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Erlotinib combined with Bevacizumab is effective in first-line treatment of advanced NSCLC
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BEVERLY study shows that Erlotinib combined with Bevacizumab is effective in first-line treatment of advanced NSCLC. PFS extended by 5.8 months, not only effective in Asians.
J Thorac Oncol丨Adding bevacizumab to Erlotinib as first-line treatment for patients with EGFR-mutant advanced non-squamous non-small cell lung cancer: the BEVERLY multicenter randomized phase III trials.
In the Japanese JO25567 trials, the addition of bevacizumab to Erlotinib prolonged PFS in patients with EGFR-mutant advanced NSCLC, but limited data are available in non-Asian patients.
BEVERLY is an Italian, multicenter, randomized Phase III study of the addition of bevacizumab to Erlotinib as first-line treatment for advanced EGFR-mutant NSCLC.
Eligible patients were randomly assigned in a 1:1 ratio to Erlotinib plus bevacizumab or Erlotinib alone.
Investigator-assessed PFS (IA-PFS) and blinded independent central review PFS (BICR-PFS) were the co-primary endpoints.
80% power at detecting 0.60 HR and a 2-sided alpha error of 0.05, requiring 126 events in 160 patients. The trial is registered as NCT02633189 and EudraCT 2015-002235-17.
From April 11, 2016 to February 27, 2019, 160 patients were randomly assigned to receive Erlotinib plus bevacizumab (80) or Erlotinib alone (80).
At a median follow-up of 36.3 months, the median IA-PFS was 15.4 months (95% CI: 12.2–18.6) for Erlotinib plus bevacizumab and 9.6 months ( 95% CI: 12.2–18.6) for Erlotinib. %CI: 8.2–10.6) (HR = 0.66; 95% CI: 0.47–0.92 ). BICR-PFS analysis confirmed this result.
There was a statistically significant interaction between smoking habits and treatment effect (P = 0.0323), and PFS prolongation was clinically meaningful only in current or former smokers.
Hypertension (grade ≥3: 24% vs 5%), rash (grade ≥3: 31% vs 14%), thromboembolic events (any grade: 11% vs 4%), and proteinuria (any grade) in the combination arm : 23% vs 6%) more frequently.
The addition of bevacizumab to first-line Erlotinib prolonged PFS in Italian patients with EGFR-mutant NSCLC; this combination increased toxicity without unexpected safety concerns.
Piccirillo MC, Bonanno L, Garassino MC, et al. Addition of bevacizumab to Erlotinib as first-line treatment of patients with EGFR-mutated advanced nonsquamous non-small cell lung cancer. The BEVERLY multicenter randomized phase III trial. J Thorac Oncol. 2022 June 01. DOI: https://doi.org/10.1016/j.jtho.2022.05.008.
Erlotinib combined with bevacizumab is effective in first-line treatment of advanced NSCLC
(source:internet, reference only)