Carfilzomib's Real-World Safety Outcomes in Korea: Target Trial Emulation Study Using Electronic Health Records.
Ha Young JangHyun Kyung LeeChae Jeong KimSung Soo YoonIn-Wha KimJung Mi OhPublished in: International journal of environmental research and public health (2022)
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.
Keyphrases
- multiple myeloma
- electronic health record
- low dose
- high dose
- clinical trial
- skeletal muscle
- adverse drug
- risk factors
- emergency department
- risk assessment
- adipose tissue
- study protocol
- type diabetes
- palliative care
- mesenchymal stem cells
- bone marrow
- metabolic syndrome
- phase ii
- open label
- weight loss
- advanced cancer
- single molecule
- double blind