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.

Papillary thyroid carcinoma is the most common type of thyroid cancer, for which surgery following preoperative staging and risk assessment is the standard treatment. Afatinib is an orally active irreversible ErbB-family inhibitor that binds to the kinase domain of epidermal growth factor receptors (EGFRs), HER2, and HER4, and has been approved as monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer with activated EGFR mutations. Recently, we observed an unexpected effect of afatinib administered to treat lung cancer on untreated papillary thyroid carcinoma.

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.

BACKGROUND: Ultrasound-guided greater occipital nerve (GON) block has been frequently used to treat various types of headaches, and botulinum toxin has recently begun to be used in patients with headache. Our study presents the long-term effect of botulinum toxin on GON block using ultrasound in patients with chronic headache in occipital area. METHODS: Patients with occipital headache were divided into two groups (bupivacaine: BUP group [n = 27], botulinum toxin: BTX group [n = 27]), and ultrasound-guided GON block was performed at the C2 level. GON was detected with ultrasound and distance from GON to midline, from the skin surface to GON, and size of GON were measured in both groups. Visual analogue scale (VAS) scores and Likert scale were assessed at pretreatment and at 1, 4, 8, and 24 weeks after treatment in both groups. RESULTS: The distance from GON to midline was 18.9 ± 4.4 mm (right) and 17.3 ± 3.8 mm (left). The depth from the skin was 12.9 ± 1.5 mm (right) and 13.4 ± 1.6 mm (left). GON size was 3.1 mm on both sides. The VAS score and patient satisfaction score (Likert scale) in 4, 8, and 24 weeks after injection were superior for the BTX than the BUP group. CONCLUSIONS Ultrasound-guided GON block using BTX is effective in reducing short-term and long-term pain in patients with chronic headache in the occipital area.

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

BACKGROUND: Ultrasound-guided greater occipital nerve (GON) block has been frequently used to treat various types of headaches, and botulinum toxin has recently begun to be used in patients with headache. Our study presents the long-term effect of botulinum toxin on GON block using ultrasound in patients with chronic headache in occipital area. METHODS: Patients with occipital headache were divided into two groups (bupivacaine: BUP group [n = 27], botulinum toxin: BTX group [n = 27]), and ultrasound-guided GON block was performed at the C2 level. GON was detected with ultrasound and distance from GON to midline, from the skin surface to GON, and size of GON were measured in both groups. Visual analogue scale (VAS) scores and Likert scale were assessed at pretreatment and at 1, 4, 8, and 24 weeks after treatment in both groups. RESULTS: The distance from GON to midline was 18.9 ± 4.4 mm (right) and 17.3 ± 3.8 mm (left). The depth from the skin was 12.9 ± 1.5 mm (right) and 13.4 ± 1.6 mm (left). GON size was 3.1 mm on both sides. The VAS score and patient satisfaction score (Likert scale) in 4, 8, and 24 weeks after injection were superior for the BTX than the BUP group. CONCLUSIONS: Ultrasound-guided GON block using BTX is effective in reducing short-term and long-term pain in patients with chronic headache in the occipital area.
Botulinum Toxins ; Headache ; Headache Disorders ; Humans ; Nerve Block ; Patient Satisfaction ; Skin ; Ultrasonography

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

BACKGROUND: A "difficult airway" can be simulated with an extrication collar, which restricts cervical motion and mouth opening. The purpose of this study is to compare the efficacy of the GlideScope and the McGrath in difficult airway simulation. METHODS: Patients were randomized using computer-generated numbers and were placed into the GlideScope group or the McGrath group. The total intubation time was defined as the time measured from when the anesthesiologist picks up the device to the time at which three successive end-tidal CO2 values are acquired after intubation. RESULTS: There was no significant difference in total intubation time between the two groups (73.0 ± 25.3 sec vs. 72.3 ± 20.9 sec, P = 0.92). The success rates of the first intubation attempt did not differ between the two groups (82.8% vs. 83.3%, P = 0.95). CONCLUSIONS: Our results suggest that there are no significant differences in the intubations with GlideScope and McGrath using vascular forceps and tube exchangers in difficult intubation scenarios.
Airway Management ; Humans ; Intubation* ; Intubation, Intratracheal ; Laryngoscopes ; Mouth ; Surgical Instruments*

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

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