Carfilzomib's Real-World Safety Outcomes in Korea: Target Trial Emulation Study Using Electronic Health Records

Area of Science:

• Oncology
• Pharmacovigilance
• Hematology

Background:

• Carfilzomib is a key treatment for relapsed/refractory multiple myeloma (RRMM).
• Existing real-world data primarily focuses on cardiovascular safety, necessitating comprehensive adverse event evaluations.
• There is a significant need to understand the safety profile of carfilzomib in diverse patient populations.

Purpose of the Study:

• To comprehensively assess the risk and patterns of adverse events associated with carfilzomib in Korean patients with RRMM.
• To compare adverse event profiles between the carfilzomib, lenalidomide, and dexamethasone (KRd) regimen and the lenalidomide and dexamethasone (Rd) regimen.
• To provide real-world evidence for optimizing the safe and effective use of KRd therapy.

Main Methods:

• A retrospective cohort study involving 138 matched patients with RRMM.
• Patients were divided into two groups: 69 receiving KRd and 69 receiving Rd.
• Evaluation of 12 specific adverse events, with follow-up across 18 cycles and analysis of event timing and severity.

Main Results:

• Over 75% of adverse events occurred within the first six cycles of treatment, with incidence decreasing in later cycles.
• Most adverse events were of mild to moderate severity (Grade 1-2).
• The KRd regimen was significantly associated with increased risks of dyspnea (aHR 2.27), muscle spasm (aHR 5.12), and thrombocytopenia (aHR 1.84) compared to Rd.

Conclusions:

• Carfilzomib, while effective, is associated with a notable incidence of adverse events in RRMM patients, particularly early in treatment.
• The KRd regimen presents specific risks including dyspnea, muscle spasms, and thrombocytopenia.
• Understanding these adverse event patterns is crucial for enhancing the safety and efficacy of carfilzomib-based therapies in clinical practice.