1.Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea
Seo-Yeon AHN ; Sang Kyun SON ; Gyu Hyung LEE ; Inho KIM ; June-Won CHEONG ; Won Sik LEE ; Byung Soo KIM ; Deog-Yeon JO ; Chul Won JUNG ; Chu Myoung SEONG ; Jae Hoon LEE ; Young Jin YUH ; Min Kyoung KIM ; Hun-Mo RYOO ; Moo-Rim PARK ; Su-Hee CHO ; Hoon-Gu KIM ; Dae Young ZANG ; Jinny PARK ; Hawk KIM ; Seryeon LEE ; Sung-Hyun KIM ; Myung Hee CHANG ; Ho Sup LEE ; Chul Won CHOI ; Jihyun KWON ; Sung-Nam LIM ; Suk-Joong OH ; Inkyung JOO ; Dong-Wook KIM
Blood Research 2022;57(2):144-151
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.
2.Concurrent Chemoradiotherapy with Temozolomide Followed by Adjuvant Temozolomide for Newly Diagnosed Glioblastoma Patients: A Retrospective Multicenter Observation Study in Korea.
Byung Sup KIM ; Ho Jun SEOL ; Do Hyun NAM ; Chul Kee PARK ; Il Han KIM ; Tae Min KIM ; Jeong Hoon KIM ; Young Hyun CHO ; Sang Min YOON ; Jong Hee CHANG ; Seok Gu KANG ; Eui Hyun KIM ; Chang Ok SUH ; Tae Young JUNG ; Kyung Hwa LEE ; Chae Yong KIM ; In Ah KIM ; Chang Ki HONG ; Heon YOO ; Jin Hee KIM ; Shin Hyuk KANG ; Min Kyu KANG ; Eun Young KIM ; Sun Hwan KIM ; Dong Sup CHUNG ; Sun Chul HWANG ; Joon Ho SONG ; Sung Jin CHO ; Sun Il LEE ; Youn Soo LEE ; Kook Jin AHN ; Se Hoon KIM ; Do Hun LIM ; Ho Shin GWAK ; Se Hoon LEE ; Yong Kil HONG
Cancer Research and Treatment 2017;49(1):193-203
PURPOSE: The purpose of this study was to investigate the feasibility and survival benefits of combined treatment with radiotherapy and adjuvant temozolomide (TMZ) in a Korean sample. MATERIALS AND METHODS: A total of 750 Korean patients with histologically confirmed glioblastoma multiforme, who received concurrent chemoradiotherapy with TMZ (CCRT) and adjuvant TMZ from January 2006 until June 2011, were analyzed retrospectively. RESULTS: After the first operation, a gross total resection (GTR), subtotal resection (STR), partial resection (PR), biopsy alone were achieved in 388 (51.7%), 159 (21.2%), 96 (12.8%), and 107 (14.3%) patients, respectively. The methylation status of O6-methylguanine-DNA methyltransferase (MGMT) was reviewed retrospectively in 217 patients. The median follow-up period was 16.3 months and the median overall survival (OS) was 17.5 months. The actuarial survival rates at the 1-, 3-, and 5-year OS were 72.1%, 21.0%, and 9.0%, respectively. The median progression-free survival (PFS) was 10.1 months, and the actuarial PFS at 1-, 3-, and 5-year PFS were 42.2%, 13.0%, and 7.8%, respectively. The patients who received GTR showed a significantly longer OS and PFS than those who received STR, PR, or biopsy alone, regardless of the methylation status of the MGMT promoter. Patients with a methylated MGMT promoter also showed a significantly longer OS and PFS than those with an unmethylated MGMT promoter. Patients who received more than six cycles of adjuvant TMZ had a longer OS and PFS than those who received six or fewer cycles. Hematologic toxicity of grade 3 or 4 was observed in 8.4% of patients during the CCRT period and in 10.2% during the adjuvant TMZ period. CONCLUSION: Patients treated with CCRT followed by adjuvant TMZ had more favorable survival rates and tolerable toxicity than those who did not undergo this treatment.
Biopsy
;
Chemoradiotherapy*
;
Disease-Free Survival
;
Follow-Up Studies
;
Glioblastoma*
;
Humans
;
Korea*
;
Methylation
;
Radiotherapy
;
Retrospective Studies*
;
Survival Rate
3.A Unique Mutational Spectrum of MLC1 in Korean Patients With Megalencephalic Leukoencephalopathy With Subcortical Cysts: p.Ala275Asp Founder Mutation and Maternal Uniparental Disomy of Chromosome 22.
