1.A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation
Guk Jin LEE ; Hyunho KIM ; Sung Shim CHO ; Hyung Soon PARK ; Ho Jung AN ; In Sook WOO ; Jae Ho BYUN ; Ji Hyung HONG ; Yoon Ho KO ; Der Sheng SUN ; Hye Sung WON ; Jong Youl JIN ; Ji Chan PARK ; In-Ho KIM ; Sang Young ROH ; Byoung Yong SHIM
Journal of Gastric Cancer 2023;23(2):315-327
Purpose:
Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy.
Materials and Methods:
Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level.
Results:
Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250–0.890; P=0.020).
Conclusions
After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.
2.Investigating the Feasibility of Targeted Next-Generation Sequencing to Guide the Treatment of Head and Neck Squamous Cell Carcinoma.
Sun Min LIM ; Sang Hee CHO ; In Gyu HWANG ; Jae Woo CHOI ; Hyun CHANG ; Myung Ju AHN ; Keon Uk PARK ; Ji Won KIM ; Yoon Ho KO ; Hee Kyung AHN ; Byoung Chul CHO ; Byung Ho NAM ; Sang Hoon CHUN ; Ji Hyung HONG ; Jung Hye KWON ; Jong Gwon CHOI ; Eun Joo KANG ; Tak YUN ; Keun Wook LEE ; Joo Hang KIM ; Jin Soo KIM ; Hyun Woo LEE ; Min Kyoung KIM ; Dongmin JUNG ; Ji Eun KIM ; Bhumsuk KEAM ; Hwan Jung YUN ; Sangwoo KIM ; Hye Ryun KIM
Cancer Research and Treatment 2019;51(1):300-312
PURPOSE: Head and neck squamous cell carcinoma (HNSCC) is a deadly disease in which precision medicine needs to be incorporated. We aimed to implement next-generation sequencing (NGS) in determining actionable targets to guide appropriate molecular targeted therapy in HNSCC patients. MATERIALS AND METHODS: Ninety-three tumors and matched blood samples underwent targeted sequencing of 244 genes using the Illumina HiSeq 2500 platform with an average depth of coverage of greater than 1,000×. Clinicopathological data from patients were obtained from 17 centers in Korea, and were analyzed in correlation with NGS data. RESULTS: Ninety-two of the 93 tumors were amenable to data analysis. TP53 was the most common mutation, occurring in 47 (51%) patients, followed by CDKN2A (n=23, 25%), CCND1 (n=22, 24%), and PIK3CA (n=19, 21%). The total mutational burden was similar between human papillomavirus (HPV)–negative vs. positive tumors, although TP53, CDKN2A and CCND1 gene alterations occurred more frequently in HPV-negative tumors. HPV-positive tumors were significantly associated with immune signature-related genes compared to HPV-negative tumors. Mutations of NOTCH1 (p=0.027), CDKN2A (p < 0.001), and TP53 (p=0.038) were significantly associated with poorer overall survival. FAT1 mutations were highly enriched in cisplatin responders, and potentially targetable alterations such as PIK3CA E545K and CDKN2A R58X were noted in 14 patients (15%). CONCLUSION: We found several targetable genetic alterations, and our findings suggest that implementation of precision medicine in HNSCC is feasible. The predictive value of each targetable alteration should be assessed in a future umbrella trial using matched molecular targeted agents.
Biomarkers
;
Carcinoma, Squamous Cell*
;
Cisplatin
;
Epithelial Cells*
;
Head*
;
Humans
;
Korea
;
Molecular Targeted Therapy
;
Neck*
;
Precision Medicine
;
Statistics as Topic
3.Clinical Outcomes of Hospital-Acquired Acute Cholecystitis in the Elderly.
