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: Menopausal status can increase the risk of cardiocerebrovascular diseases (CCVDs) in women with type 2 diabetes mellitus (T2DM). Regular exercise is well-known to reduce this risk. This study explored the impact of exercise on CCVD and mortality in women with T2DM according to their menopausal status. Methods: A total of 32,477 premenopausal and 53,690 postmenopausal Korean women with T2DM aged 40 to 60 years from a national health examination cohort (2009 to 2018) were included. We evaluated risks for stroke, myocardial infarction (MI), and mortality based on exercise intensity. Cox proportional hazard regression analyses were performed to obtain the adjusted hazard ratio (aHR) and 95% confidence interval. Results: Exercise reduced stroke, MI, and mortality risks in women with T2DM, regardless of menopausal status. The highest effects of aHR compared to the sedentary group were 0.68 for stroke, 0.66 for MI, and 0.81 for mortality. Postmenopausal women experienced significant MI risk reductions at most exercise intensities, with the greatest reduction in the ≥1,500 metabolic equivalent of task score group unlike premenopausal women. However, stroke and mortality risk reductions in postmenopausal women were less pronounced compared to premenopausal women. Conclusion Exercise reduces CCVD risk in women with T2DM across menopausal status. Postmenopausal women with T2DM had more benefits from exercise on MI but fewer benefits on stroke and mortality than premenopausal women. In premenopausal women with T2DM, exercise was not associated with a lower MI risk.

Purpose: We aimed to investigate the prevalence and genotype distribution of human papillomavirus (HPV) among Korean males and explore implications for targeted vaccination strategies. Materials and Methods: A total of 44,065 males underwent HPV testing between March 2014 and February 2022 using the Anyplex™ II HPV 28 system, detecting 19 high-risk (HR) and 9 low-risk (LR) HPV types. Additionally, data from 507 male patients at local clinic (2017–2022) were analyzed to compare genotype prevalence between those with (WAT group) and without (WAT X group) genital warts. Results: Overall HPV positivity was 59.1%. HPV 6 (33.3%) and HPV 11 (11.0%) were the most prevalent LR genotypes, while HPV 16 (5.2%) dominated HR infection. Multiple HPV genotype co-infection occurred in 49.3% of positive cases, with 11.3% involving multiple HR types. Younger males (teens, 20s) exhibited higher HR-HPV positivity, although total HPV positivity peaked in the 40s (60.1%). Non–9-valent HR genotypes (HPV 53, 51, 39, 66) accounted for 27.6%–35.0% of infections annually. At local clinic, HPV 43 was significantly associated with genital warts (p=0.017). Conclusions These data support including males in national HPV vaccination strategies using the current 9-valent vaccine and underscore the need for ongoing genotype surveillance to monitor non‑vaccine high‑risk types and inform public health policy, and support inclusion of males in national HPV vaccination strategies using the current 9‑valent vaccine.

Background: The prevalence of diabetes mellitus and early-onset dementia (EOD), defined as dementia diagnosed at an age <65 years, is increasing worldwide, with significant socioeconomic implications. We investigated the association between diabetes, prediabetes, and EOD, focusing on the influence of diabetes duration on EOD risk. Methods: Using the Korean National Health Insurance Service database, we analyzed data from 1,979,509 patients aged 40–60 years who underwent health checkups in 2009. Patients were categorized into five groups: normal, impaired fasting glucose (IFG), newly diagnosed diabetes, diabetes duration <5 years, and diabetes duration ≥5 years. Cox proportional hazard models were used to estimate the adjusted hazard ratios (aHRs) for EOD after adjusting for demographic and clinical covariates. Results: During the observation period (mean 7.75 years), 8,921 patients with EOD were identified. The diabetes group demonstrated a significantly higher incidence of EOD compared to the normal group (aHR, 1.334; 95% confidence interval [CI], 1.226 to 1.451). EOD risk increased with longer diabetes duration, with the highest risk observed in patients with diabetes ≥5 years (aHR, 1.543; 95% CI, 1.368 to 1.741). No significant difference was observed between the IFG and normal groups (aHR, 0.989; 95% CI, 0.938 to 1.043). Additionally, the hypertension group exhibited a significantly higher incidence of EOD compared to the non-hypertension group (aHR, 1.364; 95% CI, 1.291 to 1.442). Conclusion Diabetes is independently associated with increased risk of EOD, and this risk increases with longer diabetes duration. This association remained significant regardless of the presence and duration of hypertension.

