1.A Phase 3 Randomized Clinical Trial to Compare Efficacy and Safety between Combination Therapy and Monotherapy in Elderly Patients with Advanced Gastric Cancer (KCSG ST13-10)
Keun-Wook LEE ; Dae Young ZANG ; Min-Hee RYU ; Hye Sook HAN ; Ki Hyang KIM ; Mi-Jung KIM ; Sung Ae KOH ; Sung Sook LEE ; Dong-Hoe KOO ; Yoon Ho KO ; Byeong Seok SOHN ; Jin Won KIM ; Jin Hyun PARK ; Byung-Ho NAM ; In Sil CHOI
Cancer Research and Treatment 2023;55(4):1250-1260
Purpose:
This study evaluated whether combination therapy is more effective than monotherapy in elderly patients with metastatic or recurrent gastric cancer (MRGC) as first-line chemotherapy.
Materials and Methods:
Elderly (≥ 70 years) chemo-naïve patients with MRGC were allocated to receive either combination therapy (group A: 5-fluorouracil [5-FU]/oxaliplatin, capecitabine/oxaliplatin, capecitabine/cisplatin, or S-1/cisplatin) or monotherapy (group B: 5-FU, capecitabine, or S-1). In group A, starting doses were 80% of standard doses, and they could be escalated to 100% at the discretion of the investigator. Primary endpoint was to confirm superior overall survival (OS) of combination therapy vs. monotherapy.
Results:
After 111 of the planned 238 patients were randomized, enrollment was terminated due to poor accrual. In the full-analysis population (group A [n=53] and group B [n=51]), median OS of combination therapy vs. monotherapy was 11.5 vs. 7.5 months (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.56 to 1.30; p=0.231). Median progression-free survival (PFS) was 5.6 vs. 3.7 months (HR, 0.53; 95% CI, 0.34 to 0.83; p=0.005). In subgroup analyses, patients aged 70-74 years tended to have superior OS with combination therapy (15.9 vs. 7.2 months, p=0.056). Treatment-related adverse events (TRAEs) occurred more frequently in group A vs. group B. However, among severe TRAEs (≥ grade 3), there were no TRAEs with a frequency difference of > 5%.
Conclusion
Combination therapy was associated with numerically improved OS, although statistically insignificant, and a significant PFS benefit compared with monotherapy. Although combination therapy showed more frequent TRAEs, there was no difference in the frequency of severe TRAEs.
2.Effect of Peritoneal Dialysis Modality on the 1-Year Rate of Decline of Residual Renal Function.
Chan Ho KIM ; Hyung Jung OH ; Mi Jung LEE ; Young Eun KWON ; Yung Ly KIM ; Ki Heon NAM ; Kyoung Sook PARK ; Seong Yeong AN ; Kwang Il KO ; Hyang Mo KOO ; Fa Mee DOH ; Seung Hyeok HAN ; Tae Hyun YOO ; Beom Seok KIM ; Shin Wook KANG ; Kyu Hun CHOI
Yonsei Medical Journal 2014;55(1):141-148
PURPOSE: The effect of different peritoneal dialysis (PD) modalities on the decline in residual renal function (RRF) is unclear due to inconsistencies among studies. In particular, the effect of automated peritoneal dialysis (APD) modalities [continuous cyclic peritoneal dialysis (CCPD) and nightly intermittent peritoneal dialysis (NIPD)] on RRF has not been examined in a large cohort. MATERIALS AND METHODS: We conducted a single-center retrospective study to investigate the association between PD modalities and decline in RRF in 142 incident PD patients [34 on CCPD, 36 on NIPD, and 72 on continuous ambulatory peritoneal dialysis (CAPD)]. RRF was measured within 2 months from PD start and at 1 year after PD initiation. RESULTS: The RRF at 1 year after PD initiation was 1.98+/-2.20 mL/min/1.73 m2 in CCPD patients and 3.63+/-3.67 mL/min/1.73 m2 in NIPD patients, which were moderately lower than 4.23+/-3.51 mL/min/1.73 m2 in CAPD patients (p=0.064). Moreover, there was no significant difference in the 1-year rate of decline of RRF between CCPD and NIPD patients, although APD patients had a faster 1-year RRF decline rate than CAPD patients (CCPD and NIPD vs. CAPD: -45.68 and -36.69 vs. 1.17%/year, p=0.045). APD was associated with a more rapid decline in RRF in patients with end-stage renal disease undergoing PD, although multivariate analysis attenuated the significance of this finding (beta=-31.50; 95% CI, -63.61 to 0.62; p=0.052). CONCLUSION: Our results suggest that CAPD might be more helpful than APD for preserving RRF during the first year of dialysis therapy, although there was no significant difference in the 1-year rate of decline of RRF between the two APD modalities.
