Purpose: This study aimed to assess the prognostic significance of bulky nodal involvement in patients with anal squamous cell carcinoma treated with definitive chemoradiotherapy. Materials and Methods: We retrospectively analyzed medical records of patients diagnosed with anal squamous cell carcinoma who underwent definitive chemoradiotherapy at three medical centers between 2004 and 2021. Exclusion criteria included distant metastasis at diagnosis, 2D radiotherapy, and salvage treatment for local relapse. Bulky N+ was defined as nodes with a long diameter of 2 cm or greater. Results: A total of 104 patients were included, comprising 51 with N0, 46 with non-bulky N+, and seven with bulky N+. The median follow-up duration was 54.0 months (range, 6.4 to 162.2 months). Estimated 5-year progression-free survival (PFS), loco-regional recurrence-free survival (LRRFS), and overall survival (OS) rates for patients with bulky N+ were 42.9%, 42.9%, and 47.6%, respectively. Bulky N+ was significantly associated with inferior PFS, LRRFS, and OS compared to patients without or with non-bulky N+, even after multivariate analysis. We proposed a new staging system incorporating bulky N+ as N2 category, with estimated 5-year LRRFS, PFS, and OS rates of 81.1%, 80.6%, and 86.2% for stage I, 67.7%, 60.9%, and 93.3% for stage II, and 42.9%, 42.9%, and 47.6% for stage III disease, enhancing the predictability of prognosis. Conclusion Patients with bulky nodal disease treated with standard chemoradiotherapy experienced poor survival outcomes, indicating the potential necessity for further treatment intensification.

Background and Objectives: Ultimaster™, a third-generation sirolimus-eluting stent using biodegradable polymer, has been introduced to overcome long term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate the 12-month clinical outcomes of Ultimaster™ stents in Korean patients with coronary artery disease. Methods: This study is a multicenter, prospective, observational registry across 12 hospitals. To reflect real-world clinical evidence, non-selective subtypes of patients and lesions were included in this study. The study end point was target lesion failure (TLF) (the composite of cardiac death, target vessel myocardial infarction [MI], and target lesion revascularization [TLR]) at 12-month clinical follow up. Results: A total of 576 patients were enrolled between November 2016 and May 2021. Most of the patients were male (76.5%), with a mean age of 66.0±11.2 years. Among the included patients, 40.1% had diabetes mellitus (DM) and 67.9% had acute coronary syndrome (ACS).At 12 months, the incidence of TLF was 4.1%. The incidence of cardiac death was 1.5%, MI was 1.0%, TLR was 2.7%, and stent thrombosis was 0.6%. In subgroup analysis based on the presence of ACS, DM, hypertension, dyslipidemia, or bifurcation, there were no major differences in the incidence of the primary endpoint. Conclusions The present registry shows that Ultimaster™ stent is safe and effective for routine real-world clinical practice in non-selective Korean patients, having a low rate of adverse events at least up to 12 months.

Purpose: The incidence and prognostic implications of atrial fibrillation (AF) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) are controversial, especially for Korean patients. Furthermore, the pattern of antithrombotic therapy for these patients is unknown. The present study sought to identify the impact of AF on Korean patients undergoing TAVI and demonstrate the status of antithrombotic therapy for these patients. Materials and Methods: A total of 660 patients who underwent TAVI for severe AS were recruited from the nationwide K-TAVI registry in Korea. The enrolled patients were stratified into sinus rhythm (SR) and AF groups. The primary endpoint was all-cause death at 1-year. Results: AF was recorded in 135 patients [pre-existing AF 108 (16.4%) and new-onset AF 27 (4.1%)]. The rate of all-cause death at 1 year was significantly higher in patients with AF than in those with SR [16.2% vs. 6.4%, adjusted hazard ratio (HR): 2.207, 95% confidence interval (CI): 1.182–4.120, p=0.013], regardless of the onset timing of AF. The rate of new pacemaker insertion at 1 year was also significantly higher in patients with AF than in those with SR (14.0% vs. 5.5%, adjusted HR: 3.137, 95%CI: 1.621–6.071, p=0.001).Among AF patients, substantial number of patients received the combination of multiple antithrombotic agents (77.8%), and the most common combination was that of aspirin and clopidogrel (38.1%). Conclusion AF was an independent predictor of 1-year mortality and new pacemaker insertion in Korean patients undergoing TAVI.

