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

Hsu 2008.

Methods Randomized phase II trial
Inclusion criteria
  • Cytologically or histologically confirmed NSCLC

  • Stage IIIB or IV by AJCC

  • ≥ 18 years of age

  • PS: 0 to 2

  • Adequate organ function

  • Bi‐dimensionally measurable disease


Exclusion criteria
  • Brain metastasis

  • Prior serious cardiac or neurological conditions

Participants GE arm: 43 participants (ITT population) ‐ median age: 62.3 years (33.9 to 78.6)/elderly participants not reported
GP arm: 42 participants (ITT population) ‐ median age: 60.9 years (37.6 to 76)/elderly participants not reported
Interventions GE arm: gemcitabine 1000 mg/m2 over 30‐minute i.v. infusion on days 1, 8, and 15 plus epirubicin 70 mg/m2 on day 15
GP arm: gemcitabine 1000 mg/m2 on days 1, 8, and 15 plus cisplatin 100 mg/m2 over 3‐hour i.v. infusion on day 15. Dose of cisplatin reduced to 80 mg/m2 after first 10 participants randomly assigned because of toxicity
Outcomes Primary outcome
  • Objective response rate


Secondary outcomes
  • Overall survival (defined from date of randomization to death)

  • Time‐to‐progression: defined from date of randomization to death; progression or withdrawalfrom toxicity

  • Toxicity

Notes Despite multiple attempts, we could not contact study authors to retrieve data on the elderly population
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomization was performed by an independent statistical office at the clinical trial centre of National Taiwan University Hospital, using a computer‐generated randomisation allocation sequence. The sequence was concealed until the treatment arms were assigned by the statistical office. EligIble patients were randomised in 1:1 ratio to two treatment arms, namely gemcitabine plus conventional‐dose epirubicin (GE) or gemcitabine—cisplatin (GC) arms"
Allocation concealment (selection bias) Low risk Sequence concealed until treatment arms assigned by the statistical office
Blinding of outcome assessment (detection bias) 
 OS and 1y OS rate outcome Unclear risk Open‐label study considered to have unclear impact 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 One participant refused randomization; 5 participants refused protocol treatment after randomization (1 in GC arm and 4 in GE arm)
Selective reporting (reporting bias) Low risk No evidence of selective reporting
Other bias Unclear risk Study designed for general population; elderly subgroup analysis not planned nor available