ABSTRACT
Background@#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. @*Conclusions@#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
Background@#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. @*Conclusions@#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: Opioid analgesics, for postoperative pain management, are an indispensable group of medication; however, they also have a variety of adverse drug reactions (ADR). Multimodal methods, combining non-opioid analgesics with opioid analgesics, have been investigated to increase the effects of analgesics and reduce ADR with opioid-sparing effects. The purpose of this study was to compare the effects of patient-controlled analgesia (PCA) with fentanyl alone, and PCA with fentanyl and intravenous (i.v.) propacetamol to determine the effects of pain control, cumulative opioid usage, and opioid ADR. METHODS: The subjects were patients who underwent total knee arthroplasty at the Seoul Veterans hospital from January 1, 2015 to December 31, 2016. The study period was from postoperative day 0 (POD0) to day 3 (POD3), and the retrospective study was conducted using electronic medical records. RESULTS: Pain severity was significantly low at POD1 (p = 0.017), POD2 (p = 0.003), and POD3 (p = 0.002) in the multimodal group. The fentanyl only group frequently reported both moderate and severe pain at a statistically significant level. This was consistent with the analysis of the pro re nata (PRN) intramuscular analgesia usage at the time of numerical rating scale (NRS) 4 and above. The opioid-sparing effect confirmed that the average opioid dose equivalent to i.v. morphine dose was 9.4 mg more than that used for the multimodal group in the fentanyl only group. The ADRs and length of stay between the two groups were not statistically different. CONCLUSION: The results of this study suggest that the combination therapy of fentanyl and i.v. propacetamol is superior to fentanyl monotherapy.