Department of Radiation Oncology, The Second Hospital of Jilin University, Changchun, Jilin, People's Republic of China.
NHC Key Laboratory of Radiobiology, School of Public Health, Jilin University, Changchun, Jilin, People's Republic of China.
Int J Nanomedicine. 2024 Nov 14;19:11847-11858. doi: 10.2147/IJN.S490400. eCollection 2024.
Abraxane (nanoparticle albumin-bound paclitaxel) is a chemotherapeutic employed commonly for the management of various cancers including breast cancer, non-small cell lung cancer, and pancreatic adenocarcinoma. Although it has clinically beneficial properties, Abraxane is accompanied by multiple adverse events (AEs) that require close observation. This study aims to evaluate the AE profile of Abraxane using recently available data from January 2004 through December 2023 in the FDA Adverse Event Reporting System (FAERS).
The data for Abraxane-related AEs were obtained from the FAERS database. The dataset consisted of patient demographic characteristics as well as information on the types and outcomes of AEs reported. Reporting odds ratios (ROR) as well as proportional reporting ratio (PRR), considering the used definition of anti-cancer agent and AEs, were calculated to investigate any association with Abraxane.
A total of 10,310 reports associated with Abraxane AEs were identified. Blood and lymphatic system disorders were the most frequent (ROR 6.44), followed by hepatobiliary (ROR 3.16), infections (ROR 1.45), and gastrointestinal disorders (ROR 1.42). Serious outcomes included hospitalization in 36.35% and death in 29.76% of cases. The top adverse reactions matched known profiles, including peripheral sensory neuropathy (ROR: 49.48). The analysis also found new adverse reactions, such as scleroderma-like reactions (ROR: 95.4) and vascular pseudoaneurysm ruptures (ROR: 87.71).
Our results re-emphasize the importance of a robust Post Marketing Surveillance system and suggest this FAERS database based analysis provides an updated, independent information on Abraxane related AEs to enrich its safety profile. A process of continuous vigilance and additional investigations on specific areas that may have some undesired events are imperative to increase our knowledge on how Abraxane should be handled in terms of its safety.
Abraxane（纳米白蛋白结合紫杉醇）是一种化疗药物，常用于治疗多种癌症，包括乳腺癌、非小细胞肺癌和胰腺腺癌。尽管它具有临床益处，但 Abraxane 伴随着多种需要密切观察的不良反应（AE）。本研究旨在使用 2004 年 1 月至 2023 年 12 月期间 FDA 不良事件报告系统（FAERS）中最近获得的数据评估 Abraxane 的 AE 概况。
从 FAERS 数据库中获取与 Abraxane 相关 AE 的数据。该数据集包括患者人口统计学特征以及报告的 AE 类型和结局信息。计算报告比值比（ROR）和比例报告比（PRR），考虑到所用的抗癌药物和 AE 的定义，以研究与 Abraxane 的任何关联。
共确定了 10310 份与 Abraxane AE 相关的报告。血液和淋巴系统疾病最常见（ROR 6.44），其次是肝胆疾病（ROR 3.16）、感染（ROR 1.45）和胃肠道疾病（ROR 1.42）。严重结局包括 36.35%的住院和 29.76%的死亡。最常见的不良反应与已知的情况相符，包括周围感觉神经病（ROR：49.48）。分析还发现了新的不良反应，如硬皮病样反应（ROR：95.4）和假性血管动脉瘤破裂（ROR：87.71）。
我们的结果再次强调了强大的上市后监测系统的重要性，并表明基于 FAERS 数据库的分析为丰富其安全性概况提供了关于 Abraxane 相关 AE 的更新、独立信息。持续监测和对可能存在某些不良事件的特定领域进行额外调查对于增加我们对 Abraxane 安全性的了解至关重要。