Background: and Purpose Previous research on patients with acute ischemic stroke (AIS) has shown a 0.5% incidence of major gastrointestinal bleeding (GIB) requiring blood transfusion during hospitalization. The existing literature has insufficiently explored the long-term incidence in this population despite the decremental impact of GIB on stroke outcomes. Methods: We analyzed the data from a cohort of patients with AIS admitted to 14 hospitals as part of a nationwide multicenter prospective stroke registry between 2011 and 2013. These patients were followed up for up to 6 years. The occurrence of major GIB events, defined as GIB necessitating at least two units of blood transfusion, was tracked using the National Health Insurance Service claims data. Results: Among 10,818 patients with AIS (male, 59%; mean age, 68±13 years), 947 (8.8%) experienced 1,224 episodes of major GIB over a median follow-up duration of 3.1 years. Remarkably, 20% of 947 patients experienced multiple episodes of major GIB. The incidence peaked in the first month after AIS, reaching 19.2 per 100 person-years, and gradually decreased to approximately one-sixth of this rate by the 2nd year with subsequent stabilization. Multivariable analysis identified the following predictors of major GIB: anemia, estimated glomerular filtration rate <60 mL/min/1.73 m2 , and a 3-month modified Rankin Scale score of ≥4. Conclusion Patients with AIS are susceptible to major GIB, particularly in the first month after the onset of AIS, with the risk decreasing thereafter. Implementing preventive strategies may be important, especially for patients with anemia and impaired renal function at stroke onset and those with a disabling stroke.

Purpose: To compare the perioperative and postoperative outcomes between traditional trans-vesical robot-assisted simple prostatectomy (TV-RASP) and the newly introduced urethral-sparing (US) RASP. Materials and Methods: We retrospectively reviewed 42 patients who underwent TV-RASP (n=22) or US-RASP (n=20) performed by two experienced surgeons at two tertiary centers. Perioperative outcomes including operation time, estimated blood loss, length of hospital stay, and catheterization time were assessed. Postoperative outcomes were evaluated using the International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, Male Sexual Health Questionnaire-Ejaculation Dysfunction-Short Form (MSHQ-EjD-SF) scores, and maintenance of anterograde ejaculation. Results: This study analyzed 22 and 20 patients who underwent TV-RASP and US-RASP, respectively. Except for the TV-RASP group being older (70.0 years) than the US-RASP group (64.5 years) (p=0.028), no differences among other baseline characteristics existed. Perioperative outcomes indicated that hospital stay and catheterization time were significantly shorter in the US-RASP group than in the TV-RASP group (p<0.001). At postoperative month 1, the median IPSS and QoL scores were significantly better in the US-RASP group than in the TV-RASP group (p=0.001 and p=0.002, respectively). However, at months 6 and 12, no significant differences were noted in IPSS, QoL, maximum flow rate, and postvoid residual urine between the two groups. Sexually active patients in the US-RASP group maintained postoperative MSHQ-EjD functional and bother scores, whereas the TV-RASP group experienced a decline. Notably, 75.0% of patients in the US-RASP group preserved antegrade ejaculation, compared to only 20.0% in the TV-RASP group (p<0.001). Conclusions US-RASP is not inferior to TV-RASP in terms of functional outcomes. In addition, US-RASP yielded more rapid symptom improvements and preserved antegrade ejaculation than TV-RASP. However, larger prospective studies are required to confirm these findings and to further investigate the long-term efficacy and safety of US-RASP.

Purpose: To compare the perioperative and postoperative outcomes between traditional trans-vesical robot-assisted simple prostatectomy (TV-RASP) and the newly introduced urethral-sparing (US) RASP. Materials and Methods: We retrospectively reviewed 42 patients who underwent TV-RASP (n=22) or US-RASP (n=20) performed by two experienced surgeons at two tertiary centers. Perioperative outcomes including operation time, estimated blood loss, length of hospital stay, and catheterization time were assessed. Postoperative outcomes were evaluated using the International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, Male Sexual Health Questionnaire-Ejaculation Dysfunction-Short Form (MSHQ-EjD-SF) scores, and maintenance of anterograde ejaculation. Results: This study analyzed 22 and 20 patients who underwent TV-RASP and US-RASP, respectively. Except for the TV-RASP group being older (70.0 years) than the US-RASP group (64.5 years) (p=0.028), no differences among other baseline characteristics existed. Perioperative outcomes indicated that hospital stay and catheterization time were significantly shorter in the US-RASP group than in the TV-RASP group (p<0.001). At postoperative month 1, the median IPSS and QoL scores were significantly better in the US-RASP group than in the TV-RASP group (p=0.001 and p=0.002, respectively). However, at months 6 and 12, no significant differences were noted in IPSS, QoL, maximum flow rate, and postvoid residual urine between the two groups. Sexually active patients in the US-RASP group maintained postoperative MSHQ-EjD functional and bother scores, whereas the TV-RASP group experienced a decline. Notably, 75.0% of patients in the US-RASP group preserved antegrade ejaculation, compared to only 20.0% in the TV-RASP group (p<0.001). Conclusions US-RASP is not inferior to TV-RASP in terms of functional outcomes. In addition, US-RASP yielded more rapid symptom improvements and preserved antegrade ejaculation than TV-RASP. However, larger prospective studies are required to confirm these findings and to further investigate the long-term efficacy and safety of US-RASP.