Sun Ah CHOI ; Soo Yeon KIM ; Jihoo YOON ; Joongmoon CHOI ; Sung Sup PARK ; Moon Woo SEONG ; Hunmin KIM ; Hee HWANG ; Ji Eun CHOI ; Jong Hee CHAE ; Ki Joong KIM ; Seunghyo KIM ; Yun Jin LEE ; Sang Ook NAM ; Byung Chan LIM
Annals of Laboratory Medicine 2017;37(6):516-521
BACKGROUND: Megalencephalic leukoencephalopathy with subcortical cysts (MLC) is a rare inherited disorder characterized by infantile-onset macrocephaly, slow neurologic deterioration, and seizures. Mutations in the causative gene, MLC1, are found in approximately 75% of patients and are inherited in an autosomal recessive manner. We analyzed MLC1 mutations in five unrelated Korean patients with MLC. METHODS: Direct Sanger sequencing was used to identify MLC1 mutations. A founder effect of the p.Ala275Asp variant was demonstrated by haplotype analysis using single-nucleotide polymorphic (SNP) markers. Multiple ligation-dependent probe amplification (MLPA) and comparative genomic hybridization plus SNP array were used to detect exonic deletions or uniparental disomy (UPD). RESULTS: The most prevalent pathogenic variant was c.824C>A (p.Ala275Asp) found in 7/10 (70%) alleles. Two pathogenic frameshift variants were found: c.135delC (p.Cys46Alafs*12) and c.337_353delinsG (p.Ile113Glyfs*4). Haplotype analysis suggested that the Korean patients with MLC harbored a founder mutation in p.Ala275Asp. The p.(Ile113Glyfs*4) was identified in a homozygous state, and a family study revealed that only the mother was heterozygous for this variant. Further analysis of MLPA and SNP arrays for this patient demonstrated loss of heterozygosity of chromosome 22 without any deletion, indicating UPD. The maternal origin of both chromosomes 22 was demonstrated by haplotype analysis. CONCLUSIONS: This study is the first to describe the mutational spectrum of Korean patients with MLC, demonstrating a founder effect of the p.Ala275Asp variant. This study also broadens our understanding of the mutational spectrum of MLC1 by demonstrating a homozygous p.(Ile113Glyfs*4) variant resulting from UPD of chromosome 22.
Alleles
;
Chromosomes, Human, Pair 22*
;
Comparative Genomic Hybridization
;
Exons
;
Founder Effect
;
Haplotypes
;
Humans
;
Leukoencephalopathies*
;
Loss of Heterozygosity
;
Megalencephaly
;
Mothers
;
Seizures
;
Uniparental Disomy*
4.Consideration of Discontinuance of Malaria Antibody Test for Blood Donor Screening.
Jae Won KANG ; Kyoung Won YOUN ; Kwang HUH ; Chae Seung LIM ; Byung Chul CHUN ; Joon Sup YEOM ; Deok Ja OH
Korean Journal of Blood Transfusion 2016;27(1):38-44
BACKGROUND: Since 2001, the Korean Red Cross has performed malaria antibody test for blood donors in malaria-risk areas to prevent transfusion-transmitted malaria. However, due to insufficient sensitivity and specificity the malaria antibody assay is not considered an efficient screening method. Therefore, we have considered discontinuing malaria antibody testing for blood donors. METHODS: We analyzed the results of malaria antibody test from 2001 to 2014 utilizing data from the Blood Information Management System of the Korean Red Cross. RESULTS: Among 16,650,812 donations tested from 2001 to 2014, 50,143 donations (0.30%) showed positive results. However, there was no truly infected case at the time of donation. The positive rate among blood donations was between 34 and 39 per 10,000 in 2001, but between 9 and 10 per 10,000 in 2014. There was no interregional disparity in the positive rate of blood donations. CONCLUSION: Korea is in a malaria elimination phase and malaria antibody testing in limited areas is not effective, therefore we propose discontinuing the malaria antibody test.
Blood Donors*
;
Humans
;
Information Management
;
Korea
;
Malaria*
;
Mass Screening*
;
Red Cross
;
Sensitivity and Specificity
5.Spinal anesthesia for emergency cesarean section in a preeclampsia patient diagnosed with type 1 neurofibromatosis.
