible patients
  • Stage IIIB (wet)/IV or relapsed NSCLC

  • ≥ 70 years of age

  • Chemotherapy‐naive

  • Unfit for bolus platinum administration

  • ECOG PS: 0 to 2


Exclusion criteria not presented
Participants D arm: not informed
DG arm: not informed
Demographics for study population: 75 randomly assigned, 69 participants (ITT population), median age 75 years (range 70 to 82)
Interventions D arm: docetaxel 35 mg/m2 i.v. infusion on days 1, 8, and 15, every 4 weeks
DG arm: docetaxel 35 mg/m2 i.v. infusion and gemcitabine 800 mg/m2 i.v. infusion on days 1, 8, and 15, every 4 weeks
Outcomes Primary outcome
  • Response rate (according to RECIST) ‐ study planned to detect a better regimen for evaluation in further studies, defined as ≥ 8 objective responses required to select a regimen


Secondary outcomes
  • Toxicity

  • Time‐to‐progression (TTP)

  • Survival

Notes Study prematurely stopped because of slow accrual
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. Study considered to have unclear impact on mortality outcomes
Blinding of outcome assessment (detection bias) 
 Other outcomes Unclear risk No information on blinding of assessors for other outcomes
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No information for attrition bias analysis
Selective reporting (reporting bias) High risk Results presented in abstract form only. Characteristics of included patients and toxicity partially presented
Other bias High risk Trial was stopped prematurely because of slow accrual