College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul 08826, Korea.
Department of Internal Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongro-gu, Seoul 03080, Korea.
Int J Environ Res Public Health. 2022 Oct 19;19(20):13560. doi: 10.3390/ijerph192013560.
Carfilzomib is a promising anticancer drug for relapsed/refractory multiple myeloma (RRMM). However, real-world evidence has only investigated the cardiovascular safety of carfilzomib, and there is a high demand for thorough safety evaluations. We aimed to comprehensively evaluate the risk of adverse events associated with carfilzomib in Korean patients with RRMM. We followed up with 138 matched patients with RRMM (69 KRd (carfilzomib, lenalidomide, and dexamethasone) and 69 Rd (lenalidomide and dexamethasone) users). A total of 12 adverse events were evaluated. More than 75% of adverse events occurred during the early cycle (1-6 cycles), and the incidence rate showed a tendency to decrease in the later cycle (7-12 and 13-18 cycles). Severities of most adverse events were evaluated as grade 1-2. The KRd regimen were related with significantly increased risks of dyspnea (adjusted HR (aHR) 2.27, 95% confidence interval (CI) 1.24-4.16), muscle spasm (aHR 5.12, 95% CI 1.05-24.9) and thrombocytopenia (aHR 1.84, 95% CI 1.10-3.06). Although the severities were low, carfilzomib has many side effects in treating RRMM; hence, findings on the patterns of its adverse events could lead to both effective and safe use of KRd therapy in real-world settings.
卡非佐米是一种有前途的用于治疗复发/难治性多发性骨髓瘤(RRMM)的抗癌药物。然而,真实世界的证据仅调查了卡非佐米的心血管安全性,并且对彻底的安全性评估有很高的需求。我们旨在全面评估卡非佐米在韩国 RRMM 患者中相关不良事件的风险。我们对 138 名 RRMM 匹配患者进行了随访(69 名 KRd(卡非佐米、来那度胺和地塞米松)和 69 名 Rd(来那度胺和地塞米松)使用者)。共评估了 12 种不良事件。超过 75%的不良事件发生在早期周期(1-6 个周期),并且在后期周期(7-12 和 13-18 个周期)中发生率呈下降趋势。大多数不良事件的严重程度评估为 1-2 级。KRd 方案与呼吸困难(调整后的 HR(aHR)2.27,95%置信区间(CI)1.24-4.16)、肌肉痉挛(aHR 5.12,95%CI 1.05-24.9)和血小板减少症(aHR 1.84,95%CI 1.10-3.06)的风险显著增加相关。尽管严重程度较低,但卡非佐米在治疗 RRMM 时具有许多副作用;因此,对其不良事件模式的发现可能会导致 KRd 治疗在真实环境中的有效和安全使用。