Purpose: Alectinib has been approved for anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) at 300 mg twice daily in Japan, lower than global standard of 600 mg twice daily. This study evaluated the clinical relevance of the reduced dose by comparing outcomes between the two doses. Materials and Methods: This study included patients with advanced ALK-positive NSCLC who received alectinib at Samsung Medical Center, Korea. The progression-free survival (PFS), overall survival, cumulative incidence of central nervous system (CNS) progression, and safety profiles were retrospectively reviewed and compared. Results: Among 306 patients, 32 and 274 received alectinib at either 300 or 600 mg twice daily, respectively. The 300 mg group showed a slight but not significant advantage in PFS (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.44 to 1.51; p=0.51) and overall survival (HR, 0.51; 95% CI, 0.20 to 1.21; p=0.13). Superior outcome with 300 mg was remarkable in patients with lower body weight (≤ 60 kg), but diminished in patients with higher body weights. Patients with baseline brain metastasis in the 300 mg group exhibited a slight increase in incidence of CNS failure (HR, 1.76; 95% CI, 0.53 to 5.8; p=0.36). Although the safety profiles were mostly mild, adverse events were more frequent in the 600 mg group, 50% of which requiring dose reduction. Conclusion Alectinib at 300 mg twice daily seems an acceptable dose in East Asians with ALK-positive NSCLC. Notably, our data favor 300 mg twice daily in patients with lower body weight and no baseline brain metastasis, considering the more tolerable safety profiles and the potential to reduce medical costs.

Background: Remimazolam, a new benzodiazepine, is known for its quick onset of effects and recovery time. Recently, it has been licensed for general anesthesia and sedation in Korea and its use is increasing in other countries. However, less is known about its effect on postoperative recovery. We used a patient-reported outcome questionnaire to examine the effect of remimazolam on postoperative recovery. Methods: Patients who underwent hysteroscopy on day surgery basis were administered an induction dose of remimazolam 6 mg/kg/h followed by a maintenance dose of 1–2 mg/kg/h. After surgery, the translated Korean version of 15-item Quality of Recovery scale (QoR-15K) including post-discharge nausea and vomiting (PDNV) and/or pain, was surveyed 24 h after surgery to evaluate patient recovery. Results: Total of 38 patients were enrolled in this prospective, observational study. All patients successfully completed QoR-15K. Only one patient scored low for moderate pain and PDNV. On average, patients scored 9 and above for all QoR-15K items except for moderate pain (8.66 ± 1.68). When QoR-15K items were grouped into dimensions, all dimensions scored an average of 9 or higher on a 10-point scale. In addition, 19 out of 38 patients gave score range of 148 to 150 out of possible 150. Conclusions Psychometric evaluation based on postoperative QoR-15K among patients receiving remimazolam shows satisfactory patient recovery profiles without significant pain or PDNV. Considering its effectiveness and safety, remimazolam could be one of useful agents for general anesthesia of day surgery in terms of postoperative recovery.

Purpose: To report a case of acute myopic change and anterior chamber depth decrease induced by zonisamide, which is an antiepileptic drug.Case summary: A 40-year-old male with no ophthalmologic history, who was admitted to the neurology department through the emergency center for evaluation and treatment of frontal lobe epilepsy, was referred to the ophthalmology department due to a visual disturbance that occurred while the patient was being treated with 100 mg of zonisamide during hospitalization. Corrected visual acuities with the patient’s own glasses were 0.3 in both eyes, with intraocular pressure of 16 and 17 mmHg in the right and left eye, respectively. Automated refraction revealed a bilateral myopic change of -1.25 diopters (D) in the right eye and -1.00 D in the left eye, and the anterior chambers in both eyes were shallow under slit-lamp examination. As we assumed these symptoms were related to the intake of zonisamide, we immediately instructed the patient to discontinue the drug. At 3 days after discontinuing the drug, his myopia improved, and corrected visual acuities with the previous glasses increased to 1.0 in both eyes. Conclusions Zonisamide is a sulfonamide anticonvulsant that may cause acute myopic shift and a reduction in the anterior chamber depth. Therefore, physicians must consider the possibility of these complications occurring, when diagnosing a sudden blurring of vision in patients who are taking sulfonamide medications.

Purpose: To report a case of acute myopic change and anterior chamber depth decrease induced by zonisamide, which is an antiepileptic drug.Case summary: A 40-year-old male with no ophthalmologic history, who was admitted to the neurology department through the emergency center for evaluation and treatment of frontal lobe epilepsy, was referred to the ophthalmology department due to a visual disturbance that occurred while the patient was being treated with 100 mg of zonisamide during hospitalization. Corrected visual acuities with the patient’s own glasses were 0.3 in both eyes, with intraocular pressure of 16 and 17 mmHg in the right and left eye, respectively. Automated refraction revealed a bilateral myopic change of -1.25 diopters (D) in the right eye and -1.00 D in the left eye, and the anterior chambers in both eyes were shallow under slit-lamp examination. As we assumed these symptoms were related to the intake of zonisamide, we immediately instructed the patient to discontinue the drug. At 3 days after discontinuing the drug, his myopia improved, and corrected visual acuities with the previous glasses increased to 1.0 in both eyes. Conclusions Zonisamide is a sulfonamide anticonvulsant that may cause acute myopic shift and a reduction in the anterior chamber depth. Therefore, physicians must consider the possibility of these complications occurring, when diagnosing a sudden blurring of vision in patients who are taking sulfonamide medications.

