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: 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

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 conducted to investigate whether the use of HA-CMC solution in thyroid surgery influences drainage amount and hospital stay. METHODS: Between November 2012 and December 12, 147 patients with thyroid cancer who underwent total thyroidectomy with central compartment neck dissection were analyzed retrospectively. The patients were divided into four groups; those with or without HA-CMC solution application and high or low output drainage. RESULTS: There were no differences in hospital stay and mean total drainage between the with and without HA-CMC solution application groups (P=0.230, P=0.732). The mean hospital stay was 2.2±0.4 days for the low output of drainage group and 3.1±0.6 days for the high output drainage group (P<0.001). There was no significant difference in the use of HA-CMC solution (41.1% vs. 56.8%, P=0.070). CONCLUSION: The use of HA-CMC solution in thyroid cancer surgery might not increase drainage amount and make hospital stay longer.
Drainage* ; Humans ; Length of Stay ; Neck Dissection ; Retrospective Studies ; Thyroid Gland* ; Thyroid Neoplasms* ; Thyroidectomy

Crohn's disease is a condition of chronic inflammation potentially involving any location of the alimentary tract from mouth to anus. Numerous extraintestinal manifestations can also be present. Urologic complications of inflammatory bowel disease are seen in up to 25% of patients, but renal parenchymal disease has been rarely reported. IgA nephropathy is recognized worldwide as a most common form of primary glomerulonephritis. Clinical manifestations vary, ranging from microscopic hematuria to nephrotic syndrome. Recently, IgA nephropathy associated with systemic diseases has been reported. We describe a case of a 22 year-old man with Crohn's disease associated with IgA nephropathy. At the age of 8 years, microscopic hematuria appeared. After fourteen years, he presented with melena, mild fever, recurrent oral ulcer, microscopic hematuria and proteinuria. Colonoscopic examination revealed characteristic features of Crohn's disease such as multiple ulcers. Microscopic findings showed superficial ulceration with small noncaseating granulomas. Renal biopsy revealed IgA nephropathy. The patient was treated with oral prednisolone, olsalazine, and metronidazole followed by maintenance therapy with sulfasalazine and azathioprine resulting in clinical improvement of Crohn's disease and IgA nephropathy.
Adult ; Crohn Disease/*complications/pathology ; Glomerulonephritis, IGA/*complications/pathology ; Humans ; Male

Leiomyosarcoma is an uncommon tumor which arises from various sites including uterus, stomach, retroperitoneum, superficial soft tissues, bladder, kidney, and lung. Primary hepatic leiomyosarcoma is a very rare tumor and fewer than 70 cases of primary hepatic leiomyosarcoma have been reported since the first publication in Japan. And there was only one case report of cutaneous metastasis from hepatic leiomyosarcoma. We recently experienced a case of primary hepatic leiomyosarcoma presenting as subcutaneous palpable mass. Herein we report this case with a review of literatures.
Head and Neck Neoplasms/*secondary ; Humans ; Leiomyosarcoma/diagnosis/*secondary ; Liver Neoplasms/diagnosis/*pathology ; Male ; Middle Aged ; *Scalp ; Skin Neoplasms/*secondary

PURPOSE: We prospectively conducted a multi-center, open-label, randomized phase II trial to compare the efficacy and safety of docetaxel plus cisplatin (DC) and etoposide plus cisplatin (EC) for treating advanced stage non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: Seventy-eight previously untreated patients with locally advanced, recurrent or metastatic NSCLC were enrolled in this study. The patients received cisplatin 75 mg/m2 on day 1 and either docetaxel 75 mg/m2 on day 1 or etoposide 100 mg/m2 on days 1 to 3 in the DC or EC arm, respectively, every 3 weeks. RESULTS: The objective response rate was 39.4% (15/38) and 18.4% (7/38) (p=0.023) in the DC and EC arms, respectively. The median time to progression (TTP) was 5.9 and 2.7 months (p=0.119), and the overall survival was 12.1 and 8.7 months (p=0.168) in the DC and EC arms, respectively. The prognostic factors for longer survival were an earlier disease stage (stage III, p=0.0095), the responders to DC (p=0.0174) and the adenocarcinoma histology (p=0.0454). The grades 3 and 4 toxicities were similar in both arms, with more febrile neutropenia (7.9% vs. 0%) and fatigue (7.9% vs. 0%) being noted in the DC arm. CONCLUSION: DC offered a superior overall response rate than does EC, along with tolerable toxicity profiles, although the DC drug combination did not show significantly improved survival and TTP.
Adenocarcinoma ; Arm ; Carcinoma, Non-Small-Cell Lung* ; Cisplatin* ; Etoposide* ; Fatigue ; Febrile Neutropenia ; Humans ; Prospective Studies

BACKGROUND: Recognition of ischemic right ventricular (RV) dysfunction in the course of inferior wall left ventricular (LV) acute myocardial infarction is important in clinical practice. The Doppler Tei index is useful for estimating global cardiac function. However, the clinical usefulness of RV Tei index to diagnose subclinical RV dysfunction has not been investigated. The purpose of this study was to assess the clinical value of RV Tei index for diagnosis of subclinical RV dysfunction associated with inferior wall acute myocardial infarction who did not have definite ECG changes at right precordial leads. METHODS: The study population consisted of 22 consecutive patients (male 10, average age 57+/-12) with acute inferior myocardial infarction who did not have specific ST segment changes at right precordial leads. RV Tei index was measured by Doppler echocardiography and RV ejection fraction (EF) was measured by multigated blood pool (MUGA) SPECT. We defined subclinical RV dysfuntion as estimated RA pressure was > or =10 mmHg (group 1) by right heart catheterization. RESULTS: In patients with RV dysfunction, RV Tei index was significantly increased compared with those who did not have RV dysfunction (0.51+/-0.22 vs 0.35+/-0.18, p<0.05). RVEF by MUGA blood pool SPECT was significantly decreased in patients with RV dysfunction (35+/-11% vs 47+/-12, p<0.05). CONCLUSION: RV Tei index is simple and useful non-invasive method for diagnosis of subclinical RV dysfunction associated with inferior wall acute myocardial infarction who did not have typical ECG changes at right precordial leads.
Cardiac Catheterization ; Cardiac Catheters ; Diagnosis ; Echocardiography, Doppler ; Electrocardiography ; Humans ; Inferior Wall Myocardial Infarction ; Myocardial Infarction* ; Tomography, Emission-Computed, Single-Photon ; Ventricular Dysfunction, Right*

This study investigated the biochemical changes of abnormal fruiting bodies grown under artificial environmental conditions in P. ostreatus. Abnormal mushroom growth during cultivation damages the production of good quality mushroom. This study showed that different environmental conditions produced morphological changes in the fruiting bodies of P. ostreatus. The fruiting bodies with morphological changes were collected and examined for differences in biochemical properties, enzyme activities, and carbohydrates composition. The enzyme activities assay showed that glucanase and chitinase activities decreased when the temperature was below or above the optimum cultivation temperature for P. ostreatus. The biochemical compositions of the abnormal mushroom were significantly different from the normal fruiting bodies. It was suggested that the changes in the biochemical composition of abnormal mushroom were caused by the unfavorable environmental conditions during mushroom cultivation.
Agaricales ; Carbohydrates ; Chitinase ; Fruit* ; Pleurotus*