Adult
;
Female
;
Glomerular Filtration Rate/physiology
;
Humans
;
Kidney/pathology/physiopathology
;
Kidney Failure, Chronic/*therapy
;
Male
;
Middle Aged
;
Peritoneal Dialysis/*adverse effects
;
Retrospective Studies
3.Impact of immunosuppressant therapy on early recurrence of hepatocellular carcinoma after liver transplantation.
Ju Yeun LEE ; Yul Hee KIM ; Nam Joon YI ; Hyang Sook KIM ; Hye Suk LEE ; Byung Koo LEE ; Hyeyoung KIM ; Young Rok CHOI ; Geun HONG ; Kwang Woong LEE ; Kyung Suk SUH
Clinical and Molecular Hepatology 2014;20(2):192-203
BACKGROUND/AIMS: The most commonly used immunosuppressant therapy after liver transplantation (LT) is a combination of tacrolimus and steroid. Basiliximab induction has recently been introduced; however, the most appropriate immunosuppression for hepatocellular carcinoma (HCC) patients after LT is still debated. METHODS: Ninety-three LT recipients with HCC who took tacrolimus and steroids as major immunosuppressants were included. Induction with basiliximab was implemented in 43 patients (46.2%). Mycophenolate mofetil (MMF) was added to reduce the tacrolimus dosage (n=28, 30.1%). The 1-year tacrolimus exposure level was 7.2 +/- 1.3 ng/mL (mean +/- SD). RESULTS: The 1- and 3-year recurrence rates of HCC were 12.9% and 19.4%, respectively. Tacrolimus exposure, cumulative steroid dosages, and MMF dosages had no impact on HCC recurrence. Induction therapy with basiliximab, high alpha fetoprotein (AFP; >400 ng/mL) and protein induced by vitamin K absence/antagonist-II (PIVKA-II; >100 mAU/mL) levels, and microvascular invasion were significant risk factors for 1-year recurrence (P<0.05). High AFP and PIVKA-II levels, and positive 18fluoro-2-deoxy-d-glucose positron-emission tomography findings were significantly associated with 3-year recurrence (P<0.05). CONCLUSIONS: Induction therapy with basiliximab, a strong immunosuppressant, may have a negative impact with respect to early HCC recurrence (i.e., within 1 year) in high-risk patients.
Adult
;
Aged
;
Biological Markers/analysis
;
Carcinoma, Hepatocellular/mortality/pathology/*therapy
;
Female
;
Humans
;
Immunosuppressive Agents/*therapeutic use
;
Liver Neoplasms/mortality/pathology/*therapy
;
*Liver Transplantation
;
Male
;
Middle Aged
;
Neoplasm Recurrence, Local
;
Positron-Emission Tomography
;
Protein Precursors/analysis
;
Prothrombin/analysis
;
Regression Analysis
;
Risk Factors
;
Severity of Illness Index
;
Survival Rate
;
alpha-Fetoproteins/analysis
4.Trends in Antibiotic Use in a Single University Hospital.
