Purpose: This phase II, open-label, multicenter study aimed to investigate the efficacy and safety of a rituximab intensification for the 1st cycle with every 21-day of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP-21) among patients with previously untreated advanced-stage or bulky diffuse large B-cell lymphoma (DLBCL). Materials and Methods: Ninety-two patients with stage III/IV or bulky DLBCL from 21 institutions were administered 8 cycles of R-CHOP-21 with an additional one dose of rituximab intensification on day 0 of the 1st cycle (RR-CHOP). The primary endpoint was a complete response (CR) rate after 3 cycles of chemotherapy. Results: Among the 92 DLBCL patients assessed herein, the response rate after 3 cycles of chemotherapy was 88.0% (38.0% CR+50.0% partial response [PR]). After the completion of 8 cycles of chemotherapy, the overall response rate was observed for 68.4% (58.7% CR+9.8% PR). The 3-year progression-free survival rate was 64.0%, and the 3-year overall survival rate was 70.4%. Febrile neutropenia was one of the most frequent grade 3 adverse events (40.0%) and 5 treatment-related deaths occurred. Compared with the clinical outcomes of patients who received R-CHOP chemotherapy as a historical control, the interim CR rate was higher in male patients with RR-CHOP (20.5% vs. 48.8%, p=0.016). Conclusion Rituximab intensification on days 0 to the 1st cycle of the standard 8 cycles R-CHOP-21 for advanced DLBCL yielded favorable response rates after the 3 cycles of chemotherapy and acceptable toxicities, especially for male patients. ClinicalTrials.gov ID: NCT01054781.

Background: Sterility and safety assurance of hematopoietic stem cell (HSC) products is critical in transplantation. Microbial contamination can lead to product disposal and increases the risk of unsuccessful clinical outcomes. Therefore, it is important to implement and maintain good practice guidelines and regulations for the HSC collection and processing unit in each hospital. We aimed to share our experiences and suggest strategies to improve the quality assurance of HSC processing. Methods: We retrospectively analyzed microbial culture results of 11,743 HSC products processed over a 25-year period (January 1996 to May 2021). Because of reorganization of the HSC management system in 2008, the 25-year period was divided into periods 1 (January 1996 to December 2007) and 2 (January 2008 to May 2021). We reviewed all culture results of the HSC products and stored aliquot samples and collected culture results for peripheral blood and catheter samples. Results: Of the 11,743 products in total, 35 (0.3%) were contaminated by microorganisms, including 19 (0.5%) of 3,861 products during period 1 and 16 (0.2%) of 7,882 products during period 2. Penicillium was the most commonly identified microorganism (15.8%) during period 1 and coagulase-negative Staphylococcus was the most commonly identified (31.3%) during period 2. HSC product contamination occurred most often during HSC collection and processing. Conclusions The contamination rate decreased significantly during period 2, when the HSC management system was reorganized. Our results imply that handling HSC products by trained personnel and adopting established protocols, including quality assurance programs, aid in decreasing the contamination risk.

Purpose: We aimed to investigate manifestations and patterns of care for patients with brain metastasis (BM) from breast cancer (BC) and compared their overall survival (OS) from 2005 through 2014 in Korea. Materials and Methods: We retrospectively reviewed 600 BC patients with BM diagnosed between 2005 and 2014. The median follow-up duration was 12.5 months. We categorized the patients into three groups according to the year when BM was initially diagnosed (group I [2005-2008], 98 patients; group II [2009-2011], 200 patients; and group III [2012-2014], 302 patients). Results: Over time, the median age at BM diagnosis increased by 2.2 years (group I, 49.0 years; group II, 48.3 years; and group III, 51.2 years; p=0.008). The percentage of patients with extracranial metastasis was 73.5%, 83.5%, and 86.4% for group I, II, and III, respectively (p=0.011). The time interval between BC and BM was prolonged in patients with stage III primary BC (median, 2.4 to 3 years; p=0.029). As an initial brain-directed treatment, whole-brain radiotherapy alone decreased from 80.0% in 2005 to 41.1% in 2014. Meanwhile, stereotactic radiosurgery or fractionated stereotactic radiotherapy alone increased from 13.3% to 34.7% during the same period (p=0.005). The median OS for group I, II, and III was 15.6, 17.9, and 15.0 months, respectively, with no statistical significance. Conclusion The manifestations of BM from BC and the pattern of care have changed from 2005 to 2014 in Korea. However, the OS has remained relatively unchanged over the 10 years.

