• Title/Summary/Keyword: fatal adverse events

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Peripheral Blood Immune Cell-based Biomarkers in Anti-PD-1/PD-L1 Therapy

  • Kyung Hwan Kim;Chang Gon Kim;Eui-Cheol Shin
    • IMMUNE NETWORK
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    • v.20 no.1
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    • pp.8.1-8.15
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    • 2020
  • Immune checkpoint blockade targeting PD-1 and PD-L1 has resulted in unprecedented clinical benefit for cancer patients. Anti-PD-1/PD-L1 therapy has become the standard treatment for diverse cancer types as monotherapy or in combination with other anticancer therapies, and its indications are expanding. However, many patients do not benefit from anti-PD-1/PD-L1 therapy due to primary and/or acquired resistance, which is a major obstacle to broadening the clinical applicability of anti-PD-1/PD-L1 therapy. In addition, hyperprogressive disease, an acceleration of tumor growth following anti-PD-1/PD-L1 therapy, has been proposed as a new response pattern associated with deleterious prognosis. Anti-PD-1/PD-L1 therapy can also cause a unique pattern of adverse events termed immune-related adverse events, sometimes leading to treatment discontinuation and fatal outcomes. Investigations have been carried out to predict and monitor treatment outcomes using peripheral blood as an alternative to tissue biopsy. This review summarizes recent studies utilizing peripheral blood immune cells to predict various outcomes in cancer patients treated with anti-PD-1/PD-L1 therapy.

Clinical Characteristics and Treatment of Immune-Related Adverse Events of Immune Checkpoint Inhibitors

  • Juwhan Choi;Sung Yong Lee
    • IMMUNE NETWORK
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    • v.20 no.1
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    • pp.9.1-9.21
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    • 2020
  • Immune checkpoint inhibitors (ICIs) have been changing the paradigm of cancer treatment. However, immune-related adverse effects (irAEs) have also increased with the exponential increase in the use of ICIs. ICIs can break up the immunologic homeostasis and reduce T-cell tolerance. Therefore, inhibition of immune checkpoint can lead to the activation of autoreactive T-cells, resulting in various irAEs similar to autoimmune diseases. Gastrointestinal toxicity, endocrine toxicity, and dermatologic toxicity are common side effects. Neurotoxicity, cardiotoxicity, and pulmonary toxicity are relatively rare but can be fatal. ICI-related gastrointestinal toxicity, dermatologic toxicity, and hypophysitis are more common with anti- CTLA-4 agents. ICI-related pulmonary toxicity, thyroid dysfunction, and myasthenia gravis are more common with PD-1/PD-L1 inhibitors. Treatment with systemic steroids is the principal strategy against irAEs. The use of immune-modulatory agents should be considered in case of no response to the steroid therapy. Treatment under the supervision of multidisciplinary specialists is also essential, because the symptoms and treatments of irAEs could involve many organs. Thus, this review focuses on the mechanism, clinical presentation, incidence, and treatment of various irAEs.

