Purpose: This multicenter, open-label, phase II trial evaluated the efficacy and safety of bortezomib combined with dexamethasone for the treatment of relapsed/refractory cutaneous T-cell lymphoma (CTCL) in previously treated patients across 14 institutions in South Korea. Materials and Methods: Between September 2017 and July 2020, 29 patients with histologically confirmed CTCL received treatment, consisting of eight 4-week cycles of induction therapy followed by maintenance therapy, contingent upon response, for up to one year. The primary endpoint was the proportion of patients achieving an objective global response. Results: Thirteen of the 29 patients (44.8%) achieved an objective global response, including two complete responses. The median progression-free survival (PFS) was 5.8 months, with responders showing a median PFS of 14.0 months. Treatment-emergent adverse events were generally mild, with a low incidence of peripheral neuropathy and hematologic toxicities. Despite the trend toward shorter PFS in patients with higher mutation burdens, genomic profiling before and after treatment showed no significant emergence of new mutations indicative of disease progression. Conclusion This study supports the use of bortezomib and dexamethasone as a viable and safe treatment option for previously treated CTCL, demonstrating substantial efficacy and manageability in adverse effects. Further research with a larger cohort is suggested to validate these findings and explore the prognostic value of mutation profiles.

Purpose: This multicenter, open-label, phase II trial evaluated the efficacy and safety of bortezomib combined with dexamethasone for the treatment of relapsed/refractory cutaneous T-cell lymphoma (CTCL) in previously treated patients across 14 institutions in South Korea. Materials and Methods: Between September 2017 and July 2020, 29 patients with histologically confirmed CTCL received treatment, consisting of eight 4-week cycles of induction therapy followed by maintenance therapy, contingent upon response, for up to one year. The primary endpoint was the proportion of patients achieving an objective global response. Results: Thirteen of the 29 patients (44.8%) achieved an objective global response, including two complete responses. The median progression-free survival (PFS) was 5.8 months, with responders showing a median PFS of 14.0 months. Treatment-emergent adverse events were generally mild, with a low incidence of peripheral neuropathy and hematologic toxicities. Despite the trend toward shorter PFS in patients with higher mutation burdens, genomic profiling before and after treatment showed no significant emergence of new mutations indicative of disease progression. Conclusion This study supports the use of bortezomib and dexamethasone as a viable and safe treatment option for previously treated CTCL, demonstrating substantial efficacy and manageability in adverse effects. Further research with a larger cohort is suggested to validate these findings and explore the prognostic value of mutation profiles.

Purpose: This multicenter, open-label, phase II trial evaluated the efficacy and safety of bortezomib combined with dexamethasone for the treatment of relapsed/refractory cutaneous T-cell lymphoma (CTCL) in previously treated patients across 14 institutions in South Korea. Materials and Methods: Between September 2017 and July 2020, 29 patients with histologically confirmed CTCL received treatment, consisting of eight 4-week cycles of induction therapy followed by maintenance therapy, contingent upon response, for up to one year. The primary endpoint was the proportion of patients achieving an objective global response. Results: Thirteen of the 29 patients (44.8%) achieved an objective global response, including two complete responses. The median progression-free survival (PFS) was 5.8 months, with responders showing a median PFS of 14.0 months. Treatment-emergent adverse events were generally mild, with a low incidence of peripheral neuropathy and hematologic toxicities. Despite the trend toward shorter PFS in patients with higher mutation burdens, genomic profiling before and after treatment showed no significant emergence of new mutations indicative of disease progression. Conclusion This study supports the use of bortezomib and dexamethasone as a viable and safe treatment option for previously treated CTCL, demonstrating substantial efficacy and manageability in adverse effects. Further research with a larger cohort is suggested to validate these findings and explore the prognostic value of mutation profiles.

