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.

PURPOSE: This study was performed to evaluate the role of colonoscopy in children with hematochezia. METHODS: We retrospectively reviewed the medical records of 277 children who underwent colonoscopy because of hematochezia between January, 2003 and July, 2010. RESULTS: The mean age of the patients was 6.0+/-4.4 (7 days~17.8 years) years. The male to female ratio was 2.2 : 1. The duration between the 1st episode of hematochezia and colonoscopy was 4.9+/-12.1 months. Characteristics of hematochezia included red stool (65.1%), blood on wipe (12.8%), bloody toilet (11.9%), and blood dripping (10.2%). The most proximal region of colonoscopic approach was terminal ileum (84.5%), cecum (9.5%), hepatic flexure (2.8%), and splenic flexure (3.2%). Eighty five patients (30.6%) had no specific abnormal findings. Major causes of hematochezia were polyp (26.4%), food protein induced proctocolitis (6.9%), infectious colitis (5.4%), lymphofolliculitis (5.7%), non specific colitis (5.7%), and vascular ectasia (5.1%). The hemorrhagic sites included the rectum (24.0%), rectosigmoid junction (18.1%), sigmoid colon (13.5%), ascending colon (14.2%), transverse colon (11.3%), descending colon (7.8%), cecum (8.1%), and terminal ileum (3.1%). The recurrence rate of hematochezia after colonoscopy was 19.1%. Colonoscopy was performed in 262 patients (94.6%) with conscious sedation. Endoscopic hemostasis was performed in 5 patients. Complications of colonoscopy or sedation were not found. CONCLUSION: The causes and lesional localization of pediatric hematochezia were diverse. Colonoscopy has an important role in the diagnosis and treatment of hematochezia in children. Total colonoscopy is recommended to detect the cause of hematochezia.
Cecum ; Child ; Colitis ; Colon, Ascending ; Colon, Descending ; Colon, Sigmoid ; Colon, Transverse ; Colonoscopy ; Conscious Sedation ; Dilatation, Pathologic ; Female ; Gastrointestinal Hemorrhage ; Hemostasis, Endoscopic ; Humans ; Ileum ; Male ; Medical Records ; Polyps ; Proctocolitis ; Rectum ; Recurrence ; Retrospective Studies

PURPOSE: Ultrasonography (US) is widely used as a screening test in patients with abdominal pain (AP). We investigated the usefulness of US by a pediatrician in children with AP. METHODS: We retrospectively analysed the medical records of children with AP who undertook US from December, 2008 to July, 2010. RESULTS: A total of 628 patients (325 male, 303 female) were enrolled in this study. The mean age of patients was 8.08+/-4.61 years. Duration of AP was acute in 427 and chronic in 201 patients. Localization of AP was diffuse (36.9%), periumbilical (24.4%), epigastric (21.0%), and right lower quadrant (8.1%). On the examination, there were no abnormal findings in 327 patients (52.1%). Abnormal ultrasonographic findings were mesenteric lymphadenitis (27.1%), intestinal mural thickening (10.0%), intussusception (3.0%), appendicitis (2.6%), choledochal cyst (1.6%), and pancreatitis (0.3%). We performed additional imaging studies such as computed tomography (CT) or magnetic resonance imaging (MRI) in 39 patients who showed obscure findings on the US. In 33 patients (84.6%), the same results were obtained from CT or MRI. Two cases of appendicitis, one case of pancreatitis and one case of Henoch-Shonlein purpura were diagnosed by the CT examination. However, there were two cases of appendicitis diagnosed by US thathad no evidence of appendicitis on the CT. Diagnostic accuracy of initial US in children with abdominal pain was 99.4%. CONCLUSION: US by a pediatrician as a screening test in children with AP provides a rapid and accurate diagnostic indication and has non-invasive and radiation-free advantages.
Abdominal Pain ; Appendicitis ; Child ; Choledochal Cyst ; Humans ; Intussusception ; Magnetic Resonance Imaging ; Male ; Mass Screening ; Medical Records ; Mesenteric Lymphadenitis ; Pancreatitis ; Purpura ; Retrospective Studies

