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Thématique :
- Cancers autres (hors CCR et CHC)
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Originalité :
Très original
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Pas encore
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Nom du veilleur :
Professeur Astrid LIÈVRE
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Journal of clinical oncology (JCO)
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2016/06
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2016 May 1;34(13):1448-54
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doi: 10.1200/JCO.2015.63.5995
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Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction.
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Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H
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http://www.ncbi.nlm.nih.gov/pubmed/26884585
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PURPOSE:
There is currently no standard treatment strategy for patients with advanced metastatic gastric cancer experiencing progression after two or more lines of chemotherapy. We assessed the efficacy and safety of apatinib, a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, in patients with advanced gastric or gastroesophageal junction adenocarcinoma for whom at least two lines of prior chemotherapy had failed.
PATIENTS AND METHODS:
This was a randomized, double-blind, placebo-controlled phase III trial. Patients from 32 centers in China with advanced gastric or gastroesophageal junction adenocarcinoma, for whom two or more prior lines of chemotherapy had failed, were enrolled. Patients were randomly assigned to oral apatinib 850 mg or placebo once daily. The primary end points were overall (OS) and progression-free survival (PFS).
RESULTS:
Between January 2011 and November 2012, 267 patients were enrolled. Median OS was significantly improved in the apatinib group compared with the placebo group (6.5 months; 95% CI, 4.8 to 7.6 v 4.7 months; 95% CI, 3.6 to 5.4; P = .0149; hazard ratio, 0.709; 95% CI, 0.537 to 0.937; P = .0156). Similarly, apatinib significantly prolonged median PFS compared with placebo (2.6 months; 95% CI, 2.0 to 2.9 v 1.8 months; 95% CI, 1.4 to 1.9; P < .001; hazard ratio, 0.444; 95% CI, 0.331 to 0.595; P < .001). The most common grade 3 to 4 nonhematologic adverse events were hand-foot syndrome, proteinuria, and hypertension.
CONCLUSION:
These data show that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy.
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Evaluer l’efficacité de l’apatinib, un inhibiteur tyrosine kinase (ITK) anti-VEGFR2 oral versus placebo en 3ème ligne thérapeutique des cancers gastriques avancés .
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Efficacité significative de l’apatinib en termes de survie globale et de survie sans progression, associée à une bonne tolérance.
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Cette étude montre pour la première fois l’efficacité d’un ITK anti-angiogénique dans le traitement du cancer gastrique. L’apatinib n’est actuellement pas disponible en France mais ces résultats renforcent l’approche de l’inhibition de la voie du VEGF et notamment du VEGFR2 (après les résultats positifs des essais REGARD et RAINBOW avec le ramucirumab) dans le traitement du cancer gastrique avancé pré-traité.
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