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/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.

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.

Signal transducer and activator of transcription 3 (STAT3) has a crucial role in various autoimmune disorders including, inflammatory bowel disease (IBD). Our previous study demonstrated that STAT3 activation by IL-6 in colonic epithelial cells exacerbates experimental ulcerative colitis. Activated T lymphocytes are also found in ulcerative colitis patients with intestinal inflammation, but the role of STAT3 in T cells remains elusive. To determine the STAT3 function of T cells in intestinal inflammation, we generated T cell-specific STAT3 knockout (KO) mice and used dextran sulfate sodium (DSS) to induce colitis. In this study, we demonstrated that T cell-specific STAT3 deletion alleviated DSS-induced colitis in mice, resulting in reduced histological scores and myeloperoxidase (MPO) activity. Importantly, the population of T cells in the spleen and lymph nodes was significantly decreased in the control and DSS-induced groups of STAT3 KO mice. In addition, STAT3 deficiency in T cells markedly reduced the production of interferon (IFN)-γ, IL-6, and IL-17A, whereas IL-10 secretion was increased. Collectively, the results suggest that STAT3 in T cells may be a therapeutic target in ulcerative colitis by balancing the immune response through T cell homeostasis.
Animals ; Colitis* ; Colitis, Ulcerative ; Colon ; Cytokines ; Dextran Sulfate* ; Dextrans* ; Epithelial Cells ; Homeostasis ; Humans ; Inflammation ; Inflammatory Bowel Diseases ; Interferons ; Interleukin-10 ; Interleukin-17 ; Interleukin-6 ; Lymph Nodes ; Mice ; Peroxidase ; Spleen ; STAT3 Transcription Factor ; T-Lymphocytes

STUDY DESIGN: A case report. OBJECTIVES: To report a rare case of remote cerebellar hemorrhage (RCH) as a complication of spinal surgery. SUMMARY OF LITERATURE REVIEW: Remote cerebellar hemorrhage is rare but lethal as a complication of spinal surgery. Interestingly, dural tears and cerebrospinal fluid (CSF) leakage are reported in all published cases of RCH. MATERIALS AND METHODS: A 67-year-old man had posterior lumbar decompression and posterolateral fusion for spinal stenosis at L4/5/S1. Intraoperatively, the dura was torn and there was a loss of CSF. The dural tear was sutured immediately in a water-tight manner. After surgery, the patient complained of headache and dizziness. On postoperative day 44, brain magnetic resonance imaging (MRI) showed meningeal enhancement suggesting meningitis. On postoperative day 54, brain computed tomography (CT) showed cerebellar edema and hemorrhage, and external ventricular derivation was performed. RESULTS: The patient died. CONCLUSIONS: Special attention should be paid to prevent dural damage during spinal surgery or minimize CSF leakage in the case of dural damage and tears during spinal surgery, and CT and MRI should be promptly performed for symptomatic patients.
Aged ; Brain ; Cerebrospinal Fluid* ; Decompression ; Dizziness ; Edema ; Headache ; Hemorrhage* ; Humans ; Magnetic Resonance Imaging ; Meningitis* ; Spinal Stenosis ; Tears

STUDY DESIGN: Retrospective patient data collection and investigator survey. PURPOSE: To investigate patterns of opioid treatment for pain caused by spinal disorders in Korea. OVERVIEW OF LITERATURE: Opioid analgesic prescription and adequacy of consumption measures in Korea have markedly increased in the past decade, suggesting changing patterns in pain management practice; however, there is lack of integrated data specific to Korean population. METHODS: Patient data were collected from medical records at 34 university hospitals in Korea. Outpatients receiving opioids for pain caused by spinal disorders were included in the study. Treatment patterns, including opioid types, doses, treatment duration, outcomes, and adverse drug reactions (ADRs), were evaluated. Investigators were interviewed on their perceptions of opioid use for spinal disorders. RESULTS: Among 2,468 analyzed cases, spinal stenosis (42.8%) was the most common presentation, followed by disc herniation (24.2%) and vertebral fracture (17.5%). In addition, a greater proportion of patients experienced severe pain (73.9%) rather than moderate (19.9%) or mild (0.7%) pain. Oxycodone (51.9%) and fentanyl (50.8%) were the most frequently prescribed opioids; most patients were prescribed relatively low doses. The median duration of opioid treatment was 84 days. Pain relief was superior in patients with longer treatment duration (≥2 months) or with nociceptive pain than in those with shorter treatment duration or with neuropathic or mixed-type pain. ADRs were observed in 8.6% of cases. According to the investigators' survey, "excellent analgesic effect" was a perceived advantage of opioids, while safety concerns were a disadvantage. CONCLUSIONS: Opioid usage patterns in patients with spinal disorders are in alignment with international guidelines for spinal pain management. Future prospective studies may address the suitability of opioids for spinal pain treatment by using appropriate objective measurement tools.
Analgesics, Opioid ; Chronic Pain ; Data Collection ; Drug-Related Side Effects and Adverse Reactions ; Fentanyl ; Hospitals, University ; Humans ; Korea* ; Medical Records ; Nociceptive Pain ; Outpatients ; Oxycodone ; Pain Management ; Prescriptions ; Prospective Studies ; Research Personnel ; Retrospective Studies* ; Spinal Diseases ; Spinal Stenosis ; Spine

