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: This study examined the long-term outcomes of undifferentiated-type early gastric cancer (UD EGC) with positive horizontal margins (HMs) after endoscopic resection (ER) and compared them between additional surgery and nonsurgical management. Methods: From 2005 to 2015, a total of 1,124 patients with UD EGC underwent ER at 18 tertiary hospitals in Korea. Of them, 92 patients with positive HMs as the only noncurative factor (n=25) or with both positive HMs and tumor size >2 cm (n=67) were included. These patients underwent additional surgery (n=40), underwent additional endoscopic treatment (n=6), or were followed up without further treatment (n=46). Results: No lymph node (LN) metastasis was found in patients who underwent additional surgery. During a median follow-up of 57.7 months (interquartile range, 27.6 to 68.8 months), no LN or distant metastases or gastric cancer-related deaths occurred in the overall cohort. At baseline, the residual cancer rate was 57.8% (26/45) after additional surgery or ER. The 5-year local recurrence rate was 33.6% among patients who were followed up without additional treatment. The 5-year overall survival rates were 95.0% and 87.8% after additional surgery and nonsurgical management (endoscopic treatment or close follow-up), respectively (log-rank p=0.224). In the multivariate Cox regression analysis, nonsurgical management was not associated with an increased risk of mortality. Conclusions UD EGC with positive HMs after ER may have favorable long-term outcomes and a very low risk of LN metastasis. Nonsurgical management may be suggested as an alternative, particularly for patients with old age or chronic illness.

Background/Aims: This study examined the long-term outcomes of undifferentiated-type early gastric cancer (UD EGC) with positive horizontal margins (HMs) after endoscopic resection (ER) and compared them between additional surgery and nonsurgical management. Methods: From 2005 to 2015, a total of 1,124 patients with UD EGC underwent ER at 18 tertiary hospitals in Korea. Of them, 92 patients with positive HMs as the only noncurative factor (n=25) or with both positive HMs and tumor size >2 cm (n=67) were included. These patients underwent additional surgery (n=40), underwent additional endoscopic treatment (n=6), or were followed up without further treatment (n=46). Results: No lymph node (LN) metastasis was found in patients who underwent additional surgery. During a median follow-up of 57.7 months (interquartile range, 27.6 to 68.8 months), no LN or distant metastases or gastric cancer-related deaths occurred in the overall cohort. At baseline, the residual cancer rate was 57.8% (26/45) after additional surgery or ER. The 5-year local recurrence rate was 33.6% among patients who were followed up without additional treatment. The 5-year overall survival rates were 95.0% and 87.8% after additional surgery and nonsurgical management (endoscopic treatment or close follow-up), respectively (log-rank p=0.224). In the multivariate Cox regression analysis, nonsurgical management was not associated with an increased risk of mortality. Conclusions UD EGC with positive HMs after ER may have favorable long-term outcomes and a very low risk of LN metastasis. Nonsurgical management may be suggested as an alternative, particularly for patients with old age or chronic illness.

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.

BACKGROUND/AIMS: The incidental finding of gastrointestinal subepithelial tumors (SETs) is increasing with national cancer screening endoscopy. In a Swedish population, screening endoscopy found a prevalence of SETs of 0.36%. However, the prevalence of gastric SETs in Korean patients has not been described. Therefore, this study evaluated the prevalence of SETs of the stomach in a Korean patient population. METHODS: We reviewed endoscopic reports of 11,712 subjects who underwent screening esophagogastroduodenoscopy (EGD) at Hanyang University Hospital between July 2012 and June 2013. RESULTS: Among 11,712 patients, 194 (1.7%) had SET of the stomach. Of these, 71 (prevalence, 0.6%) were male and 123 (prevalence, 1.1%) were female. When grouped by age, the prevalence of SET was as follows: 1.0% for patients in their twenties, 6.2% for those in their thirties, 19.1% for those in their forties, 33.0% for those in their fifties, 30.4% for those in their sixties, and 10.3% for those over 70 years of age. CONCLUSIONS: The overall prevalence of gastric SET among healthy examinees was 1.7%. The prevalence of gastric SET increased with age and was higher in female.
Adult ; Age Factors ; Aged ; Asian Continental Ancestry Group ; Early Detection of Cancer ; Endoscopy, Digestive System ; Female ; Humans ; Male ; Middle Aged ; Neoplasms, Glandular and Epithelial/diagnosis/*epidemiology ; Prevalence ; Republic of Korea/epidemiology ; Retrospective Studies ; Risk Factors ; Sex Factors ; Stomach Neoplasms/diagnosis/*epidemiology

PURPOSE: We wanted to evaluate the value of intravenous contrast enhanced abdomen-pelvis computed tomography (CT) for diagnosing acute appendicitis and we wanted to determine which patients groups will benefit from preoperative CT. METHODS: Between January and June 2006, the medical records of 354 patients who had clinically suspected acute appendicitis were retrospectively reviewed. Appendectomy was performed in 260 patients and CT was conducted in 108 patients of the 260 patients. The 5mm slice CT scans were evaluated for the presence of appendicitis. The sensitivity, specificity and accuracy of CT were calculated. The negative appendectomy rate (NAR) was compared between the patients with CT scans and those without CT scans. Furthermore, the patients were classified into the children and adults groups and the male and female groups and the differences of the NARs were analyzed for each group. RESULTS: The sensitivity, specificity and accuracy were 95%, 93% and 94%, respectively. The NAR was lower for the patients with a CT scan (12%) compared to 27% for those patients without CT scans (P=0.002). The difference of the NAR between the preoperative CT group and the without CT group was statistically significant for the female (P=0.004) and adult groups (P=0.012) (14% vs 36%, 11% vs 26%, respectively). CONCLUSION: Preoperative intravenous contrast enhanced abdomen-pelvis CT was effective in reducing the negative appendectomy rate in patients who were suspected of having acute appendicitis. Especially, the adults and women benefit more from CT scanning and they had a significantly lower negative appendectomy rate than the children and men, respectively.
Adult ; Appendectomy ; Appendicitis ; Child ; Female ; Humans ; Male ; Medical Records ; Retrospective Studies ; Sensitivity and Specificity