Wang Yong LEE ; Yong Sup SHIN ; Chae Seong LIM ; Woo Suk CHUNG ; Byung Muk KIM
Korean Journal of Anesthesiology 2013;65(6 Suppl):S91-S92
No abstract available.
Anesthesia, Spinal*
;
Cesarean Section*
;
Emergencies*
;
Female
;
Humans
;
Neurofibromatosis 1*
;
Pre-Eclampsia*
;
Pregnancy
6.Sonographically Guided Alcohol Injection in Painful Stump Neuroma.
Kil Byung LIM ; Young Sup KIM ; Jeong A KIM
Annals of Rehabilitation Medicine 2012;36(3):404-408
Stump neuroma is a common cause of pain from disorganized proliferation of nerve fascicles occurring after limb amputation. Ultrasound guided alcohol injection in painful stump neuroma has been tried as a new treatment approach. Herein, we report 2 male patients, who had traumatic amputation and claimed severe and diffuse burning pain in the stump area. Neuroma at the distal end of an amputated nerve was clearly identified on sonography. The patients gradually developed increasing severe pain that could not be managed with conservative care. They were treated with neurolysis using alcohol solution. Using ultrasonographical guidance, 1.2 ml of 100% dehydrated alcohol was injected into the nerves proximal to neuroma. No complications occurred. The patients were initially pain free. After a few months, however, their stump pain recurred slightly. Repeat neurolysis was performed using 0.3 ml of 100% dehydrated alcohol. During the three months follow-up period, mild stump pain occurred but the patients did not require any analgesics.
Amputation
;
Amputation, Traumatic
;
Analgesics
;
Burns
;
Extremities
;
Follow-Up Studies
;
Humans
;
Male
;
Neuroma
7.Back Pain Secondary to Brucella Spondylitis in the Lumbar Region.
Kil Byung LIM ; Yee Gyung KWAK ; Dug Young KIM ; Young Sup KIM ; Jeong A KIM
Annals of Rehabilitation Medicine 2012;36(2):282-286
Brucellosis is a systemic, infectious disease caused by the bacterial genus Brucella and a common zoonosis that still remains a major health problem in certain parts of the world such as the Mediterranean region, the Middle East, and Latin America. It may involve multiple organs and tissues. Osteoarticular involvement is the most frequent complication of brucellosis, in which the diagnosis of brucellar spondylitis is often difficult since the clinical presentation may be obscured by many other conditions. There are only a few reports on brucellar spondylitis in Korea. Here, we report a case of spondylitis due to brucella in an elderly male.
Aged
;
Back Pain
;
Brucella
;
Brucellosis
;
Communicable Diseases
;
Humans
;
Korea
;
Latin America
;
Lumbosacral Region
;
Male
;
Mediterranean Region
;
Middle East
;
Spondylitis
8.Shoulder Joint Infectious Arthritis and Acromioclavicular Joint Osteomyelitis due to Candida.
Kil Byung LIM ; Yee Gyung KWAK ; Young Sup KIM ; Kyung Rok PARK
Annals of Rehabilitation Medicine 2012;36(4):573-577
Candida species inhabit the skin and mucous membranes of healthy individuals with low virulence, and osteomyelitis due to candida is very rare. However, the incidence of invasive candidal infection caused by intravenous drug use, broad-spectrum antibiotics, and indwelling central venous catheter is increasing. A 73-year old man visited the outpatient clinic complaining of right shoulder pain that radiated to the right acromioclavicular joint. He had undergone multiple injection procedures followed by nonsteroidal anti-inflammatory drug therapy for several weeks. The ultrasonographic findings showed a heterogeneous mass around the right acromioclavicular joint, while the right shoulder MRI and the overall findings of the body bone scan were suggestive of osteomyelitis. Pathologic findings of ultrasonographically guided joint aspiration fluid showed acute and chronic nonspecific inflammation, while the tissue culture and staining revealed Candida parapsilosis.
Acromioclavicular Joint
;
Ambulatory Care Facilities
;
Anti-Bacterial Agents
;
Arthritis, Infectious
;
Candida
;
Central Venous Catheters
;
Incidence
;
Inflammation
;
Joints
;
Mucous Membrane
;
Osteomyelitis
;
Shoulder
;
Shoulder Joint
;
Shoulder Pain
;
Skin
9.Gender Differences Associated with Pain Patterns and Psychological Variables in Chronic Musculoskeletal Pain Patients.
