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.Gastric Mucosa-Associated Lymphoid Tissue Lymphoma Followed by Primary Central Nervous System Lymphoma.
Ki Seong EOM ; Moo Rim PARK ; Keum Ha CHOI ; Tae Young KIM
Journal of Korean Neurosurgical Society 2012;51(6):377-379
Mucosa-associated lymphoid tissue (MALT) lymphoma is one of the most common lymphomas and accounts for about 7% of all newly diagnosed non-Hodgkin's lymphoma (NHL). The clinical course of MALT lymphoma is relatively indolent and, in the majority of cases (50%), the lymphoma arises within the stomach. Primary central nervous system lymphoma (PCNSL), an uncommon variant of extranodal NHL, can affect any part of the neuraxis, including the eyes, brain, leptomeninges, or spinal cord. Herein, we present a rare case of PCNSL, which occurred one year after radiochemotherapy of gastric MALT lymphoma. A 62-year-old man presented with a 3-day history of left facial palsy. One year ago, he underwent antibiotic eradication therapy of Helicobacter pylori, local stomach fractional radiotherapy, and chemotherapy for gastric MALT lymphoma. Magnetic resonance imaging revealed a strong enhancing solid mass in the right frontal lobe. The tumor was completely removed, and the histological diagnosis of PCNSL developing from diffuse large B-cell lymphoma was made. Although elucidating the correlation between the first gastric MALT lymphoma and the second PCNSL seemed difficult, we have postulated and discussed some possible pathogeneses, together with a review of literature.
Brain
;
Central Nervous System
;
Chemoradiotherapy
;
Eye
;
Facial Paralysis
;
Frontal Lobe
;
Helicobacter pylori
;
Humans
;
Lymphoid Tissue
;
Lymphoma
;
Lymphoma, B-Cell
;
Lymphoma, B-Cell, Marginal Zone
;
Lymphoma, Non-Hodgkin
;
Magnetic Resonance Imaging
;
Middle Aged
;
Spinal Cord
;
Stomach
3.A Case of Primary Pericardial Undifferentiated Sarcoma.
Nam Ho KIM ; Kyoung Hee KWEON ; Seok Kyu OH ; Moo Rim PARK ; Ki Jung YUN ; Seon Kwan JUHNG ; Jong Bum CHOI ; Jin Won JEONG
Journal of Korean Medical Science 2003;18(5):742-745
Primary pericardial sarcomas are extremely rare. The authors report a case of a 46-yr-old woman in whom a large mediastinal mass was discovered. The patient presented with cough, dyspnea, and orthopnea. Diagnostic investigations, such as echocardiography, computed tomography, and exploratory thoracotomy provided the evidence of a large mass in the mediastinum, attached by a broad base to the superior portion of the pericardium. A excisional biopsy was performed, and histologic examination of a biopsy specimen showed undifferentiated sarcoma. However, the complete removal of the mass was impossible due to adhesion to the adjacent great vessels. After the completion of the chemotherapy the patient was completely asymptomatic. However, follow-up transesophageal echocardiography showed a residual 3x4 cm-sized mass. The patient received the radiotherapy with a total dose of 55 Gy over 6 weeks. At present, there is no evidence of disease progression.
Biopsy
;
Cough
;
Disease Progression
;
Dyspnea
;
Echocardiography
;
Female
;
Human
;
Mediastinal Neoplasms/*diagnosis/radiography
;
Middle Aged
;
Prognosis
;
Sarcoma/*diagnosis/radiography
;
Tomography, X-Ray Computed
4.A Case of Complete Heart Block Complicating Bacterial Endocarditis.
Nam Ho KIM ; Jin Won JEONG ; Kyung Ho YUN ; Nam Jin YOO ; Eun Mi LEE ; Moo Rim PARK ; Seok Kyu OH ; Soon Ho CHOI ; Ock Kyu PARK
Korean Circulation Journal 2003;33(6):528-532
Active infective endocarditis, involving native, is often complicated by conduction abnormalities. These conduction disturbances are considered to represent an extension of the infection from the valve to the annulus, and to the surrounding myocardium. We describe a case of a 59-year-old woman who presented with dyspnea due to staphylococcal endocarditis, which was complicated by a complete heart block.
