Purpose: This 6-year post-marketing surveillance (PMS) study was conducted in South Korea to evaluate the real-world safety and effectiveness of eribulin in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes. Materials and Methods: During the study period (17 August 2012 to 16 August 2018), case-report files (CRFs) of patients receiving eribulin were collected. The main study endpoint was to assess the safety of eribulin. Evaluation of the effectiveness of eribulin was an exploratory endpoint. Patients were followed for 1 year after eribulin initiation. Results: CRFs were collected from 64 investigators at 64 sites for 1,079 patients. The safety analysis set (SAS) included 1,001 eribulin recipients; effectiveness was assessed in 244 patients. In the SAS, patients were predominantly female (99.6%), with a median age of 53.0 years, and diagnosed with metastatic breast cancer (92.0%). Eribulin was administered as a median 4th line chemotherapy. A total of 2,124 treatment-emergent adverse events (TEAEs) were reported in 661 patients (66.0%). Neutropenia was the most common TEAE (32.5% of patients), occurring at a median of 9-11 days from initial eribulin administration. Overall response and disease control rates were 31.7% and 95.6%, respectively, and the median duration of eribulin use (time to treatment failure) was 3.0 months. Conclusion This large real-world PMS analysis in patients with advanced or metastatic breast cancer demonstrated the effectiveness of eribulin and found no new safety concerns relative to safety information from prior clinical and real-world studies, and approvals in South Korea and other countries.

Background: Cough is a prominent symptom of chronic respiratory diseases, including asthma, idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD), and bronchiectasis (BE). Some patients develop chronic cough (CC), defined as lasting more than 8 weeks, yet its characteristics remain poorly understood. This study aimed to characterize CC across various chronic respiratory diseases using validated cough assessment tools. Methods: The Cough Assessment in Chronic Respiratory Diseases (COASESS) study, a multicenter, prospective cross-sectional study, was conducted at 10 university hospitals. CC was evaluated in terms of intensity (numeric rating scale [NRS]), frequency (cough symptom score [CSS]), and quality of life (using the cough assessment test [COAT] and Leicester cough questionnaire [LCQ]). Cough hypersensitivity was assessed with the cough hypersensitivity questionnaire (CHQ). Data on age, sex, and smoking status were also collected. Results: Among the 303 enrolled patients, 266 with chronic respiratory diseases were included in the analysis. Patients with asthma were younger, predominantly female, and non-smokers, whereas those with COPD and IPF were older males who had previously smoked (p<0.001). Scores for COAT, LCQ, NRS, and CSS showed significant differences across the diseases, with asthma and IPF patients experiencing a greater symptom burden and lower quality of life compared to those with COPD or BE (p<0.001). Although CHQ total scores were similar across groups, asthma patients more frequently reported triggers such as talking and post-nasal drip. Conclusion This study revealed distinct characteristics of CC across different chronic respiratory diseases. Asthma and IPF were associated with a higher symptom burden, and cough hypersensitivity varied depending on the underlying condition. These findings highlight the necessity for disease-specific assessments and management strategies for CC.

Purpose: Bronchiolitis obliterans syndrome (BOS) can develop as a manifestation of graft-versus-host disease following allogeneic hematopoietic stem cell transplantation (allo-HSCT), and may ultimately require lung transplantation (LT). However, reports on LT outcomes for BOS after allo-HSCT are limited. This study aimed to compare the outcomes of LT for BOS following allo-HSCT with those for idiopathic pulmonary fibrosis (IPF). Materials and Methods: A total of 487 patients underwent LT between January 2010 and August 2023. Among them, the baseline characteristics and outcomes of 35 patients with BOS following allo-HSCT and 216 patients with IPF were analyzed. Results: The BOS group was younger and had a lower body mass index (BMI) compared to the IPF group (33.7±11.9 years vs.59.7±7.3 years, p<0.001; 17.6±3.7 kg/m2 vs. 22.0±3.6 kg/m2 , p<0.001, respectively). The proportion of male patients was lower in the BOS group than in the IPF group (54.3% vs. 84.3%, p<0.001). Preoperative ventilator support was more common in the BOS group compared to the IPF group (62.9% vs. 32.4%, p=0.001). In Kaplan–Meier survival analysis, the 5-year survival rate was significantly higher in the BOS group than in the IPF group (71.0% vs. 44.9%, p=0.022). In the Cox proportional hazards model, age was the only factor significantly associated with survival [hazard ratio (95% confidence interval): 1.04 (1.02–1.07), p<0.001]. Conclusion The survival rate of the BOS group was not inferior to that of the IPF group after adjusting for sex, age, and BMI. Therefore, LT should be actively considered as a treatment option for patients with BOS following allo-HSCT.

