• Title/Summary/Keyword: immune-related adverse events

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Lumbosacral polyradiculoneuropathy associated with combination therapy of nivolumab and ipilimumab

  • Cho, Eun Bin;Kim, Seung Joo;Yang, Tae-Won;Jung, Seunguk;Jeong, Heejeong;Park, Ki-Jong
    • Annals of Clinical Neurophysiology
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    • v.24 no.1
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    • pp.26-29
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    • 2022
  • Immune checkpoint inhibitors (ICIs) have emerged as one of the most promising therapeutic options for advanced cancers. While ICIs have improved survival in multiple cancers, their increased use is restricted by various immune-related adverse events. In this report we describe a patient with renal cell carcinoma who received a combination of ICIs, nivolumab plus ipilimumab, and who developed lumbosacral polyradiculoneuropathy. Corticosteroid use was an effective treatment for this patient.

Analysis of Pembrolizumab-induced Blood Glucose Level Change in Cancer Patients (암환자에서 Pembrolizumab 투여로 인한 혈당수치 변화 분석)

  • Jung, Hee Yoon;Hong, Min-Soo;Jung, Woo Jin;Choi, Sun Ok;Chae, Jung-woo;Yun, Hwi-yeol
    • Korean Journal of Clinical Pharmacy
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    • v.31 no.3
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    • pp.237-246
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    • 2021
  • Background: Pembrolizumab, an anti-cancer drug, is known to increase the activity of the immune system, leading to side effects called immune-related adverse events (irAE), including type 1 diabetes. This study analyzed the correlation between blood glucose level and pembrolizumab administration and investigated the covariates that affect those changes in cancer treatment. Methods: The information of 133 adult cancer patients was obtained from the electronic medical record (EMR) to identify the changes in random blood glucose (RBG) levels during the pembrolizumab treatment. Subjects were classified into subgroups according to their baseline RBG level, history of diabetes, and the use of steroids, and linear regression analysis was conducted. In addition, a secondary analysis was performed within the group of subjects having a strong correlation to glycemic change, which was based on the Pearson correlation coefficient being less than -0.7 or greater than +0.7. Univariate and multivariate logistic regressions were conducted to identify the risk factors to glycemic increase. Results: The RBG level tended to descend without significant differences in total patients during the administration period of pembrolizumab. Despite the insignificance, the logistic regression analysis presents that the odds ratios of baseline RBG less than 130 mg/dL, prophylactic steroid use, and higher dose of pembrolizumab per cycle (mg/kg/cycle) were greater than 1. Conclusions: Prophylactic administration of steroids and a higher dose of pembrolizumab per cycle may increase the blood glucose level as irAE in cancer patients with a strong tendency to glycemic change.

Effects of Korean Medicine Treatment in Post-acute COVID-19 Syndrome: A Retrospective Case Series of 15 Patients (한방병원에 내원한 급성기 이후 코로나-19 환자 15명에 대한 임상적 특징 및 치료 분석 : 사례군 연구)

  • Park, Jiwon;Hong, Sung-eun;Shin, Jeong-Won;Kim, Kwan-Il;Lee, Beom-Joon;Jung, Hee-Jae
    • The Journal of Internal Korean Medicine
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    • v.43 no.3
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    • pp.396-412
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    • 2022
  • Objective: The aim of this study was to identify the clinical features of post-acute COVID-19 syndrome and the efficacy and safety of Korean medicine treatment. Methods: This study was conducted on 15 patients with post-acute COVID-19 syndrome who visited the outpatient Allergy, Immune, and Respiratory System Department at Kyung Hee University Korean Medicine Hospital from January 10, 2021 to April 10, 2022. We retrospectively analyzed the charts of 15 patients and collected clinical characteristics, Korean medicine treatments, outcome variables (Numeral Rating Scale (NRS), modified Medical Research Council scale (mMRC), Leicester Cough Questionnaire (LCQ), Quality of Life Visual Analog Scale (QOL-VAS), The Post-COVID-19 Functional Status (PCFS)), adverse events, etc. Results: Of the 15 patients, seven (46.7%) were men, and the average age of all patients was 49.7±13 years. The most common symptom was cough (n=9, 60%), and it was followed by dyspnea or increased respiratory effort, fatigue, insomnia, anosmia, etc. The herbal medicine was prescribed for all 15 patients, and Saengmaek-san (n=8, 53.5%) was the most prescribed. Additionally, acupuncture and cupping were performed in four patients (26.7%) each, and electroacupuncture was applied to one patient (6.7%). As a result of Korean medicine treatment, NRS, mMRC, LCQ, QOL-VAS, and PCFS showed improvement, and adverse events were mild. Conclusions: This study presented the clinical features of post-acute COVID-19 syndrome and suggested that Korean medicine treatment may be effective in alleviating related symptoms and enhancing quality of life.

Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study

  • Cho, Soo-Kyung;Kim, Dam;Yoo, Dasomi;Jang, Eun Jin;Jun, Jae-Bum;Sung, Yoon-Kyoung
    • Journal of Ginseng Research
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    • v.42 no.2
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    • pp.144-148
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    • 2018
  • Background: Panax ginseng is a well-known immune modulator, and there is concern that its immune-enhancing effects may negatively affect patients with rheumatoid arthritis (RA) by worsening symptoms or increasing the risk of adverse effects from other drugs. In this randomized, crossover clinical trial, we evaluated the impact of Korean Red Ginseng (KRG) on disease activity and safety in RA patients. Methods: A total of 80 female RA patients were randomly assigned to either the KRG (2 g/d, n = 40) treatment or placebo (n = 40) groups for 8 wk, followed by crossover to the other treatment group for an additional 8 wk. The primary outcome was the disease flare rate, defined as worsening disease activity according to the disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR). The secondary outcomes were development of adverse events (AEs) and patient reported outcomes. Outcomes were evaluated at baseline and 8 wk and 16 wk. The outcomes were compared using the Chi-square test. Results: Of the 80 patients, 70 completed the full study. Their mean age was 51.9 yr, and most exhibited low disease activity (mean DAS28-ESR $3.5{\pm}1.0$) at enrollment. After intervention, the flare rate was 3.7% in each group. During KRG treatment, 10 AEs were reported, while five AEs were developed with placebo; however, this difference was not statistically significant (p = 0.16). Gastrointestinal- and nervous system-related symptoms were frequent in the KRG group. Conclusion: KRG is not significantly associated with either disease flare rate or the rate of AE development in RA patients.

Evaluation of Efficacy and Safety of Nivolumab and Pembrolizumab in Elderly Cancer Patients (고령 암환자에서의 nivolumab과 pembrolizumab의 유효성과 안전성 평가)

  • Kim, Hye Sung;Jeong, HyoKeun;Shim, Mi Kyong
    • Korean Journal of Clinical Pharmacy
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    • v.30 no.1
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    • pp.11-18
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    • 2020
  • 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 treatment-related 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.

Two Cases of Intravenous Immun Globulin Non-responded Kawasaki Disease (정맥용 면역 글로불린 무반응성 가와사끼병 2례)

  • Kim, Hyeon-Bu;Cho, Byung-Soo;CHa, Sung-Ho
    • Pediatric Infection and Vaccine
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    • v.5 no.1
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    • pp.147-151
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    • 1998
  • On the treatment of Kawasaki disease, approximately 10% of children treated with IVIG have persistent or recrudescent fever despite IVIG treatment. We had experienced two children with Kawasaki disease who did not respond after multiple dosages of IVIG. They were treated within the first 10 days of onset of fever and were given oral aspirin (100mg/kg/day) and IVIG(2gm/kg) in a single infusion for 8 to 10 hours. The first child had not resolution of symptoms after three intravenous doses of IVIG(total 4gm/kg). And then treated with high dose methylprednisolone(30mg/kg) for 2 to 3 hours intravenously without symptoms improvement. On fifth hospital days, he was retreated with IVIG (2gm/kg) again with ultimate resolution of symptoms. The second child had resolution of symptoms after three intravenous doses of IVIG(total 4gm/kg). No adverse events were associated with the administration of IVIG or steroid. We reported two cases of IVIG non-responded Kawasaki disease with a brief review of the related literatures.

