Background: Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea. Methods: An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response. Results: During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients). Conclusion This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.

PURPOSE: This study aims to investigate treatment of cancer patients at a secondary hospital. METHODS: A retrospective analysis was performed with electronic medical records of cancer patients admitted to a secondary hospital from January 1, 2009 through September 31, 2017. RESULTS: A total of 223 patients were studied. Sixty-nine patients were hospitalized for supportive care after receiving a surgery, chemotherapy, and radiotherapy at a tertiary hospital, 58 patients for other supportive care, 53 patients for symptom control, 16 patients with a decision not to take active cancer treatment, and 27 patients for treatment of cancer that was diagnosed during their hospital stay. Among 75 patients who were discharged to other institutions, 50 were transferred to tertiary hospitals, 10 to long-term care hospitals, eight to hospice hospitals, four to nursing homes and two to secondary hospitals. Comorbidities were found in 120 patients (53.8%). For patients who consulted with more than one department, more consultations were for non-cancer diseases than cancer. Seventy-three patients had a do-not-resuscitate order. CONCLUSION: For treatment of cancer patients, it is needed to establish a cooperation system among medical institutions and provide comprehensive management including treatment of comorbidities.
Comorbidity ; Drug Therapy ; Electronic Health Records ; Hospices ; Humans ; Korea* ; Length of Stay ; Long-Term Care ; Nursing Homes ; Palliative Care ; Radiotherapy ; Referral and Consultation ; Resuscitation Orders ; Retrospective Studies ; Secondary Care Centers ; Tertiary Care Centers

PURPOSE: The aim of this study was to confirm the efficacy and safety of regorafenib for advanced gastrointestinal stromal tumors (GISTs) reported in the GRID phase III trial in Korean patients. MATERIALS AND METHODS: Fifty-seven Korean patientswith advanced GISTwho experienced both imatinib and sunitinib failure were enrolled in the management access program between December 2012 and November 2013 and treated with regorafenib (160 mg orally once daily in a 3 weeks on/1 week off). RESULTS: None of the patients achieved a complete or partial response while 25 patients (44%) showed stable disease for ≥ 12 weeks. With a median follow-up of 12.7 months (range, 0.2 to 27.6 months), the median progression-free survival and overall survival were 4.5 months (95% confidence interval [CI], 3.8 to 5.3) and 12.9 months (95% CI, 8.1 to 17.7), respectively. Interestingly, 15 patients (26%) experienced an exacerbation of their cancer-related symptoms (abdominal pain in eight and abdominal distension in five) during the rest period for regorafenib, but all were ameliorated upon the resumption of regorafenib. The most common grade 3 or 4 adverse event was a hand-foot skin reaction (25%). The regorafenib dose was reduced in 44 patients (77%) due to toxicity, which manifested mainly as a hand-foot skin reaction (n=31). CONCLUSION: This study confirmed the efficacy and safety of regorafenib for advanced GIST after imatinib and sunitinib failure in Korean patients. Considering the exacerbation of the cancer-related symptoms observed during the rest periods, further exploration of the continuous dosing schedule of regorafenib is warranted in future clinical trials.
Appointments and Schedules ; Disease-Free Survival ; Follow-Up Studies ; Gastrointestinal Stromal Tumors* ; Humans ; Imatinib Mesylate* ; Skin