BACKGROUND: Data on drug-coated balloon (DCB) treatment in elderly patients are limited. This study was to evaluate the efficacy of DCB treatment in percutaneous coronary intervention (PCI) among elderly patients. METHODS: A retrospective analysis included 232 patients aged 75 years or older with coronary artery disease who underwent successful PCI using either DCB alone or in combination with drug-eluting stent (DES) based on pre-dilation results (DCB-based PCI). These patients were compared with 1818 elderly patients who underwent second-generation DES implantation (DES-only PCI). The endpoint was major adverse cardiovascular events (MACE) at 2-year follow-up. RESULTS: In the DCB-based PCI, 61.2% of patients received DCB-only treatment. Compared to DES-only PCI, the DCB-based PCI group had fewer stents (0.5 ± 0.7 and 1.7 ± 0.8, P < 0.001), shorter stent lengths (13.3 ± 20.9 mm and 37.4 ± 23.0 mm, P < 0.001), and lower usage of small stents with a diameter of 2.5 mm or less (15.6% and 28.7%, P = 0.010). The DCB-based PCI group exhibited lower rate of MACE (5.5% and 13.1%, P = 0.003), target vessel revascularization (1.1% and 5.6%, P = 0.017) and major bleeding (0.7% and 5.1%, P = 0.009) at 2-year follow-up. The reduced risk in 2-year MACE was consistently observed across various matching procedures, with the most significant reduction noted in target vessel revascularization and major bleeding. CONCLUSION The DCB-based PCI reduced stent burden, particularly in the usage of small diameter stents, and was associated with lower risks of MACE, target vessel revascularization, and major bleeding compared to DES-only PCI in elderly patients.

Background: Acute deterioration of patients in general wards often leads to major adverse events (MAEs), including unplanned intensive care unit transfers, cardiac arrest, or death. Traditional early warning scores (EWSs) have shown limited predictive accuracy, with frequent false positives. We conducted a prospective observational external validation study of an artificial intelligence (AI)-based EWS, the VitalCare - Major Adverse Event Score (VC-MAES), at a tertiary medical center in the Republic of Korea. Methods: Adult patients from general wards, including internal medicine (IM) and obstetrics and gynecology (OBGYN)—the latter were rarely investigated in prior AI-based EWS studies—were included. The VC-MAES predictions were compared with National Early Warning Score (NEWS) and Modified Early Warning Score (MEWS) predictions using the area under the receiver operating characteristic curve (AUROC), area under the precision-recall curve (AUPRC), and logistic regression for baseline EWS values. False-positives per true positive (FPpTP) were assessed based on the power threshold. Results: Of 6,039 encounters, 217 (3.6%) had MAEs (IM: 9.5%, OBGYN: 0.26%). Six hours prior to MAEs, the VC-MAES achieved an AUROC of 0.918 and an AUPRC of 0.352, including the OBGYN subgroup (AUROC, 0.964; AUPRC, 0.388), outperforming the NEWS (0.797 and 0.124) and MEWS (0.722 and 0.079). The FPpTP was reduced by up to 71%. Baseline VC-MAES was strongly associated with MAEs (P<0.001). Conclusions The VC-MAES significantly outperformed traditional EWSs in predicting adverse events in general ward patients. The robust performance and lower FPpTP suggest that broader adoption of the VC-MAES may improve clinical efficiency and resource allocation in general wards.

Background: Our study aimed to evaluate the clinical and radiologic results of all-arthroscopic treatment of terrible triad injuries followed-up for a minimum of 5 years and investigate how arthroscopic partial excision for radial head fractures affects the results at the final follow-up. Methods: We retrospectively reviewed consecutive patients with terrible triad injuries who underwent all-arthroscopic treatment between January 2011 and June 2018. In group I, we performed conservative or arthroscopic fixation of stable radial head fractures, while in group II, arthroscopic partial excision of unstable radial head fractures involving <30%–50% of the articular surface area was performed. Clinical outcomes were measured by visual analog scale score and assessment of instability, range of motion (ROM), and Mayo Elbow Performance Score. Radiological outcomes were evaluated using x-rays, and the integrity of the repaired lateral collateral ligament complex was confirmed through magnetic resonance imaging. Results: Thirty-two patients with an average age of 49.5±16.2 years met the inclusion criteria and were followed-up for a mean of 82.7±22.2 months. Twenty patients were assigned to group I and 12 patients to group II. Clinical outcomes showed no significant differences between the two groups at the final follow-up (P>0.05). On radiological evaluation, more heterotopic ossifications were found in the radial head excision group (group II, 66.7% vs. group I, 35%; P=0.02); however, there was no significant difference in ROM between the two groups (P>0.05). Conclusions In all-arthroscopic treatment of terrible triad injuries, arthroscopic partial excision of the radial head did not seem to have a significant impact on elbow joint stability.Level of evidence: III.

