Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): A double-blind, placebo-controlled, phase III trial
The Lancet, 05/31/2011
Clinical Article
Herbst RS et al. – Addition of bevacizumab to erlotinib does not improve survival in patients with recurrent or refractory NSCLC.
Methods- Double-blind, placebo-controlled, randomised phase III trial (BeTa)
- Enrolled patients with recurrent or refractory NSCLC who presented to 177 study sites in 12 countries after failure of first-line treatment
- Patients randomly allocated in one-to-one ratio to receive erlotinib plus bevacizumab (bevacizumab group) or erlotinib plus placebo (control group) according to computer-generated randomisation sequence by use of an interactive voice response system
- Primary endpoint OS in all enrolled patients
- Patients, study staff, and investigators masked to treatment assignment
- Assessed safety by calculation of incidence of AEs
- Tissue was collected for biomarker analyses
- OS did not differ between 317 controls and 319 patients in bevacizumab group (HR 0·97, 95% CI 0·80—1·18, p=0·7583)
- Median OS 9·3 months (IQR 4·1—21·6) for patients in bevacizumab group compared with 9·2 months (3·8—20·2) for controls
- PFS seemed to be longer in bevacizumab group (3·4 months [1·4—8·4]) than in the control group (1·7 months [1·3—4·1]; HR 0·62, 95% CI 0·52—0·75) and objective response rate suggested some clinical activity of bevacizumab and erlotinib
- Secondary endpoint differences could not be defined as significant because study prespecified that primary endpoint had to be significant before testing of secondary endpoints could be done, to control type I error rate
- In bevacizumab group, 130 (42%) of 313 patients with safety data had serious AE, compared with 114 (36%) controls
- 20 (6%) grade 5 AEs, including 2 arterial thromboembolic events, in bevacizumab group, and 14 (4%) in control group