PURPOSE: Our study aims to analyze prognosis after implantable cardioverter-defibrillator (ICD) implantation in Korean patients with Brugada syndrome (BrS). MATERIALS AND METHODS: This was a retrospective study of BrS patients implanted with an ICD at one of four centers in Korea between January 1998 and April 2012. Sixty-nine patients (68 males, 1 female) were implanted with an ICD based on aborted cardiac arrest (n=38, 55%), history of syncope (n=17, 25%), or induced ven tricular tachyarrhythmia on electrophysiologic study in asymptomatic patients (n=14, 20%). A family history of sudden cardiac death and a spontaneous type 1 electrocardiography (ECG) were noted in 13 patients (19%) and 44 patients (64%), respectively. RESULTS: During a mean follow-up of 59+/-46 months, 4.6+/-5.5 appropri ate shocks were delivered in 19 patients (28%). Fourteen patients (20%) experienced 5.2+/-8.0 inappropriate shocks caused by supraventricular arrhythmia, lead failure, or abnormal sensing. Six patients were admitted for cardiac causes during follow-up, but no cardiac deaths occurred. An episode of aborted cardiac arrest was a significant predictor of appropriate shock, and the composite of cardiac events in the Cox pro portional hazard model [hazard ratio (95% confidence interval) was 11.34 (1.31-97.94) and 4.78 (1.41-16.22), respectively]. However, a spontaneous type 1 ECG was not a predictor of cardiac events. CONCLUSION: Appropriate shock (28%) and inappropriate shock (20%) were noted during a mean follow-up of 59+/-46 months in Korean BrS patients implanted with an ICD. An episode of aborted cardiac ar rest was the most powerful predictor of cardiac events.
Adult ; Brugada Syndrome/*therapy ; Death, Sudden, Cardiac ; *Defibrillators, Implantable ; Electrocardiography ; Female ; Humans ; Male ; Middle Aged ; Prognosis ; Republic of Korea ; Retrospective Studies ; Treatment Outcome

Mutation or common intronic variants in cardiac ion channel genes have been suggested to be associated with sudden cardiac death caused by idiopathic ventricular tachyarrhythmia. This study aimed to find mutations in cardiac ion channel genes of Korean sudden cardiac arrest patients with structurally normal heart and to verify association between common genetic variation in cardiac ion channel and sudden cardiac arrest by idiopathic ventricular tachyarrhythmia in Koreans. Study participants were Korean survivors of sudden cardiac arrest caused by idiopathic ventricular tachycardia or fibrillation. All coding exons of the SCN5A, KCNQ1, and KCNH2 genes were analyzed by Sanger sequencing. Fifteen survivors of sudden cardiac arrest were included. Three male patients had mutations in SCN5A gene and none in KCNQ1 and KCNH2 genes. Intronic variant (rs2283222) in KCNQ1 gene showed significant association with sudden cardiac arrest (OR 4.05). Four male sudden cardiac arrest survivors had intronic variant (rs11720524) in SCN5A gene. None of female survivors of sudden cardiac arrest had SCN5A gene mutations despite similar frequencies of intronic variants between males and females in 55 normal controls. Common intronic variant in KCNQ1 gene is associated with sudden cardiac arrest caused by idiopathic ventricular tachyarrhythmia in Koreans.
Adolescent ; Adult ; Aged ; Arrhythmias, Cardiac/genetics ; *Death, Sudden, Cardiac ; Ether-A-Go-Go Potassium Channels/genetics ; Female ; Genetic Markers ; Genetic Predisposition to Disease ; Genetic Variation ; Heart/physiology ; Heart Conduction System/abnormalities ; Humans ; KCNQ1 Potassium Channel/*genetics ; Male ; Middle Aged ; NAV1.5 Voltage-Gated Sodium Channel/*genetics ; Republic of Korea ; Tachycardia, Ventricular/*genetics ; Ventricular Fibrillation/*genetics ; Young Adult

BACKGROUND: Heavy alcohol consumption increases the risk of hypertension, but the effect of light to moderate alcohol consumption on the risk of hypertension remains controversial. In this cross-sectional study we aimed to identify the association between alcohol consumption and hypertension, and verify whether this association is influenced by age. METHODS: Study participants were 498 men and 610 women, aged 23 to 88 years, who underwent periodic health examinations at one institute in Incheon, Korea. RESULTS: Compared with nondrinkers, multivariate-adjusted odds ratio (OR) (95% confidence interval, CI) for hypertension according to the number of standard drinks consumed weekly was as follows: 1 to 3 drinks, OR = 1.13 (95% CI, 0.56-2.29); 4 to 10 drinks, OR = 0.51 (95% CI, 0.27-0.97); 11 to 18 drinks, OR = 1.11 (95% CI, 0.55-2.20); > or = 19 drinks per week, OR = 1.97 (95% CI, 1.18-3.29). A positive association between the prevalence of hypertension and alcohol consumption of > or = 19 drinks per week was found for patients aged > or = 60 years (OR = 2.47; 95% CI, 1.21-5.05), but not in patients aged < 60 years (OR = 1.54; 95% CI, 0.72-3.32). Light to moderate alcohol consumption from 4 to 10 drinks per week was significantly associated with a decreased risk of hypertension in subjects aged < 60 years (OR = 0.32; 95% CI, 0.11-0.97), but not in subjects aged > or = 60 years (OR = 0.70; 95% CI, 0.31-1.58). CONCLUSIONS: Light to moderate alcohol consumption can decrease the risk of hypertension, whereas heavy alcohol intake is associated with an increased risk of hypertension. The association between alcohol consumption and hypertension may be changed by age.
Age Factors ; Aged ; Alcohol Drinking ; Coronary Disease ; Cross-Sectional Studies ; Female ; Humans ; Hypertension ; Light ; Male ; Odds Ratio ; Prevalence

Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. There are no generally accepted diagnostic criteria for PsA. Indeed, the diagnosis of this inflammatory arthritis is made by exclusion of other possible diseases and based upon immunologic, radiologic, and clinical features which are consistent with the diagnosis. Inflammatory arthritis in a patient with psoriasis can be an important clue for the diagnosis of PsA, but the possibility for diagnosis of other inflammatory arthritides ever remains. Herein we report a case of a female patient who was not diagnosed with PsA, but with rheumatoid arthritis, even though she had psoriasis.
Adult ; Arthritis/classification/*diagnosis/*immunology ; Arthritis, Psoriatic/classification/*diagnosis/*immunology ; Bone and Bones/radiography/radionuclide imaging ; Diagnosis, Differential ; Female ; Humans ; Skin/pathology

PURPOSE: To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, Infanrix(TM) IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). METHODS: A total of 458 infants aged 8-12 weeks were randomized to receive three-dose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. RESULTS: One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were > or =99.5% and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. CONCLUSION: Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization.
Aged ; Appointments and Schedules ; Humans ; Immunization ; Incidence ; Infant ; Pentetic Acid ; Poliovirus ; Vaccination ; Vaccines ; Whooping Cough

Kikuchi-Fujimoto's disease (KFD), or histiocytic necrotizing lymphadenitis, is a rare benign and self-limiting disease. KFD are confused with systemic autoimmune disease as they present with localized lymphadenopathy, fever, fatigue, arthritis, leukopenia. Furthermore as KFD can occur associated with other autoimmune disease, we need to diagnose carefully. Here, we describe a case of 27-year-old female patient, diagnosed as KFD, who subsequently developed adult onset Still's disesase (AOSD). As far as we know, this is the first case of KFD with AOSD in Korea.
Adult ; Male ; Female ; Humans

BACKGROUND/AIMS: Several criteria have been proposed to increase the objectivity, reliability and validity of causality assessment of adverse drug reactions (ADR). We compared the Naranjo probability scale and the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality categories to evaluate the validity and clinical usefulness of these criteria. METHODS: We evaluated 100 ADR cases with the Naranjo probability scale and the WHO-UMC causality categories. The Spearman rank coefficient was used to determine the correlation of these criteria. The evaluation of the ADR was categorized into four groups for the Naranjo system: definite, probable, possible, and doubtful, and six groups for the WHO UMC: certain, probable, possible, unlikely, conditional/unclassified, and unassessable. RESULTS: The criteria used form these two systems showed some differences when compared with the same ADR cases. The Spearman rank coefficient was 0.519 (p<0.001) and the agreement was 55% between the Naranjo probability scale and the WHO-UMC causality categories. The Naranjo probability scale includes measurements for drug concentration, objective evidence of ADR, ADR to previous exposures, responses to placebo, and the dose adjustment of drugs. However, few cases were evaluated for all of these measures. CONCLUSIONS: The Naranjo probability scale may be helpful for assessing unexpected ADRs and useful for evaluators with little experience. However, some of the items are not utilized and there are discrepancies when compared with the WHO-UMC causality criteria.
Drug Toxicity ; Reproducibility of Results ; World Health ; World Health Organization