Ji Hun BONG ; Dong Kee JANG ; Jun Kyu LEE ; Yu Jin KO ; Byoung Yen KIM ; Seong Yeon PARK ; Jae Woo CHUNG ; Sang Hyub LEE
Korean Journal of Pancreas and Biliary Tract 2017;22(4):172-178
BACKGROUND/AIM: Antimicrobials for nosocomial infections are generally chosen discriminately from community-acquired diseases from concerns for resistance to which the elderly are highly exposed. The elderly are affected frequently by acute cholecystitis (AC), for which appropriate antimicrobial therapy is particularly important. Also, cholecystectomy for elderly patients with co-morbidities is expectedly not as feasible as for uncomplicated young patients. Characteristics of hospital-acquired AC in the elderly patients were investigated in this study. METHODS: Records of patients over 65 years and older diagnosed with AC between March 2006 and February 2015 were reviewed retrospectively. Hospital-acquired AC was defined as development of AC in patients who were admitted for other disorders. Community-acquired AC was defined as presence of AC at the time of admission. Community-acquired AC group (CG) was used as a control group that was matched for age and sex with a ratio of 1:2. RESULTS: There were 40 patients in hospital-acquired AC group (HG) and 80 in CG. Demographics did not differ except higher prevalence of underlying illnesses in HG. Necessity to change initial antimicrobials for worsening conditions was more common in HG than in CG (20.0% vs. 2.5%, p < 0.01). Time to recovery was longer in HG (23.3 ± 5.6 days vs. 10.1 ± 0.7 days, p = 0.02). Rate of early cholecystectomy was lower (7.5% vs. 40.0%, p < 0.01) and that of open conversion was higher (20.0% vs. 6.3%, p = 0.02) in HG. CONCLUSIONS: For the elderly patients with hospital-acquired AC, antimicrobial and surgical management should be performed more meticulously since they showed distinct characteristics.
Aged*
;
Cholecystectomy
;
Cholecystitis, Acute*
;
Cross Infection
;
Demography
;
Gallstones
;
Humans
;
Prevalence
;
Retrospective Studies
4.Mitochondrial pyruvate dehydrogenase phosphatase 1 regulates the early differentiation of cardiomyocytes from mouse embryonic stem cells.
Hye Jin HEO ; Hyoung Kyu KIM ; Jae Boum YOUM ; Sung Woo CHO ; In Sung SONG ; Sun Young LEE ; Tae Hee KO ; Nari KIM ; Kyung Soo KO ; Byoung Doo RHEE ; Jin HAN
Experimental & Molecular Medicine 2016;48(8):e254-
Mitochondria are crucial for maintaining the properties of embryonic stem cells (ESCs) and for regulating their subsequent differentiation into diverse cell lineages, including cardiomyocytes. However, mitochondrial regulators that manage the rate of differentiation or cell fate have been rarely identified. This study aimed to determine the potential mitochondrial factor that controls the differentiation of ESCs into cardiac myocytes. We induced cardiomyocyte differentiation from mouse ESCs (mESCs) and performed microarray assays to assess messenger RNA (mRNA) expression changes at differentiation day 8 (D8) compared with undifferentiated mESCs (D0). Among the differentially expressed genes, Pdp1 expression was significantly decreased (27-fold) on D8 compared to D0, which was accompanied by suppressed mitochondrial indices, including ATP levels, membrane potential, ROS and mitochondrial Ca²⁺. Notably, Pdp1 overexpression significantly enhanced the mitochondrial indices and pyruvate dehydrogenase activity and reduced the expression of cardiac differentiation marker mRNA and the cardiac differentiation rate compared to a mock control. In confirmation of this, a knockdown of the Pdp1 gene promoted the expression of cardiac differentiation marker mRNA and the cardiac differentiation rate. In conclusion, our results suggest that mitochondrial PDP1 is a potential regulator that controls cardiac differentiation at an early differentiation stage in ESCs.
Adenosine Triphosphate
;
Animals
;
Cell Lineage
;
Embryonic Stem Cells
;
Membrane Potentials
;
Mice*
;
Mitochondria
;
Mouse Embryonic Stem Cells*
;
Myocytes, Cardiac*
;
Oxidoreductases
;
Pyruvate Dehydrogenase (Lipoamide)-Phosphatase*
;
Pyruvic Acid*
;
RNA, Messenger
5.Transvenous Lead Extraction via the Inferior Approach Using a Gooseneck Snare versus Simple Manual Traction.