BACKGROUND/AIMS: Recently, the incidence of acute hepatitis A has increased nationwide and is related to the low rate of IgG anti-HAV. This study compared the prevalence of IgG anti-HAV in two university hospitals located in a large city and in a small city including a rural region according to age, gender, and the year of diagnosis. METHODS: IgG anti-HAV was measured in a total of 4299 patients, who visited Seoul or Guri Hanyang University Hospital between January 2002 and December 2006. RESULTS: The positive rates of the antibody in Seoul and Guri hospitals were 52.7% vs 57.1% in under the age of 1, 40.7% vs 42.2% in age of 1 to 4, 31.8% vs 30.3% in age of 5 to 9, 24.8% vs 27.1% in age of 10 to 14, 11.6% vs 18.2% in age of 15 to 19, 23.0% vs 20.3% in age of 20 to 24, 40.5% vs 42.9% in age of 25 to 29, 67.5% vs 75.0% in age of 30 to 34, 86.5% vs 88.1% in age of 35 to 39, 95.3% vs 93.6% in age of 40 to 44, 97.0% vs 98.7% in age of 45 to 49, and 98.5% vs 98.6% in patients who were more than 50, respectively. The positive rates of the antibody were not significantly different between two sites according to each age group and gender. CONCLUSIONS: The results confirmed the low rates of IgG anti-HAV, particularly in the ages of 10-24 that match the age group of recently increased incidence of acute hepatitis A nationwide. Therefore, measurement of the antibody and vaccination should be considered in this age group.
Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Female ; Hepatitis A/*epidemiology ; Hepatitis A Antibodies/*blood ; Hepatitis A Virus, Human/immunology ; Hospitals ; Humans ; Immunoglobulin G/*blood ; Infant ; Korea/epidemiology ; Male ; Middle Aged ; Rural Population ; Seroepidemiologic Studies ; Urban Population

OBJECTIVE: To provide clinical information for the best diagnosis and treatment of primary malignant cervical lymphoma based on the information obtained from these cases. METHODS: Between 1989 and 2006, six women with primary malignant cervical lymphoma were diagnosed and treated at our institution. Data were obtained from their medical records and were retrospectively analyzed. RESULTS: The mean patient age at the time of diagnosis was 63 (range 19-74). The chief complaint was vaginal bleeding in five women and the voiding difficulty for one woman. five of six patient had the cervical lesions (erosion and tumoral mass), while the other was non specific cervical findings. The Papanicolaou test was performed on three women, one of whom was HSIL. All six patients were confirmed with cervical lymphoma through the pathologic diagnosis. Surgical treatment (radical hysterectomy with bilateral salpingo- oophorectomy, pelvic lymph node dissection, and para-aortic lymph node dissection) was performed in one case, simple hysterectomy with complementary chemotherapy in two, and chemotherapy in one. Two patients refused treatment. Among four patients treated, one experienced recurrence in an ovary and the others have remained in remission. CONCLUSION: Primary malignant cervical lymphoma is a rare malignancy. Physicians can miss early detection of this disease because of its 'silent' symptoms and very low incidence. The accumulated data regarding this tumor can make it easy to detect at an early stage, thereby allowing it to be successfully treated. Further studies should be conducted to obtain further information regarding the cervical lymphoma.
Cervix Uteri ; Diagnosis ; Drug Therapy ; Female ; Humans ; Hysterectomy ; Incidence ; Lymph Node Excision ; Lymph Nodes ; Lymphoma* ; Medical Records ; Ovariectomy ; Ovary ; Papanicolaou Test ; Recurrence ; Retrospective Studies ; Uterine Hemorrhage

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/AIMS: Low-dose aspirin therapy is widely used to prevent cardiovascular thrombotic events. However, the safety of low-dose aspirin therapy in the gastrointestinal tract is uncertain. Our aim was to evaluate endoscopic findings in patients taking low-dose aspirin. METHODS: Sixty-two patients who received 100 mg enteric coated aspirin daily more than 30 days were included in this study. Patients' medical records and endoscopic data were reviewed retrospectively. As controls, 70 of age- and gender-matched patients who received an endoscopy without gastrointestinal symptoms were employed. RESULTS: The overall prevalence of gastroduodenal mucosal injury was higher in the aspirin group than in the control group. Erosive gastritis was noted more frequently in the aspirin group than in the control group. However, the prevalence of ulcer was not different between the aspirin group and the control group. CONCLUSIONS: Patients treated with low-dose aspirin therapy are more likely to have endoscopic evidence of mucosal damage. Our study suggests that even a low-dose aspirin therapy can induce a gastroduodenal mucosal injury. In the future, a prospective randomized control study is needed.
Aged ; Aspirin/administration & dosage/*adverse effects ; Cardiovascular Diseases/prevention & control ; Esophagitis/chemically induced ; Female ; Gastritis/chemically induced ; Gastrointestinal Diseases/*chemically induced ; Humans ; Male ; Middle Aged ; Platelet Aggregation Inhibitors/administration & dosage/*adverse effects ; Tablets, Enteric-Coated/adverse effects