Background: and Purpose Previous research on patients with acute ischemic stroke (AIS) has shown a 0.5% incidence of major gastrointestinal bleeding (GIB) requiring blood transfusion during hospitalization. The existing literature has insufficiently explored the long-term incidence in this population despite the decremental impact of GIB on stroke outcomes. Methods: We analyzed the data from a cohort of patients with AIS admitted to 14 hospitals as part of a nationwide multicenter prospective stroke registry between 2011 and 2013. These patients were followed up for up to 6 years. The occurrence of major GIB events, defined as GIB necessitating at least two units of blood transfusion, was tracked using the National Health Insurance Service claims data. Results: Among 10,818 patients with AIS (male, 59%; mean age, 68±13 years), 947 (8.8%) experienced 1,224 episodes of major GIB over a median follow-up duration of 3.1 years. Remarkably, 20% of 947 patients experienced multiple episodes of major GIB. The incidence peaked in the first month after AIS, reaching 19.2 per 100 person-years, and gradually decreased to approximately one-sixth of this rate by the 2nd year with subsequent stabilization. Multivariable analysis identified the following predictors of major GIB: anemia, estimated glomerular filtration rate <60 mL/min/1.73 m2 , and a 3-month modified Rankin Scale score of ≥4. Conclusion Patients with AIS are susceptible to major GIB, particularly in the first month after the onset of AIS, with the risk decreasing thereafter. Implementing preventive strategies may be important, especially for patients with anemia and impaired renal function at stroke onset and those with a disabling stroke.

Purpose: To compare the perioperative and postoperative outcomes between traditional trans-vesical robot-assisted simple prostatectomy (TV-RASP) and the newly introduced urethral-sparing (US) RASP. Materials and Methods: We retrospectively reviewed 42 patients who underwent TV-RASP (n=22) or US-RASP (n=20) performed by two experienced surgeons at two tertiary centers. Perioperative outcomes including operation time, estimated blood loss, length of hospital stay, and catheterization time were assessed. Postoperative outcomes were evaluated using the International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, Male Sexual Health Questionnaire-Ejaculation Dysfunction-Short Form (MSHQ-EjD-SF) scores, and maintenance of anterograde ejaculation. Results: This study analyzed 22 and 20 patients who underwent TV-RASP and US-RASP, respectively. Except for the TV-RASP group being older (70.0 years) than the US-RASP group (64.5 years) (p=0.028), no differences among other baseline characteristics existed. Perioperative outcomes indicated that hospital stay and catheterization time were significantly shorter in the US-RASP group than in the TV-RASP group (p<0.001). At postoperative month 1, the median IPSS and QoL scores were significantly better in the US-RASP group than in the TV-RASP group (p=0.001 and p=0.002, respectively). However, at months 6 and 12, no significant differences were noted in IPSS, QoL, maximum flow rate, and postvoid residual urine between the two groups. Sexually active patients in the US-RASP group maintained postoperative MSHQ-EjD functional and bother scores, whereas the TV-RASP group experienced a decline. Notably, 75.0% of patients in the US-RASP group preserved antegrade ejaculation, compared to only 20.0% in the TV-RASP group (p<0.001). Conclusions US-RASP is not inferior to TV-RASP in terms of functional outcomes. In addition, US-RASP yielded more rapid symptom improvements and preserved antegrade ejaculation than TV-RASP. However, larger prospective studies are required to confirm these findings and to further investigate the long-term efficacy and safety of US-RASP.

Purpose: To compare the perioperative and postoperative outcomes between traditional trans-vesical robot-assisted simple prostatectomy (TV-RASP) and the newly introduced urethral-sparing (US) RASP. Materials and Methods: We retrospectively reviewed 42 patients who underwent TV-RASP (n=22) or US-RASP (n=20) performed by two experienced surgeons at two tertiary centers. Perioperative outcomes including operation time, estimated blood loss, length of hospital stay, and catheterization time were assessed. Postoperative outcomes were evaluated using the International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, Male Sexual Health Questionnaire-Ejaculation Dysfunction-Short Form (MSHQ-EjD-SF) scores, and maintenance of anterograde ejaculation. Results: This study analyzed 22 and 20 patients who underwent TV-RASP and US-RASP, respectively. Except for the TV-RASP group being older (70.0 years) than the US-RASP group (64.5 years) (p=0.028), no differences among other baseline characteristics existed. Perioperative outcomes indicated that hospital stay and catheterization time were significantly shorter in the US-RASP group than in the TV-RASP group (p<0.001). At postoperative month 1, the median IPSS and QoL scores were significantly better in the US-RASP group than in the TV-RASP group (p=0.001 and p=0.002, respectively). However, at months 6 and 12, no significant differences were noted in IPSS, QoL, maximum flow rate, and postvoid residual urine between the two groups. Sexually active patients in the US-RASP group maintained postoperative MSHQ-EjD functional and bother scores, whereas the TV-RASP group experienced a decline. Notably, 75.0% of patients in the US-RASP group preserved antegrade ejaculation, compared to only 20.0% in the TV-RASP group (p<0.001). Conclusions US-RASP is not inferior to TV-RASP in terms of functional outcomes. In addition, US-RASP yielded more rapid symptom improvements and preserved antegrade ejaculation than TV-RASP. However, larger prospective studies are required to confirm these findings and to further investigate the long-term efficacy and safety of US-RASP.