Background: Our study aimed to evaluate the clinical and radiologic results of all-arthroscopic treatment of terrible triad injuries followed-up for a minimum of 5 years and investigate how arthroscopic partial excision for radial head fractures affects the results at the final follow-up. Methods: We retrospectively reviewed consecutive patients with terrible triad injuries who underwent all-arthroscopic treatment between January 2011 and June 2018. In group I, we performed conservative or arthroscopic fixation of stable radial head fractures, while in group II, arthroscopic partial excision of unstable radial head fractures involving <30%–50% of the articular surface area was performed. Clinical outcomes were measured by visual analog scale score and assessment of instability, range of motion (ROM), and Mayo Elbow Performance Score. Radiological outcomes were evaluated using x-rays, and the integrity of the repaired lateral collateral ligament complex was confirmed through magnetic resonance imaging. Results: Thirty-two patients with an average age of 49.5±16.2 years met the inclusion criteria and were followed-up for a mean of 82.7±22.2 months. Twenty patients were assigned to group I and 12 patients to group II. Clinical outcomes showed no significant differences between the two groups at the final follow-up (P>0.05). On radiological evaluation, more heterotopic ossifications were found in the radial head excision group (group II, 66.7% vs. group I, 35%; P=0.02); however, there was no significant difference in ROM between the two groups (P>0.05). Conclusions In all-arthroscopic treatment of terrible triad injuries, arthroscopic partial excision of the radial head did not seem to have a significant impact on elbow joint stability.Level of evidence: III.

Background: Our study aimed to evaluate the clinical and radiologic results of all-arthroscopic treatment of terrible triad injuries followed-up for a minimum of 5 years and investigate how arthroscopic partial excision for radial head fractures affects the results at the final follow-up. Methods: We retrospectively reviewed consecutive patients with terrible triad injuries who underwent all-arthroscopic treatment between January 2011 and June 2018. In group I, we performed conservative or arthroscopic fixation of stable radial head fractures, while in group II, arthroscopic partial excision of unstable radial head fractures involving <30%–50% of the articular surface area was performed. Clinical outcomes were measured by visual analog scale score and assessment of instability, range of motion (ROM), and Mayo Elbow Performance Score. Radiological outcomes were evaluated using x-rays, and the integrity of the repaired lateral collateral ligament complex was confirmed through magnetic resonance imaging. Results: Thirty-two patients with an average age of 49.5±16.2 years met the inclusion criteria and were followed-up for a mean of 82.7±22.2 months. Twenty patients were assigned to group I and 12 patients to group II. Clinical outcomes showed no significant differences between the two groups at the final follow-up (P>0.05). On radiological evaluation, more heterotopic ossifications were found in the radial head excision group (group II, 66.7% vs. group I, 35%; P=0.02); however, there was no significant difference in ROM between the two groups (P>0.05). Conclusions In all-arthroscopic treatment of terrible triad injuries, arthroscopic partial excision of the radial head did not seem to have a significant impact on elbow joint stability.Level of evidence: III.

Background: Our study aimed to evaluate the clinical and radiologic results of all-arthroscopic treatment of terrible triad injuries followed-up for a minimum of 5 years and investigate how arthroscopic partial excision for radial head fractures affects the results at the final follow-up. Methods: We retrospectively reviewed consecutive patients with terrible triad injuries who underwent all-arthroscopic treatment between January 2011 and June 2018. In group I, we performed conservative or arthroscopic fixation of stable radial head fractures, while in group II, arthroscopic partial excision of unstable radial head fractures involving <30%–50% of the articular surface area was performed. Clinical outcomes were measured by visual analog scale score and assessment of instability, range of motion (ROM), and Mayo Elbow Performance Score. Radiological outcomes were evaluated using x-rays, and the integrity of the repaired lateral collateral ligament complex was confirmed through magnetic resonance imaging. Results: Thirty-two patients with an average age of 49.5±16.2 years met the inclusion criteria and were followed-up for a mean of 82.7±22.2 months. Twenty patients were assigned to group I and 12 patients to group II. Clinical outcomes showed no significant differences between the two groups at the final follow-up (P>0.05). On radiological evaluation, more heterotopic ossifications were found in the radial head excision group (group II, 66.7% vs. group I, 35%; P=0.02); however, there was no significant difference in ROM between the two groups (P>0.05). Conclusions In all-arthroscopic treatment of terrible triad injuries, arthroscopic partial excision of the radial head did not seem to have a significant impact on elbow joint stability.Level of evidence: III.

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.