Kang Il JUN ; Hei Lim KOO ; Min Kyung KIM ; Chang Kyung KANG ; Min Jae KIM ; Shin Hye CHUN ; Jung Sook SONG ; Hyang Sook KIM ; Nam Joong KIM ; Eui Chong KIM ; Myoung Don OH
Korean Journal of Nosocomial Infection Control 2013;18(2):44-50
BACKGROUND: The aim of this study was to evaluate antibiotic consumption by adult patients at a single university hospital in Korea between 2001 and 2012. METHODS: We used the 2004 World Health Organization Anatomical Therapeutic Chemical Classification System definition of defined daily doses (DDD) per 1,000 patient-days to calculate the annual antibiotic consumption for 18 antibiotic groups. Chi-square linear-by-linear analysis was performed to evaluate antibiotic consumption trends for each group. RESULTS: Average annual antibiotic consumption during 2001-2012 was 644.6 DDD/1,000 patient-days (standard deviation, 33.3 DDD/1,000 patient-days). Although no statistically significant change was observed during the study period, consumption of first- and second-generation cephalosporins, and aminoglycosides was significantly decreased, while that of beta-lactam/beta-lactamase inhibitors, fourth-generation cephalosporins, carbapenem, glycopeptide, linezolid, colistin, and quinolone increased significantly. CONCLUSION: The total amount of prescribed antibiotics did not change, but the use of broad-spectrum antibiotics increased during the study period.
Adult
;
Aminoglycosides
;
Anti-Bacterial Agents
;
Cephalosporins
;
Classification
;
Colistin
;
Hospitals, University
;
Humans
;
Korea
;
World Health Organization
;
Linezolid
5.A Case of Barley Anaphylaxis due to Infant's Weaning Food.
Jeongmin LEE ; Nam Hyang KOO ; Eun Jin KIM ; Soo Young LEE
Pediatric Allergy and Respiratory Disease 2010;20(4):297-301
Barley is not a rare dietary content in Asian food but very few cases of anaphylactic reactions to barley have been reported. Furthermore, most reports are in adult patients with allergic reactions to beer containing barley components or occupational asthmatics known as 'baker's asthma'. We present a case of 11-month old boy who experienced an episode of anaphylaxis with generalized urticaria, periorbital swelling, wheeze and dyspnea after eating baby food containing barley, chestnut, glutinous rice, nonglutinous rice, within 30 minutes. Laboratory tests demonstrated high total serum IgE (531 kU/L) and revealed high level of IgE sensitizations to wheat (64.3 kU/L), barley (35.2 kU/L), rice (1.39 kU/L). Using the IgE-immunoblot assay, 7, 14, 25, and 26 kDa of IgE binding bands were identified and high degree of IgE cross-reactivity between barley and wheat extracts were revealed using IgE-immunoblot inhibition and ELISA-inhibition tests in this case.
Adult
;
Anaphylaxis
;
Asian Continental Ancestry Group
;
Beer
;
Dyspnea
;
Eating
;
Hordeum
;
Humans
;
Hypersensitivity
;
Immunoglobulin E
;
Triticum
;
Urticaria
;
Weaning
6.Musculo-skeletal Symptoms of Municipal Sanitation Workers and Ergonomic Evaluation on Upperlimb.
Jun Pyo MYONG ; Hyang Ki LEE ; Hyoung Ryoul KIM ; Hye Sun JUNG ; Eun Hee JEONG ; Woong NAM ; Jung Wan KOO
Korean Journal of Occupational and Environmental Medicine 2008;20(2):93-103
OBJECTIVES: The aim of this study was to estimate musculo-skeletal symtoms of municipal sanitation workers and to evaluate working conditions of municipal sanitation workers to search for the factors related to musculo-skeletal symptoms. METHODS: We conducted a descriptive cross-sectional survey. The study subjects were comprised of 543 municipal sanitation workers in some divisions of Seoul and the Gyeonggi province. Musculo-skeletal analysis was done by using the modified criteria of NIOSH musuclo-skeletal symptoms, RULA and, REBA. Statistical analysis was done by using the chi-square test, multiple logistic regression analysis. RESULTS: 72.2% of the subjects complained musculo-skeletal symptoms (39.6% on the upperlimbs, 30.0% on the lumbar region, 27.4% on the legs). For the musculo-skeletal symptoms criteria (1~3), street cleaners complained of more musculo-skeletal symptoms than the solid waste collectors, after classifying the jobs of sanitation workers. On logistic regression analysis of the musculo-skeletal "symptoms criteria1" positive groups, age was related to the criteria positive (prevalence odds ratio=1.018, 95% CI: 0.993-1.046). The worktime was significantly related to 'criteria positive 1 and, 2' (prevalence odds ratio=2.165 (95% CI: 1.156-4.131), 2.187 times (95% CI: 1.071-4.651)). The RULA score, the subtotal A score of RULA, the REBA score and , the total A REBA score of the upperlimbs of solid waste collectors were higher than those of the street cleaners. CONCLUSIONS: In spite of the lower ergonomic evaluation score of the street cleaner, the street cleaners complained of more musculo-skeletal symptoms than did the solid waste collectors due to more frequent repetitive motions, a longer work time (over 10 hours) etc. It is suggested that the sanitation workers need to use the proper methods to avoid musculo-skeletal disease.
