Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea

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.

Alpha Stent for Coiling of Unruptured, Wide-Necked, Distal Internal Carotid Artery Aneurysms: Safety and Effectiveness at 6 Months

Diagnosis of Cerebral Aneurysm Via Magnetic Resonance Angiography Screening: Emphasis on Legal Responsibility Increases False Positive Rate / 신경중재치료의학

PURPOSE: False positive diagnoses of cerebral aneurysm via magnetic resonance angiography (MRA) screening may increase unnecessary cerebral catheter angiography. The purpose of this study was to investigate the effects of medical liability on medical decision-making during radiologic interpretation. MATERIALS AND METHODS: We included 56 consecutive patients who were referred with suspected aneurysm based on MRA or computed tomography angiography (CTA) and showed no aneurysm on subsequent digital subtraction angiography (DSA). MRA and CTA were reviewed twice by two neuroradiology fellows who were blind as to whether the suspected lesions were true aneurysms or not. The second review was repeated after proposing that their decision was subject to legal liability and they would be responsible for medico-legal problems related to their diagnoses. Diagnostic differences based on each review were analyzed, focusing on changes in false positive diagnosis rates. RESULTS: A total of 63 suspected aneurysmal lesions detected via MRA or CTA were found to be negative based on DSA. At first review, 32 lesions were diagnosed as true aneurysms by observer 1 and 27 by observer 2, corresponding to false positive rates of 51% and 43% respectively. At the second review, 39 lesions (62%) were diagnosed by observer 1, and 30 (48%) by observer 2. Thus, there was an overall increase in false positive aneurysm diagnosis of 11% for observer 1 and 5% for observer 2, after emphasizing their responsibilities in the context of medical litigation. CONCLUSION: Concerns about medical liability could result in increased false positive diagnoses of cerebral aneurysms via MRA screening. Whether repeated follow-up of the suspected lesion or catheter angiographic confirmation is better with regard to long-term patient outcomes requires further study.

The first case of paroxysmal nocturnal hemoglobinuria and Budd-Chiari syndrome treated with complement inhibitor eculizumab in Korea

No abstract available.

Transdural Segment of the Radicular Vein in Spinal Dural Arteriovenous Fistula / 신경중재치료의학

No abstract available.

Bench-top Comparison of Physical Properties of 4 Commercially-Available Self-Expanding Intracranial Stents / 신경중재치료의학

PURPOSE: To better understand the performance of four commercially available neurovascular stents in intracranial aneurysm embolization, the stents were compared in terms of their basic morphological and mechanical properties. MATERIALS AND METHODS: Four different types of stents that are currently being used for cerebral aneurysm embolization were prepared (two stents per type). Two were laser-cut stents (Neuroform and Enterprise) and two were braided from a single nitinol wire (LEO and LVIS stents). All were subjected to quantitative measurements of stent size, pore density, metal coverage, the force needed to load, push, and deploy the stent, radial force on deployment, surface roughness, and corrosion resistance. RESULTS: Compared to their nominal diameters, all stents had greater diameters after deployment. The length generally decreased after deployment. This was particularly marked in the braided stents. The braided stents also had higher pore densities than the laser-cut stents. Metal coverage was highest in the LEO stent (14%) and lowest in the Enterprise stent (5%). The LIVS stent had the highest microcatheter loading force (81.5 gf). The LEO stent had the highest passage force (55.0 gf) and deployment force (78.9 gf). The LVIS and LEO stents had the highest perpendicular (37.1 gf) and circumferential (178.4 gf) radial forces, respectively. The Enterprise stent had the roughest stent wire, followed by the LVIS, LEO, and Neuroform stents. CONCLUSION: The four neurovascular stent types differed in terms of morphological and physical characteristics. An understanding of this diversity may help to decide which stent is most suitable for specific clinical situations.

Successful treatment of steroid-refractory immune thrombocytopenia with alemtuzumab

No abstract available.

First Case of Diffuse Large B-Cell Lymphoma Subtype of Monomorphic Post-Transplant Lymphoproliferative Disorder With 3q27 Translocation

No abstract available.