Background: Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease that culminates in respiratory failure and death due to irreversible scarring of the distal lung. While initially considered a chronic inflammatory disorder, the aberrant function of the alveolar epithelium is now acknowledged as playing a central role in the pathophysiology of IPF. This study aimed to investigate the regenerative capacity of alveolar type 2 (AT2) cells using IPF-derived alveolar organoids and to examine the effects of disease progression on this capacity. Methods: Lung tissues from three pneumothorax patients and six IPF patients (early and advanced stages) were obtained through video-assisted thoracoscopic surgery and lung transplantation. HTII-280+ cells were isolated from CD31-CD45-epithelial cell adhesion molecule (EpCAM)+ cells in the distal lungs of IPF and pneumothorax patients using fluorescence-activated cell sorting (FACS) and resuspended in 48-well plates to establish IPF-derived alveolar organoids. Immunostaining was used to verify the presence of AT2 cells. Results: FACS sorting yielded approximately 1% of AT2 cells in early IPF tissue, and the number decreased as the disease progressed, in contrast to 2.7% in pneumothorax. Additionally, the cultured organoids in the IPF groups were smaller and less numerous compared to those from pneumothorax patients. The colony forming efficiency decreased as the disease advanced. Immunostaining results showed that the IPF organoids expressed less surfactant protein C (SFTPC) compared to the pneumothorax group and contained keratin 5+ (KRT5+) cells. Conclusion This study confirmed that the regenerative capacity of AT2 cells in IPF decreases as the disease progresses, with IPF-derived AT2 cells inherently exhibiting functional abnormalities and altered differentiation plasticity.

Background: Differentiating between asymptomatic bacteriuria (ASB) and urinary tract infection (UTI) is difficult in patients who have difficulty communicating their symptoms.This study aimed to evaluate the diagnostic accuracy of urine leukocytes in distinguishing between UTI and ASB, and the clinical outcomes of patients with UTI according to the degree of pyuria. Methods: This retrospective cohort study included patients with positive urine cultures between July 2022 and June 2023 at two hospitals. UTI and ASB were diagnosed through a comprehensive review of medical records. We evaluated the differences in urine leukocyte counts between patients with UTI and ASB. The diagnostic performance of urine leukocytes to differentiate between UTI and ASB was evaluated. To investigate the clinical outcomes based on the degree of pyuria, we classified patients with upper UTI according to their urine leukocyte counts. Results: Of the 1,793 eligible patients with bacteriuria included, 1,464 had UTI and 329 had ASB. Patients with UTI had higher urinary leukocytes than patients with ASB did (490.4 vs.123.5 cells/µL; P < 0.001). The area under the receiver operating characteristic curve was 0.702 for discriminating between ASB and UTI. The optimal urine leukocyte cutoff was 195.35 cells/µL, with a sensitivity and specificity of 0.70 and 0.60, respectively. A sequential rise in secondary bacteremia rate was observed according to an increase in urine leukocytes in patients with upper UTI, whereas in-hospital mortality showed no corresponding trend. Conclusion Urine leukocyte counts could be used to predict UTI occurrence and bacteremia secondary to UTI. Higher degrees of pyuria were associated with bacteremia but not with mortality. Urine leukocyte counts can provide additive information for patients with bacteriuria with vague symptoms.