Dyspnea
;
Endocarditis
;
Endocarditis, Bacterial*
;
Female
;
Heart Block*
;
Heart*
;
Humans
;
Middle Aged
;
Myocardium
5.Patterns of Voiding Dysfunction of Stroke Patients during Rehabilitation.
Moo Kyum KIM ; Hoan Nyoung LEE ; Ki Rim KIM ; Kyoung Min LEE ; In Kil LEE ; Eun Ho CHOI
Journal of the Korean Academy of Rehabilitation Medicine 2001;25(4):551-558
OBJECTIVE: The purpose of this study is to evaluate the patterns of voiding dysfunction of stroke patients during rehabilitation. METHOD: We evaluated 53 patients with complaints of voiding dysfunction following the strokes. After the comprehensive history and physical examination, all patients underwent cystometric study and males underwent the transrectal ultrasound. RESULTS: The incidences of detrusor hyperreflexia, detrusor areflexia, and normal finding on the cystometry were 50.9%, 32.1%, and 17.0%, respectively (p<0.05). There was a significantly high incidence of detrusor hyperreflexia in the groups of subcortical lesion, large lesion, and the over 3 months after stroke (p<0.05). However, there was no statistical difference on cystometric findings according to the other characteristics of the stroke such as the age, sex, type of stroke, cognition, aphasia, and diabetes mellitus. The incidences of irritative, obstructive, and mixed symptoms according to the presenting voiding complaints were 49.1%, 32.1%, and 18.9%, respectively (p<0.05). There was no significant statistical difference on the cystometric findings according to the 3 voiding symptom groups as well as none of significant statistical difference on prostate enlargement in males in according to the 3 voiding symptom groups. CONCLUSION: Only with the pattern of voiding, we could not predict the cystometric finding or the presence of bladder outlet obstruction. Thus, we recommend the further studies including cystometry and evaluation of the bladder outlet obstruction for the treatment of voiding dysfunction of stroke patients during rehabilitation.
Aphasia
;
Cognition
;
Diabetes Mellitus
;
Humans
;
Incidence
;
Male
;
Physical Examination
;
Prostate
;
Reflex, Abnormal
;
Rehabilitation*
;
Stroke*
;
Ultrasonography
;
Urinary Bladder Neck Obstruction
6.Radiation Absorbed Dose Measurement after I-131 Metaiodobenzylguanidine Treatment in a patient with Pheochromycytoma.
Weon Il YANG ; Byeung Il KIM ; Jae Sung LEE ; Jeong Rim LEE ; Chang Woon CHOI ; Sang Moo LIM ; Sung Woon HONG
Korean Journal of Nuclear Medicine 1999;33(4):422-429
PURPOSE: The measurement of radiation absorbed dose is useful to predict the response after I-131 labeled metaiodobenzylguanidine (MIBG) therapy and determine therapy dose in patients with unresectable or malignant pheochromocytoma. We estimated the absorbed dose in tumor tissue after high dose I-131 MIBG in a patient with pheochromocytoma using a gamma camera and Medical Internal Radiation Dose (MIRD) formula. MATERIALS AND METHODS: A 64-year old female patient with pheochromocytoma who had multiple metastases of mediastinum, right kidney and periaortic lymph nodes, received 74 GBq (200 mCi) of I-131 MIBG. We obtained anterior and posterior images at 0.5, 16, 24, 64 and 145 hours after treatment. Two standard sources of 37 and 74 MBq of I-131 were imaged simultaneously. Cummulated I-131 MIBG uptake in tumor tissue was calculated after the correction of background activity, attenuation, system sensitivity and count loss at a high count rate. RESULTS: The calculated absorbed radiation dose was 32-63 Gy/ 74 GBq, which was lower than the known dose for tumor remission (150-200 Gy). Follow-up studies at 1 month showed minimally reduced tumor size on computed tomography, and mildly reduced I-131 MIBG uptake. CONCLUSION: We estimated radiation absorbed dose after therapeutic I-131 MIBG using a gamma camera and MIRD formula, which can be peformed in a clinical nuclear medicine laboratory. Our RESULTS suggest that the measurement of radiation absorbed dose in I-131 MIBG therapy is feasible as a routine clinical practice that can guide further treatment plan. The accuracy of dose measurement and correlation with clinical outcome should be evaluated further.
