Wang Lei, Yang Kunpeng, Zhao Hui, Lv Peiyun, Cai Chenglun, Wang Zhe, Wang Bao
Jilin Cancer Hospital, Changchun, China.
Changchun University of Chinese Medicine, Changchun, China.
Front Med (Lausanne). 2025 Jun 16;12:1590738. doi: 10.3389/fmed.2025.1590738. eCollection 2025.
Carboplatin is frequently employed in the treatment of non-small cell lung cancer (NSCLC), yet the real-world safety profile-including underrecognized adverse events (AEs) and subgroup-specific risk variations-remains incompletely understood. This study aims to systematically assess carboplatin-related AEs and explore demographic factors that may influence risk.
A retrospective analysis was performed using data from the FDA Adverse Event Reporting System (FAERS) spanning the first quarter of 2004 to the third quarter of 2024. Standardized terminology harmonization and multiple disproportionality methods-including reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian analysis-were applied to detect potential safety signals. Subgroup analyses were conducted to identify sex- and age-specific variations in risk.
Among 4,748 reports meeting inclusion criteria, known hematologic toxicities (e.g., anemia, neutropenia) and renal impairment were confirmed. Additionally, previously unlabeled risks emerged, such as abdominal pain (higher incidence in females), neutropenic sepsis (predominant in males and older adults), and hypothyroidism. Subgroup analyses revealed distinct patterns: males exhibited increased infection-related events, whereas females were more prone to gastrointestinal and hepatic complications. Patients aged ≥65 years showed increased multisystem involvement, particularly affecting hematologic and renal functions.
These findings underscore the necessity of tailored monitoring strategies for carboplatin, taking into account patient sex and age, especially when used in conjunction with immunotherapy. The study's insights support refining pharmacovigilance strategies and updating clinical guidelines to enable early intervention and improve personalized management for patients with NSCLC.
卡铂常用于治疗非小细胞肺癌（NSCLC），但其实际的安全性概况，包括未被充分认识的不良事件（AE）和亚组特异性风险差异，仍未完全明确。本研究旨在系统评估与卡铂相关的不良事件，并探索可能影响风险的人口统计学因素。
使用美国食品药品监督管理局不良事件报告系统（FAERS）中2004年第一季度至2024年第三季度的数据进行回顾性分析。应用标准化术语协调和多种不成比例方法，包括报告比值比（ROR）、比例报告比值（PRR）和贝叶斯分析，以检测潜在的安全信号。进行亚组分析以确定性别和年龄特异性的风险差异。
在4748份符合纳入标准的报告中，确认了已知的血液学毒性（如贫血、中性粒细胞减少）和肾功能损害。此外，还出现了以前未标注的风险，如腹痛（女性发病率较高）、中性粒细胞减少性败血症（在男性和老年人中占主导）和甲状腺功能减退。亚组分析揭示了不同的模式：男性表现出与感染相关的事件增加，而女性更容易出现胃肠道和肝脏并发症。年龄≥65岁的患者表现出多系统受累增加，尤其影响血液学和肾功能。
这些发现强调了针对卡铂制定个性化监测策略的必要性，要考虑患者的性别和年龄，特别是在与免疫疗法联合使用时。该研究的见解支持完善药物警戒策略和更新临床指南，以便能够早期干预并改善对NSCLC患者的个性化管理。
