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

Depierre 1994.

Methods Randomized phase III trial, multi‐center
Eligibility criteria
  • Stage IIIA, IIB, or IV histologically proven non‐small cell lung cancer

  • Stage III unacceptable for surgery or radiotherapy

  • < 75 years of age

  • No previous chemotherapy or radiotherapy

  • Performance status according to WHO: 0 to 2

  • ≥ 1 measurable lesion

  • Adequate hematological, hepatic, and renal function


Exclusion criteria
  • Brain metastases

  • Previous or concomitant malignancies (except basal cell skin carcinoma)

  • Any neurological or auditory history

  • Non‐controlled bacterial infection

Participants PV arm: 121 ITT population ‐ median age (range): 59.2 years (not reported)/number of elderly participants not reported
V arm: 119 ITT population ‐ median age (range): 58.8 years (not reported)/number of elderly participants not reported
Interventions PV arm: cisplatin 80 mg/m2 i.v. infusion every 3 weeks and vinorelbine 30 mg/m2 weekly. Hydration with 2000 mL of 5% dextrose solution administered 30 minutes before cisplatin infusion. Administration of methylprednisolone (120 mg) and of metoclopramide recommended to prevent nausea and vomiting
V arm: vinorelbine 30 mg/m2 i.v. infusion, weekly
Outcomes Overall survival (OS) defined as interval from randomization to death from any cause
Time‐to‐progression (TTP) defined as interval from randomization to progressive disease
Response rate
Toxicity according to WHO criteria
Notes No planned elderly subgroup analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk No evidence of selection bias. "Randomization was performed through a centralized blind telephone assignment procedure, with stratification by centre and stage"
Allocation concealment (selection bias) Unclear risk No information on allocation concealment analysis
Blinding of outcome assessment (detection bias) 
 OS and 1y OS rate outcome Unclear risk No information on blinding of assessors
Blinding of outcome assessment (detection bias) 
 Other outcomes Unclear risk No information on blinding of assessors
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No information on judgment of attrition bias for the elderly
Selective reporting (reporting bias) Low risk No evidence of reporting bias
Other bias Unclear risk Study designed for general adult population; no elderly subgroup analysis planned