Korean J Clin Pharm.  2018 Jun;28(2):88-94. 10.24304/kjcp.2018.28.2.88.

Evaluation of Nivolumab Use and Factors related to Treatment Outcomes in a Cancer Center of a Top Tier General Hospital

• Eoum G
• Cho Y
• Rhie SJ

• KMID: 2416666
• DOI: http://doi.org/10.24304/kjcp.2018.28.2.88

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.

Keyword

Nivolumab; programmed death-ligand 1; drug evaluation criteria; immune-oncology therapy; immune-checkpoint blockade

MeSH Terms

Carcinoma, Non-Small-Cell Lung
Electronic Health Records
Hospitals, General*
Humans
Odds Ratio
Pharmacists
Retrospective Studies
Seoul
Treatment Outcome
United States Food and Drug Administration