PURPOSE: This study was aimed to evaluate the effect of time of surgery for acute appendicitis on surgical outcomes to optimize the timing of appendectomies. METHODS: Medical records of patients who underwent an appendectomy were reviewed to obtain data on time of symptom onset, time of hospital presentation, and start times of surgery. Surgical findings were used to define appendicitis as either uncomplicated or complicated. The uncomplicated group included patients with simple, focal, or suppurative appendicitis, and the complicated group included patients with gangrenous, perforated appendicitis or periappendiceal abscess formation. The 2 groups were analyzed by age, sex, and time. RESULTS: A total of 192 patients were analyzed. The mean time from symptom onset to start of operation showed a significant difference between both groups (1,652.9 minutes vs. 3,383.8 minutes, P < 0.001). The mean time from hospital visit to start of operation showed no difference between both groups (398.7 minutes vs. 402.0 minutes, P = 0.895). Operating within 24 hours of symptom onset had a relative risk of 1.738 (95% confidence interval, 1.319-2.425) for complications. Operating more than 36 hours after symptom onset was associated with an increased risk of postoperative ileus and a longer hospital stay. CONCLUSION: Complicated appendicitis is associated with a delay in surgery from symptom onset rather than a delay at hospital arrival. Surgeons should take into account the time from symptom onset when deciding on the timing of appendectomy. We recommend that appendectomy be performed within 36 hours from symptom onset.
Abscess ; Appendectomy ; Appendicitis* ; Humans ; Ileus ; Length of Stay ; Medical Records ; Surgeons ; Treatment Outcome

Osteoporosis is a medical condition of global concern, with increasing incidence in both sexes. Bone mineral density (BMD), a highly heritable trait, has been proven a useful diagnostic factor in predicting fracture. Because medical information is lacking about male osteoporotic genetics, we conducted a genome-wide association study of BMD in Korean men. With 1,176 participants, we analyzed 4,414,664 single nucleotide polymorphisms (SNPs) after genomic imputation, and identified five SNPs and three loci correlated with bone density and strength. Multivariate linear regression models were applied to adjust for age and body mass index interference. Rs17124500 (p = 6.42 × 10⁻⁷), rs34594869 (p = 6.53 × 10⁻⁷) and rs17124504 (p = 6.53 × 10⁻⁷) in 14q31.3 and rs140155614 (p = 8.64 × 10⁻⁷) in 15q25.1 were significantly associated with lumbar spine BMD (LS-BMD), while rs111822233 (p = 6.35 × 10⁻⁷) was linked with the femur total BMD (FT-BMD). Additionally, we analyzed the relationship between BMD and five genes previously identified in Korean men. Rs61382873 (p = 0.0009) in LRP5, rs9567003 (p = 0.0033) in TNFSF11 and rs9935828 (p = 0.0248) in FOXL1 were observed for LS-BMD. Furthermore, rs33997547 (p = 0.0057) in ZBTB and rs1664496 (p = 0.0012) in MEF2C were found to influence FT-BMD and rs61769193 (p = 0.0114) in ZBTB to influence femur neck BMD. We identified five SNPs and three genomic regions, associated with BMD. The significance of our results lies in the discovery of new loci, while also affirming a previously significant locus, as potential osteoporotic factors in the Korean male population.
Asian Continental Ancestry Group ; Body Mass Index ; Bone Density* ; Femur ; Femur Neck ; Genetics ; Genome-Wide Association Study* ; Humans ; Incidence ; Linear Models ; Male ; Osteoporosis ; Polymorphism, Single Nucleotide ; Spine

Timing of surgery is important for prognosis. In patients with acute abdomen, the urgency means timing of surgery is even more important. However early emergency surgery is often logistically daunting because of constraints on resources such as operating room, supporting anesthesiologist, and nurses. Therefore it is worthwhile reviewing the timing of surgery in the patient with acute abdomen. The authors discuss the ideal time to surgery based on their experience and a review of the literature. For appendicitis and for peptic ulcer perforation, the authors recommend surgery within 24 hours from symptom onset. However, for other acute abdomen disease, evidence for a consensus is not as strong. If a surgeon faces a large number of emergent patients, if resources are limited, the surgeon must decide priorities for surgery. Therefore, an emergency triage system is needed, based on expert opinion and evidence. Although several triage systems are described in the literature, there is some controversy. If we follow a triage system, utilization of resources will be more efficient and acute care surgery might be performed within the ideal time.
Abdomen, Acute* ; Appendicitis ; Consensus ; Emergencies ; Expert Testimony ; Humans ; Operating Rooms ; Peptic Ulcer Perforation ; Prognosis ; Time Management ; Time-to-Treatment ; Triage

STUDY DESIGN: A case report. OBJECTIVES: To report a rare case of epidermoid cyst in the spinal canal. SUMMARY OF LITERATURE REVIEW: Epidermoid cyst in the spinal canal is rare. Idiopathic epidermoid cyst in the spinal canal not associated with a trauma or infection is even rarer. MATERIAL AND METHODS: A 73 year-old female presented with a 1 year history of progressive paresthesia and motor weakness of both lower extremeties. MRI showed a cystic mass on the 7th thoracic canal. We performed total laminectomy at the T6-T8 level. The cystic mass was excised after durotomy using a posterior approach. RESULTS: We confirmed the presence of an epidermoid cyst for histopathology. CONCLUSION: Idiopathic epidermoid cyst in the spine is very rare and requires accurate differential diagnosis. Preoperative MRI scans are necessary to differentiatie epidermoid cysts from other intradural masses. Confirmative diagnosis can be done by histopatholoty.
Diagnosis ; Diagnosis, Differential ; Epidermal Cyst* ; Female ; Humans ; Laminectomy ; Magnetic Resonance Imaging ; Paresthesia ; Spinal Canal ; Spine