Purpose: This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non–small cell lung cancer (NSCLC). Materials and Methods: Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS). Results: In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment–related AEs occurred with lazertinib than gefitinib. Conclusion Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population.

Background: Sutureless valves are widely used in aortic valve replacement surgery, with Perceval valves and Intuity valves being particularly prominent. However, concerns have been raised about postoperative thrombocytopenia with Perceval valves (Corcym, UK). We conducted a comparative analysis with the Intuity valve (Edwards Lifesciences, USA), and assessed how thrombocytopenia affected patient and transfusion outcomes. Methods: Among 595 patients who underwent aortic valve replacement from June 2016 to March 2023, sutureless valves were used in 53 (Perceval: n=23; Intuity: n=30). Platelet counts were monitored during hospitalization and outpatient visits. Daily platelet count changes were compared between groups, and the results from patients who underwent procedures using Carpentier Edwards Perimount Magna valves were used as a reference group. Results: Compared to the Intuity group, the Perceval group showed a significantly higher amount of platelet transfusion (5.48±1.64 packs vs. 0.60±0.44 packs, p=0.008). During the postoperative period, severe thrombocytopenia (<50,000/μL) was significantly more prevalent in the Perceval group (56.5%, n=13) than in the Intuity group (6.7%, n=2). After initial postoperative depletion, daily platelet counts increased, with significant differences observed in the extent of improvement between the Perceval and Intuity groups (p<0.001).However, there was no significant difference in early mortality or the incidence of neurological complications between the 2 groups. Conclusion The severity of postoperative thrombocytopenia differed significantly between the Perceval and Intuity valves. The Perceval group showed a significantly higher prevalence of severe thrombocytopenia and higher platelet transfusion volumes. However, thrombocytopenia gradually recovered during the postoperative period in both groups, and the early outcomes were similar in both groups.

Background: Current international guidelines recommend against deep sedation as it is associated with worse outcomes in the intensive care unit (ICU). However, in Korea the prevalence of deep sedation and its impact on patients in the ICU are not well known. Methods: From April 2020 to July 2021, a multicenter, prospective, longitudinal, noninterventional cohort study was performed in 20 Korean ICUs. Sedation depth extent was divided into light and deep using a mean Richmond Agitation–Sedation Scale value within the first 48 hours. Propensity score matching was used to balance covariables; the outcomes were compared between the two groups. Results: Overall, 631 patients (418 [66.2%] and 213 [33.8%] in the deep and light sedation groups, respectively) were included. Mortality rates were 14.1% and 8.4% in the deep and light sedation groups (P = 0.039), respectively. Kaplan-Meier estimates showed that time to extubation (P < 0.001), ICU length of stay (P = 0.005), and death P = 0.041) differed between the groups. After adjusting for confounders, early deep sedation was only associated with delayed time to extubation (hazard ratio [HR], 0.66; 95% confidence inter val [CI], 0.55– 0.80; P < 0.001). In the matched cohort, deep sedation remained significantly associated with delayed time to extubation (HR, 0.68; 95% 0.56–0.83; P < 0.001) but was not associated with ICU length of stay (HR, 0.94; 95% CI, 0.79–1.13; P = 0.500) and in-hospital mortality (HR, 1.19; 95% CI, 0.65–2.17; P = 0.582). Conclusion In many Korean ICUs, early deep sedation was highly prevalent in mechanically ventilated patients and was associated with delayed extubation, but not prolonged ICU stay or in-hospital death.