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Chinese Patients with Gastric Cancer Need Targeted Adjuvant Chemotherapy Schemes

  • Shi, Wen-Tao;Wei, Lei;Xiang, Jin;Su, Ke;Ding, Qiong;Tang, Meng-Jie;Li, Ji-Qiang;Guo, Yi;Wang, Pu;Zhang, Jing-Wei
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.10
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    • pp.5263-5272
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    • 2012
  • Background: Gastric cancer (GC) is one of the most common cancers in China. Adjuvant chemotherapy (AC) is a routine auxiliary treatment for GC recommended by the guidelines issued in 2011 by the Ministry of Health of the People's Republic of China, but the relevant credible consequences in China have been insufficient because of China's late start and ethical concerns. Methods: A series of databases, including Cochrane Library, MEDLINE, EMBASE, the Chinese database of the National Knowledge Infrastructure and the VIP database, were searched by 2 reviewers independently for studies investigating AC for GC through March 2012. The retrieved literature was screened according to the eligibility criteria. Results: A total of 35 randomized control trials (RCTs) were subjected to the final analysis, including 4,043 patients in treatment group and 3,884 in the control group, as well as 4 clinical-control trials (CCTs), which accessed the final analysis with 238 and 252 patients, respectively. AC reduced the risk of death as a protective treatment with statistical significance (HR=0.91, 95%CI: [0.85, 0.97], P=0.002), and it seemed more effective for Asian than non-Asian patients. The effects of AC were not influenced by the starting time (P>0.05). D2 lymphadenectomy-based chemotherapy was effective (HR=0.89, 95%CI: [0.80, 0.99], P=0.04). Oral S-1 40 mg/m2 after D2 lymphadenectomy might be a better choice for Asians with advanced GC and might result in a greater reduction of adverse events than in non-Asian patients. GRADE quality assessment determined that the strength of the evidence from foreign studies from Europe, the United States and Asian countries other than China was high, while it was moderate for Chinese studies. Conclusion: AC was effective or even curative in Chinese patients in general, although it is still necessary to optimize a targeted AC scheme for Chinese patients with GC.

Proof-of-concept study of the caninized anti-canine programmed death 1 antibody in dogs with advanced non-oral malignant melanoma solid tumors

  • Masaya Igase;Sakuya Inanaga;Shoma Nishibori;Kazuhito Itamoto;Hiroshi Sunahara;Yuki Nemoto;Kenji Tani;Hiro Horikirizono;Munekazu Nakaichi;Kenji Baba;Satoshi Kambayashi;Masaru Okuda;Yusuke Sakai;Masashi Sakurai;Masahiro Kato;Toshihiro Tsukui;Takuya Mizuno
    • Journal of Veterinary Science
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    • v.25 no.1
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    • pp.15.1-15.15
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    • 2024
  • Background: The anti-programmed death 1 (PD-1) antibody has led to durable clinical responses in a wide variety of human tumors. We have previously developed the caninized anti-canine PD-1 antibody (ca-4F12-E6) and evaluated its therapeutic properties in dogs with advance-staged oral malignant melanoma (OMM), however, their therapeutic effects on other types of canine tumors remain unclear. Objective: The present clinical study was carried out to evaluate the safety profile and clinical efficacy of ca-4F12-E6 in dogs with advanced solid tumors except for OMM. Methods: Thirty-eight dogs with non-OMM solid tumors were enrolled prospectively and treated with ca-4F12-E6 at 3 mg/kg every 2 weeks of each 10-week treatment cycle. Adverse events (AEs) and treatment efficacy were graded based on the criteria established by the Veterinary Cooperative Oncology Group. Results: One dog was withdrawn, and thirty-seven dogs were evaluated for the safety and efficacy of ca-4F12-E6. Treatment-related AEs of any grade occurred in 13 out of 37 cases (35.1%). Two dogs with sterile nodular panniculitis and one with myasthenia gravis and hypothyroidism were suspected of immune-related AEs. In 30 out of 37 dogs that had target tumor lesions, the overall response and clinical benefit rates were 6.9% and 27.6%, respectively. The median progression-free survival and overall survival time were 70 days and 215 days, respectively. Conclusions: The present study demonstrated that ca-4F12-E6 was well-tolerated in non-OMM dogs, with a small number of cases showing objective responses. This provides evidence supporting large-scale clinical trials of anti-PD-1 antibody therapy in dogs.