Background: Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease that culminates in respiratory failure and death due to irreversible scarring of the distal lung. While initially considered a chronic inflammatory disorder, the aberrant function of the alveolar epithelium is now acknowledged as playing a central role in the pathophysiology of IPF. This study aimed to investigate the regenerative capacity of alveolar type 2 (AT2) cells using IPF-derived alveolar organoids and to examine the effects of disease progression on this capacity. Methods: Lung tissues from three pneumothorax patients and six IPF patients (early and advanced stages) were obtained through video-assisted thoracoscopic surgery and lung transplantation. HTII-280+ cells were isolated from CD31-CD45-epithelial cell adhesion molecule (EpCAM)+ cells in the distal lungs of IPF and pneumothorax patients using fluorescence-activated cell sorting (FACS) and resuspended in 48-well plates to establish IPF-derived alveolar organoids. Immunostaining was used to verify the presence of AT2 cells. Results: FACS sorting yielded approximately 1% of AT2 cells in early IPF tissue, and the number decreased as the disease progressed, in contrast to 2.7% in pneumothorax. Additionally, the cultured organoids in the IPF groups were smaller and less numerous compared to those from pneumothorax patients. The colony forming efficiency decreased as the disease advanced. Immunostaining results showed that the IPF organoids expressed less surfactant protein C (SFTPC) compared to the pneumothorax group and contained keratin 5+ (KRT5+) cells. Conclusion This study confirmed that the regenerative capacity of AT2 cells in IPF decreases as the disease progresses, with IPF-derived AT2 cells inherently exhibiting functional abnormalities and altered differentiation plasticity.

Background: Differentiating between asymptomatic bacteriuria (ASB) and urinary tract infection (UTI) is difficult in patients who have difficulty communicating their symptoms.This study aimed to evaluate the diagnostic accuracy of urine leukocytes in distinguishing between UTI and ASB, and the clinical outcomes of patients with UTI according to the degree of pyuria. Methods: This retrospective cohort study included patients with positive urine cultures between July 2022 and June 2023 at two hospitals. UTI and ASB were diagnosed through a comprehensive review of medical records. We evaluated the differences in urine leukocyte counts between patients with UTI and ASB. The diagnostic performance of urine leukocytes to differentiate between UTI and ASB was evaluated. To investigate the clinical outcomes based on the degree of pyuria, we classified patients with upper UTI according to their urine leukocyte counts. Results: Of the 1,793 eligible patients with bacteriuria included, 1,464 had UTI and 329 had ASB. Patients with UTI had higher urinary leukocytes than patients with ASB did (490.4 vs.123.5 cells/µL; P < 0.001). The area under the receiver operating characteristic curve was 0.702 for discriminating between ASB and UTI. The optimal urine leukocyte cutoff was 195.35 cells/µL, with a sensitivity and specificity of 0.70 and 0.60, respectively. A sequential rise in secondary bacteremia rate was observed according to an increase in urine leukocytes in patients with upper UTI, whereas in-hospital mortality showed no corresponding trend. Conclusion Urine leukocyte counts could be used to predict UTI occurrence and bacteremia secondary to UTI. Higher degrees of pyuria were associated with bacteremia but not with mortality. Urine leukocyte counts can provide additive information for patients with bacteriuria with vague symptoms.

Background: Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease that culminates in respiratory failure and death due to irreversible scarring of the distal lung. While initially considered a chronic inflammatory disorder, the aberrant function of the alveolar epithelium is now acknowledged as playing a central role in the pathophysiology of IPF. This study aimed to investigate the regenerative capacity of alveolar type 2 (AT2) cells using IPF-derived alveolar organoids and to examine the effects of disease progression on this capacity. Methods: Lung tissues from three pneumothorax patients and six IPF patients (early and advanced stages) were obtained through video-assisted thoracoscopic surgery and lung transplantation. HTII-280+ cells were isolated from CD31-CD45-epithelial cell adhesion molecule (EpCAM)+ cells in the distal lungs of IPF and pneumothorax patients using fluorescence-activated cell sorting (FACS) and resuspended in 48-well plates to establish IPF-derived alveolar organoids. Immunostaining was used to verify the presence of AT2 cells. Results: FACS sorting yielded approximately 1% of AT2 cells in early IPF tissue, and the number decreased as the disease progressed, in contrast to 2.7% in pneumothorax. Additionally, the cultured organoids in the IPF groups were smaller and less numerous compared to those from pneumothorax patients. The colony forming efficiency decreased as the disease advanced. Immunostaining results showed that the IPF organoids expressed less surfactant protein C (SFTPC) compared to the pneumothorax group and contained keratin 5+ (KRT5+) cells. Conclusion This study confirmed that the regenerative capacity of AT2 cells in IPF decreases as the disease progresses, with IPF-derived AT2 cells inherently exhibiting functional abnormalities and altered differentiation plasticity.

