Safety Of Ziv-aflibercept Research Articles

Efficacy and safety of Ziv-aflibercept in patients with central retinal vein occlusion

Background Retinal vein occlusion is one of the most common vascular disorders that can cause visual loss. It is classified into central retinal vein occlusion (CRVO) and branch retinal vein occlusion. The most common cause of visual loss in CRVO is cystoid macular edema. Intravitreal injection of many antivascular endothelial growth factor agents can treat cystoid macular edema that occur owing to CRVO.Purpose The aim of the present study was to evaluate the efficacy of a new drug (Ziv-aflibercept) in the management of patients with CRVO.Patients and methods This is a prospective interventional study that was conducted on 15 eyes of 15 patients of recently diagnosed nonischemic CRVO of less than 2-month duration. Three loading doses of 1.25 mg of Ziv-aflibercept were given 1 month apart for each patient and then continued as needed in a pro re nata regimen. Complete ophthalmic evaluation was done at the Ophthalmology Department of Tanta University, including best-corrected visual acuity (BCVA), fundus examination, intraocular pressure measurement, and anterior segment examination. Optical coherence tomography (TOPCON 3D optical coherence tomography machine) was done for all patients at presentation and 1 month after each injection and then monthly during the follow-up period, which persisted for 6 months.Results The intraocular pressure did not show a statistically significant increase after intravitreal injection of Ziv-aflibercept. The BCVA improved significantly from 0.87±0.10 to 0.32±0.12 LogMAR after injection (P=0.001). The central macular thickness decreased significantly from a baseline value of 771±141.87 μm before injection to 306.67±91.51 μm after the three loading doses and to 208.07±12.97 μm after 6 months (P=0.001). There was no statistically significant correlation between the final BCVA and the final central macular thickness after 6 months (r=0.054, P=0.848). No serious complications were reported, such as endophthalmitis, vitreous hemorrhage, retinal detachment, or stroke.Conclusion Ziv-aflibercept is a highly effective drug in cases of nonischemic CRVO with a high safety profile and a relatively low cost.

Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema.

To evaluate the safety and efficacy of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Bridgewater, NJ/Regeneron Pharmaceuticals, Tarrytown, NY) in the treatment of refractory diabetic macular edema (DME). Retrospective case series looking at the safety of ziv-aflibercept in patients with DME refractory to previous anti-vascular endothelial growth factor (VEGF) therapy. Detailed ophthalmologic examination, best-corrected visual acuity, and optical coherence tomography measurements were performed pre-switch, as well as at each monthly follow-up visit. The study included 34 eyes of 26 patients. The mean number of ziv-aflibercept injections post-switch was 2.03 injections. Visual acuity improved from a mean of 0.63 logMAR pre-switch to 0.51 logMAR after the first visit and 0.46 logMAR after the second visit post-switch (P < .084). Macular thickness improved from a mean of 513.79 μm to 411.79 μm (P = .006) on the first visit and 426.76 μm (P = .029) after the second visit post-switch. No adverse ocular or systemic side effects were reported on any of the follow visits. Ziv-aflibercept appears to be safe and effective in patients with refractory DME previously treated with other anti-VEGF agents in the short term. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:399-405.].

A phase II multicentre study of ziv-aflibercept in combination with cisplatin and pemetrexed in patients with previously untreated advanced/metastatic non-squamous non-small cell lung cancer

Background:This study evaluated the efficacy and safety of ziv-aflibercept in combination with cisplatin and pemetrexed in non-small cell lung cancer (NSCLC).Methods:This single arm, multicentre phase II trial enrolled patients with previously untreated, locally advanced or metastatic non-squamous NSCLC. Patients received intravenous ziv-aflibercept 6 mg kg−1, pemetrexed 500 mg m−2, and cisplatin 75 mg m−2, every 21 days for up to six cycles. Maintenance administration of ziv-aflibercept was to continue until disease progression, intolerable toxicity or other cause for withdrawal. The co-primary end points were objective response rate (ORR) and progression-free survival (PFS). Planned sample size was 72 patients.Results:The study was closed prematurely because of three confirmed and two suspected cases of reversible posterior leukoencephalopathy syndrome (RPLS). A total of 42 patients were enrolled. Median age was 61.5 years; 55% were male, 86% Caucasian and 50% had Eastern Cooperative Oncology Group performance status (ECOG PS)=0. A median of four cycles of ziv-aflibercept was administered. The most common treatment-emergent adverse events (TEAEs) of any grade were nausea (69%) and fatigue (67%), with hypertension (36%) as the most common grade 3/4 TEAE. Of the 38 evaluable patients, ORR was 26% and median PFS was 5 months.Conclusion:Cases of RPLS had been observed in other studies in the ziv-aflibercept clinical development programme but the rate observed in this study was higher than previously observed. This might be related to declining renal function and/or hypertension. Although ORR and PFS were in accordance with most historical first-line NSCLC studies, this combination of ziv-aflibercept/cisplatin/pemetrexed will not be further explored in NSCLC.

Ziv-aflibercept (Zaltrap) for the Treatment of Metastatic Colorectal Cancer

Review pharmacology, pharmacokinetics, efficacy, and safety of ziv-aflibercept in combination with FOLFIRI for treatment of metastatic colorectal cancer (mCRC) resistant to or progressed following oxaliplatin-containing regimens. Articles indexed in PubMed (1948-August 2013), TOXLINE (2001-August 2013), and Google Scholar as well as meeting abstracts were identified using the search terms ziv-aflibercept and colorectal cancer. Available English-language articles Ziv-aflibercept, a selective vascular endothelial growth factor antagonist, was evaluated as monotherapy for treatment of mCRC in a phase 2 study and added to FOLFIRI in a phase 3 trial. Patient response to ziv-aflibercept as monotherapy did not reach statistical significance. Results suggest that response to ziv-aflibercept treatment is not influenced by prior bevacizumab therapy. A phase 3 trial compared the safety and efficacy of ziv-aflibercept plus FOLFIRI with placebo plus FOLFIRI in patients with mCRC who experienced disease progression on an oxaliplatin-containing regimen. Patients in the ziv-aflibercept arm had a median overall survival of 13.5 months, versus 12.06 months for those receiving placebo (hazard ratio [HR] = 0.817, 95% CI = 0.713 to 0.937). Progression-free survival for patients receiving ziv-aflibercept was higher compared with placebo (HR = 0.758; 95% CI = 0.661 to 0.869). The most common adverse effects observed were anemia, diarrhea, and neutropenia. Ziv-aflibercept is a safe and effective option in combination with FOLFIRI for the treatment of mCRC in patients who progress on oxaliplatin-containing therapy. Superiority over other antiangiogenic treatment has not been established.