PURPOSE: Early prediction of treatment outcomes represents an essential step towards increased treatment efficacy and survival in patients with hepatocellular carcinoma (HCC). In this study, we performed two-dimensional electrophoresis (2-DE) followed by protein profiling to identify biomarkers predictive of therapeutic outcomes in patients with HCC who received liver-directed therapy (LDTx) involving local radiotherapy (RT), and studied the underlying mechanisms of the identified proteins. MATERIALS AND METHODS: 2-DE analysis was conducted by pooling sera from patients with a good or poor prognosis; serum proteomic profiles of the two groups were compared and analyzed using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. Identified proteins were confirmed via enzyme-linked immunosorbent assay. An invasion assay was performed after overexpression and knockdown of target protein in Huh7 cells. RESULTS: Levels of inter-alpha inhibitor H4 (ITIH4), fibrinogen gamma chain, keratin 9/1 complex, carbonic anhydrase I, and carbonmonoxyhemoglobin S were changed by more than 4-fold in response to LDTx. In particular, pre-LDTx ITIH4 expression was more than 5-fold higher in patients with a good prognosis, compared to patients with a poor prognosis. The migration ability of Huh7 cells was significantly suppressed and enhanced by ITIH4 overexpression and knockdown, respectively. The tumors of patients with HCC and a good prognosis expressed high levels of ITIH4, compared to those of patients with a poor prognosis. CONCLUSION: Taken together, ITIH4 may be a potential therapeutic target that could inhibit cancer metastasis, as well as a prognostic marker for patients with HCC who are receiving LDTx.
Biomarkers ; Carbonic Anhydrase I ; Carboxyhemoglobin ; Carcinoma, Hepatocellular* ; Electrophoresis ; Enzyme-Linked Immunosorbent Assay ; Fibrinogen ; Humans ; Mass Spectrometry ; Neoplasm Metastasis ; Prognosis ; Radiotherapy ; Treatment Outcome

PURPOSE: A case of bilateral lacrimal caruncle steatocystoma simplex and sebaceous gland hyperplasia, which rarely occurs in the periocular area, is reported. CASE SUMMARY: A 42-year-old female presented with a bilateral caruncular mass, which had been growing for a few months. A physical examination revealed soft, non-tender, rounded masses and no other ophthalmic findings. Under local anesthesia, the masses were completely excised. In the histopathological examination, a cystic mass containing a sebaceous gland in the stratified squamous epithelium cyst wall was found. A hyperplastic sebaceous gland and a dilated sebaceous gland duct were also found. Steatocystoma simplex and sebaceous gland hyperplasia, respectively, were diagnosed. There was no recurrence or complication after excision. CONCLUSIONS: Steatocystoma simplex and sebaceous gland hyperplasia are benign tumors that rarely occur in the lacrimal caruncle. They can be diagnosed and treated by complete excision. Steatocystoma simplex and sebaceous gland hyperplasia should therefore be considered as differential diagnoses of a lacrimal caruncle mass.
Adult ; Anesthesia, Local ; Diagnosis, Differential ; Epithelium ; Female ; Humans ; Hyperplasia ; Physical Examination ; Recurrence ; Sebaceous Glands

PURPOSE: Tadalafil is a phosphodiesterase type 5 inhibitor that is used for the treatment of erectile dysfunction (ED). Previous clinical trials have assessed its efficacy and safety in Western populations, but this drug has not been investigated in a large clinical trial involving Korean men with ED. Thus, the aim of this study was to assess the efficacy and safety of 20 mg tadalafil in comparison to placebo when it is taken on demand by Korean men suffering with ED over a study period of 12 weeks. MATERIALS AND METHODS: Men more than 18 years of age with mild to severe ED of various etiologies were randomized to receive placebo or tadalafil 20 mg that was taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary and Global Assessment Questions (GAQ). RESULTS: Tadalafil significantly improved erectile function, as measured by the erectile function domain of the IIEF, compared to placebo (p<0.001). At the endpoint, the patients receiving tadalafil 20mg reported a greater mean per-patient percentage of successful intercourse attempts (SEP3: 71% compared to 31% for placebo) and a greater proportion of improved erections (GAQ: 80% compared to 44%). The most common treatment emergent adverse events were headache (16.3%), flushing (5%) and eye pain (5%), and most of the adverse events were mild or moderate in severity. CONCLUSIONS: Tadalafil was an effective, well-tolerated therapy for Korean men suffering with ED of broad-spectrum severity and etiology.
Erectile Dysfunction* ; Eye Pain ; Flushing ; Headache ; Humans ; Korea* ; Male ; Tadalafil