Uk JO ; Jun KIM ; You Mi HWANG ; Ji Hyun LEE ; Min Su KIM ; Hyung Oh CHOI ; Woo Seok LEE ; Chang Hee KWON ; Gi Young KO ; Hyun Ki YOON ; Gi Byoung NAM ; Kee Joon CHOI ; You Ho KIM
Korean Circulation Journal 2016;46(2):186-196
BACKGROUND AND OBJECTIVES: The number of patients with cardiac implantable electronic devices needing lead extraction is increasing for various reasons, including infections, vascular obstruction, and lead failure. We report our experience with transvenous extraction of pacemaker and defibrillator leads via the inferior approach of using a gooseneck snare as a first-line therapy and compare extraction using a gooseneck snare with extraction using simple manual traction. SUBJECTS AND METHODS: The study included 23 consecutive patients (43 leads) who underwent transvenous lead extraction using a gooseneck snare (group A) and 10 consecutive patients (17 leads) who underwent lead extraction using simple manual traction (group B). Patient characteristics, indications, and outcomes were analyzed and compared between the groups. RESULTS: The dwelling time of the leads was longer in group A (median, 121) than in group B (median, 56; p=0.000). No differences were noted in the overall procedural success rate (69.6% vs. 70%), clinical procedural success rate (82.6% vs. 90%), and lead clinical success rate (86% vs. 94.1%) between the groups. The procedural success rates according to lead type were 89.2% and 100% for pacing leads and 66.7% and 83.3% for defibrillator leads in groups A and B, respectively. Major complications were noted in 3 (mortality in 1) patients in group A and 2 patients in group B. CONCLUSION: Transvenous extraction of pacemaker leads via an inferior approach using a gooseneck snare was both safe and effective. However, stand-alone transvenous extraction of defibrillator leads using the inferior approach was suboptimal.
Defibrillators
;
Defibrillators, Implantable
;
Device Removal
;
Humans
;
Pacemaker, Artificial
;
SNARE Proteins*
;
Traction*
6.The Clinical Significance of Specialized Intestinal Metaplasia in the Diagnosis of Barrett's Esophagus: Nationwide Prospective Multicenter Study.
Hyun Kyung PARK ; Nayoung KIM ; Byoung Hwan LEE ; Jin Il KIM ; So Young LEE ; Hyun Min CHA ; Hyerang KIM ; Soo Hyun PARK ; Jong Jae PARK ; Sang Woo LEE ; Ki Nam SHIM ; Seong Eun KIM ; Su Jin HONG ; Il Kwun CHUNG ; Gwang Ho BAIK ; Hyun Soo KIM ; Sungkook KIM ; Jae Kyu SEONG ; Geom Seog SEO ; Sam Ryong JEE ; Jeong Seop MOON ; Mee Yon CHO ; Jae Woo KIM ; Moon Gi CHUNG ; Seon Mee PARK ; Byung Kyu NAH ; Su Youn NAM ; Kang Seok SEO ; Byung Sung KO ; Yun Ju JO ; Jae Young JANG ; Byeong Gwan KIM ; Ji Won KIM ; Kyung Sik PARK ; Hyun Shin PARK ; Young Sun KIM ; Seon Hee LIM ; Chung Hyeon KIM ; Min Jung PARK ; Jeong Yoon YIM ; Kyung Ran CHO ; Donghee KIM ; Seun Ja PARK ; Geun Am SONG ; Hyun Jin KIM ; Sang Wook KIM ; Eui Hyeog IM ; Kyoung Soo LEE ; Dong Hyo HYUN ; Hyun Young KIM ; Sun Mi KIM ; Jeong Eun SHIN ; Chan Guk PARK ; Chang Hun YANG ; Soo Heon PARK ; Hyun Chae JUNG ; In Sik CHUNG
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2012;12(3):171-177
BACKGROUND/AIMS: The meaning of specialized intestinal metaplasia (SIM) in the diagnosis of Barrett's esophagus (BE) is not clear. This study was designed to determine the clinical significance of SIM in the diagnosis of Barrett's esophagus. MATERIALS AND METHODS: Biopsies were taken from 601 subjects with endoscopically suspected columnar-lined esophagus. Under light microscopy with Alcian-blue stain, SIM was identified. Demographic characteristics, gastroesophageal (GE) reflux symptoms and endoscopic findings were compared between the SIM-present group and the SIM-absent group. RESULTS: Among 601 subjects, 184 (30.6%) were confirmed by pathology to have SIM. Age over 40 years (P<0.001) and a medication history of proton pump inhibitor or H2 blocker were found more frequently in the SIM-present group (P=0.01) than in the SIM-absent group. Any of 7 GE reflux symptoms (heartburn, acid regurgitation, chest pain, hoarseness, globus sensation, cough and epigastric soreness) were more frequent in the SIM-present group than SIM-absent group (P<0.001). Specifically, heartburn, chest pain and cough were significantly more common in the SIM-present group. There was no clinically significant difference associated with endoscopic findings or other clinical characteristics. CONCLUSIONS: When subjects with endoscopically suspected BE are analyzed based on the presence or absence of SIM, the SIM-present group was significantly associated with GE reflux symptoms suggestive of frequent GE reflux. However, the presence of SIM did not correlate with endoscopic findings.