Background: Tenofovir disoproxil fumarate (TDF, Viread® ) had been used as a standard treatment option of chronic hepatitis B (CHB). This clinical trial was conducted to evaluate the efficacy and safety of DA-2802 (tenofovir disoproxil orotate) compared to TDF. Methods: The present study was a double blind randomized controlled trial. Patients with CHB were recruited from 25 hospitals in Korea and given DA-2802 at a dose of 319 mg once daily or Viread® at a dose of 300 mg once daily for 48 weeks from March 2017 to January 2019. Change in hepatitis B virus (HBV) DNA level at week 48 after dosing compared to baseline was the primary efficacy endpoint. Secondary efficacy endpoints were proportions of subjects with undetectable HBV DNA, those with normal alanine aminotransferase (ALT) levels, and those with loss of hepatitis B envelop antigen (HBeAg), those with loss of hepatitis B surface antigen (HBsAg). Adverse events (AEs) were also investigated. Results: A total of 122 patients (DA-2802 group: n = 61, Viread® group: n = 61) were used as full analysis set for efficacy analysis. Mean age, proportion of males, laboratory results and virologic characteristics were not different between the two groups. The change in HBV DNA level at week 48 from baseline was −5.13 ± 1.40 in the DA-2802 group and −4.97 ± 1.40 log 10 copies/mL in the Viread® group. The analysis of primary endpoint using the nonparametric analysis of covariance showed statistically significant results (P < 0.001), which confirmed non-inferiority of DA-2802 to Viread® by a prespecified noninferiority margin of 1. The proportion of undetectable HBV DNA was 78.7% in the DA-2802 group and 75.4% in the Viread® group (P = 0.698). The proportion of subjects who had normal ALT levels was 75.4% in the DA-2802 group and 73.3% in the Viread® group (P = 0.795). The proportion of those with HBeAg loss was 8.1% in the DA-2802 group and 10.8% in the Viread® group (P = 1.000). No subject showed HBsAg loss. The frequency of AEs during treatment was similar between the two groups. Most AEs were mild to moderate in severity. Conclusion DA-2802 is considered an effective and safe treatment for patients with CHB.

Background: Given the expanding clinical use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPis), there is a significant need for optimal strategies with which to treat patients whose cancer progresses while using a PARPi. However, the treatment consensus after PARPi has not been established. The aim of the Korean Gynecologic Oncology Group (KGOG) 3056/NIRVANA-R trial is to investigate the efficacy of niraparib in combination with bevacizumab as a maintenance therapy in platinum-sensitive ovarian cancer patients who were previously treated with a PARPi. Methods The KGOG 3056/NIRVANA-R is a multi-centre, investigator-initiated, single-arm, phase II trial of patients with platinum-sensitive recurrent ovarian cancer recruited from seven KGOG sites. This study included patients with platinum-sensitive recurrent epithelial ovarian cancer who received at least 2 previous courses of platinum-containing therapy and had been treated with a PARPi. Mucinous histology type was excluded. Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study. Forty-four patients will be recruited. All enrolled patients are treated with niraparib and bevacizumab for maintenance therapy until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint of the study is 6-month progression-free survival rate. Accrual is expected to be completed in 2022, followed by presentation of results in 2023.

