고령 암환자에서의 nivolumab과 pembrolizumab의 유효성과 안전성 평가
Evaluation of Efficacy and Safety of Nivolumab and Pembrolizumab in Elderly Cancer Patients
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Objective: Nivolumab and pembrolizumab are antagonists of the programmed death-ligand 1 (PD-L1) receptor that function as immuno-oncological agents. This study aimed to evaluate the safety and efficacy of nivolumab and pembrolizumab in elderly patients in outpatient settings. Methods: The safety and efficacy of nivolumab and pembrolizumab were compared retrospectively among patients at the Veterans Health Service (VHS) Medical Center in Seoul, South Korea, from September 1, 2017 to August 25, 2018. Results: Eighty-seven patients were selected for the study. The median progression-free survival was 63 days for nivolumab (95% confidence interval (CI), [14 to 282]) vs. 243 days for pembrolizumab (95% CI, [22 to 348]) (p =0.04). The objective response rate (ORR) was 0% in the nivolumab group vs 5.6% in the pembrolizumab group (p =0.310). All the patients exhibited treatmentrelated adverse effects. More than 89% of the patients exhibited diseases of the gastrointestinal (GI) tract. Pneumonia, of grades three or higher, was the most common adverse effect, followed by weakness and anorexia. Conclusion: There was no statistically significant difference between the nivolumab group and the pembrolizumab group with respect to the ORR. The incidence and severity of the adverse effects in this study were higher than those of previous studies; however, these adverse effects are generally manageable in a real-world clinical setting. Further randomized controlled studies will be necessary to confirm these results in elderly patients.
Abstract
Objective: Nivolumab and pembrolizumab are antagonists of the programmed death-ligand 1 (PD-L1) receptor that function as immuno-oncological agents. This study aimed to evaluate the safety and efficacy of nivolumab and pembrolizumab in elderly patients in outpatient settings. Methods: The safety and efficacy of nivolumab and pembrolizumab were compared retrospectively among patients at the Veterans Health Service (VHS) Medical Center in Seoul, South Korea, from September 1, 2017 to August 25, 2018. Results: Eighty-seven patients were selected for the study. The median progression-free survival was 63 days for nivolumab (95% confidence interval (CI), [14 to 282]) vs. 243 days for pembrolizumab (95% CI, [22 to 348]) (p =0.04). The objective response rate (ORR) was 0% in the nivolumab group vs 5.6% in the pembrolizumab group (p =0.310). All the patients exhibited treatmentrelated adverse effects. More than 89% of the patients exhibited diseases of the gastrointestinal (GI) tract. Pneumonia, of grades three or higher, was the most common adverse effect, followed by weakness and anorexia. Conclusion: There was no statistically significant difference between the nivolumab group and the pembrolizumab group with respect to the ORR. The incidence and severity of the adverse effects in this study were higher than those of previous studies; however, these adverse effects are generally manageable in a real-world clinical setting. Further randomized controlled studies will be necessary to confirm these results in elderly patients.
참고문헌 (16)
- Siegel RL, "Cancer statistics, 2018", Cancer J Clin, 68, pp.7~30 (2018)
- 정규원, "Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2016", Cancer Research and Treatment, 51(2), pp.417~430 (2019), 대한암학회
- Michot JM, "Immune-related adverse events with immune checkpoint blockade : a comprehensive review", Eur J Cancer, 54, pp.139~148 (2016)
- 엄고혜, "상급종합병원 암센터에서 Nivolumab 사용평가와 치료성과에 미치는 영향인자", 한국임상약학회지, 28(2), pp.88~94 (2018), 한국임상약학회[DOI]
- Kang YK, "Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to,or intolerant of, at least two previous chemotherapy regimens(ONO-4538-12,ATTRACTION-2): a randomized, double-blind, placebo-controlled, phase 3 trial", Lancet, 390, pp.2461~2471 (2017)
- Herbst RS, "Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE 010): a randomized controlled trial", Lancet, 387, pp.1540~1550 (2016)
- Montecino-Rodriguez E, "Causes, consequences, and reversal of immune system aging", J Clin Invest, 123, pp.958~965 (2013)
- Hao C, "Efficacy and safety of anti-PD-1 and anti-PD-1 combined with anti-CTLA-4 immunotherapy to advanced melanoma: A systematic review and meta-analysis of randomized controlled trials", Medicine (Baltimore), 96(26), pp.e7325~ (2017)
- Johnson DB, "Immune checkpoint inhibitors in challenging populations", Cancer, 123(11), pp.1904~1911 (2017)
- Kanesvaran R, "Immunotherapy in older adults with advanced cancers : implications for clinical decisionmaking and future research", Am Soc Clin Oncol Educ Book, 38, pp.400~414 (2018)
- "Question and answer for medical care application of immune checkpoint inhibitors, nivolumab and pembrolizumab"[URL]
- Passiglia F, "Looking for the best immunecheckpoint inhibitor in pre-treated NSCLC patients: An indirect comparison between nivolumab, pembrolizumab and atezolizumab", Int J Cancer, 142(6), pp.1277~1284 (2018)
- Ellis PM, "Immune checkpoint inhibitors for patients with advanced non-small-cell lung cancer : A systematic review", Clin Lung Cancer, 18(5), pp.444~459 (2017)
- Yan tie, "Safety and efficacy of nivolumab in the treatment of cancers : A meta-analysis of 27prospective clinical trials", Int J Cancer, 140, pp.948~958 (2017)
- Wang M, "Safety and efficacy profile of pembrolizumab in solid cancer : pooled reanalysis based on randomized controlled trials", Drug Des Devel Ther, 11, pp.2851~2860 (2017)
- Reck M, "Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer", N Engl J Med, 375, pp.1823~1833 (2016)