1.Second-Line Fluoropyrimidine-Based Chemotherapy in Advanced Biliary Tract Cancer: A Meta-analysis Based on Individual Patient-Level Data of Randomized Trials
Jaewon HYUNG ; Minsu KANG ; Ilhwan KIM ; Kyu-pyo KIM ; Baek-Yeol RYOO ; Jaekyung CHEON ; Hyewon RYU ; Ji Sung LEE ; Ji-Won KIM ; In Sil CHOI ; Jin Hyun PARK ; Ghassan K. ABOU-ALFA ; Jin Won KIM ; Changhoon YOO
Cancer Research and Treatment 2025;57(2):519-527
Purpose:
While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head.
Materials and Methods:
We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens.
Results:
A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy.
Conclusion
Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.
2.Second-Line Fluoropyrimidine-Based Chemotherapy in Advanced Biliary Tract Cancer: A Meta-analysis Based on Individual Patient-Level Data of Randomized Trials
Jaewon HYUNG ; Minsu KANG ; Ilhwan KIM ; Kyu-pyo KIM ; Baek-Yeol RYOO ; Jaekyung CHEON ; Hyewon RYU ; Ji Sung LEE ; Ji-Won KIM ; In Sil CHOI ; Jin Hyun PARK ; Ghassan K. ABOU-ALFA ; Jin Won KIM ; Changhoon YOO
Cancer Research and Treatment 2025;57(2):519-527
Purpose:
While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head.
Materials and Methods:
We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens.
Results:
A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy.
Conclusion
Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.
3.Second-Line Fluoropyrimidine-Based Chemotherapy in Advanced Biliary Tract Cancer: A Meta-analysis Based on Individual Patient-Level Data of Randomized Trials
Jaewon HYUNG ; Minsu KANG ; Ilhwan KIM ; Kyu-pyo KIM ; Baek-Yeol RYOO ; Jaekyung CHEON ; Hyewon RYU ; Ji Sung LEE ; Ji-Won KIM ; In Sil CHOI ; Jin Hyun PARK ; Ghassan K. ABOU-ALFA ; Jin Won KIM ; Changhoon YOO
Cancer Research and Treatment 2025;57(2):519-527
Purpose:
While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head.
Materials and Methods:
We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens.
Results:
A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy.
Conclusion
Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.
4.Mucosa-Associated Lymphoid Tissue Lymphoma of the Labial Minor Salivary Glands: Case Report
Jung Eun LEE ; Dawool HAN ; Hyun Sil KIM ; Chena LEE ; YounJung PARK ; Jeong-Seung KWON
Journal of Oral Medicine and Pain 2024;49(1):22-27
A 74-year-old female presented with a complaint of dry mouth, continuous spontaneous burning sensation in the tongue, and asymptomatic submucosal soft tissue mass on both sides of the lower labial mucosa. She refused to undergo total excision of the mass due to concern about the possibility of complications such as nerve damage because of the large size of the mass. As her clinical features and magnetic resonance imaging indicated the possibility of Sjögren’s syndrome, a biopsy of the minor salivary gland of the right lower lip was performed. Consequently, she was diagnosed with mucosa-associated lymphoid tissue (MALT) lymphoma. Although the patient had typical signs and symptoms of Sjögren’s syndrome, the histopathological result of MALT lymphoma made it impossible to determine whether the patient had a history of Sjögren’s syndrome. For patients with risk factors for MALT lymphoma, such as Sjögren’s syndrome, a biopsy of the labial minor salivary gland with immunohistochemical staining can be helpful in the diagnosis of not only Sjögren’s syndrome but also MALT lymphoma.
5.Current Status of Public Long-term Care Insurance Services and Future Perspective: A Questionnaire Survey and National Health Insurance Service Data of South Korea
Eun Hyang SONG ; Yeon Sil MOON ; Jung Hyun PARK ; Byung Euk JOO ; Ho Seong HAN ; Chan-Nyoung LEE ; Hyun Jeong HAN ; Jae Moon KIM
Journal of the Korean Neurological Association 2024;42(1):1-12
The continuing growth of population aged 65 years and above, the socioeconomic burden of long-term care insurance has consistently increased. This study aimed to review the current system and efficiently develop long-term care insurance services according to changes in socioeconomic situations. First, a 21 items questionnaire survey was conducted from August 16 to August 31, 2022, for all members of the Korean Neurological Association. The survey was divided into seven areas, and individualized results were analyzed. Second, cumulative data on long-term care insurance services were collected and analyzed from July 1, 2008 to December 31, 2021, for the National Health Insurance system, and the results were summarized. In the survey, approximately 21% of the neurologists answered a web-based questionnaire survey on current doctors’ referral slips for long-term insurance services. Most (94%) had doctor referral slips for long-term insurance services. However, the authors estimated that doctors’ referral slips did not sufficiently affect the grading of longterm insurance services. The long-term care insurance services data according to several categories were classified and then, we statistically analyzed the socioeconomic burden of long-term insurance. Those cumulative data showed a gradual increase in the recipient number, diversity of geriatric diseases, and socioeconomic burden. We suggested that it is necessary for the government and academic society to continue to cooperate to develop the long-term care insurance systems for elderly.
