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Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302)

BACKGROUND: Anlotinib (AL3818) is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. The objective of this study was to assess the safety and efficacy of third-line anlotinib for patients with refractory advanced non-small-cell lung cancer (RA...

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Detalles Bibliográficos
Autores principales: Han, Baohui, Li, Kai, Zhao, Yizhuo, Li, Baolan, Cheng, Ying, Zhou, Jianying, Lu, You, Shi, Yuankai, Wang, Zhehai, Jiang, Liyan, Luo, Yi, Zhang, Yiping, Huang, Cheng, Li, Qiang, Wu, Guoming
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5846072/
https://www.ncbi.nlm.nih.gov/pubmed/29438373
http://dx.doi.org/10.1038/bjc.2017.478
Descripción
Sumario:BACKGROUND: Anlotinib (AL3818) is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. The objective of this study was to assess the safety and efficacy of third-line anlotinib for patients with refractory advanced non-small-cell lung cancer (RA-NSCLC). METHODS: Eligible patients were randomised 1 : 1 to receive anlotinib (12 mg per day, per os; days 1–14; 21 days per cycle) or a placebo. The primary end point was progression-free survival (PFS). RESULTS: A total of 117 eligible patients enrolled from 13 clinical centres in China were analysed in the full analysis set. No patients received immune check-point inhibitors and epidermal growth factor receptor status was unknown in 60.7% of the population. PFS was better with anlotinib compared with the placebo (4.8 vs 1.2 months; hazard ratio (HR)=0.32; 95% confidence interval (CI), 0.20–0.51; P<0.0001), as well as overall response rate (ORR) (10.0% 95% CI, 2.4–17.6% vs 0% 95% CI, 0–6.27% P=0.028). The median overall survival (OS) was 9.3 months (95% CI, 6.8–15.1) for the anlotinib group and 6.3 months (95% CI, 4.3–10.5) for the placebo group (HR=0.78; 95% CI, 0.51–1.18; P=0.2316). Adverse events were more frequent in the anlotinib than the placebo group. The percentage of grade 3–4 treatment-related adverse events was 21.67% in the anlotinib group. CONCLUSIONS: Anlotinib as a third-line treatment provided significant PFS benefits to patients with RA-NSCLC when compared with the placebo, and the toxicity profiles showed good tolerance.