Background/Aims: The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. Results: According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Background: We aimed to investigate the associations of critical care provided in a cardiac surgical intensive care unit (CSICU) staffed by an attending intensivist with improvements in intensive care unit (ICU) quality and reductions in postoperative complications. Methods: Patients who underwent elective isolated coronary artery bypass grafting (CABG) between January 2007 and December 2012 (the control group) were propensity- matched (1:1) to CABG patients between January 2013 and June 2018 (the intensivist group). Results: Using propensity score matching, 302 patients were extracted from each group. The proportion of patients with at least 1 postoperative complication was significantly lower in the intensivist group than in the control group (17.2% vs. 28.5%, p=0.001). In the intensivist group, the duration of mechanical ventilation (6.4±13.7 hours vs. 13.7±49.3 hours, p=0.013) and length of ICU stay (28.7±33.9 hours vs. 41.7±90.4 hours, p=0.018) were significantly shorter than in the control group. The proportions of patients with prolonged mechanical ventilation (2.3% vs. 7.6%, p=0.006), delirium (1.3% vs. 6.3%, p=0.003) and acute kidney injury (1.3% vs. 5.3%, p=0.012) were significantly lower in the intensivist group than in the control group. Conclusion A transition from an open ICU model with trainee coverage to a closed ICU model with attending intensivist coverage can be expected to yield improvements in CSICU quality and reductions in postoperative complications.

Background: Iliac artery aneurysm is frequently found in patients undergoing surgical repair of an abdominal aortic aneurysm. The use of commercial bifurcated grafts is insufficient for aorto-biiliac replacement with complete iliac artery aneurysm resection. We evaluated the effectiveness of handmade composite grafts for this purpose. Methods: A total of 233 patients underwent open surgery for abdominal aortic aneurysm between 2003 and 2019, including 155 patients (67%) treated with commercial grafts and 78 patients (33%) treated with handmade composite grafts. Their operative characteristics, postoperative outcomes, and late outcomes were retrospectively reviewed. Results: The early mortality rate did not differ significantly between the groups. On average, the handmade composite graft technique took approximately 15 minutes longer than the commercial graft technique (p=0.037). Among patients who underwent elective surgery, no significant differences between the conventional and composite groups were observed in the major outcomes, including red blood cell transfusion volume (2.8±4.7 units vs. 3.1±4.7 units, respectively; p=0.680), reoperation for bleeding (2.7% vs. 3.1%, respectively; p>0.999), bowel ischemia (0% vs. 1.6%, respectively; p=0.364), and intensive care unit stay duration (1.9±6.6 days vs. 1.6±2.4 days, respectively; p=0.680). The incidence of target vessel occlusion also did not differ significantly between groups. Conclusion The increased technical demand involved with handmade composite grafting did not negatively impact the outcomes. This technique may be a viable option because it overcomes problems associated with commercial grafts.

Purpose: The introduction of immune checkpoint inhibitors represents a major advance in the treatment of lung cancer, allowing sustained recovery in a significant proportion of patients. Nivolumab is a monoclonal anti–programmed death cell protein 1 antibody licensed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. In this study, we describe the demographic and clinical outcomes of patients with advanced NSCLC treated with nivolumab in the Korean expanded access program. Materials and Methods: Previously treated patients with advanced non-squamous and squamous NSCLC patients received nivolumab at 3 mg/kg every 2 weeks up to 36 months. Efficacy data including investigator-assessed tumor response, progression data, survival, and safety data were collected. Results: Two hundred ninety-nine patients were treated across 36 Korean centers. The objective response rate and disease control rate were 18% and 49%, respectively; the median progression-free survival was 2.1 months (95% confidence interval [CI], 1.87 to 3.45), and the overall survival (OS) was 13.2 months (95% CI, 10.6 to 18.9). Patients with smoking history and patients who experienced immune-related adverse events showed a prolonged OS. Cox regression analysis identified smoking history, presence of immune-related adverse events as positive factors associated with OS, while liver metastasis was a negative factor associated with OS. The safety profile was generally comparable to previously reported data. Conclusion This real-world analysis supports the use of nivolumab for pretreated NSCLC patients, including those with an older age.