3-Iodobenzylguanidine
;
Female
;
Follow-Up Studies
;
Gamma Cameras
;
Humans
;
Kidney
;
Lymph Nodes
;
Mediastinum
;
Middle Aged
;
Neoplasm Metastasis
;
Nuclear Medicine
;
Pheochromocytoma
7.An Assessment of the Accuracy of 3 Dimensional Acquisition in F-18 fluorodeoxyglucose Brain PET Imaging.
Sang Eun KIM ; Chang Woon CHOI ; Sang Moo LIM ; Yong CHOI ; Kyung Han LEE ; Jeong Rim LEE ; Seong Wun HONG ; Byung Tae KIM
Korean Journal of Nuclear Medicine 1999;33(3):327-336
PURPOSE: To assess the quantitative accuracy and the clinical utility of 3D volumetric PET imaging with FDG in brain studies, 24 patients with various neurological disorders were studied. MATERIALS AND METHODS: Each patient was injected with 370 MBq of 2-[18F]fluoro-2-deoxy-D-glucose. After a 30 min uptake period, the patients were imaged for 30 min in 2 dimensional acquisition (2D) and subsequently for 10 min in 3 dimensional acquisition imaging (3D) using a GE AdvanceTM PET system. The scatter corrected 3D (3D SC) and non scatter-corrected 3D images were compared with 2D images by applying ROIs on gray and white matter, lesion and contralateral normal areas. Measured and calculated attenuation correction methods for emission images were compared to get the maximum advantage of high sensitivity of 3D acquisition. RESULTS: When normalized to the contrast of 2D images, the contrasts of gray to white matter were 0.75+/-0.13 (3D) and 0.95+/-0.12 (3D SC). The contrasts of normal area to lesion were 0.83+/-0.05 (3D) and 0.96+/-0.05 (3D SC). Three nuclear medicine physicians judged 3D SC images to be superior to the 2D with regards to resolution and noise. Regional counts of calculated attenuation correction was not significantly different to that of measured attenuation correction. CONCLUSION:: 3D PET images with the scatter correction in FDG brain studies provide quantitatively and qualitatively similar images to 2D and can be utilized in a routine clinical setting to reduce scanning time and patient motion artifacts.
Artifacts
;
Brain*
;
Humans
;
Nervous System Diseases
;
Noise
;
Nuclear Medicine
;
Positron-Emission Tomography
8.A Case of Synchronous Gastric Non - Hodgkin's Lymphoma and Renal Cell Carcinoma.
Je Jung LEE ; Moo Rim PARK ; Young Eun JOO ; Young Jin KIM ; Hyeoung Joon KIM ; Chan CHOI ; Ik Joo CHUNG
Journal of the Korean Cancer Association 1999;31(3):635-640
We report a 58-year-old man who developed synchronous gastric non-Hodgkin`s lymphoma (NHL) and renal cell carcinoma. He presented with epigastric discomfort for 2 months. Endoscopic finding of the stomach disclosed a large inegular ulceration with nodular margin on the upper body. Constrast enhanced CT scan of the abdomen showed an ulceration and focal wall thickening in the greater curvature side of stomach, and an enhanced bulging mass in the left kidney incidentally. The tissue obtained by radical proximal gastrectomy and nephrectomy showed diffuse large B-cell lymphoma on stomach and chromophobic type of renal cell carcinoma on kidney. To our knowledge, this is the first report of synchronous gastric NHL and renal cell carcinoma in Korea.
Abdomen
;
Carcinoma, Renal Cell*
;
Gastrectomy
;
Hodgkin Disease*
;
Humans
;
Kidney
;
Korea
;
Lymphoma
;
Lymphoma, B-Cell
;
Middle Aged
;
Nephrectomy
;
Stomach
;
Tomography, X-Ray Computed
;
Ulcer
9.Frequency of bcl-2 mbr/JH Rearrangement and Prognostic Implication of bcl-2, c-myc Protein Expression in Non-Hodgkin's Lymphoma.