Risk of Treatment-related Mortality with Sorafenib in Patients with Cancer

  • Zhang, Xin-Ji;Zhang, Tian-Yi;Yu, Fei-Fei;Wei, Xin;Li, Ye-Sheng;Xu, Feng;Wei, Li-Xin;He, Jia
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.11
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    • pp.6681-6686
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    • 2013
  • Background: Fatal adverse events (FAEs) have been reported with sorafenib, a vascular endothelial growth factor receptor kinase inhibitor (VEGFR TKI). We here performed an up-to-date and detailed meta-analysis to determine the overall risk of FAEs associated with sorafenib. Methods: Databases, including PubMed, Embase and Web of Science, and abstracts presented at the American Society of Clinical Oncology annual meetings were searched to identify relevant studies. Eligible studies included randomized controlled trials evaluating sorafenib effects in patients with all malignancies. Summary incidence rates, relative risks (RRs), and 95% confidence intervals (CIs) were calculated for FAEs. In addition, subgroup analyses were performed according to tumor type and therapy regimen. Results: 13 trials recruiting 5,546 patients were included in our analysis. The overall incidence of FAEs with sorafenib was 1.99% (95%CI, 0.98-4.02%). Patients treated with sorafenib had a significantly increased risk of FAEs compared with patients treated with control medication, with an RR of 1.77 (95%CI 1.25-2.52, P=0.001). Risk varied with tumour type, but appeared independent of therapy regimen. A significantly increased risk of FAEs was observed in patients with lung cancer (RR 2.26; 95% CI 1.03-4.99; P= 0.043) and renal cancer (RR 1.84; 95% CI 1.15-2.94; P= 0.011). The most common causes of FAEs were hemorrhage (8.6%) and thrombus or embolism (4.9%). Conclusions: It is important for health care practitioners to be aware of the risks of FAEs associated with sorafenib, especially in patients with renal and lung cancer.

A Case of Recurrent Ventricular Tachycardia after Pimozide and Haloperidol Overdose (Pimozide와 Haloperidol 과량 복용 후 반복적으로 발생한 심실 빈맥 1례)

  • Jung, Jin-Hee;Jang, Hye-Young;Eo, Eun-Kyung
    • Journal of The Korean Society of Clinical Toxicology
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    • v.3 no.1
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    • pp.67-70
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    • 2005
  • Pimozide and haloperidol are typical antipsychotics. They share a similarity in pharmacotherapeutic and adverse effect profiles. Cardiovascular effects may be seen as alterations in heart rate, blood pressure, and cardiac conduction. Conduction disturbances may occur ranging from asymptomatic prolongation of the QT interval to fatal ventricular arrhythmia. So in the case of anti psychotics overdose, the patient must be carefully monitored by continuous electrocardiography (ECG). We experienced a 34-year-old woman of schizophrenia with recurrent ventricular tachycardia after pimozide and haloperidol overdose. Initially she was slightly drowsy, however her ECG showed normal sinus rhythm. After 6 hours on emergency department entrance, her ECG monitoring showed ventricular tachycardia and we successfully defibrillated. There were five times events of ventricular arrhythmia during the in-hospital stay. She was discharged 5 days later without any other complications.

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Left Ventricular Ejection Fraction Predicts Poststroke Cardiovascular Events and Mortality in Patients without Atrial Fibrillation and Coronary Heart Disease

  • Lee, Jeong-Yoon;Sunwoo, Jun-Sang;Kwon, Kyum-Yil;Roh, Hakjae;Ahn, Moo-Young;Lee, Min-Ho;Park, Byoung-Won;Hyon, Min Su;Lee, Kyung Bok
    • Korean Circulation Journal
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    • v.48 no.12
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    • pp.1148-1156
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    • 2018
  • Background and Objectives: It is controversial that decreased left ventricular function could predict poststroke outcomes. The purpose of this study is to elucidate whether left ventricular ejection fraction (LVEF) can predict cardiovascular events and mortality in acute ischemic stroke (AIS) without atrial fibrillation (AF) and coronary heart disease (CHD). Methods: Transthoracic echocardiography was conducted consecutively in patients with AIS or transient ischemic attack at Soonchunhyang University Hospital between January 2008 and July 2016. The clinical data and echocardiographic LVEF of 1,465 patients were reviewed after excluding AF and CHD. Poststroke disability, major adverse cardiac events (MACE; nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death) and all-cause mortality during 1 year after index stroke were prospectively captured. Cox proportional hazards regressions analysis were applied adjusting traditional risk factors and potential determinants. Results: The mean follow-up time was $259.9{\pm}148.8days$ with a total of 29 non-fatal strokes, 3 myocardial infarctions, 33 cardiovascular deaths, and 53 all-cause mortality. The cumulative incidence of MACE and all-cause mortality were significantly higher in the lowest LVEF (<55) group compared with the others (p=0.022 and 0.009). In prediction models, LVEF (per 10%) had hazards ratios of 0.54 (95% confidence interval [CI], 0.36-0.80, p=0.002) for MACE and 0.61 (95% CI, 0.39-0.97, p=0.037) for all-cause mortality. Conclusions: LVEF could be an independent predictor of cardiovascular events and mortality after AIS in the absence of AF and CHD.

