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: 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: This randomized phase III study was designed to compare the efficacy and safety of irinotecan plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC). MATERIALS AND METHODS: Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8+cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival. RESULTS: A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were no significant differences between IP and EP arms for the median overall survival (10.9 months vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 months vs. 5.8 months, p=0.115). However, there was a significant difference in response rate (62.4% vs. 48.2%, p=0.006). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 months vs. 10.1 months, p=0.036), < 65 years old (12.7 months vs. 11.3 months, p=0.024), and Eastern Cooperative Oncology Group performance status 0/1 (12.4 months vs. 10.9 months, p=0.040) patient groups. The severity of treatment-related adverse events such as grade 3/4 anemia, nausea and diarrhea was more frequent in patients treated with IP. CONCLUSION: The IP chemotherapy did not significantly improve the survival compared with EP chemotherapy in Korean patients with extensive-disease SCLC.
Anemia ; Arm ; Cisplatin* ; Diarrhea ; Disease Progression ; Disease-Free Survival ; Drug Therapy ; Etoposide* ; Humans ; Lung Neoplasms ; Male ; Nausea ; Small Cell Lung Carcinoma*

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

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

Nowadays, infectious aortitis has become a rare disease thanks to antibiotics, but remains life-threatening. We present a case of a patient with acupuncture-induced infectious aortitis leading to aortic dissection. Chest computed-tomogram scan revealed Stanford type A dissection with pericardial effusion. Under the impression of an impending rupture, emergent surgery was performed. During surgery, infectious aortitis was identified incidentally, so she underwent resection of the infected aorta including surrounding tissues. Then the ascending aorta and hemi-arch were replaced with a prosthetic graft as an in situ fashion. The resected tissue and blood cultures revealed Staphylococcus aureus, so prolonged antibiotherapy was prescribed.
Acupuncture ; Aged, 80 and over ; Anti-Bacterial Agents/therapeutic use ; Aortic Aneurysm, Thoracic/microbiology/*surgery ; Aortitis/drug therapy/microbiology/*radiography ; Cardiopulmonary Bypass ; Female ; Humans ; Staphylococcus aureus/isolation & purification ; Tomography, X-Ray Computed

PURPOSE: Anaplastic thyroid cancer is known to have a poor prognosis due to its aggressive and rapid metastasis with median survival of less than 6 months. Multimodal treatment involving surgery and chemoradiotherapy has been used to improve the survival of patients. Here, we retrospectively review of treatment outcome of 13 consecutive patients who were treated at a single center. MATERIALS AND METHODS: We retrospectively reviewed medical records of 13 anaplastic thyroid cancer patients who received multidisciplinary treatment between 2006 and 2010. Kaplan-Meier survival curve was used to analyze progression-free survival and overall survival of patients. RESULTS: The median patient age at diagnosis was 69 years, and six patients had stage IVc diseases. Eight patients received primary surgery followed by radiotherapy or concurrent chemoradiotherapy (CCRT). Five patients received weekly doxorubicin-based definitive CCRT, but only one patient's condition remained stable, while the rest experienced rapid disease progression. The median progression-free survival was 2.8 months (95% CI, 1.2-4.4 months), and the median overall survival was 3.8 months (95% CI, 3.0-4.6 months). CONCLUSION: Patients with anaplastic thyroid cancer showed poor prognosis despite multimodality treatment. Therefore, identification of novel therapeutic targets is warranted to take an effective mode of treatment.
Aged ; Aged, 80 and over ; Antineoplastic Agents/therapeutic use ; Combined Modality Therapy ; Disease-Free Survival ; Doxorubicin/therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Thyroid Neoplasms/*drug therapy/mortality ; Treatment Outcome

Lateral neck node metastasis is an important prognostic factor in thyroid carcinoma. We developed a scoring system for use in prediction of lateral neck node metastasis from papillary thyroid cancer. In this study, 161 consecutive patients were included in the training data set. This scoring system, named the Yonsei Estimated Value (YEV) for lymph node metastasis in papillary thyroid cancer, was developed on the basis of results from multivariate logistic regression analysis of preoperative clinical and radiologic data. Sixty eight consecutive patients were included for testing of the validity of the scoring system. The equation for prediction of lateral neck node metastasis was follows: YEV (Yonsei Estimated Value) = 1/(1+X) X = Exp (5.333-[0.902 x sex]+[0.036 x age]-[1.020 x tumor size]-[0.177 x lymph node size]-[0.032 x lymph node density]) When the YEV was 0.3 or more, the probability of lateral neck node metastasis was 79.0%, with sensitivity of 76.3%, specificity of 69.8%, positive predictive value of 56.7%, and negative predictive value of 85.1% in the training set. When fine needle aspiration biopsy for suspicious lateral neck nodes is not possible, or the results are inadequate, our scoring system for prediction of lateral neck node metastasis can be helpful in optimization of the surgical extent for each patient.
Adolescent ; Adult ; Aged ; Algorithms ; Female ; Head and Neck Neoplasms/*diagnosis/secondary ; Humans ; Logistic Models ; Lymphatic Metastasis/*diagnosis ; Male ; Middle Aged ; *Predictive Value of Tests ; Thyroid Neoplasms/*pathology/radiography ; Tomography, X-Ray Computed