Altitude Stress During Participation of Medical Congress / 신경중재치료의학

Medical congresses often held in highlands. We reviewed several medical issues associated with altitude stress especially while physicians have participated medical congress held in high altitude. Altitude stress, also known as an acute mountain sickness (AMS), is caused by acute exposure to low oxygen level at high altitude which is defined as elevations at or above 1,200 m and AMS commonly occurs above 2,500 m. Altitude stress with various symptoms including insomnia can also be experienced in airplane. AMS and drunken state share many common features in symptoms, neurologic manifestations and even show multiple microbleeds in corpus callosum and white matter on MRI. Children are more susceptible to altitude stress than adults. Gradual ascent is the best method for the prevention of altitude stress. Adequate nutrition (mainly carbohydrates) and hydration are recommended. Consumption of alcohol can exacerbate the altitude-induced impairments in judgment and the visual senses and promote psychomotor dysfunction. For prevention or treatment of altitude stress, acetazolamide, phosphodiesterase inhibitors, dexamethasone and erythropoietin are helpful. Altitude stress can be experienced relatively often during participation of medical congress. It is necessary to remind the harmful effect of AMS because it can cause serious permanent organ damage even though the symptoms are negligible in most cases.

Maximum standardized uptake value on positron emission tomography/computed tomography predicts clinical outcome in patients with relapsed or refractory diffuse large B-cell lymphoma

BACKGROUND: Few clinical studies have clarified the prognostic factors that affect clinical outcomes for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after immunochemotherapy. METHODS: A total of 158 patients with relapsed or refractory DLBCL were enrolled. All patients underwent positron emission tomography/computed tomography (PET/CT) before and after salvage therapy. All enrolled patients previously received the ifosfamide, carboplatin, and etoposide regimen. Clinical outcomes were compared according to several factors (age > or = 65 years, low age-adjusted International Prognostic Index [aa-IPI], maximum standardized uptake value [SUVmax] or =12 months, complete response after salvage therapy). A low aa-IPI, SUVmax or = 12 months were independent prognostic factors for survival. RESULTS: In univariate analysis and multivariate analysis, SUVmax below 6.0 (P<0.001 for progression-free survival (PFS), P<0.001 for overall survival (OS)) and low aa-IPI (P<0.001 for PFS, P<0.001 for OS) were independent prognostic factors associated with favorable outcome. CONCLUSION: The aa-IPI and initial SUVmax were powerful prognostic factors in patients with relapsed or refractory DLBCL.

Reversible Cerebellar Ataxia Related to Extrapontine Myelinolysis without Hyponatremia after Cisplatin-Based Chemotherapy for Cholangiocarcinoma / Journal of the Korean Cancer Association, 대한암학회지

A 60-year-old woman presented with cerebellar signs including dysarthria and ataxia, after intravenous infusion of cisplatin-based chemotherapy. Several blood tests showed mild neutropenia, normocytic normochromic anemia, but no evidence of a marked hyponatremia. Brain magnetic resonance imaging with diffusion-weighted sequences showed hyper-intense signal abnormalities in the extrapontine region, sparing the basis pontis. Here, we report on the case of a patient with reversible cerebellar ataxia related to extrapontine myelinolysis without hyponatremia after treatment with cisplatin-based chemotherapy for cholangiocarcinoma and discuss the literature on cerebellar ataxia in patients who underwent recent chemotherapy for malignancy.

Usefulness of Real-time PCR to Detect Mycobacterium tuberculosis and Nontuberculous Mycobacteria / 결핵및호흡기질환

