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.

Esophageal actinomycosis is a rare, chronic granulomatous disease caused by Actinomyces species. Endoscopy and biopsy are essential for making a diagnosis. This paper reports a case of esophageal actinomycosis that developed after an endoscopic mucosal resection (EMR) for a subepithelial tumor (SET). A 74-year-old male patient had a 3 cm flat, smooth elevation in the esophagus without symptoms. The SET was partially resected, and histology revealed “nonspecific degenerated mesenchymal tissue”. Three months later, the patient exhibited a persistently large ulceration at the EMR site, and a biopsy revealed actinomycosis. CT of the chest and abdomen revealed no abnormal findings. Ampicillin treatment was administered for six months, and the ulceration on the esophageal SET improved.

Background: Most unintentional injuries that occur at home are preventable. However, it may be difficult to sufficiently reduce the number of falls occurring at home by only identifying risk factors focused on specific age groups. Therefore, this study aimed to identify the risk factors (especially age and places where injuries occurred at home) for intracranial injury (ICI) caused by unintentional falls at home. Methods: Using the Emergency Department (ED)-Based Injury In-depth Surveillance, we analyzed the data of patients who visited the ED due to unintentional falls at home. Risk factors were identified using multivariable logistic regression according to age groups and interactions between place of injury occurrence and age groups, and sex and age groups were assessed. Results: In total, 232,124 patients were included in the analysis; older adults had a higher adjusted odds ratio (aOR) 14.05 (95% confidence interval [CI], 12.74–15.49) of ICI than infants. The corridor was associated with ICI in the male pediatric group (aOR, 2.71; 95% CI, 1.08–6.84) and the balcony with the female pediatric group (aOR, 2.04; 95% CI, 1.03–4.04). In the adult group, aOR of kitchen was 1.38 (95% CI, 1.02–1.88) in females and 0.56 (95% CI, 0.48–0.66) in males. Conclusion In this study, we identified the risk factors of ICI caused by falls at home using ED-based injury surveillance data. The risk of ICI was different among places of occurrence in the home depending on the age groups and sex.

Background: Most unintentional injuries that occur at home are preventable. However, it may be difficult to sufficiently reduce the number of falls occurring at home by only identifying risk factors focused on specific age groups. Therefore, this study aimed to identify the risk factors (especially age and places where injuries occurred at home) for intracranial injury (ICI) caused by unintentional falls at home. Methods: Using the Emergency Department (ED)-Based Injury In-depth Surveillance, we analyzed the data of patients who visited the ED due to unintentional falls at home. Risk factors were identified using multivariable logistic regression according to age groups and interactions between place of injury occurrence and age groups, and sex and age groups were assessed. Results: In total, 232,124 patients were included in the analysis; older adults had a higher adjusted odds ratio (aOR) 14.05 (95% confidence interval [CI], 12.74–15.49) of ICI than infants. The corridor was associated with ICI in the male pediatric group (aOR, 2.71; 95% CI, 1.08–6.84) and the balcony with the female pediatric group (aOR, 2.04; 95% CI, 1.03–4.04). In the adult group, aOR of kitchen was 1.38 (95% CI, 1.02–1.88) in females and 0.56 (95% CI, 0.48–0.66) in males. Conclusion In this study, we identified the risk factors of ICI caused by falls at home using ED-based injury surveillance data. The risk of ICI was different among places of occurrence in the home depending on the age groups and sex.

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: 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

PURPOSE: We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexed-cisplatin chemotherapy followed by gefitinib maintenance therapy (PC/G) with gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). Here, we report on a post hoc subgroup analysis of that study assessing the demographics and disposition of the Korean patient subgroup, and comparing the tolerability of PC/G and gefitinib monotherapy and the tumor response with respect to epidermal growth factor receptor (EGFR) status. MATERIALS AND METHODS: Patients, who were ≥ 18 years, chemonaïve, Korean, light ex-smokers/never-smokers with advanced NSCLC, were randomly assigned (1:1) to PC/G or gefitinib monotherapy. Treatment-emergent adverse events (TEAEs) were graded, and tumor response was measured as change in lesion sum from baseline at best response. The study was registered with ClinicalTrials. gov, NCT01017874. RESULTS: Overall, 111 Korean patients were treated (PC/G, 51; gefitinib, 60). Between-arm characteristics were balanced and similar to those of the overall population. Treatment discontinuations due to adverse events were low (PC/G: 1, 2.0%; gefitinib: 7, 11.7%). Overall, 92 patients (82.9%) reported ≥ 1 TEAE (PC/G, 44; gefitinib, 48); few patients (PC/G, 16; gefitinib, 7) reported severe TEAEs; the most frequent was neutropenia (PC/G arm) and elevated alanine aminotransferase (gefitinib arm). The lesion sum was decreased by PC/G treatment in most patients, regardless of EGFR mutation status, while gefitinib monotherapy reduced the lesion sum in EGFR-positive patients but had no effect in EGFR-negative patients. CONCLUSION: Our results confirm that both PC/G and gefitinib were well tolerated in Korean patients, regardless of EGFR status; however, patients with EGFR wild-type NSCLC may not benefit from gefitinib monotherapy.
Alanine Transaminase ; Carcinoma, Non-Small-Cell Lung* ; Demography ; Drug Therapy ; Humans ; Korea ; Neutropenia ; Receptor, Epidermal Growth Factor