Background: The optimal treatment of BRCA wild-type patients with platinum-sensitive recurrent ovarian cancer remains unknown. Recently, there is an increase in the evidence to support the role of the combination of a poly(adenosine diphosphate-ribose) polymerase inhibitor, anti-angiogenic agents, and immunotherapy as maintenance therapy in BRCA wild-type patients with platinum-sensitive recurrence. We hypothesized that adding pembrolizumab and bevacizumab to olaparib maintenance can increase progression-free survival (PFS) in BRCA wild-type patients with platinum-sensitive recurrent ovarian cancer. Methods BRCA wild-type patients who received two previous courses of platinum-containing therapy, achieved complete or partial response to last treatment, and the treatment-free interval is >6 months after the penultimate platinum-based chemotherapy offered olaparib maintenance with pembrolizumab and bevacizumab. Forty-four patients will be included from 4 sites across Singapore and Korea. The primary endpoint of the study is 6-month PFS rate.

BACKGROUND AND OBJECTIVES: Atrial fibrillation (AF) is associated with a higher long-term risk of major cardiovascular events. However, its clinical implications with respect to peri-operative cardiovascular outcomes in patients undergoing non-cardiac surgery is unclear. We tried to examine the association between pre-operative AF and peri-operative cardiovascular outcomes. METHODS: We retrospectively analyzed data from 26,501 consecutive patients who underwent comprehensive preoperative cardiac evaluations for risk stratification prior to receiving non-cardiac surgery at our center. Preoperative AF was diagnosed in 1,098 patients (4.1%), and their cardiovascular outcomes were compared with those of patients without AF. The primary outcome was the rate of major adverse cardiac and cerebrovascular events (MACCE) during immediate post-surgery period (<30 days). RESULTS: Patients with AF were older and had higher proportion of male sex, higher rate of extra-cardiac comorbidities, higher CHA₂DS₂-VASc score, and higher revised cardiac risk index (RCRI) compared with those without AF. The rate of MACCE was significantly higher in AF patients compared to non-AF patients (4.6% vs. 1.2%, p<0.001). Preoperative AF was associated with higher risk of MACCE, even after multivariable adjustment (odds ratio, 2.97; 95% confidence interval, 2.13–4.07, p<0.001). The relative contribution of AF to MACCE was larger in patients with lower RCRI (p for interaction=0.010). The discriminating performance of RCRI was significantly enhanced by addition of AF. CONCLUSIONS In patients undergoing non-cardiac surgery, preoperative AF was associated with a higher risk of peri-operative cardiovascular outcomes.

Background and Objectives: Pacemaker (PM) implantation is a well-accepted treatment option for patients with paroxysmal atrial fibrillation (AF) and related tachycardiabradycardia syndrome (TBS). Data on the long-term clinical outcomes after radiofrequency catheter ablation (RFCA) or PM implantation are sparse. Methods: The medical records of 217 patients with TBS were retrospectively assessed.Outcomes in patients who underwent RFCA (n=108, 49.8%) were compared to those with PM implantation (n=109, 50.2%). The clinical outcomes were sinus rhythm maintenance, conversion to persistent AF, additional procedure or crossover, and the composite of cardiovascular hospitalization and death. Results: During the follow-up period (mean 3.5±2.0 years), the RFCA group, compared to the PM group, showed better sinus rhythm maintenance (adjusted hazard ratio [aHR], 0.27;95% confidence interval [CI], 0.15–0.46; p=0.002) and less progression to persistent AF (aHR, 0.20; 95% CI, 0.06–0.63; p=0.006). Additional procedure or crossover did not differ significantly between the groups (aHR, 2.07; 95% CI, 0.71–6.06; p=0.185 and aHR, 0.69; 95% CI, 10.8–2.67; p=0.590, respectively). Most RFCA patients (92.6%) did not require pacemaker implantation during long term follow-up period (>3.5 years). The composite endpoint of cardiovascular rehospitalization and death was not significantly different between the groups (aHR, 0.92; 95% CI, 0.50–1.66; p=0.769).Background and Objectives: Pacemaker (PM) implantation is a well-accepted treatment option for patients with paroxysmal atrial fibrillation (AF) and related tachycardiabradycardia syndrome (TBS). Data on the long-term clinical outcomes after radiofrequency catheter ablation (RFCA) or PM implantation are sparse. Methods: The medical records of 217 patients with TBS were retrospectively assessed.Outcomes in patients who underwent RFCA (n=108, 49.8%) were compared to those with PM implantation (n=109, 50.2%). The clinical outcomes were sinus rhythm maintenance, conversion to persistent AF, additional procedure or crossover, and the composite of cardiovascular hospitalization and death. Results: During the follow-up period (mean 3.5±2.0 years), the RFCA group, compared to the PM group, showed better sinus rhythm maintenance (adjusted hazard ratio [aHR], 0.27;95% confidence interval [CI], 0.15–0.46; p=0.002) and less progression to persistent AF (aHR, 0.20; 95% CI, 0.06–0.63; p=0.006). Additional procedure or crossover did not differ significantly between the groups (aHR, 2.07; 95% CI, 0.71–6.06; p=0.185 and aHR, 0.69; 95% CI, 10.8–2.67; p=0.590, respectively). Most RFCA patients (92.6%) did not require pacemaker implantation during long term follow-up period (>3.5 years). The composite endpoint of cardiovascular rehospitalization and death was not significantly different between the groups (aHR, 0.92; 95% CI, 0.50–1.66; p=0.769). Conclusions RFCA is an effective alternative to PM implantation in patients with TBS.In these patients, successful RF ablation of AF is related to a higher rate of sinus rhythm maintenance compared to PM implantation, and the composite outcome of cardiovascular rehospitalization and death is similar.