BACKGROUND: The purpose of this study was to evaluate recently developed real-time polymerase chain reaction (PCR) assay kit to detect Mycobacterium tuberculosis (MTB) and nontuberculous mycobacteria (NTM) in respiratory specimens. METHODS: We assessed the positive rate of the real-time PCR assay to detect MTB and NTM in 87 culture-positive specimens (37 sputum, 50 bronchial washing), which were performed real-time PCR by using Real-Q(TM) MTB&NTM Kit from January 2009 to June 2009, at Gyeongsang University Hospital. To compare the efficacy with the TB-PCR assay, we evaluated 63 culture-positive specimens (19 sputum, 44 bronchial washing) for MTB or NTM, which were performed TB-PCR by using ABSOLUTE(TM) MTB II PCR Kit from March 2008 to August 2008. RESULTS: Among 87 specimens tested using real-time PCR, MTB and NTM were cultured in 58 and 29, respectively. The positive rate of real-time PCR assay to detect MTB was 71% (22/31) and 92.6% (25/27) in AFB stain-negative and stain-positive specimens. For NTM, the positive rate of real-time PCR was 11.1% (2/18) and 72.7% (8/11) in AFB stain-negative and stain-positive specimens. Among 63 specimens performed using TB-PCR, MTB and NTM were cultured in 46 and 17, respectively. The positive rate of TB-PCR was 61.7% (21/34) and 100% (12/12) in AFB stain-negative and stain-positive specimens. TB-PCR was negative in all NTM-cultured 17 specimens. CONCLUSION: TB/NTM real-time PCR assay is useful to differentiate MTB and NTM in AFB stain-positive respiratory specimens and it is as effective in detecting MTB with TB-PCR.

Intradural Involvement of Multicentric Myxoid Liposarcoma

Liposarcomas are malignant tumors of the soft tissue, with myxoid liposarcoma being the second most common subtype, tending to occur in the limbs, particularly in the thighs. Myxoid liposarcomas have an intermediate prognosis between well-differentiated and pleomorphic tumors. Spinal metastasis is usual but intradural involvement is extremely rare. We present an unusual case of a multicentric myxoid liposarcoma with intradural involvement. A 41-year-old woman complained of tingling sensation on her left arm. Radiological evaluation revealed multiple masses in her cervical spine, abdominal wall, liver, heart and right thigh, all of which were resected. She was histologically diagnosed with small round cell myxoid sarcoma and underwent adjuvant chemotherapy. However, magnetic resonance imaging analysis after 1 year revealed a large metastatic mass with bony invasion at the C6-T1 level. This mass consisted of extradural and intradural components causing severe compression of the spinal cord. She underwent resection via a posterior facetectomy of C6-7 and an anterior C7 corpectomy. However, the patient died of multiple metastases 18 months after the first diagnosis.

Nutrition Knowledge, Dietary Attitudes, Dietary Habits and Awareness of Food-Nutrition Labelling by Girl's High School Students / 대한지역사회영양학회지

This study was carried out to investigate the nutrition knowledge, dietary attitudes, and dietary habits of girl's high school students in Kunsan, and to investigate their recognition of food-nutrition labeling. The results are summarized as follows. General nutrition knowledge is relatively low, with an average of 0.57. It was shown that high school female students skipped breakfast rather than lunch or dinner, with a skipping rate of 28.9% for breakfast, 0.7% for lunch, and 8.6% for dinner. Regarding snacks, 35.5% of all the surveyed students had 1 snack per day, with 31.9% having them between lunch and dinner. The most popular snacks include biscuits (22.3%), noodles (18.3%) and bakery (13.3%). The most popular response was that students 'sometimes checked' the food label of processed domestic and imported processed food. The level of satisfaction with food labels is moderate, with an average of 2.96, out of 5. The most satisfactory title about food labels was 'helpful for food selection' with 3.19. On the other hand, the least satisfactory title was 'understands the label' with 2.78. Regarding the identification of the nutrition labeling, the highest response was 'sometimes watched, sometimes not,' with 40.5%. Products which were most often checked were milk/milk products (3.44), snacks/bread (3.33), and soft drinks (3.07). Among nutrition labeling items, total calories was the most important, followed by fat, carbohydrate, cholesterol and calcium. The question regarding the knowledge of nutrition labeling rated an average of 0.58 (out of 1). There was a significant positive correlation between the degree of the nutrition label verification and the dietary attitude score, along with the nutrition labeling knowledge and the nutrition knowledge score of the subjects. On the other hand, the degree of the nutrition label verification and the knowledge on nutrition labeling had a significant negative correlation. Hence, it is of the opinion that education on properly reading nutrient information is necessary to enable adolescents to apply that in real life. Furthermore, labeling nutritional information on processed food through a more comprehensive method is deemed necessary as a supporting measure.