PURPOSE: Early diagnosis of active tuberculosis (TB) in children is difficult. The widely used tuberculin skin test has low sensitivity and cross reactivity with non-tuberculous mycobacteria or Bacille Calmette-Guerin vaccination. Interferon gamma release assays have been shown good diagnostic accuracy for active in adults. But studies in children were limited. The purpose of this study was to examine the performance of enzyme-linked immunospot assay (ELISpot) as an initial test in the diagnosis of active tuberculosis in children. METHODS: In a hospital-based study, we prospectively examined the performance of ELISPot in 33 children suspected of active TB. TB was confirmed bacteriologically or histologically. RESULTS: Among 33 patients, 9 had active tuberculosis. When tested, they all had a positive test result from the ELISpot. The sensitivity and specificity of the assay were 100% (95% CI, 66.4-100%) and 95.8% (95% CI, 78.9-99.9%) respectively. CONCLUSION: ELISpot might be an useful and improved clinical diagnostic method for the detection of active TB in children.
Adult ; Child ; Early Diagnosis ; Enzyme-Linked Immunospot Assay ; Humans ; Interferon-gamma ; Interferon-gamma Release Tests ; Pilot Projects ; Prospective Studies ; Sensitivity and Specificity ; Skin Tests ; Tuberculin ; Tuberculosis ; Vaccination

PURPOSE: The aim of this study was to evaluate the clinical features and factors contributing to treatment outcome for chronic functional constipation in children. METHODS: We analyzed the medical records of patients with constipation, who visited the inpatient or outpatient clinic of the Department of Pediatrics of Pusan National University Hospital, between January 1998 and December 2007. The clinical features, outcomes, and factors affecting the treatment response according to the main drug (lactulose vs. PEG 4000) were analyzed retrospectively. RESULTS: Two hundred forty children (142 males and 98 females) were enrolled in this study. The mean age was 51.2+/-37.9 months. The duration of symptoms was 32.6+/-33.7 months. The accompanying symptoms were as follows: encopresis, 91 (30.4%); abdominal pain, 76 (31.6%); and blood-tinged stool, 37 (15.4%). The treatment response was achieved earlier in females (p<0.001), patients with accompanying symptoms (p<0.05), and patients treated with PEG 4000 (p=0.001). The duration of symptoms (p<0.05) and stool frequency before treatment (p<0.05) were related to a delayed treatment response. Relapse occurred in 7 children, all of whom were treated successfully later. CONCLUSION: Factors contributing to treatment response are female gender, accompanying symptoms, duration of symptoms, and stool frequency before treatment. PEG 4000 is superior to lactulose in response time and taken into consideration as a primary drug for the treatment of functional constipation of children. Early treatment and sufficient treatment time may also be important factors to achieve an early response and prevent relapse.
Abdominal Pain ; Ambulatory Care Facilities ; Child ; Constipation ; Encopresis ; Female ; Humans ; Inpatients ; Lactulose ; Male ; Medical Records ; Pediatrics ; Reaction Time ; Recurrence ; Treatment Outcome

Sigmoid volvulus may cause acute or subacute colonic obstruction. Excessive length of the sigmoid colon may be a contributing factor. Typically, the patient develops bilious vomiting and marked gaseous abdominal distension. We report a case of sigmoid volvulus in a 9-year-old boy who presented with recurrent, sudden onset abdominal pain, abdominal distension, and vomiting for 1 year, which was diagnosed by simple abdominal X-ray, barium enema, computed tomography, and colonoscopic examination. Colonoscopic reduction failed and a sigmoid colectomy with primary repair was performed. The intra-operative findings showed that the sigmoid colon was noted to be dilated, and redundant with a lax mesentery. Two clear areas of compression (proximal and distal) were present. After sigmoidectomy, the symptoms resolved. After 5 years of follow-up, he had no new symptoms.
Abdominal Pain ; Barium ; Child ; Colectomy ; Colon ; Colon, Sigmoid ; Enema ; Follow-Up Studies ; Humans ; Intestinal Volvulus ; Mesentery ; Vomiting

Sigmoid volvulus may cause acute or subacute colonic obstruction. Excessive length of the sigmoid colon may be a contributing factor. Typically, the patient develops bilious vomiting and marked gaseous abdominal distension. We report a case of sigmoid volvulus in a 9-year-old boy who presented with recurrent, sudden onset abdominal pain, abdominal distension, and vomiting for 1 year, which was diagnosed by simple abdominal X-ray, barium enema, computed tomography, and colonoscopic examination. Colonoscopic reduction failed and a sigmoid colectomy with primary repair was performed. The intra-operative findings showed that the sigmoid colon was noted to be dilated, and redundant with a lax mesentery. Two clear areas of compression (proximal and distal) were present. After sigmoidectomy, the symptoms resolved. After 5 years of follow-up, he had no new symptoms.
Abdominal Pain ; Barium ; Child ; Colectomy ; Colon ; Colon, Sigmoid ; Enema ; Follow-Up Studies ; Humans ; Intestinal Volvulus ; Mesentery ; Vomiting