Purpose: Salvage second-line chemotherapy is usually recommended for patients with advanced epithelial ovarian cancer (AEOC) who develop progressive disease (PD) after neoadjuvant chemotherapy (NAC). Herein, we investigated the role of cytoreductive surgery (CRS) for such patients. Materials and Methods: We retrospectively reviewed the medical records of 36 patients with AEOC who developed PD after receiving NAC at two tertiary academic centers with different treatment strategies between 2001 and 2016. Patients who developed PD after NAC were consistently treated with CRS at one hospital (group A; n=13) and second-line chemotherapy at another (group B;n=23). The clinical characteristics and treatment outcomes were compared between the groups. Results: Overall survival (OS) was longer in group A than in group B (19.4 months vs. 7.9 months; p=0.011). High-grade serous histology was associated with longer OS than non-high-grade serous types. In group A, optimal surgery resection (<1 cm) was achieved after CRS in 6 patients (46%). Multivariate analysis showed that the treatment option was the only independent predictive factor for OS (hazard ratio, 2.30; 95% confidence interval, 1.02–5.17; p=0.044). Conclusion CRS may result in a survival benefit even in patients with AEOC who develop PD after NAC.

Objective: This study examined the characteristics of the patients taking poison intentionally at the pre-hospital stage to prevent it at the community level. Methods: We retrospectively reviewed the data that had been reported to fire stations from January 2017 to December 2018. This data included sex, age, occupation, the season of the year, time, place, methods, alcohol ingestion, transferred to the hospital or not, and we examined how taking poison had an effect on the suicide success rate. Results: The subjects were a total of 1,356 patients who had been reported to fire stations due to intentionally taking poison. Forty-five point five percent of them were male, and 54.5% were female. The most common method of intentional taking poison was sedatives (58.3%), followed by pesticides (24.6%), antidepressants (19.0%), and other methods (12.6%). The home place was preferred more than any other places. The suicide success rate was 2.1% in males and 1.4% in females. For the age groups, those patients 40-64 years old tried taking poison much more than the other age groups. In the aspect of the season of the year, summer was the highest season for taking poison, at 30.3%. The daytime was more preferred than the night time. Conclusion In this study, we analyzed the characteristics of the pre-hospital intentional poisoning cases according to gender, age, occupation, season of the year, time, and between the transferred and the untransferred groups. Efforts should be made in cooperation with the community to prevent suicide attempts by intentionally taking poison.