Medical disputes related to advanced endoscopic procedures with endoscopic retrograde cholangiopancreatography or endoscopic ultrasonography for the management of pancreas and biliary tract diseases

  • Yoon Suk Lee;Jae-Young Jang;Jun Yong Bae;Eun Hye Oh;Yehyun Park;Yong Hwan Kwon;Jeong Eun Shin;Jun Kyu Lee;Tae Hee Lee;Chang Nyol Paik
    • Clinical Endoscopy
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    • v.56 no.4
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    • pp.499-509
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    • 2023
  • Background/Aims: This study aimed to evaluate the characteristics of endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasonography (EUS)-related adverse events (AEs) that eventually lead to medical disputes or claims on medical professional liability. Methods: Medical disputes for ERCP/EUS-related AEs filed in the Korea Medical Dispute Mediation and Arbitration Agency between April 2012 and August 2020 were evaluated using corresponding medical records. AEs were categorized into three sections: procedure-related, sedation-related, and safety-related AEs. Results: Among a total of 34 cases, procedure-related AEs were 26 (76.5%; 12 duodenal perforations, 7 post-ERCP pancreatitis, 5 bleedings, 2 perforations combined with post-ERCP pancreatitis); sedation-related AEs were 5 (14.7%; 4 cardiac arrests, 1 desaturation), and safety-related AEs were 3 (8.8%; 1 follow-up loss for stent removal, 1 asphyxia, 1 fall). Regarding clinical outcomes, 20 (58.8%) were fatal and eventually succumbed to AEs. For the types of medical institutions, 21 cases (61.8%) occurred at tertiary or academic hospitals, and 13 (38.2%) occurred at community hospitals. Conclusions: The ERCP/EUS-related AEs filed in Korea Medical Dispute Mediation and Arbitration Agency showed distinct features: duodenal perforation was the most frequent AE, and clinical outcomes were fatal, resulting in at least more than permanent physical impairment.

Functional Dyspepsia (기능성 소화불량증)

  • Song, Kyung Ho
    • Korean Journal of Psychosomatic Medicine
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    • v.24 no.1
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    • pp.3-8
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    • 2016
  • Functional dyspepsia is one of the most common bowel disorders as prevalent of 7.7% Korean population. The cardinal manifestations include bothersome postprandial fullness, early satiation, epigastric burning or pain. These features are chronic and should be presented recurrently with no other compatible organic disease to explain the symptoms. Even though it is not life-shortening, functional dyspepsia usually make the health-related quality of life worse especially if other functional bowel disorder coexist. The coexistence of functional bowel disorders is called as 'overlap syndrome'. Anxiety, somatization and insomnia is more prevalent in overlap syndrome compared with sole functional bowel disorder. Therefore, it is worthwhile that physician interviews and elucidates whether the dyspeptic patient had other kinds of functional bowel disorders, and manages the underlying psychotic pathology. Placebo effect is large in functional dyspepsia, and there is only four kinds of prokinetics that is proven to be superior to placebo. Adverse events relating prolonged administration of prokinetics sometimes fatal or irreversible, physician willing to describe prokinetics should be familiar to the possible adverse effects and the relating risk factors. Pathologic acid reflux is not uncommon in functional dyspepsia, and acid-suppressant is equivalent to the prokientics in most of dyspeptic patients.