PURPOSE: This study aimed to evaluate the usefulness of the needle aspiration alternative to open surgical drainage of children with suppurative cervical lymphadenitis requiring surgical drainage. METHODS: From January 1998 to June 2008, we retrospectively reviewed 38 children treated with needle aspiration as management with suppurative cervical lymphadenitis instead of open surgical drainage. RESULTS: All 38 children underwent only 1 puncture. Two patients (5.2%) out of 38 patients experienced reformation of an abscess and all recovered completely after re-treatment with antibiotics. Minor complications were detected in 2 patients (5.2%). One complication originated from remnant necrotic tissue and the other involved formation of a small scar in two patients, which resolved spontaneously. There were no major complications. CONCLUSION: Needle aspiration can be a simple, safe, and effective alternative procedure to open surgical drainage of children with suppurative cervical lymphadenitis requiring surgical drainage.
Abscess ; Anti-Bacterial Agents ; Child ; Cicatrix ; Drainage ; Humans ; Lymphadenitis ; Needles ; Punctures ; Retrospective Studies ; Suppuration

PURPOSE: In adults, valproate (VPA) has been reported to be associated with thrombocytopenia. However, few studies have investigated this association in children, and the factors affecting platelet counts remain controversial. This study was undertaken to investigate changes in platelet counts following VPA therapy and related factors in children with epilepsy. METHODS: Our subjects comprised 75 epileptic children who had received VPA monotherapy for at least 1 year between January 2000 and December 2005. We regularly examined platelet counts at intervals of 6 to 12 months after baseline platele t counts before VPA treatme nt. We analyze d changes in platelet counts according to seve ral factors such as sex, seizure type, underlying causes of epilepsy, age at the start of medication as well as at the last follow up, duration of VPA administration, VPA dose, serum VPA level, and body weight at the last follow up. RESULTS: Overall, the platelet counts decreased significantly after VPA therapy. The average baseline platelet count was 312.5+/-109.1x10(6)/mL. At the last follow up, the average platelet count was 261.7+/-72.2x10(6)/mL. We observed the relationship between platelet counts and serum levels of VPA; while children with serum VPA <75 microgram/mL showed no change in platelet counts (P=0.102), children with serum VPA >75 microgram/mL showed a significant decrease in platelet counts. CONCLUSION: VPA may cause a significantly decreased platelet count in children with epilepsy. High serum VPA levels were associated with development of thrombocytopenia.
Adult ; Blood Platelets ; Body Weight ; Child ; Epilepsy ; Follow-Up Studies ; Humans ; Platelet Count ; Seizures ; Thrombocytopenia ; Valproic Acid

PURPOSE: To assess the height growth of children with epilepsy receiving antiepileptic drugs (AEDs) and the related factors. METHODS: The subjects were 148 children diagnosed with epilepsy at Pusan National University Hospital between January 1996 and December 2003, who received AEDs for more than 3 y. We measured height at the initiation of AED medication and at the last visit during AED medication. We analyzed the mean height standard deviation score (SDS) according to several factors, including sex, age at initial medication, seizure type, underlying causes of epilepsy, seizure frequency before AED medication, seizure control, number of AEDs, height SDS before medication, and duration of medication. RESULTS: In the total population, height SDS at initial therapy and last follow-up were -0.06+/-1.39 versus 0.10+/-1.12 (P=0.09). Children with controlled seizures showed a significant increase in height SDS, from -0.12+/-1.39 to 0.10+/-1.09 (P=0.04), and children on medication for less than 6 y showed a significant increase in height SDS, from -0.09+/-1.54 to 0.21+/-1.07 (P=0.03). Also, children with negative initial height SDS showed a significant increase in height SDS (P<0.05). No height SDS changes were observed in any of the other groups, regardless of sex, seizure type, underlying causes of epilepsy, or age at initial medication. CONCLUSION: Neither epilepsy nor AED medication affects long-term height growth. Controlled seizure and short duration of AED medication are positive factors for height growth in children with epilepsy.
Anticonvulsants ; Child ; Epilepsy ; Follow-Up Studies ; Humans ; Seizures