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

Manegold 1998.

Methods Two randomized phase II trials conducted in Europe and Taiwan
Eligible patients for the 2 trials ‐ almost identical

  • Cytologically or histologically confirmed NSCLC

  • Stage IIIA if inoperable, IIIB or IV

  • No previous chemotherapy

  • No prior radiation

  • No prior immunotherapy

  • ≥ 18 years of age

  • WHO PS: 0 to 2

  • Adequate hepatic and renal function


Exclusion criteria

  • Central nervous system metastasis

  • Hypercalcemia

  • Serious concomitant systemic disorders

  • Concomitant treatment with nephrotoxic antibiotics

  • NSCLC as second malignancy
Participants G arm (Europe): 71 participants (ITT population) ‐ median age (range): 59 (32 to 80) years/elderly participants not reported
G arm (Taiwan): 27 participants (ITT population) ‐ median age (range): 63 (36 to 75) years/elderly participants not reported
EP arm (Europe): 75 participants (ITT population) ‐ median age (range): 59 (33 to 78) years/elderly participants not reported
EP arm (Taiwan): 26 participants (ITT population) ‐ median age (range): 60 (35 to 75) years/elderly participants not reported
Interventions G arm: gemcitabine 1000 mg/m2 over 30‐minute i.v. infusion on days 1, 8, and 15 every 4 weeks (Europe)/gemcitabine 1250 mg/m2 over 30‐minute i.v. infusion on days 1, 8, and 15, every 4 weeks (Taiwan)
EP arm: cisplatin 100 mg/m2 i.v. infusion on day 1 and etoposide 100 mg/m2 i.v. infusion on days 1, 2, and 3, every 4 weeks (Europe)/cisplatin 80 mg/m2 i.v. infusion on day 1 and etoposide 80 mg/m2 i.v. infusion on days 1, 2, and 3, every 4 weeks (Taiwan)
Outcomes Neither primary nor secondary outcomes reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomise to receive either..."
No further information on randomization process provided
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 assessment
Blinding of outcome assessment (detection bias) 
 Other outcomes High risk No information on blinding of outcome assessment
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 No separate elderly subgroup analysis