PURPOSE: The purpose of this study was to analyze the diagnostic availability and to examine the co-relation between pedobaragraphy and radiography of pediatric flexible flatfoot. MATERIALS AND METHODS: Seventeen patients and ten normal children were studied. In radiographic evaluation, the talo-1st metatarsal angle was measured on anteroposterior radiographs; and the talo-1st metatarsal angle, the talo-horizontal angle, the calcaneal pitch, and the talocalcaneal angle were measured on lateral radiographs. In pedobarography, foot pressures were subdivided into eight areas for measurement of contact time, ratio of measured area and to investigate the relation between the degree of the medial deviation of the Center of pressure line and the radiographic measurements. RESULTS: Flat foot group and normal group showed statistically significant difference in every angle measured in lateral radiographs. The foot pressure ratios of the lateral sides in forefoot and the medial and lateral sides of midfoot and the medial side of hindfoot between the flexible flatfoot group and normal group showed statistically significant difference in pedobarography and ratio of contact area in forefoot and hindfoot showed significant change in statistics but no changes in contact time. The relation between pedobarography and radiography was investigated: foot pressure of the medial and lateral side of forefoot and the talocalcaneal angle showed significant relation in statistics and foot pressure of the medial and lateral side of mid foot and every angle measured in lateral radiographs showed significant relation in statistics. Contact time of midfoot and every radiographic value measured in lateral radiograph showed significant relation in statistics and contact area of forefoot and midfoot showed significant relation with every radiographic value measured in lateral radiographs. In addition, medial deviation of center of pressure line showed significant relation in statistics with talus-first metatarsal angle measured on anteroposterior radiographs and talo-horizontal angle and talus-first metatarsal angle measured on lateral radiographs. CONCLUSION: The results of this study showed correlation between radiologic methods and pedobarography in diagnosis of pediatric flexible flatfoot and pedobarography is an useful tool in quantitative and qualitative analysis of the degree of foot deformity and medial deviation of center of pressure line.
Child ; Diagnosis ; Flatfoot* ; Foot ; Foot Deformities ; Humans ; Metatarsal Bones ; Radiography

BACKGROUND: Uterine leiomyomas are common benign smooth muscle tumors among the reproductive aged-women. The research has been aimed to identify the differentially expressed genes between normal myometrium and leiomyoma and to investigate the effects of E2 on their expression. METHODS: Gene microarray analysis was performed to identify the differentially expressed genes between normal myomerium and leiomyoma. The data was confirmed at protein level by tissue microarray. RESULTS: Gene microarray analysis revealed 792 upregulated genes in leiomyoma. Four genes (tropomyosin 4 [TPM4], collagen, type IV, alpha 2 [COL4alpha2], insulin-like growth factor binding protein 5 [IGFBP5], tripartite motif-containing 28 [TRIM28]) showed the most dramatic upregulation in all leiomyoma samples. Tissue microarray analyses of 262 sample pairs showed significantly elevated expression of TPM4, IGFBP5, estrogen receptor-alpha, and progesterone receptor (PR) protein in leiomyoma from the patients in their forties, COL4alpha2 in the forties and fifties age-groups, and TRIM28 in the thirties age-group. PR, insulin-like growth factor 1 (IGF-1), IGF-1 receptor (IGF-1R) and IGFBP5 were induced by E2 in in vitro culture of tissue explants from which cells migrated throughout the plate. Among these, PR, IGF-1, IGFBP5 genes showed higher expression in tissue compared to cells-derived from tissue in leiomyoma and IGF-1R in leiomyoma cell. CONCLUSIONS: This observation implies the importance of the whole tissue context including the cells-derived from tissue in the research for the understanding of molecular mechanism of leiomyoma. Here, we report higher expression of TRIM28 in leiomyoma for the first time and identify E2-responsive genes that may have important roles in leiomyoma development.
Animals ; Collagen Type IV ; Estrogens ; Female ; Gene Expression ; Humans ; Immunohistochemistry ; Insulin-Like Growth Factor Binding Protein 5 ; Insulin-Like Growth Factor I ; Leiomyoma ; Mice ; Microarray Analysis ; Myometrium ; Oligonucleotide Array Sequence Analysis ; Receptor, IGF Type 1 ; Receptors, Progesterone ; Smooth Muscle Tumor ; Tissue Array Analysis ; Transcriptome ; Up-Regulation ; Uterus

Splenic rupture is a frequent surgical emergency in blunt abdominal trauma patients. There are several treatment options, including conservative treatment, a partial splenectomy, splenorrhaphy, and a splenectomy for splenic injury. Although reports on the safety and the efficacy of an elective laparoscopic splenectomy are abundant in the literature, a laparoscopic splenectomy for a ruptured spleen has only been reported in a few cases. We report a case of a laparoscopic splenectomy in the patient with Grade III traumatic splenic injury. To our knowledge, this is the first report in which a laparoscopic splenectomy was performed in Korea for the treatment of a traumatic splenic injury.
Emergencies ; Humans ; Korea ; Spleen ; Splenectomy ; Splenic Rupture