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

Gricorescu 2007.

Methods Randomized phase II trial
Eligible patients

  • Inoperable NSCLC with no previous chemotherapy or radiotherapy (> 60 Gy)

  • 18 to 75 years of age

  • Karnofsky Performance status ≥ 70

  • Uni‐ or bi‐dimensionally measurable disease

  • Adequate bone, cardiac, hepatic, and renal function


Exclusion criteria

  • Serious cardiovascular disease during last 3 months

  • Symptomatic (progressive) brain metastasis

  • Previous or concomitant malignancy, except basal cell carcinoma and cervical carcinoma in situ

  • Pregnant or breast‐feeding

  • Taking any investigational drug within past 30 days
Participants GV/GI arm: 50 (ITT population) ‐ median age: 59 years/elderly participants not reported
GP arm: 52 (ITT population) ‐ median age: 56 years/elderly participants not reported
Interventions GV/GI arm: gemcitabine 1000 mg/m2 plus vinorelbine 25 mg/m2 on days 1 and 8 for 2 cycles, followed by gemcitabine 1000 mg/m2 on days 1 and 8 plus ifosfamide 2000 mg/m2 on day 1, for 2 cycles. To prevent hemorrhagic cystitis, mesna was administrated at a dose equivalent to 20% of ifosfamide dose
GP arm: gemcitabine 1250 mg/m2 on days 1 and 8 with cisplatin 70 mg/m2 given on day 1, for 4 cycles
Outcomes Primary outcome

  • Objective response rate


Secondary outcomes

  • Overall survival

  • Progression‐free survival

  • Toxicity
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) Unclear risk Random sequence generation not mentioned
Allocation concealment (selection bias) Unclear risk Allocation concealment not mentioned
Blinding of outcome assessment (detection bias) 
 OS and 1y OS rate outcome Unclear risk Open‐label study considered to have unclear influence on mortality outcomes
Blinding of outcome assessment (detection bias) 
 Other outcomes Unclear risk Open‐label study
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