Barrett Esophagus
;
Biopsy
;
Chest Pain
;
Cough
;
Esophagus
;
Gastroesophageal Reflux
;
Heartburn
;
Hoarseness
;
Light
;
Metaplasia
;
Microscopy
;
Prospective Studies
;
Proton Pumps
;
Sensation
7.Analgesic Effects of Tramadol During Panretinal Photocoagulation.
Byoung Woo KO ; Jae Hang SHIM ; Byung Ro LEE ; Hee Yoon CHO
Korean Journal of Ophthalmology 2009;23(4):273-276
PURPOSE: To evaluate the effectiveness of tramadol for the reduction of pain in panretinal photocoagulation (PRP). METHODS: A double-masked randomized controlled study was performed. Fifty-eight eyes in 29 patients with proliferative diabetic retinopathy were enrolled. The eyes of the patients were randomized into two groups. Group A received an empty capsule. Group B received an oral intake of 100 mg tramadol. The capsule used in Group A had the same appearance as that used in Group B. Pain during PRP was assessed using a visual analog scale. Vital signs, including blood pressure and heart rate, were measured. RESULTS: The mean pain scores for groups A and B were 4.80+/-2.10 and 3.83+/-1.82 (p=0.09). There were no significant differences in the mean pain scores between the two groups. More patients in group A complained of greater pain than moderate intensity (visual analogue scale=4). Systemic blood pressure increased significantly in group A after laser treatment. However, there were no significant differences in the diastolic blood pressure changes between the two groups. We found no statistical correlation in the heart rate changes. CONCLUSIONS: We failed to prove that tramadol is effective for pain relief because of the small sample size. However, tramadol was effective for the relief of more severe pain. It was also found to stabilize vital sign changes, such as systolic blood pressure during PRP.
Administration, Oral
;
Adult
;
Aged
;
Analgesia/*methods
;
Analgesics, Opioid/*administration & dosage
;
Case-Control Studies
;
Diabetic Retinopathy/*surgery
;
Dose-Response Relationship, Drug
;
Double-Blind Method
;
Follow-Up Studies
;
Humans
;
Laser Coagulation/*methods
;
Middle Aged
;
Pain/*drug therapy/physiopathology
;
Pain Measurement
;
Prospective Studies
;
Tramadol/*administration & dosage
;
Treatment Outcome
;
Vitreoretinopathy, Proliferative/*surgery
8.Comparison of Macular Thickness Measurements Between Fourier-Domain and Time-Domain Optical Coherence Tomography in Normal Eyes and Eyes With Macular Diseases.
Byoung Woo KO ; Yong Woon SHIN ; Jeong Min LEE ; Yumi SONG ; Byung Ro LEE
Journal of the Korean Ophthalmological Society 2009;50(11):1661-1668
PURPOSE: To define and measure macular thickness and volume using Fourier domain OCT (FD OCT) and compare the values with Stratus OCT in normal eyes and eyes with macular disease. METHODS: On the same day, macular thicknesses of the ETDRS 9 subfield and total macular volumes were measured in 35 eyes of 23 normal subjects and 19 diseased eyes of 24 patients with FD OCT and Stratus OCT. The macular cube scan protocol for FD OCT and the fast macular thickness map protocol for Stratus OCT were used to measure macular thicknesses. RESULTS: Foveal thickness of the central subfield in FD OCT (251.49+/-79.45 micrometer) was thicker than the value of Stratus OCT (210.26+/-60.57 micrometer) (p<0.001) in all eyes. Total macular volume was 7.72+/-1.06 mm3 and 7.04+/-0.96 mm3 for FD OCT and Stratus OCT, respectively (p<0.001). Retina thickness of the ETDRS 9 subfields in FD OCT was thicker than the value obtained using Stratus OCT. In addition, foveal thickness differences were statistically significant in both the normal and diseased eye groups. CONCLUSIONS: Macular thickness and total macular volume as measured by the FD OCT were larger than the values obtained using the Stratus OCT in both the normal and the diseased eye groups. The measuring algorithm of FD OCT defines the top of RPE as the outer retinal boundary, but Stratus OCT defines the outer retinal boundary as the IS/OS junction of the photoreceptor. Therefore, macular thicknesses of FD OCT are thicker than those of Stratus OCT. This difference should be considered when comparing the results of FD OCT with those of Stratus OCT.
