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KMID : 1011320180100020068
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Journal of Pharmacoepidemiology and Risk Management
2018 Volume.10 No. 2 p.68 ~ p.76
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A Post Marketing Surveillance to Evaluate the Safety and Effectiveness of Everolimus (Afinitor®) in Korean Patients
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Jeong Ka-Young
Beck Sung-Ho
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Abstract
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Objective: The purpose of this study was to evaluate the safety and effectiveness of everolimus in Korean patients with renal cell carcinoma (RCC), breast cancer (BC), pancreatic neuroendocrine tumor (pNET), and tuberous sclerosis complex (TSC)-related subependymal giant cell astrocytoma (SEGA) or renal angiomyolipoma (AML) in the real-world setting, as a regulatory requirement of Ministry of Food and Drug Safety (MFDS) in Korea.
Methods: This study was a multi-center, open-label, prospective, non-comparative, non-interventional study to evaluate the safety and effectiveness of everolimus. A total of 278 RCC subjects were enrolled in 37 hospitals from June 2009 to June 2013. However, to meet a requirement of MFDS, 43 subjects with BC, pNET, and TSC-SEGA/AML (26, 14, and 3, respectively) were additionally enrolled in 11 hospitals from March 2014 to March 2015. The primary endpoint was the incidence of adverse events (AEs) and the secondary endpoint was the best overall response according to response evaluation criteria in solid tumors (RECIST) 1.1 for RCC, BC, and pNET or the response according to magnetic resonance imaging (MRI) or computed tomography (CT) for TSC-SEGA/AML up to between two to three months after administration of everolimus.
Results: Out of the 321 subjects, 309 were included in the safety analysis set and 192 out of the 309 were included in the effectiveness analysis set. The incidences of all grades AEs were as follows: RCC 79.70%, BC 65.38%, pNET 78.57%, and
TSC-SEGA/AML 33.33%. The incidences of ADRs were as follows: RCC 63.91%, BC 42.31%, pNET 64.29%, and TSC-SEGA/AML 33.33%. The effectiveness was evaluated three months after administration, and the cases with ‘efficacious’ are as it follows: RCC 75.00% (132/176 subjects, 95% confidence interval [CI]: 68.60 81.40), BC 72.73% (8/11 subjects, 95% CI: 39.03 93.98), and pNET 75.00% (3/4 subjects, 95% CI: 19.41 99.37). One subject with TSC-SEGA was evaluated as ‘response’.
Conclusion: The safety results in the surveillance showed no newly identified safety concern in patients who have received everolimus in clinical practice in Korea.
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KEYWORD
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Everolimus, Carcinoma, Renal cell, Breast neoplasms, Neuroendocrine tumors, Astrocytoma, Angiomyolipoma
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