OBJECTIVE: The aim of this study was to investigate the effects of omega-3 fatty acids added to statin monotherapy in Korean patients with type 2 diabetes who have persistent hypertriglyceridemia despite statin therapy. METHODS: This study was a randomized controlled trial conducted in 4 clinical sites between February 2009 and February 2011. The inclusion criteria were patients with type 2 diabetes who had received ≥6 weeks of statin therapy and had fasting triglyceride (TG) levels ≥1.7mmol/L and low-density lipoprotein (LDL) cholesterol levels <2.6 mmol/L. The study regimen consisted of 16 weeks of randomized treatment with omega-3 fatty acids (4 g/day) plus a statin (n=26) or statin only (n=30). The primary endpoint was the change from baseline to final visit in mean TG level. RESULTS: A total of 56 participants were analyzed. At week 16, the change in the TG level in the combination therapy group differed significantly from the change in the statin monotherapy group (−34.8% vs. −15.2%, p=0.0176). Treatment with omega-3 fatty acids plus a statin was also associated with a significant decrease in non-high-density lipoprotein cholesterol compared with baseline, but the difference was not significant compared with the statin monotherapy group (−8.0% vs. −2.5%, p=0.165). The changes in LDL cholesterol and HbA1c levels did not differ significantly between groups. The study medications were well tolerated, and adverse events were comparable between two groups. CONCLUSION: Adding omega-3 fatty acids to statin treatment reduced TG levels more effectively than statin monotherapy without undesirable effects in Korean type 2 diabetic patients who had hypertriglyceridemia despite well-controlled LDL cholesterol on stable statin therapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02305355
Cholesterol ; Cholesterol, LDL ; Diabetes Mellitus, Type 2 ; Fasting ; Fatty Acids, Omega-3 ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Hypertriglyceridemia ; Lipoproteins ; Prescriptions ; Triglycerides

PURPOSE: To investigate the correlations between parameters of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and prognostic factors in rectal cancer. MATERIALS AND METHODS: We studied 29 patients with rectal cancer who underwent gadolinium contrast-enhanced, T1-weighted DCE-MRI with a three Tesla scanner prior to surgery. Signal intensity on DCE-MRI was independently measured by two observers to examine reproducibility. A time-signal intensity curve was generated, from which four semiquantitative parameters were calculated: steepest slope (SLP), time to peak (Tp), relative enhancement during a rapid rise (Erise), and maximal enhancement (Emax). Morphologic prognostic factors including T stage, N stage, and histologic grade were identified. Tumor angiogenesis was evaluated in terms of microvessel count (MVC) and microvessel area (MVA) by morphometric study. As molecular factors, the mutation status of the K-ras oncogene and microsatellite instability were assessed. DCE-MRI parameters were correlated with each prognostic factor using bivariate correlation analysis. A p-value of <0.05 was considered significant. RESULTS: Erise was significantly correlated with N stage (r=-0.387 and -0.393, respectively, for two independent data), and Tp was significantly correlated with histologic grade (r=0.466 and 0.489, respectively). MVA was significantly correlated with SLP (r=-0.532 and -0.535, respectively) and Erise (r=-0.511 and -0.446, respectively). MVC was significantly correlated with Emax (r=-0.435 and -0.386, respectively). No significant correlations were found between DCE-MRI parameters and T stage, K-ras mutation, or microsatellite instability. CONCLUSION: DCE-MRI may provide useful prognostic information in terms of histologic differentiation and angiogenesis in rectal cancer.
Adult ; Aged ; Aged, 80 and over ; Cell Differentiation ; Contrast Media/*pharmacology ; DNA Mutational Analysis ; Female ; Gadolinium/pharmacology ; Genes, ras ; Humans ; Magnetic Resonance Imaging/*methods ; Male ; Microcirculation ; Microsatellite Instability ; Middle Aged ; Neoplasm Staging ; Neovascularization, Pathologic ; Prognosis ; Rectal Neoplasms/*diagnosis/genetics/*pathology ; Retrospective Studies ; Time Factors