Background: Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease that culminates in respiratory failure and death due to irreversible scarring of the distal lung. While initially considered a chronic inflammatory disorder, the aberrant function of the alveolar epithelium is now acknowledged as playing a central role in the pathophysiology of IPF. This study aimed to investigate the regenerative capacity of alveolar type 2 (AT2) cells using IPF-derived alveolar organoids and to examine the effects of disease progression on this capacity. Methods: Lung tissues from three pneumothorax patients and six IPF patients (early and advanced stages) were obtained through video-assisted thoracoscopic surgery and lung transplantation. HTII-280+ cells were isolated from CD31-CD45-epithelial cell adhesion molecule (EpCAM)+ cells in the distal lungs of IPF and pneumothorax patients using fluorescence-activated cell sorting (FACS) and resuspended in 48-well plates to establish IPF-derived alveolar organoids. Immunostaining was used to verify the presence of AT2 cells. Results: FACS sorting yielded approximately 1% of AT2 cells in early IPF tissue, and the number decreased as the disease progressed, in contrast to 2.7% in pneumothorax. Additionally, the cultured organoids in the IPF groups were smaller and less numerous compared to those from pneumothorax patients. The colony forming efficiency decreased as the disease advanced. Immunostaining results showed that the IPF organoids expressed less surfactant protein C (SFTPC) compared to the pneumothorax group and contained keratin 5+ (KRT5+) cells. Conclusion This study confirmed that the regenerative capacity of AT2 cells in IPF decreases as the disease progresses, with IPF-derived AT2 cells inherently exhibiting functional abnormalities and altered differentiation plasticity.

Background: Differentiating between asymptomatic bacteriuria (ASB) and urinary tract infection (UTI) is difficult in patients who have difficulty communicating their symptoms.This study aimed to evaluate the diagnostic accuracy of urine leukocytes in distinguishing between UTI and ASB, and the clinical outcomes of patients with UTI according to the degree of pyuria. Methods: This retrospective cohort study included patients with positive urine cultures between July 2022 and June 2023 at two hospitals. UTI and ASB were diagnosed through a comprehensive review of medical records. We evaluated the differences in urine leukocyte counts between patients with UTI and ASB. The diagnostic performance of urine leukocytes to differentiate between UTI and ASB was evaluated. To investigate the clinical outcomes based on the degree of pyuria, we classified patients with upper UTI according to their urine leukocyte counts. Results: Of the 1,793 eligible patients with bacteriuria included, 1,464 had UTI and 329 had ASB. Patients with UTI had higher urinary leukocytes than patients with ASB did (490.4 vs.123.5 cells/µL; P < 0.001). The area under the receiver operating characteristic curve was 0.702 for discriminating between ASB and UTI. The optimal urine leukocyte cutoff was 195.35 cells/µL, with a sensitivity and specificity of 0.70 and 0.60, respectively. A sequential rise in secondary bacteremia rate was observed according to an increase in urine leukocytes in patients with upper UTI, whereas in-hospital mortality showed no corresponding trend. Conclusion Urine leukocyte counts could be used to predict UTI occurrence and bacteremia secondary to UTI. Higher degrees of pyuria were associated with bacteremia but not with mortality. Urine leukocyte counts can provide additive information for patients with bacteriuria with vague symptoms.