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

Sculier 2002.

Methods Randomized multi‐center phase III trial
Eligible patients
  • Histologically or cytologically confirmed NSCLC, stage IIIB or IV (according to UICC and ISS 1987 classification)

  • Measurable or assessable lesion

  • No prior history of malignancy, except non‐melanoma skin cancer, in situ carcinoma of the uterine cervix, or cured malignant tumor (> 5 years disease‐free survival)

  • No prior chemotherapy

  • KPS ≥ 60%

  • Adequate bone marrow, renal, and liver function


Exclusion criteria
  • Hypoacusia and peripheral neuropathy

  • Recent myocardial infarction (< 3 months before treatment date)

  • Active congestive heart failure or cardiac arrhythmia requiring medical treatment

  • Uncontrolled infectious disease

  • Other serious medical or psychological factors that may prevent adherence to treatment schedule

Participants CCI arm: 94 participants (ITTpopulation) ‐ 45 participants > 60 years of age
CCG arm: 92 participants (ITT population) ‐ 52 participants > 60 years of age
IG arm: 94 participants (ITT population) ‐ 46 participants > 60 years of age
Interventions CCI arm: cisplatin 60 mg/m2 over 60‐minute i.v. infusion and carboplatin AUC3 over 30‐minute i.v. infusion and Ifosfamide 4500 mg/m2 over 18‐hour i.v. infusion on day 1, every 4 weeks
CCG arm: cisplatin 60 mg/m2 over 60‐minute i.v. infusion on day 1 and carboplatin AUC3 over 30‐minute i.v. infusion on day 1 and gemcitabine 1000 mg/m2 as on days 1, 8, and 15, every 4 weeks
IG arm: ifosfamide 4500 mg/m2 over 18‐hour i.v. infusion on day 1 and gemcitabine 1000 mg/m2 on days 1, 8, and 15, every 4 weeks
Responding participants given additional courses until best response, disease progression, or major toxicity
Outcomes Primary outcome
  • Overall survival

Notes Despite multiple attempts to contact study authors, no data related to elderly subgroup analysis obtained
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomisation was performed centrally using the minimisation technique and stratified according to centre, Karnofsky PS, presence of brain metastases and prior chest irradiation"
Allocation concealment (selection bias) Unclear risk "Treatment allocation was obtained by calling the ELCWP (European Lung Cancer Working Party) data centre"
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 "Four (1.4%) were ineligible for the study (three in the CCG arm and one in the IG arm) for the following reasons: small‐cell lung cancer histology, prior chemotherapy administration, increased bilirubinaemia prior to randomisation, absence of informed consent"
Selective reporting (reporting bias) Low risk No evidence of reporting bias
Other bias Unclear risk No separate elderly subgroup analysis