Comparing High-Intensity Versus Low-to Moderate-Intensity Statin Therapy in Korean Patients with Acute Myocardial Infarction (한국인 심근경색증 환자에서 고강도 및 저·중강도 스타틴 치료에 따른 임상경과)

  • Kim, Minah;Kim, Hyun Kuk;Ahn, Youngkeun;Park, Hyukjin;Jeong, Myung Ho;Cho, Jeong Gwan;Park, Jong Chun;Kim, Young Jo;Cho, Myeong Chan;Kim, Chong Jin
    • Journal of Lipid and Atherosclerosis
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    • v.3 no.2
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    • pp.97-104
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    • 2014
  • Objective: The aim of this study is to compare the clinical benefits between high-intensity and low-to moderate-intensity statin therapy in patients with acute myocardial infarction (AMI). Methods: A total of 1,230 patients in the Korea AMI Registry (KAMIR) were enrolled. Patients were divided into two groups according to the dosage of statin for the secondary prevention after AMI. The primary endpoint was composite of major adverse cardiac events (MACEs) including cardiac death, non-fatal MI, repeat revascularization during the 12 months of clinical follow-up. Result: The primary endpoint occurred in 101 patients (11.3%) from the low-to moderate-intensity statin group and 45 patients (13.4%) from the high-intensity statin group. The cumulative incidence of MACEs during 12-month follow-up was not significantly different between the two groups (p=0.323). After multi-variate analysis, MACEs-free survival rate was not significantly different between the two groups. Conclusion: High-intensity statin therapy did not show additional clinical benefit over low-to moderate-intensity statin therapy after AMI.

Long-term clinical outcome of acute myocardial infarction according to the early revascularization method: a comparison of primary percutaneous coronary interventions and fibrinolysis followed by routine invasive treatment

  • Min, Hyang Ki;Park, Ji Young;Choi, Jae Woong;Ryu, Sung Kee;Kim, Seunghwan;Song, Chang Sup;Kim, Dong Shin;Song, Chi Woo;Kim, Se Jong;Kim, Young Bin
    • Journal of Yeungnam Medical Science
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    • v.34 no.2
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    • pp.191-199
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    • 2017
  • Background: This study was conducted to provide a comparison between the clinical outcomes of primary percutaneous coronary intervention (PCI) and that of fibrinolysis followed by routine invasive treatment in ST elevation myocardial infarction (STEMI). Methods: A total of 184 consecutive STEMI patients who underwent primary PCI or fibrinolysis followed by a routine invasive therapy were enrolled from 2004 to 2011, and their major adverse cardiovascular events (MACEs) were compared. Results: Among the 184 patients, 146 patients received primary PCI and 38 patients received fibrinolysis. The baseline clinical characteristics were similar between both groups, except for triglyceride level ($68.1{\pm}66.62$ vs. $141.6{\pm}154.3mg/dL$, p=0.007) and high density lipoprotein level ($44.6{\pm}10.3$ vs. $39.5{\pm}8.1mg/dL$, p=0.005). The initial creatine kinase-MB level was higher in the primary PCI group ($71.5{\pm}114.2$ vs. $35.9{\pm}59.9ng/mL$, p=0.010). The proportion of pre-thrombolysis in MI 0 to 2 flow lesions (92.9% vs. 73.0%, p<0.001) was higher and glycoprotein IIb/IIIa inhibitors were administered more frequently in the primary PCI group. There was no difference in the 12-month clinical outcomes, including all-cause mortality (9.9% vs. 8.8%, p=0.896), cardiac death (7.8% vs. 5.9%, p=0.845), non-fatal MI (1.4% vs. 2.9%, p=0.539), target lesion revascularization (5.7% vs. 2.9%, p=0.517), and stroke (0% vs. 0%). The MACEs free survival rate was similar for both groups (odds ratio, 0.792; 95% confidence interval, 0.317-1.980; p=0.618). The clinical outcome of thrombolysis was not inferior, even when compared with primary PCI performed within 90 minutes. Conclusion: Early fibrinolysis with optimal antiplatelet and antithrombotic therapy followed by appropriate invasive procedure would be a comparable alternative to treatment of MI, especially in cases of shorter-symptom-to-door time.