상급종합병원 암센터에서 Nivolumab 사용평가와 치료성과에 미치는 영향인자
Evaluation of Nivolumab Use and Factors related to Treatment Outcomes in a Cancer Center of a Top Tier General Hospital
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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 cancercenter of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. Amedication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-useguidelines. Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry ofFood and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients wereadministered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overallresponse rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number ofindications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression ofprogrammed 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 unapproveddosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for theproper use of nivolumab should be considered.
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 cancercenter of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. Amedication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-useguidelines. Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry ofFood and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients wereadministered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overallresponse rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number ofindications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression ofprogrammed 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 unapproveddosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for theproper use of nivolumab should be considered.
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