Cross-Sectional Studies
;
Human Engineering
;
Humans
;
Logistic Models
;
Lumbosacral Region
;
National Institute for Occupational Safety and Health (U.S.)
;
Sanitation
;
Solid Waste
;
Task Performance and Analysis
;
Upper Extremity
7.Ankylosing Spondylitis associated with Plasmacytoma: a Case Report.
Yong Nam KIM ; Hyang Ee LEE ; Sang Hoon LEE ; Yeon A LEE ; Doo Hyun WOO ; Young HWANGBO ; Kyung Sam CHO ; Yong Koo PARK ; Hyung In YANG
The Journal of the Korean Rheumatism Association 2005;12(3):240-244
Plasmacytomas are tumors composed of plasma cells of variable maturity, which are histologically identical to those seen in multiple myeloma. Ankylosing spondylitis is a chronic inflammatory disease, probably resulting from the interaction of a genetic predisposition involving HLA-B27 with an environmental event such as enteric bacterial infection. Multiple myeloma has been intermittently reported in patients with ankylosing spondylitis. It has been proposed that the protracted stimulation of immunocytes by inflammatory lesions on the mucosal surfaces of the gastrointestinal, respiratory tracts may be implicated in the pathogenesis of multiple myeloma in some patients. We observed a 23 year old male patient with a history of plasmacytoma who subsequently developed ankylosing spondylitis. He was diagnosed as plasmacytoma 4 years ago and took a radiation therapy. There was no previous report of ankylosing spondylitis following plasmacytoma. The relationship between two diseases is uncertain until now and further study should be needed.
Bacterial Infections
;
Genetic Predisposition to Disease
;
HLA-B27 Antigen
;
Humans
;
Male
;
Multiple Myeloma
;
Plasma Cells
;
Plasmacytoma*
;
Respiratory System
;
Spondylitis, Ankylosing*
;
Young Adult
8.Review of Chromosomal Analyses Performed in a Single Hospital.
Hong Kug KIM ; Nam Hyang KOO ; Jin Soon HWANG ; Sung Hwan KIM
Korean Journal of Pediatrics 2004;47(11):1157-1160
PURPOSE: Chromosomal aberration has an effect on the lives of both patients and families. Peripheral blood chromosomal analysis is useful to make a diagnosis and counsel the patient with chromosomal abnormality. We studied the cases with peripheral blood chromosomal analyses and investigated the positivity of peripheral blood chromosomal analysis. METHODS: We analyzed 650 patients with chromosomal analyses in Ajou University Hospital during the past 10 years. We used a high-resolution banding technique to diagnose the chromosomal aberrations. RESULTS: The male to female ratio of the patients was 1.1 : 1. Among 650 patients, 108 patients had chromosomal aberrations(16.6%). Fifty seven out of 313 patients with the congenital anomalies or dysmorphologies had chromosomal aberrations. twenty six out of 166 patients with hematologic disorders had chromosomal aberrations. Fifteen out of 109 patients with developmental delay had chromosomal aberrations. Four out of 24 patients with seizures had chromosomal aberrations. Six out of 39 patients with the aberrant perinatal histories had chromosomal aberrations. CONCLUSION: Peripheral blood chromosomal analysis is an important diagnostic method in managing patients with chromosomal aberrations. Further advanced chromosomal staining and molecular genetic methods will raise the detection rate of chromosomal aberration and be useful in managing patients with chromosomal abnormalities.
Chromosome Aberrations
;
Diagnosis
;
Female
;
Humans
;
Male
;
Molecular Biology
;
Seizures
9.Acute Optic Neuritis in Children : Clinical Features, Visual Outcome, Recurrence Rate, and Subsequent Evolution into Multiple Sclerosis.