BACKGROUND: Sleep is an essential restorative physiologic phenomenon. Impaired sleep results in significant negative effect to the health. Symptoms like sleep initiation difficulty, frequent awakening, severe snoring have related to poor sleep quality. We studied frequency and compared the characteristics of common sleep disorders at family practice. METHODS: We surveyed patients over 18 years of age and their guardians who visited 16 familial practices for 6 days. We investigated sleep characteristics, frequency of sleep disorder and associated factors by questionnaires and analyzed by frequency analysis, Spearman's correlation coefficient, multiple logistic regression. RESULTS: We enrolled 1,117 participants. Older participants were more likely to report early sleep onset and off time, short sleep duration. Mean number of awakening during a typical night is 1.69. Female complained difficulties in initiation and maintenance of sleep more than male. A total of 32.5% had these insomnia symptoms and related to hypertension, stroke, stress, arthralgia, depression, urological disorder. 31.1% had excessive daytime sleepiness, related to stress, arthralgia, depression. Loud snoring and gasp for breath showed positive correlation between male, high BMI. Disrupted sleep over 3 times was related to old age, female, diabetes, hypertension, stroke, stress, arthralgia, depression. Restless leg syndrome were high in elderly, high BMI, stress, arthralgia and depression. CONCLUSION: About one in three who visit in primary medical practice have sleep disorder symptoms like insomnia, daytime fatigue, snoring. 3% of them have gasp for breath, 8% have restless leg syndrome.
Aged ; Arthralgia ; Depression ; Family Practice ; Fatigue ; Female ; Humans ; Hypertension ; Leg ; Male ; Prevalence ; Sleep Wake Disorders ; Sleep Initiation and Maintenance Disorders ; Snoring ; Stroke

BACKGROUND: The introduction of Drug Eluting Stents (DES) decreased the number of patients referred for coronary artery bypass grafting (CABG). The impact of DES on CABG (Step 1) was studied and compared with the 1-year outcome after CABG with DES (Step 2). MATERIAL AND METHOD: Surgical results for patients who underwent off-pump CABG (OPCAB) before the introduction of DES(n=298) were compared with those who underwent OPCAB after the introduction of DES (n=288) (Step 1). Postoperative 30-day and 1-year results were also compared between the patients who underwent percutaneous coronary intervention (PCI) using DES (n=220) and those who underwent OPCAB (n=255) (Step 2). RESULT: Since the introduction of DES, the ratio of CABG versus PCI decreased. In the CABG group, the number of high risk patients such as elderly patients (age 62 vs. 64, p=0.023), those with chronic renal failure (4% vs. 9%, p=0.021), calcification of the ascending aorta (9% vs. 15%, p=0.043), or frequency of urgent or emergent operations (12% vs. 22%, p=0.002) increased. However, there were no differences in the cardiac death and graft patency rates between the two groups (step 1). During the one-year follow up period, the rate of target vessel revascularization (12.3% vs. 2.4%, p<0.001) and major adverse cardiac events (MACE: death, myocardial infarct, TVR) were higher in the DES than the CABG group (13.6% vs 4.3%) (stage 2). CONCLUSION: Introduction of DES decreased the number of patients referred for surgery, and increased the comorbidity in patients who underwent CABG. DES increased the rate of target vessel revascularization, and the occurrence of MACE during the 1-year follow-up. However, there was no difference in the incidence of myocardial infarction and cardiac death between the two groups.
Aged ; Aorta ; Comorbidity ; Coronary Artery Bypass ; Coronary Artery Bypass, Off-Pump ; Coronary Artery Disease ; Coronary Vessels ; Death ; Drug-Eluting Stents ; Follow-Up Studies ; Glycosaminoglycans ; Humans ; Incidence ; Kidney Failure, Chronic ; Myocardial Infarction ; Percutaneous Coronary Intervention ; Stents ; Transplants