A Review of the Literature of the Promising Methodology of Cancer Immunotherapy Involving the Use of Traditional Oriental Herbal Medicine for Inhibiting Metastasis and Recurrence (한방 종양면역치료를 통한 전이재발 억제 방법론 연구)

  • Lee, Hyo-Jae;Lee, Yeon-Weol;Yoo, Hwa-Seung;Cho, Chong-Kwan
    • Journal of Korean Traditional Oncology
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    • v.15 no.1
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    • pp.89-103
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    • 2010
  • Background: The greatest threats to the lives of cancer patients consist of both complications due to metastasis and the recurrence of original cancer. However, the existing forms of chemotherapy do not prevent these adverse events adequately because they suppress the patients' immune systems. A new methodology is required. Aim: To provide further validation for cancer immunotherapy (involving the use of traditional oriental herbal medicine). Method: Related articles, in both Korean and English were reviewed. Results: Cancer immunotherapy involving the use of traditional oriental herbal medicine can create inhospitable conditions for cancer cells and strengthen patients' immunological functioning. These effects are a demonstration of the principles of "strengthening healthy qi (扶正)" and "eliminating pathogens (祛邪)". As a result, immunotherapy protects against metastasis and original cancer recurrence by preventing the growth of cancer cells. This is very similar to the concept of a cancer dormancy therapy. Conclusion: It is strongly urged by the authors that more advanced studies be carried out on this promising therapy in the future in order to improve patients' quality of life and increase their survival time.

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Cancer Pain Control for Advanced Cancer Patients by Using Autonomic Nerve Pharmacopuncture

  • Kang, Hwi-Joong;Yoon, Jung-Won;Park, Ji-Hye;Cho, Chong-Kwan;Yoo, Hwa-Seung
    • Journal of Pharmacopuncture
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    • v.17 no.3
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    • pp.62-69
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    • 2014
  • Objectives: The purpose of this study is to report a case series of advanced cancer patients whose cancer pain was relieved by using autonomic nerve pharmacopuncture (ANP) treatment. ANP is a subcutaneous injection therapy of mountain ginseng pharmacopuncture (MGP) along the acupoints on the spine (Hua-Tuo-Jia-Ji-Xue; 0.5 cun lateral to the lower border of the spinous processes of vertebrae) to enhance the immune system and to balance autonomic nerve function. Methods: Patients with three different types of cancer (gastric cancer, lung cancer, colon cancer with distant metastases) with cancer pain were treated with ANP. 1 mL of MGP was injected into the bilateral Hua-Tuo-Jia-Ji-Xue on the T1-L5 sites (total 12-20 mL injection) of each patient's dorsum by using the principle of symptom differentiation. During ANP treatment, the visual analogue scale (VAS) for pain was used to assess their levels of cancer pain; also, the dosage and the frequency of analgesic use were measured. Results: The cancer pain levels of all three patients improved with treatment using ANP. The VAS scores of the three patients decreased as the treatment progressed. The dosage and the frequency of analgesics also gradually decreased during the treatment period. Significantly, no related adverse events were found. Conclusion: ANP has shown benefit in controlling cancer pain for the three different types of cancer investigated in this study and in reducing the dosage and the frequency of analgesics. ANP is expected to be beneficial for reducing cancer pain and, thus, to be a promising new treatment for cancer pain.