Nam Hyang KOO ; Yeun Hee KIM ; Sung Hwan KIM
Journal of the Korean Child Neurology Society 2004;12(2):176-186
PURPOSE: Acute optic neuritis is an inflammatory optic neuropathy, and rarely occurs in children. Childhood-onset optic neuritis is different from adult-onset optic neuritis in terms of clinical and prognostic aspects. We investigated the clinical characteristics and visual prognosis related to the steroid therapy in children with acute optic neuritis. In addition, we evaluated the recurrence rate of acute optic neuritis and subsequent evolution into multiple sclerosis. METHODS: The medical records of ten children, who were previously admitted for acute optic neuritis at the Department of Pediatrics of Ajou University Medical Center from January 1995 to April 2004, were retrospectively reviewed. Nine patients were treated with intravenous methylprednisone pulse therapy, 0.5-1.0 g/day, for 3-5 days followed by an oral prednisone therapy. To 30 months after discharge, we followed up a long-term visual prognosis, recurrence rate and subsequent evolution into multiple sclerosis. RESULTS: There were 4 boys and 6 girls and the mean age of onset was 10 years. Bilateral optic neuritis was noticed in 8 children and 9 children presented with papillitis. Etiology of acute optic neuritis was idiopathic in 50% of patients. Of the remaining cases, it was related with acute disseminated encephalomyelitis(30%), sinusitis(10%), and neuromyelitis optica(10%). Orbital MRI showed optic nerve enhancement and/or enlargement and optic disc protrusion in 15 of the 18 examined eyes. Visual evoked potential (VEP) was abnormal in 12 of the 16 examined eyes; P100 response was totally attenu ated in 6 eyes, and in the others the amplitude of P100 response was normal but the latency was delayed. On follow-up VEP at 1 month after steroid pulse therapy, the amplitude of P100 response was normalized in all, but the latency was still delayed in 60% of the patients. A short-term visual acuity after treatment with steroid was normally recovered in 14 of 15 involved eyes. Acute optic neuritis recurred in one of the nine patients who were treated with high dose methylprednisone pulse therapy, but there was no subsequent development of multiple sclerosis during the follow up. CONCLUSION: The most common cause of acute optic neuritis in children is idiopathic, and presents as bilateral papillitis. On this study, a short-term visual prognosis after high dose methylprednisone pulse therapy is extremely good, but there was no significant difference in long-term visual prognosis at 6 months after treatment with steroid. Acute optic neuritis in children does not usually recur, and does not evolve into multiple sclerosis.
Academic Medical Centers
;
Age of Onset
;
Child*
;
Evoked Potentials, Visual
;
Female
;
Follow-Up Studies
;
Humans
;
Magnetic Resonance Imaging
;
Medical Records
;
Multiple Sclerosis*
;
Optic Nerve
;
Optic Nerve Diseases
;
Optic Neuritis*
;
Orbit
;
Papilledema
;
Pediatrics
;
Prednisone
;
Prognosis
;
Recurrence*
;
Retrospective Studies
;
Visual Acuity
10.A Four-year Follow-up Case of Oligomeganephronia Detected Early by School Screening Urinalysis.
Ju Yeon HAM ; Nam Hyang KOO ; Ki Soo PAI ; Hyun Yi LIM ; Kee Hyuck KIM
Journal of the Korean Society of Pediatric Nephrology 2003;7(2):223-228
Oligmeganephronia is congenital hypoplasia of kidney with renal pathology showing very small number of nephrons with compensatory hypertrophy of the remaining glomeruli. A 7- year-old girl was referred to our nephrology clinic due to hematuria detected on school screening urinalysis and diagnosed as chronic renal failure and oligomeganephronia on renal biopsy. We are reporting the clinical and histomorphometric changes for the four years follow-up with review of literatures.
Biopsy
;
Female
;
Follow-Up Studies*
;
Hematuria
;
Humans
;
Hypertrophy
;
Kidney
;
Kidney Failure, Chronic
;
Mass Screening*
;
Nephrology
;
Nephrons
;
Pathology
;
Urinalysis*

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