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. 2020 May 12;2020(5):CD013238. doi: 10.1002/14651858.CD013238.pub2

Lee 2015.

Study characteristics
Methods Randomised 2:1, open‐label, non‐comparative, multicentre
Participants 106 randomised. First‐line glioblastomas
Interventions Vandetanib + Stupp protocol vs no vandetanib + Stupp protocol
Outcomes
  • OS: 16.6 vs 15.9 months (P = 0.8, HR not available)

  • PFS: 7.7 vs 6.2 months (HR not available)

  • PFS12: 0.25 vs 0.39

  • Toxicities: mostly haematological – 4.3% clots

Notes Used MacDonald criteria for radiological assessments
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “patients were randomly assigned 2:1 at registration to receive RT and temozolomide…”
Allocation concealment (selection bias) High risk Not concealed. Open‐label trial
Blinding of participants and personnel (performance bias)
All outcomes High risk Not concealed. Open‐label trial
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Uncertain
Incomplete outcome data (attrition bias)
All outcomes Low risk 13 patients registered but did not proceed to randomisation.
Selective reporting (reporting bias) Low risk All prespecified endpoints reported.
Other bias Low risk