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

Wachters 2003.

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

  • Stage IIIB or IV

  • 1 measurable or evaluable tumor lesion

  • No previous chemotherapy and radiotherapy allowed provided ≤ 25% of bone marrow irradiated and radiation completed ≥ 4 weeks before inclusion

  • PS: 0 to 2; life expectancy > 12 weeks

  • Adequate bone marrow, liver, and renal function


Exclusion criteria
  • Active infection

  • Second primary malignancy (except carcinoma in situ of uterine cervix and adequately treated basal cell carcinoma of the skin and adequately treated upper respiratory malignancy)

  • Uncorrected hypercalcaemia

  • LVEF < 45%, as measured by MUGA

Participants GE arm: 121 participants (ITT population) ‐ median age (range): 60 (32 to 76) years/elderly subgroup not reported
GC arm: 119 participants (ITT population) ‐ median age (range): 60 (29 to 80) years/elderly subgroup not reported
Interventions GE arm: gemcitabine 1125 mg/m2 over 30‐minute i.v. infusion on days 1 and 8 plus epirubicin 100 mg/m2 over 5‐minute bolus i.v. infusion on day 1, every 3 weeks
GC arm: gemcitabine 1125 mg/m2 over 30‐minute i.v. infusion on days 1 and 8 plus cisplatin 80 mg/m2 over 3‐hour i.v. infusion on day 2. For pre‐hydration, participants in GC arm admitted to hospital for 2 days, every 3 weeks
Treatment plan consisted of 5 cycles for each treatment arm, with interruptions due to tumor progression, intolerable toxicity, or participant preference. No primary prophylaxis with G‐CSF
Outcomes Primary outcome
  • Progresion‐free survival


Secondary outcomes
  • Overall survival

  • Response rate

  • Toxicity

  • Quality of life

Notes No information on inclusion of elderly participants nor on specific subgroup analysis, despite multiple attempts to contact study authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Eligible patients were randomised by telephone to receive either cisplatin or epirubicin both with gemcitabine"
Allocation concealment (selection bias) Unclear risk No information on allocation concealment
Blinding of outcome assessment (detection bias) 
 OS and 1y OS rate outcome Low risk "After treatment, tumour responses were evaluated by an independent observer"
Blinding of outcome assessment (detection bias) 
 Other outcomes Low risk "After treatment, tumour responses were evaluated by an independent observer"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk "Three randomised patients did not receive chemotherapy because of rapidly deteriorating performance status due to progression of disease before treatment initiation. These patients were included in all analyses"
Selective reporting (reporting bias) Low risk No evidence of reporting bias
Other bias Unclear risk No separate elderly subgroup analysis