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: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare hematologic disorder caused by uncontrolled terminal complement activation, which leads to intravascular hemolysis (IVH), thromboembolism (TE), renal failure, and premature mortality. Methods: We performed a secondary analysis of data collected from patients enrolled in the Korean National PNH Registry to assess the relative importance of risk factors, specifically lactate dehydrogenase (LDH) and hemoglobin (Hb), in predicting the incidence of TE, impaired renal function, and death in complement inhibitor-naïve patients with PNH. Results: Multivariate regression modeling indicated that LDH ≥ 1.5 × upper limit of normal (ULN), male sex, and pain were associated with increased risk of TE (P = 0.016, 0.045, and 0.033, respectively), hemoglobinuria and pain were associated with an increased risk of impaired renal function (P = 0.034 and 0.022, respectively), and TE was associated with an increased incidence of death (P < 0.001). Hb < 8 g/dL was not a predictor of TE, impaired renal function, or death in multivariate regression analyses. Standardized mortality ratio analysis indicated that LDH ≥ 1.5 × ULN (P < 0.001), Hb < 8 g/dL (P < 0.001), and Hb ≥ 8 g/dL (P = 0.004) were all risk factors for death; in contrast, patients with LDH < 1.5 × ULN had similar mortality to the general population. Conclusion In complement inhibitor-naïve patients with PNH, LDH ≥ 1.5 × ULN was a significant predictor of TE, and TE was a significant predictor of death. Hb was not a significant predictor of TE, impaired renal function, or death. Therefore, controlling IVH will improve clinical outcomes for patients with PNH.

Objective: To investigate the effects of long-acting injectable 3-monthly paliperidone palmitate on the clinical and social functioning of patients with schizophrenia. Methods: This study enrolled patients with schizophrenia receiving long-acting injectable 1-monthly paliperidone palmitate for at least 4 months and who subsequently received 3-monthly paliperidone palmitate. Accordingly, 418 patients were followed up for 24 weeks. Their clinical symptoms and social functioning were measured using the Clinical Global Impression-Severity of Illness and Personal and Social Performance scales. Results: The Personal and Social Performance total score was significantly higher after 3-monthly paliperidone palmitate treatment than at baseline (baseline vs. week 24: 54.3 ± 18.0 vs. 61.0 ± 14.5 [mean ± standard deviation]; p ＜ 0.001; Wilcoxon signed-rank test); the proportion of patients in the mildly ill group (scores 71−100) also increased significantly (baseline vs. week 24: 16.5% vs. 20.6%; p＜ 0.001; McNemar-Bowker test). The mean Clinical Global Impression-Severity of Illness score decreased significantly (baseline vs. week 24: 3.7 ± 1.0 vs. 3.4 ± 0.9; p＜ 0.001; Wilcoxon signed-rank test), as did the proportion of patients in the severely ill group (baseline vs. week 24: 4.1% vs. 2.1%; p ＜ 0.001; McNemar-Bowker test). Conclusion Continuous 3-monthly paliperidone palmitate treatment significantly enhances the personal and social performance of patients with schizophrenia and reduces the proportion of those with severe illness. These findings suggest that long-acting injectable antipsychotic administration at intervals longer than 1 month might improve the social functioning of and promote return to activities of daily living in patients with schizophrenia.

The Korean Medication Algorithm Project for Depressive Disorder (KMAP-DD) first was published in 2002, and has been revised four times, in 2006, 2012, 2017, and 2021. In this review, we compared recommendations from the recently revised KMAP-DD 2021 to four global clinical practice guidelines (CPGs) for depression published after 2010. The recommendations from the KMAP-DD 2021 were similar to those from other CPGs, although there were some differences. The KMAP-DD 2021 reflected social culture and the healthcare system in Korea and recent evidence about pharmacotherapy for depression, as did other recently published evidence-based guidelines. Despite some intrinsic limitations as an expert consensus-based guideline, the KMAP-DD 2021 can be helpful for Korean psychiatrists making decisions in clinical settings by complementing previously published evidence-based guidelines, especially for some clinical situations lacking evidence from rigorously designed clinical trials.

