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Evaluation of Nivolumab Use and Factors related to Treatment Outcomes in a Cancer Center of a Top Tier General Hospital
Korean J Clin Pharm 2018;28(2):88-94
Published online June 30, 2018
© 2018 Korean College of Clinical Pharmacy.

Gohye Eoum1,2, Yoonsook Cho2, and Sandy Jeong Rhie1,3*

1Graduate School of Converging Clinical and Public Health, Ewha Womans University, Seoul 03760, Republic of Korea
2Department of Pharmacy, Seoul National University Hospital, Seoul 03080, Republic of Korea
3College of Pharmacy & Division of Life and Pharmaceutical Sciences, Ewha Womans University, Seoul 03760, Republic of Korea
Correspondence to: * Sandy Jeong Rhie, Graduate School of Converging Clinical and Public Health and College of Pharmacy & Division of Life and Pharmaceutical Sciences, Ewha Womans University, 52 ewhayeodae-gil, Seodaemun-gu, Seoul 03760, Republic of Korea
Tel: +82-2-3277-3023, Fax: +82-2-3277-2085 E-mail: sandy.rhie@ewha.ac.kr
Received June 2, 2018; Revised June 17, 2018; Accepted June 18, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: We strived to evaluate the status of nivolumab use and associated factors on the clinical efficacy of the drug.
Methods: The study was retrospectively conducted in patients who had been administered nivolumab at least once at the cancer center of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. A medication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-use guidelines.
Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry of Food and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients were administered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overall response rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number of indications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression of programmed death-ligand 1 (PD-L1) was analyzed as a factor affecting treatment response (p=0.028, odds ratio [OR]=11.331).
Conclusion: PD-L1 expression was found to affect treatment response. However, caution is required while using an unapproved dosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for the proper use of nivolumab should be considered.
Keywords : Nivolumab, programmed death-ligand 1, drug evaluation criteria, immune-oncology therapy, immune-checkpoint blockade


June 2018, 28 (2)
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