Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Evaluation of Nivolumab Use and Factors related to Treatment Outcomes in a Cancer Center of a Top Tier General Hospital

상급종합병원 암센터에서 Nivolumab 사용평가와 치료성과에 미치는 영향인자

  • Eoum, Gohye (Graduate School of Converging Clinical and Public Health, Ewha Womans University) ;
  • Cho, Yoonsook (Department of Pharmacy, Seoul National University Hospital) ;
  • Rhie, Sandy Jeong (Graduate School of Converging Clinical and Public Health, Ewha Womans University)
  • 엄고혜 (이화여자대학교 임상보건융합대학원) ;
  • 조윤숙 (서울대학교병원 약제부) ;
  • 이정연 (이화여자대학교 임상보건융합대학원)
  • Received : 2018.06.02
  • Accepted : 2018.06.18
  • Published : 2018.06.29
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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

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