Critical appraisal:De Boer RH, Arrieta Ó, Yang CH, Gottfried M, Chan V, Raats J, et al 2011 3

Critical Appraisal

Article being appraised

de Boer RH, Arrieta Ó, Yang CH, Gottfried M, Chan V, Raats J, et al. Vandetanib plus pemetrexed for the second-line treatment of advanced non-small-cell lung cancer: a randomized, double-blind phase III trial. J Clin Oncol 2011 Mar 10;29(8):1067-74 Available from: http://www.ncbi.nlm.nih.gov/pubmed/21282537.

Applicable clinical question

What is the optimal systemic therapy regimen for patients with poor performance status for treatment of stage IV inoperable NSCLC?

Key Facts

Study Design

randomised controlled trial

Number of Patients:

534

Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias

Low risk of bias

Comments: Patients (N = 534) were randomly assigned to receive vandetanib 100 mg/d plus pemetrexed 500 mg/m(2) every 21 days (n = 256) or placebo plus pemetrexed (n = 278).

Size of effect

1	Reason for decision: This study did not meet the primary end point of statistically significant PFS prolongation with vandetanib plus pemetrexed versus placebo plus pemetrexed (HR, 0.86; 97.54% CI, 0.65 to 1.13; P = .219).

Relevance of evidence