6.Unenhanced Breast MRI With Diffusion-Weighted Imaging for Breast Cancer Detection: Effects of Training on Performance and Agreement of Subspecialty Radiologists
Yeon Soo KIM ; Su Hyun LEE ; Soo-Yeon KIM ; Eun Sil KIM ; Ah Reum PARK ; Jung Min CHANG ; Vivian Youngjean PARK ; Jung Hyun YOON ; Bong Joo KANG ; Bo La YUN ; Tae Hee KIM ; Eun Sook KO ; A Jung CHU ; Jin You KIM ; Inyoung YOUN ; Eun Young CHAE ; Woo Jung CHOI ; Hee Jeong KIM ; Soo Hee KANG ; Su Min HA ; Woo Kyung MOON
Korean Journal of Radiology 2024;25(1):11-23
Objective:
To investigate whether reader training improves the performance and agreement of radiologists in interpreting unenhanced breast magnetic resonance imaging (MRI) scans using diffusion-weighted imaging (DWI).
Materials and Methods:
A study of 96 breasts (35 cancers, 24 benign, and 37 negative) in 48 asymptomatic women was performed between June 2019 and October 2020. High-resolution DWI with b-values of 0, 800, and 1200 sec/mm 2 was performed using a 3.0-T system. Sixteen breast radiologists independently reviewed the DWI, apparent diffusion coefficient maps, and T1-weighted MRI scans and recorded the Breast Imaging Reporting and Data System (BI-RADS) category for each breast. After a 2-h training session and a 5-month washout period, they re-evaluated the BI-RADS categories. A BI-RADS category of 4 (lesions with at least two suspicious criteria) or 5 (more than two suspicious criteria) was considered positive.The per-breast diagnostic performance of each reader was compared between the first and second reviews. Inter-reader agreement was evaluated using a multi-rater κ analysis and intraclass correlation coefficient (ICC).
Results:
Before training, the mean sensitivity, specificity, and accuracy of the 16 readers were 70.7% (95% confidence interval [CI]: 59.4–79.9), 90.8% (95% CI: 85.6–94.2), and 83.5% (95% CI: 78.6–87.4), respectively. After training, significant improvements in specificity (95.2%; 95% CI: 90.8–97.5; P = 0.001) and accuracy (85.9%; 95% CI: 80.9–89.8; P = 0.01) were observed, but no difference in sensitivity (69.8%; 95% CI: 58.1–79.4; P = 0.58) was observed. Regarding inter-reader agreement, the κ values were 0.57 (95% CI: 0.52–0.63) before training and 0.68 (95% CI: 0.62–0.74) after training, with a difference of 0.11 (95% CI: 0.02–0.18; P = 0.01). The ICC was 0.73 (95% CI: 0.69–0.74) before training and 0.79 (95% CI: 0.76–0.80) after training (P = 0.002).
Conclusion
Brief reader training improved the performance and agreement of interpretations by breast radiologists using unenhanced MRI with DWI.
7.Development and Validation of the Korean Version of the Multidimensional Non-Suicidal Self-Injury Scar Scale
Jinwoo MYUNG ; Young-Sil KWON ; Myoung-Ho HYUN ; Seo Jeong LEE
Psychiatry Investigation 2024;21(1):83-91
Objective:
Non-Suicidal Self-Injury (NSSI) scars are common in individuals with NSSI experiences. However, little is known about NSSI scars because related tools are limited. This study aimed to develop and validate the Korean version of the multidimensional Non-Suicidal Self-Injury Scar Scale (K-NSSI-ScarS), consisting of three components: NSSI scar measurement, NSSI scar cognition, and NSSI scar concealment.
Methods:
A total of 333 Korean adults with at least one NSSI scar and history of NSSI within the last 5 years (age: 18 to 39 years) completed the online survey. We conducted exploratory (n=133) and confirmatory (n=200) factor analyses of NSSI scar cognition. To measure the internal consistency of each subfactor of the scar cognition and scar concealment components, we used Cronbach’s α. Kappa and intraclass correlation coefficients were used to measure the test-retest reliability of the entire scale. We also assessed the convergent and construct validity of the K-NSSI-ScarS.
Results:
Factor analyses showed a 5-factor structure consisting of 23 items. Internal consistencies and test-retest reliability were excellent. The moderate correlation between the five subfactors of NSSI scar cognition and related concepts (e.g., acquired capability of suicide) confirmed the convergent validity. Lastly, moderate correlations were found between NSSI scar concealment, self-concealment, NSSI scar measurement information, and the five subfactors of NSSI scar cognition.
Conclusion
The results verify the psychometric properties and support the necessity of a multidimensional NSSI scar scale.