PURPOSE: Free-floating thrombus (FFT) of the aorta is very rare but has a high risk of distal embolization. While the necessity of treating such a condition is evident, the diagnostic and therapeutic modalities remain controversial. Thus, we reviewed seven cases of FFT of the aorta. METHODS: A retrospective study was performed usings even patients diagnosed with FFT of the aorta at the Catholic University of Korea between January 1999 and December 2008. We excluded those patients who had thrombi with concomitant atherosclerotic or aneurysmal aorta. RESULTS: The mean patient age was 59.6+/-13.6 years old. The male-to-female ratio was 3:4. Embolization to arteries of the extremities occurred in two patients and to visceral arteries in four patients. Of these seven patients, four were initially treated with anticoagulation, and two were initially treated with thrombectomy; one patient refused any kind of treatment. Of the four patients treated with anticoagulation, three experienced complete dissolution of the thrombi while anticoagulation proved ineffective in the remaining patient who subsequently underwent thrombectomy. In all of the three patients who had received thrombectomy, postoperative anticoagulation was employed. There was no recurrence of FFT of the aorta during the follow-up period. CONCLUSION: Were commend systemic anticoagulation with low molecular weight heparin (LMWH) as the first line of treatment for FFT of the aorta. If the thrombus persists or recurrent embolism occurs during anticoagulation therapy, surgery should be undertaken.
Aneurysm ; Aorta* ; Arteries ; Embolism ; Extremities ; Follow-Up Studies ; Heparin, Low-Molecular-Weight ; Humans ; Korea ; Recurrence ; Retrospective Studies ; Thrombectomy ; Thrombosis*

BACKGROUND/AIMS: Irritable bowel syndrome (IBS) is one of the most frequently observed disorders by primary care and practitioners. The aim of this study was to estimate the prevalence of IBS using the Rome II and III criteria in the general Korean population and also to compare sociodemographic differences between subjects diagnosed by these criteria. METHODS: Telephone interview surveys were performed with a total of 1,009 individuals in Korea, 15 years of age or older. The questionnaire, based on the Rome II and III criteria, was validated. RESULTS: Among the 1,009 subjects, the prevalence of IBS was 8.0% under the Rome II criteria (81 subjects; 6.4%, male; 9.6%, female), and 9.0% (91 subjects; 7.0%, male; 11.0%, female) under the Rome III criteria. The accordance rate of Rome II and III was 73.5%. Both groups showed highest frequency in the age of 30s (13.9% vs. 15.3% respectively). Female subjects showed a higher prevalence than male subjects under Rome III (91 subjects; 11.0% in female, 7.0% in male; p < 0.05), but not under Rome II criteria. Many patients older than 50 years were added when analyzed under the Rome III criteria, but not under the Rome II criteria (p = 0.017). CONCLUSIONS: The Rome III criteria were less restrictive and showed good agreement with the Rome II criteria. The prevalence of IBS was increased in young women.
Female ; Humans ; Interviews as Topic ; Irritable Bowel Syndrome ; Korea ; Male ; Prevalence ; Primary Health Care ; Surveys and Questionnaires ; Rome

PURPOSE: Infection with Helicobacter pylori is an important risk factor for gastric cancer in humans. We compared the clinicopathologic features of gastric cancer patients based on H. pylori infection. MATERIALS AND METHODS: We prospectively studied 155 patients who had gastric cancer and underwent gastrectomies in 1 hospital in Korea. We examined H. pylori infections using the rapid urease test (RUT) with gastrectomy specimens and collected clinical and pathologic data. RESULTS: The number of H. pylori infections based on the RUT was 137 (88%). The H. pylori-negative group was significantly associated with AGC and tumor histology. H. pylori infection was significantly correlated with type I/IIa in EGC and type III/IV/V in AGC. AGC was significantly correlated with larger tumor size, lymphatic invasion, perineural invasion, and H. pylori infection based on univariate and multivariate analyses. CONCLUSIONS: We report the prevalence of H. pylori based on the RUT in gastric cancer patients. H. pylori infection influences the tumor histology, progression, and growth type of gastric cancer.
Gastrectomy ; Helicobacter ; Helicobacter pylori ; Humans ; Korea ; Phenotype ; Prevalence ; Prospective Studies ; Risk Factors ; Stomach Neoplasms ; Urease