Moo Rim PARK ; Ik Joo CHUNG ; Jeong Rae BYUN ; Sang Yong KWON ; Kyeoung Sang CHOI ; Jung A NA ; Je Jung LEE ; Hyeoung Joon KIM ; Chang Soo PARK
Korean Journal of Hematology 1999;34(2):196-206
BACKGROUND: Deregulated bcl-2 appears to prolong cell survival and to cooperative with c-myc in promoting cell proliferation. We investigated whether there is any clinicopathologic correlation between the survival and the frequency of bcl-2/JH rearrangement and bcl-2, c-myc protein expression in non-Hodgkin's lymphoma. METHODS: We conducted a study for bcl-2 mbr/JH rearrangement with polymerase chain reaction and for bcl-2, c-myc expression with immunohistochemical staining in 46 formalin-fixed, paraffin-embedded non-Hodgkin's lymphoma tissues of patients treated with CHOP chemotherapy including 37 specimens of diffuse large cell type. RESULTS: The bcl-2 mbr/JH rearrangement was positive in 13% (6/46) of non-Hodgkin's lymphoma specimens. For bcl-2, strong positive reaction (3+) and 2+ positive reaction were seen in 16 (35%) and 16 cases (35%), respectively; while 3+ and 2+ reactions were found in 20 (44%) and 16 cases (35%), respectively, for c-myc by immunohistochemistry. Eighty one percent of positive cases for bcl-2 were also positive for c-myc simultaneously. The 6 cases with bcl-2 mbr/JH rearrangement were weakly positive at 3 cases and strong positive at 3 cases for bcl-2 by staining. In cases of diffuse large cell lymphoma, high expression (3+) of bcl-2 & c-myc protein tended to have a shorter 2 year survival, though it was statistically not significant. CONCLUSION: High expression of bcl-2 and c-myc protein suggest that bcl-2 cooperate with c-myc in tumorigenesis of aggressive non-Hodgkin's lymphoma. The prognostic implication of bcl-2 and c-myc expression in diffuse large cell lymphoma patients needs to be evaluated in a larger, prospective cohort to draw a definitive conclusion.
Carcinogenesis
;
Cell Proliferation
;
Cell Survival
;
Cohort Studies
;
Drug Therapy
;
Humans
;
Immunohistochemistry
;
Lymphoma, Large B-Cell, Diffuse
;
Lymphoma, Non-Hodgkin*
;
Polymerase Chain Reaction
10.Sternocleidomastoid Tendon Reflex in Normal Korean Adults.
Ju Kang LEE ; Oh Kyung LIM ; Yoon Myung LIM ; Tae Ho HA ; Moo Rim CHOI ; Do Hoon KIM ; Tae Im YI ; Gi Young PARK
Journal of the Korean Academy of Rehabilitation Medicine 1999;23(6):1207-1212
OBJECT: The purpose of this study was to establish the normal values of sternocleidomastoid (SCM) tendon reflex in normal Korean adults. METHOD: The study for SCM tendon reflex was performed in 41 normal adults using electric reflex hammer. The compound muscle action potentials (CMAP) of SCM muscle were obtained by SCM tendon tapping. From 5 repeated trials of each subject, the shortest latency and the largest peak-to-peak amplitude of CMAP were chosen for the representative value. RESULTS: Mean values of latency and amplitude were 2.19+/-0.27 msec and 0.70+/-0.38 mV for SCM tendon reflex. There was no significant difference in the latency and amplitude regardless of side or sex (p>0.05). The age and height showed no signifiant correlation with latency and amplitude of SCM tendon reflex (p>0.05). CONCLUSION: We believe that our results can be used as an evaluation method of upper cervical spinal cord.
Action Potentials
;
Adult*
;
Humans
;
Reference Values
;
Reflex
;
Reflex, Stretch*
;
Spinal Cord
;
Tendons*

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