Elijah Joseph, Puzanov Igor, Cresanti Benjamin, Hamad Lamya, Attwood Kristopher, Catalfamo Kayla, Riebandt Grazyna
School of Pharmacy and Pharmaceutical Sciences, Northeastern University, Boston, MA, USA.
Department of Medical Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
J Oncol Pharm Pract. 2024 Jul 23:10781552241264817. doi: 10.1177/10781552241264817.
Real-world safety outcomes between the two flat-dose nivolumab regimens demonstrated to be similar in a study of adjuvant nivolumab recipients for melanoma. However, this study was limited by a single oncology patient population, a small sample size, and insufficient study power. The primary objective of this study was to evaluate the incidence of immunotherapy-related adverse effects (irAEs) between nivolumab regimens with differing dosing patterns in various solid tumor patient populations.
Single-center retrospective cohort study of adult patients with solid tumor malignancies who received nivolumab 240 mg Q2W or 480 mg Q4W, or who were transitioned from 240 mg Q2W to 480 mg Q4W from March 1, 2018 to March 31, 2022 were selected for analysis from an electronic health record generated report. The primary endpoint evaluated was the incidence of irAEs. Secondary endpoints included the incidence of significant irAEs and reasons for treatment discontinuation. These endpoints were compared by univariate analysis between all three cohorts. A multivariate analysis was then conducted for the primary endpoint.
Nivolumab 240 mg Q2W was associated with a statistically significant increase in the incidence of colitis whereas the 480 mg Q4W regimen was associated with a statistically significant increase in the incidence of pruritis. The incidence of irAEs was not different between the three cohorts, while the incidence of significant irAEs was higher in the 240 mg Q2W and 240 mg Q2W to 480 mg Q4W cohorts.
Clinicians ought to be aware of differences in the irAE profiles between nivolumab regimens with differing dosing patterns.
在一项针对黑色素瘤辅助性纳武利尤单抗治疗患者的研究中，两种固定剂量的纳武利尤单抗方案在现实世界中的安全性结果显示相似。然而，这项研究受到单一肿瘤患者群体、样本量小以及研究效能不足的限制。本研究的主要目的是评估在各种实体瘤患者群体中，不同给药模式的纳武利尤单抗方案之间免疫治疗相关不良反应（irAE）的发生率。
对2018年3月1日至2022年3月31日期间接受240mg每2周一次（Q2W）或480mg每4周一次（Q4W）纳武利尤单抗治疗，或从240mg Q2W转换为480mg Q4W的成年实体瘤恶性肿瘤患者进行单中心回顾性队列研究，从电子健康记录生成的报告中选取患者进行分析。评估的主要终点是irAE的发生率。次要终点包括严重irAE的发生率和治疗中断的原因。通过单因素分析比较所有三个队列之间的这些终点。然后对主要终点进行多因素分析。
240mg Q2W的纳武利尤单抗与结肠炎发生率的统计学显著增加相关，而480mg Q4W方案与瘙痒症发生率的统计学显著增加相关。三个队列之间irAE的发生率没有差异，而240mg Q2W和从240mg Q2W转换为480mg Q4W的队列中严重irAE的发生率更高。
临床医生应意识到不同给药模式的纳武利尤单抗方案之间irAE谱的差异。
