Liguori Valerio, Anatriello Antonietta, Zinzi Alessia, Ragone Angela, Pentella Ciro, Capuano Annalisa, Rafaniello Concetta, Naviglio Silvio, Sapio Luigi
Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy.
Clin Transl Oncol. 2025 Jun 15. doi: 10.1007/s12094-025-03970-6.
Recent studies highlighted the potential role of Red cell distribution width (RDW) as a prognostic biomarker in oncology. RDW has been associated with systemic inflammation, a key factor in cancer progression. While clinical trials and cohort studies suggest a correlation between RDW alterations and poor prognosis, its specific role in patients undergoing Immune Checkpoint Inhibitor (ICI) therapy remains unclear.
This study aims to explore the potential relationship between RDW alterations and treatment outcomes in patients treated with PD-1 inhibitors using pharmacovigilance data from Eudra Vigilance (EV).
We retrieved Individual Case Safety Reports from EV database, reporting pembrolizumab or nivolumab as suspected drug (January 2015 to March 2025). The Reporting Odds Ratio (ROR) with its 95% of Confidence Interval (95% CI) was computed to assess if drugs of interest have a lower/higher probability of reporting adverse events (AEs) belonging to the System Organ Class "Investigation".
Of 12,289 ICSRs, 6981 (56.8%) involved pembrolizumab and 5308 (43.2%) nivolumab. Most ICSRs referred to male patients aged 18-64. Pembrolizumab showed higher reporting probability of "Platelet count decreased" (ROR 2.41, 95% CI 2.14-2.72), "Neutrophil count decreased" (ROR 1.55, 95% CI 1.34-1.80), "White blood cell count decreased" (ROR 1.50, 95% CI 1.26-1.78), "Blood creatinine increased" (ROR 1.19, 95% CI 1.01-1.42), "C-reactive protein increased" (ROR 1.28, 95% CI 1.07-1.53) compared to nivolumab.
This study provides new insights into the potential prognostic value of RDW in patients treated with ICIs. These results warrant further investigations to determine its utility in monitoring ICI therapy.
近期研究强调了红细胞分布宽度（RDW）作为肿瘤学预后生物标志物的潜在作用。RDW与全身炎症相关，而全身炎症是癌症进展的关键因素。虽然临床试验和队列研究表明RDW改变与预后不良之间存在关联，但其在接受免疫检查点抑制剂（ICI）治疗的患者中的具体作用仍不清楚。
本研究旨在利用欧洲药品警戒系统（Eudra Vigilance，EV）的药物警戒数据，探讨接受PD - 1抑制剂治疗的患者中RDW改变与治疗结果之间的潜在关系。
我们从EV数据库中检索了个体病例安全报告，报告中帕博利珠单抗或纳武利尤单抗为可疑药物（2015年1月至2025年3月）。计算报告比值比（ROR）及其95%置信区间（95%CI），以评估感兴趣的药物报告属于“检查”系统器官类别的不良事件（AE）的概率是更低还是更高。
在12289份个体病例安全报告中，6981份（56.8%）涉及帕博利珠单抗，5308份（43.2%）涉及纳武利尤单抗。大多数个体病例安全报告涉及年龄在18 - 64岁的男性患者。与纳武利尤单抗相比，帕博利珠单抗在“血小板计数降低”（ROR 2.41，95%CI 2.14 - 2.72）、“中性粒细胞计数降低”（ROR 1.55，95%CI 1.34 - 1.80）、“白细胞计数降低”（ROR 1.50，95%CI 1.26 - 1.78）、“血肌酐升高”（ROR 1.19，95%CI 1.01 - 1.42）、“C反应蛋白升高”（ROR 1.28，95%CI 1.07 - 1.53）方面显示出更高的报告概率。
本研究为RDW在接受ICI治疗的患者中的潜在预后价值提供了新的见解。这些结果值得进一步研究以确定其在监测ICI治疗中的效用。
