Web of Science: 13 citas, Scopus: 16 citas, Google Scholar: citas,
Meta-analysis of individual patient safety data from six randomized, placebo-controlled trials with the antiangiogenic VEGFR2-binding monoclonal antibody ramucirumab
Arnold, D (Instituto CUF de Oncologia (I.C.O.), Lisboa)
Fuchs, C S (Internal Medicine, Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA)
Tabernero Caturla, Josep (Universitat Autònoma de Barcelona)
Ohtsu, A (Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan)
Zhu, A X (Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, USA)
Garon, E B (Hematology Oncology, David Geffen School of Medicine at UCLA Translational Research in Oncology-US Network, Santa Monica, USA)
Mackey, J R (Department of Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Canada)
Paz Ares, L (Hospital Universitario Doce de Octubre. Departamento de Oncologia Médica)
Baron, A D (Division of Hematology Oncology, California Pacific Medical Center, San Francisco, USA)
Okusaka, T (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan)
Yoshino, T (Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan)
Yoon, H H (Division of Medical Oncology, Mayo Clinic, Rochester, USA)
Das, M (Oncology, Eli Lilly and Company, Indianapolis, USA)
Ferry, D (Oncology, Eli Lilly and Company, Bridgewater, USA)
Zhang, Y (Oncology, Eli Lilly and Company, Bridgewater, USA)
Lin, Y (Oncology, Eli Lilly and Company, Indianapolis, USA)
Binder, P (Oncology, Eli Lilly and Company, Bridgewater, USA)
Sashegyi, A (Oncology, Eli Lilly and Company, Indianapolis, USA)
Chau, I (Department of Medicine, Royal Marsden Hospital, Sutton, UK)

Fecha: 2017
Resumen: Ramucirumab, the human immunoglobulin G1 monoclonal antibody receptor antagonist of vascular endothelial growth factor receptor 2, has been approved for treating gastric/gastroesophageal junction, non-small-cell lung, and metastatic colorectal cancers. With the completion of six global, randomized, double-blind, placebo-controlled, phase III trials across multiple tumor types, an opportunity now exists to further establish the safety parameters of ramucirumab across a large patient population. An individual patient meta-analysis across the six completed phase III trials was conducted and the relative risk (RR) and associated 95% confidence intervals (CIs) were derived using fixed-effects or mixed-effects models for all-grade and high-grade adverse events (AEs) possibly related to vascular endothelial growth factor pathway inhibition. The number needed to harm was also calculable due to the placebo-controlled nature of all six registration standard trials. A total of 4996 treated patients (N = 2748 in the ramucirumab arm and N = 2248 in the control, placebo arm) were included in this meta-analysis. Arterial thromboembolic events [ATE; all-grade, RR: 0. 8, 95% CI 0. 5–1. 3; high-grade (grade ≥3), RR: 0. 9, 95% CI 0. 5–1. 7], venous thromboembolic events (VTE; all-grade, RR: 0. 7, 95% CI 0. 5–1. 1; high-grade, RR: 0. 7, 95% CI 0. 4–1. 2), high-grade bleeding (RR: 1. 1, 95% CI 0. 8–1. 5), and high-grade gastrointestinal (GI) bleeding (RR: 1. 1, 95% CI 0. 7–1. 7) did not demonstrate a definite increased risk with ramucirumab. A higher percentage of hypertension, proteinuria, low-grade (grade 1–2) bleeding, GI perforation, infusion-related reaction, and wound-healing complications were observed in the ramucirumab arm compared with the control arm. Ramucirumab may be distinct among antiangiogenic agents in terms of ATE, VTE, high-grade bleeding, or high-grade GI bleeding by showing no clear evidence for an increased risk of these AEs in this meta-analysis of a large and diverse patient population. Ramucirumab is consistent with other angiogenic inhibitors in the risk of developing certain AEs. Clinical Trial Numbers: NCT00917384 (REGARD), NCT01170663 (RAINBOW), NCT01168973 (REVEL), NCT01183780 (RAISE), NCT01140347 (REACH), and NCT00703326 (ROSE).
Derechos: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. Creative Commons
Lengua: Anglès.
Documento: article ; revisió ; publishedVersion
Materia: VEGF ; VEGFR ; Ramucirumab ; Antiangiogenic ; Adverse events ; Meta-analysis
Publicado en: Annals of Oncology, Vol. 28 (september 2017) , p. 2932-2942, ISSN 1569-8041

PMID: 28950290
DOI: 10.1093/annonc/mdx514

11 p, 388.8 KB

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