Antineoplastic Combined Chemotherapy Protocols
;
Cisplatin
;
Doxorubicin
;
Eye
;
Humans
;
Mitomycin
;
Retina
;
Retinaldehyde
;
Tomography, Optical Coherence
9.The Clinical Features of Patients with Early Recurrence and with Orthophoria After Intermittent Exotropia Surgery.
Byoung Woo KO ; Sun Young SHIN
Journal of the Korean Ophthalmological Society 2008;49(7):1108-1113
PURPOSE: To analyze the clinical features of patients with exodeviation of more than 15 prism diopters (PDs) within one month and with orthophoria over three years after surgical correction of intermittent exotropia. METHODS: The early recurrence group consisted of patients with a final distance and near exodeviation more than 15PDs within one month after surgical correction of intermittent exotropia. The surgical success group was defined as patients with orthophoria over three years after surgical correction of intermittent exotropia. Sex, age at onset and surgery, office control status, refraction status, A-V pattern, preoperative and postoperative angles of ocular deviation, binocular sensory status, and the presence of diplopia on postoperative one day were retrospectively investigated and compared between these two groups. RESULTS: Out of a total of 68 patients, early recurrence occurred in 33 patients, and success was achieved in 35 patients. Factors including sex, age at onset and surgery, office control status, and diplopia on postoperative one day did not differ between the two groups. Preoperative near-angles of ocular deviation, A-V pattern of strabismus, preoperative stereopsis, and the range of postoperative overcorrection contributed to early recurrence. CONCLUSIONS: Factors related to early recurrence were larger preoperative near-angles of ocular deviation, presence of A-V pattern, poor preoperative stereopsis, and a smaller amount of overcorrection on postoperative day 1.
Ambulatory Surgical Procedures
;
Depth Perception
;
Diplopia
;
Exotropia
;
Humans
;
Recurrence
;
Retrospective Studies
;
Strabismus
;
Telescopes
10.Clinical Characteristics of Primary Peritoneal Carcinoma.
Sang Young ROH ; Sook Hee HONG ; Yoon Ho KO ; Tae Hee KIM ; Myung Ah LEE ; Byoung Yong SHIM ; Jae Ho BYUN ; In Sook WOO ; Jin Hyoung KANG ; Young Seon HONG ; Kyung Shik LEE
Cancer Research and Treatment 2007;39(2):65-68
PURPOSE: The goal of this study was to determine the clinical and therapeutic characteristics of women with a primary peritoneal carcinoma (PPC). MATERIALS AND METHODS: A retrospective clinical study was conducted to evaluate 22 women diagnosed with a PPC from 1993 to 2007 at the Hospitals of The Catholic University of Korea. Diagnoses were based on the Gynecologic Oncology Group criteria and clinical data. We collected patient clinicopathological data including age, presenting symptoms, pretreatment CA-125 values (U/ml), clinical stage (based on the FIGO stage), performance status (using the Eastern Cooperative Oncology Group scale), whether cytoreductive surgery was optimal or not, types of chemotherapy and response to treatment. We evaluated the clinical characteristics and response to treatment, time to treatment failure and overall survival. RESULTS: The median overall survival of all patients was 23.1 months. The estimated 3-year survival rate was 29% (SE, 13%). The response rate to first-line platinum-based chemotherapy was 79% and the median time to treatment failure was 9.9 months (95% confidence interval, 1.38~18.4 months). By univariate and multivariate analysis, performance status was the only significant factor associated with overall survival (p<0.05). CONCLUSION: We evaluated the clinical characteristics and treatment response of patients with a primary peritoneal carcinoma. Our results showed that it is possible to achieve long-term survival in patients with PPC. A further clinical study is to need to establish clinical characteristics and treatment outcomes.
Diagnosis
;
Drug Therapy
;
Female
;
Humans
;
Korea
;
Multivariate Analysis
;
Retrospective Studies
;
Survival Rate
;
Time-to-Treatment
;
Treatment Failure

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