The development of lab-on-a-chip technology based on microfluidics has been used from diagnostic test to drug screening in biomedical science. Lab-on-a-chip technology is also being expanded to the concept of an organ-on-a-chip with the development of cell biology and biocompatible material development. In addition, artificial intelligence (AI) has brought dramatic changes over the past few years in science, industry, defense, science and healthcare. AI-generated output is beginning to prove comparable or even superior to that of human experts. Lab-on-a-chip technology in specific microfluidic devices can overcome the above bottlenecks as a platform for building and implementing AI in a large-scale, cost-effective, high-throughput, automated and multiplexed manner. This platform, high-throughput imaging, becomes an important tool because it can generate high-content information which are too complex to analyze with conventional computational tools. In addition to the capabilities of a data provider, lab-on-a-chip technology can also be leveraged to enable AI developed for the accurate identification, characterization, classification and prediction of objects in heterogeneous samples. AI will provide quantitative and qualitative analysis results close to human in the urology field with lab-on-a-chip.

Objective: No previous study examined impact of dementia in the outcome of allogeneic hematopoietic stem cell transplantation (HSCT). We aimed to investigate overall survival (OS) of patients with dementia after receiving HSCT. Methods: Among 8,230 patients who underwent HSCT between 2002 and 2018, 5,533 patients younger than 50 years were first excluded. Remaining patients were divided into those who were and were not diagnosed with dementia before HSCT (dementia group: n = 31; no dementia: n = 2,666). Thereafter, among 2,666 participants without dementia, 93 patients were selected via propensity-matched score as non-dementia group. Patients were followed from the day they received HSCT to the occurrence of death or the last follow-up day (December 31, 2018), whichever came first. Results: With median follow-up of 621 days for dementia group and 654 days for non-dementia group, 2 year-OS of dementia group was lower than that of non-dementia group (53.3% [95% confidence interval, 95% CI, 59.0−80.2%] vs. 68.8% [95% CI, 38.0−68.2%], p = 0.076). In multivariate analysis, dementia had significant impacts on OS (hazard risk = 2.539, 95% CI, 1.166−4.771, p = 0.017). Conclusion Our results indicated that patients diagnosed with dementia before HSCT have 2.539 times higher risk of mortality after transplantation than those not having dementia. With number of elderly needing HSCT is increasing, further work to establish treatment guidelines for the management of HSCT in people with dementia is needed.

Background: and Purpose The rate of donepezil discontinuation and the underlying reasons for discontinuation in Asian patients with Alzheimer’s disease (AD) are currently unknown. We aimed to determine the treatment discontinuation rates in AD patients who had newly been prescribed donepezil in routine clinical practice in Asia. Methods: This 1-year observational study involved 38 institutions in seven Asian countries, and it evaluated 398 participants aged 50–90 years with a diagnosis of probable AD and on newly prescribed donepezil monotherapy. The primary endpoint was the rate of donepezil discontinuation over 1 year. Secondary endpoints included the reason for discontinuation,treatment duration, changes in cognitive function over the 1-year study period, and compliance as assessed using a clinician rating scale (CRS) and visual analog scale (VAS). Results: Donepezil was discontinued in 83 (20.9%) patients, most commonly due to an adverse event (43.4%). The mean treatment duration was 103.67 days in patients who discontinued. Among patients whose cognitive function was assessed at baseline and 1 year, there were no significant changes in scores on the Mini-Mental State Examination, Montreal Cognitive Assessment, and Trail-Making Test–Black and White scores, whereas the Clinical Dementia Rating score increased significantly (p<0.001). Treatment compliance at 1 year was 96.8% (306/316) on the CRS and 92.6±14.1% (mean±standard deviation) on the VAS. Conclusions In patients on newly prescribed donepezil, the primary reason for discontinuation was an adverse event. Cognitive assessments revealed no significant worsening at 1 year, indicating that continuous donepezil treatment contributes to the maintenance of cognitive function.