Kil Byung LIM ; Hong Jae LEE ; Dug Young KIM ; Kyung Tae LEE ; Ji Yeong KIM ; Seong Soo KIM ; Young Sup KIM
Journal of the Korean Academy of Rehabilitation Medicine 2010;34(2):197-203
OBJECTIVE: To investigate gender differences in pain patterns and psychological variables among patients with chronic musculoskeletal pain. METHOD: Thirty-five male and thirty-eight female patients who visited our outpatient clinic due to chronic musculoskeletal pain were evaluated using a questionnaire survey. Chronic musculoskeletal pain was defined as pain lasting longer than 6 months. Patients were evaluated with visual analogue scale (VAS), pain site, pain duration and frequency. Beck depression inventory, state-trait anxiety index, somatization scale of symptom checklist-revised, symptom interpretation questionnaire, and pain catastrophizing scale were checked for psychological variables. Correlations among each variable were evaluated statistically. RESULTS: Female patients with chronic musculoskeletal pain recorded higher scores on number of pain site, pain catastrophizing scale, rumination, magnification and catastrophic attribution than male patients (p<0.05). In female patients, VAS was correlated significantly with depression, static anxiety, somatization, catastrophizing thought. rumination, magnification, helpless, and catastrophic attribution. Pain frequency was correlated significantly with somatization, catastrophizing thought, rumination, and helpless. Number of pain site was correlated with somatization, catastrophizing thought, magnification, and helpless. The correlation between pain patterns and psychological variables was also observed in male patients, but statistically less significant than female patients. CONCLUSION: We found gender difference associated with pain patterns and psychological variables in chronic musculoskeletal pain patients. Consideration of psychological factors may be important for management in female patients with chronic musculoskeletal pain.
Ambulatory Care Facilities
;
Anxiety
;
Catastrophization
;
Depression
;
Female
;
Humans
;
Male
;
Musculoskeletal Pain
;
Surveys and Questionnaires
10.Malignancy Associated with Inflammatory Bowel Disease.
Ui Sup SHIN ; Chang Sik YU ; Chan Wook KIM ; Jin Seok PARK ; Kwang Yong JEONG ; Sang Nam YOON ; Seok Byung LIM ; Joon Seon SONG ; Jin Cheon KIM
Journal of the Korean Society of Coloproctology 2009;25(3):150-156
PURPOSE: As the number of patients with inflammatory bowel disease (IBD) has steadily increased in Korea, IBD-associated cancers are expected to increase in number. This study investigated the clinical features of intestinal cancer in patients with IBD. METHODS: One hundred five patients with ulcerative colitis (UC) and 270 patients with Crohn's disease (CD) under the care of the Department of Colon and Rectal Surgery, Asan Medical Center, between December 1989 and January 2009 were reviewed retrospectively. RESULTS: Ten patients of the 105 with UC and 5 patients of the 270 with CD were found to have intestinal cancer. The mean age was 45 yr (+/-8.8), and the mean duration of IBD at the time of diagnosis of the cancer was 12.6 yr (+/-6.0). Six of the 15 cancer patients had no history of treatment for IBD of more than 3 mo before diagnosis of the cancer. Eleven cancers were located in the rectum (7 in UC, 4 in CD), including 1 case of synchronous cancer. One case of small bowel cancer was found in a patient with small bowel CD. Four cases involved a mucinous adenocarcinoma. Eight of the 12 cases of an adenocarcinoma of the colon and rectum were advanced stage. CONCLUSION: IBD-associated intestinal cancers were found at a relatively young age, were diagnosed at an advanced stage, and had a higher proportion of mucinous adenocarcinomas than in sporadic cancer. Considering the increasing incidence of IBD and the expected increase in the number of IBD-associated cancer in Korea, every effort should be made to prevent intestinal cancer in patients with IBD and to detect it early.
Adenocarcinoma
;
Adenocarcinoma, Mucinous
;
Carcinoma, Squamous Cell
;
Colitis, Ulcerative
;
Colon
;
Colorectal Neoplasms
;
Crohn Disease
;
Humans
;
Incidence
;
Inflammatory Bowel Diseases
;
Intestinal Neoplasms
;
Korea
;
Lymphoma
;
Rectum
;
Retrospective Studies

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