The addition of cilengitide to cetuximab and platinum-based chemotherapy indicated potential clinical activity as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC), a new study published in the journal Annals of Oncology has shown.
For the multicenter, open-label, controlled phase II study, researchers enrolled 169 patients with advanced NSCLC and randomly assigned them 1:1 to receive cetuximab plus platinum-based chemotherapy alone (control) or combined with cilengitide 2000mg intravenously once weekly.
Results showed that the progression-free survival was 6.2 months in the cilengitide arm versus 5.0 months in the control arm (HR = 0.72; P = 0.085).
For patients with epidermal growth factor receptor (EGFR) histoscore ≥200, the progression-free survival was 6.8 months and 5.6 months in the cilengitide and control arms, respectively (HR = 0.57; P = 0.0446).
Researchers found that median overall survival was 13.6 months in the cilengitide arm and 9.7 months in the control arm (HR = 0.81; P = 0.265), and in patients with EGFR ≥200, the median overall survival was 13.2 and 11.8 months, respectively (HR = 0.95; P = 0.855).
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In regard to safety, researchers observed no major differences in adverse events between the two groups. There was also no increased incidence of thromboembolic events or hemorrhage in the cilengitide-treated patients.
The authors conclude that further studies are needed to support the use of cilengitide in patients with advanced NSCLC.
Cilengitide is an integrin inhibitor also being studied for the treatment of glioblastoma.
- Vansteenkiste J, Barlesi F, Waller CF, et al. Cilengitide combined with cetuximab and platinum-based chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC) patients: results of an open-label, randomized, controlled phase II study (CERTO). 2015. [Epub ahead of print]. doi: 10.1093/annonc/mdv219.