Pseudoachalasia secondary to primary squamous cell carcinoma (SCC) of the liver is extremely rare and has not been reported until now. Here, we report a unique case of primary SCC of the liver initially presenting with progressive dysphagia along with short periods of significant weight loss. A 58-year-old man initially presented with progressive dysphagia along with significant weight loss over brief periods of time. The radiographic and manometric findings were consistent with achalasia. Subsequent esophagogastroduodenoscopy revealed a moderately dilated esophagus without evidence of neoplasm or organic obstruction. However, firm resistance was encountered while traversing the esophagogastric junction (EGJ), although no mucosal lesion was identified. Due to the clinical suspicion of the presence of a malignant tumor, endoscopic ultrasonography (EUS) and computed tomography scans of the chest and abdomen were obtained. A huge hepatic mass with irregular margins extending to the EGJ was found. EUS-guided fine-needle aspiration was performed, and the mass was diagnosed as a primary SCC of the liver by immunohistochemical staining.
Abdomen ; Biopsy, Fine-Needle ; Carcinoma, Squamous Cell ; Deglutition Disorders ; Endoscopy, Digestive System ; Endosonography ; Esophageal Achalasia ; Esophagogastric Junction ; Esophagus ; Humans ; Liver ; Middle Aged ; Thorax ; Weight Loss

Endoscopic retrograde biliary drainage (ERBD) is useful for the palliative decompression of biliary obstruction. However, the complications of ERBD include cholangitis, hemorrhage, acute pancreatitis, obstruction of the stent, and duodenal perforation. Pressure necrosis on the duodenal mucosa by the stent may contribute to perforation. Although duodenal perforation following ERBD is very rare compared to other complications, it can result in a fatal outcome. Recent reports describe nonsurgical treatment for small gastrointestinal perforation with localized peritonitis and suggest that endoclipping may be appropriate in the management of a well selected group of patients with iatrogenic perforation. We describe a case of duodenal perforation secondary to ERBD that was successfully treated with approximating using endoclip and detachable snare.
Bile Ducts, Extrahepatic ; Biliary Tract Diseases/complications/surgery ; Cholangiopancreatography, Endoscopic Retrograde ; Drainage ; Duodenal Diseases/*diagnosis/etiology/therapy ; Female ; Gallbladder Neoplasms/diagnosis ; Humans ; Intestinal Perforation/*diagnosis/etiology/therapy ; Middle Aged ; Plastics ; Stents/*adverse effects ; Tomography, X-Ray Computed

PURPOSE: The purpose of this study were to develop a new restraint for the intensive care units (ICU) and to investigate the application effect in comparison with a control group using existing restraints. METHOD: A non-equivalent control group non-synchronized quasi-experimental research design was used. The participants were 40 (control 20, experimental 20) patients who were recruited by convenience sampling the ICU of a university hospital. To avoid contamination of the experiment, data for the control group were collected prior to the experimental group. Measurement variables were edema and skin damage (redness and abrasion) at the application site, and nurses' perceived convenience in applying restraints. RESULTS: Three days after applying the restraint, amount of edema at the application site was small and incidence of skin damage decreased in the experimental group in comparison with the control group. Also, score for application convenience measured by the nurses was higher in for the newly developed restraint than for existing restraints. CONCLUSION: Results indicate that the newly developed restraint has lower effects such as edema and skin damage and is more convenient compared with existing restraints, and is therefore recommended for patients in the ICU.
Edema ; Humans ; Incidence ; Critical Care ; Intensive Care Units ; Research Design ; Restraint, Physical ; Skin

A 57-year-old man presented to the outpatient department with sudden bilateral hearing loss. The otological examination suggested bilateral severe sensorineural hearing loss. After several hours, the patient complained of a headache and became drowsy. The brain computed tomography showed a 3 x 4 cm intracerebral hemorrhage (ICH) of the left temporal lobe. Surgery was performed and 34 days after the procedure the patient was discharged from the hospital with severe bilateral sensorineural hearing loss (SNHL). Temporal lobe ICH should be considered in the differential diagnosis of patients with sudden bilateral hearing loss, regardless of the other neurological symptoms.
Brain ; Cerebral Hemorrhage ; Diagnosis, Differential ; Headache ; Hearing Loss, Bilateral ; Hearing Loss, Sensorineural ; Hearing Loss, Sudden ; Humans ; Middle Aged ; Outpatients ; Temporal Lobe

Renal artery pseudoaneurysm after blunt renal trauma is an uncommon complication of delayed hemorrhage, and diagnostic difficulties are experienced due to its rarity. Delayed hemorrhage after renal trauma is a lifethreatening complication. Angiography is considered the gold standard to diagnose a traumatic renal artery pseudoaneurysm. We report here a case of delayed bleeding from a renal artery pseudoaneurysm that was diagnosed at 17 days after the injury and that was managed successfully with selective renal artery embolization without medical complication.
Aneurysm, False ; Angiography ; Hemorrhage ; Kidney ; Morphinans ; Renal Artery