Objectives: The Korean Medication Algorithm Project for Depressive Disorder 2021 (KMAP-DD 2021) was a revision of previous works. The main purpose of the current study was to amend guidelines for the treatment of a major depressive disorder (MDD) for children and adolescents. Methods: The survey consisted of 21 questionnaires for children and adolescents. A total of 33 of the 46 experts in child and adolescent psychiatry answered the survey. Results: Antidepressant (AD) monotherapy was selected as the 1st line option for MDD with mild to moderate severity. As the 1st line of treatment for MDD severe without psychotic features in children and adolescents, AD monotherapy and AD augmented with atypical antipsychotics (AAP) were recommended. For MDD with psychotic features, AD augmented with AAP was preferred as the 1st line of treatment. Conclusion We developed an algorithm for child and adolescent populations with depressive disorders, more specifically than the KMAP-DD 2017. We expect this algorithm will provide clinicians useful information and help in the treatment of children and adolescents with depressive disorders.

Objectives: The Korean Medication Algorithm Project for Depressive Disorder (KMAP-DD) was developed in 2002 and revised in 2006, 2012, 2017. In 2021, the fifth edition was published.This edition reflected new findings and the latest trends in the areas of pharmacological treatment. The aim of this study is to present strategies and treatment options according to the subtype of depression using data from the KMAP-DD-2021. Methods: Ninety-seven psychiatrists with clinical experience in depressive disorder were selected. The questionnaires for KMAP-DD 2021 were sent to participants via mail. KMAP-DD 2021 consists of overall treatment strategies and treatment options under specific circumstances.Each treatment strategy or treatment option was evaluated with an overall score of nine and was divided into the three phases of recommendation that include primary, secondary, and tertiary. Results: For persisting depressive disorder, antidepressant monotherapy including selective serotonin reuptake inhibitor (SSRI) (escitalopram, fluoxetine, sertraline, paroxetine), serotoninnorepinephrine reuptake inhibitor (SNRI) (desvenlafaxine, venlafaxine, duloxetine, milnacipran), vortioxetine, and mirtazapine, was recommended as first-line medications. For melancholia of major depressive disorder, SSRI, SNRI, vortioxetine, and mirtazapine also were recommended as first-line medications. For mixed features, SSRI, bupropion, mirtazapine, SNRI, except for duloxetine, and milnacipran were recommended as first-line medications. For anxious distress, SSRI, mirtazapine, and SNRI, except milnacipran, were recommended as first-line medications. Conclusion The preferences of antidepressants by experts differed according to the subtype of depression. These findings suggest that experts treat patients with a major depressive disorder after considering the subtype of depression involved.

Objectives: The Korean Medication Algorithm Project for Depressive Disorder (KMAP-DD) is a consensus-based medication guideline. To reflect advances in pharmacotherapy for depressive disorders, we have undertaken a fourth revision of the KMAP-DD. Methods: The review committee for the new version of the KMAP-DD (KMAP-DD 2021) included 143 Korean psychiatrists with clinical experience in the field of depressive disorders. Each treatment strategy or treatment option was evaluated with an overall score of nine, and the treatment option was categorized into the three levels of recommendation of primary, secondary, and tertiary. Results: The first-line pharmacotherapeutic strategy for mild to moderate major depressive episodes (MDE) was antidepressant (AD) monotherapy. For severe MDE without psychotic features, AD monotherapy or the combination of AD and atypical antipsychotics (AAP) was the first-line strategy. The combination of AD and AAP was recommended as the first-line for the MDE with psychotic features as well. When treatment response to initial AD monotherapy was insufficient, a combination of AAP or another AD was recommended. In the case of unsatisfactory response to initial treatment with an AD and AAP combination, switching to another AAP or adding another AD was recommended. Conclusion Generally, there were no significant changes in the recommendations for MDE management in the KMAP-DD 2021 compared to previous versions. However, it was notable that the preference for the use of AAP and AD with the novel mechanism of action including vortioxetine and agomelatine increased.