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

Sederholm 2005.

Methods Randomized multi‐center phase III trial
Eligible patients
  • Histologically or cytologically confirmed NSCLC

  • Stage IIIB (with malignant pleural effusion or tumor extension of such degree that encompassment in a radiation field with curative intent was prohibitive) or IV according to AJCC

  • > 18 years of age with no upper age restrictions

  • PS: 0 to 2 (WHO criteria)

  • Acceptable liver and renal function


Exclusion criteria
  • Uncontrolled hypercalcaemia

  • Known CNS metastasis

  • Secondary malignancy within past 5 years

Participants G arm: 170 participants (ITT population)/34 elderly participants
GC arm: 164 participants (ITT population)/41 elderly participants
Interventions G arm: gemcitabine 1250 mg/m2 over 30 to 60‐minute i.v. infusion on days 1 and 8, every 3 weeks for maximum of 6 cycles, unless disease progression or intolerable toxicity.
GC arm: carboplatin AUC5 over 30 to 60‐minute i.v. infusion on day 1 and gemcitabine 1250 mg/m2 over 30 to 60‐minute i.v. infusion on days 1 and 8, every 3 weeks
Outcomes Primary outcome
  • Overall survival


Secondary outcomes
  • Objective response rate

  • Time‐to‐progression

  • Toxicity

  • Quality of life

Notes No information on subgroup analysis of elderly participants, despite multiple attempts to contact study authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomly assigned to receive either..."
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 Low risk No evidence of attrition bias
Selective reporting (reporting bias) Low risk No evidence of reporting bias
Other bias Unclear risk Study designed for general population; elderly subgroup analysis not planned