8.The Effect of Social Situations on Risky Decision-Making in Individuals With Borderline Personality Tendency
Min-Jo LEE ; Young-Sil KWON ; Myoung-Ho HYUN
Psychiatry Investigation 2023;20(4):350-356
Objective:
This study examined the effect of social situations on risky decision-making in individuals with a borderline personality tendency (BT).
Methods:
Fifty-eight participants with either high or low levels of BT were included in this study. Those who met the screening criteria were assigned to one of the two social situations (exclusion vs. inclusion) and they played the Cyberball game. Next, the participants were required to play the “Game of Dice” task to measure their decision-making pattern.
Results:
The results revealed that individuals with high BT (n=28) showed significantly higher risky decision-making, compared with low BT (n=30) in the exclusion condition. However, no significant difference was found in the social inclusion condition.
Conclusion
In the social exclusion condition, individuals with high BT made risky decision in response to negative feedback, regardless of the previous decision. These findings can be applied to develop appropriate interventions in psychotherapy for individuals with borderline personality disorder/tendency.
9.A Phase 3 Randomized Clinical Trial to Compare Efficacy and Safety between Combination Therapy and Monotherapy in Elderly Patients with Advanced Gastric Cancer (KCSG ST13-10)
Keun-Wook LEE ; Dae Young ZANG ; Min-Hee RYU ; Hye Sook HAN ; Ki Hyang KIM ; Mi-Jung KIM ; Sung Ae KOH ; Sung Sook LEE ; Dong-Hoe KOO ; Yoon Ho KO ; Byeong Seok SOHN ; Jin Won KIM ; Jin Hyun PARK ; Byung-Ho NAM ; In Sil CHOI
Cancer Research and Treatment 2023;55(4):1250-1260
Purpose:
This study evaluated whether combination therapy is more effective than monotherapy in elderly patients with metastatic or recurrent gastric cancer (MRGC) as first-line chemotherapy.
Materials and Methods:
Elderly (≥ 70 years) chemo-naïve patients with MRGC were allocated to receive either combination therapy (group A: 5-fluorouracil [5-FU]/oxaliplatin, capecitabine/oxaliplatin, capecitabine/cisplatin, or S-1/cisplatin) or monotherapy (group B: 5-FU, capecitabine, or S-1). In group A, starting doses were 80% of standard doses, and they could be escalated to 100% at the discretion of the investigator. Primary endpoint was to confirm superior overall survival (OS) of combination therapy vs. monotherapy.
Results:
After 111 of the planned 238 patients were randomized, enrollment was terminated due to poor accrual. In the full-analysis population (group A [n=53] and group B [n=51]), median OS of combination therapy vs. monotherapy was 11.5 vs. 7.5 months (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.56 to 1.30; p=0.231). Median progression-free survival (PFS) was 5.6 vs. 3.7 months (HR, 0.53; 95% CI, 0.34 to 0.83; p=0.005). In subgroup analyses, patients aged 70-74 years tended to have superior OS with combination therapy (15.9 vs. 7.2 months, p=0.056). Treatment-related adverse events (TRAEs) occurred more frequently in group A vs. group B. However, among severe TRAEs (≥ grade 3), there were no TRAEs with a frequency difference of > 5%.
Conclusion
Combination therapy was associated with numerically improved OS, although statistically insignificant, and a significant PFS benefit compared with monotherapy. Although combination therapy showed more frequent TRAEs, there was no difference in the frequency of severe TRAEs.
10.Prognostic Implication of Focal Breast Edema on Preoperative Breast Magnetic Resonance Imaging in Breast Cancer Patients
Pamela SUNG ; Jong Yoon LEE ; Jong-Ho CHEUN ; In Sil CHOI ; Jin Hyun PARK ; Jeong Hwan PARK ; Byoung Hyuck KIM ; Sohee OH ; A Jung CHU ; Ki-Tae HWANG
Journal of Breast Cancer 2023;26(5):479-491
Purpose:
In this study, we investigated the prognostic implications of focal breast edema on preoperative breast magnetic resonance imaging (MRI) in patients with breast cancer.
Methods:
Data of 899 patients with breast cancer at a single institution were retrospectively analyzed. The patients were divided into an edema-positive group (EPG) and an edemanegative group (ENG) based on the presence of peritumoral, prepectoral, or subcutaneous edema. Two radiologists evaluated the presence or absence of focal edema and its subtypes on preoperative breast MRI. Clinicopathologic characteristics and survival outcomes were compared between the two groups and among the three subtypes using Pearson’s χ2 test, Kaplan–Meier estimator, and Cox proportional hazards model.
Results:
There were 399 (44.4%) and 500 (55.6%) patients in the EPG and ENG, respectively.The EPG showed significantly higher rates of axillary lymph node metastasis (55.6% vs.19.2%, p < 0.001) and lymphovascular invasion (LVI) (57.9% vs. 12.6%, p < 0.001) than the ENG. Patients in the EPG showed significantly worse overall survival (OS) rate (log-rank p < 0.001; hazard ratio [HR], 4.83; 95% confidence interval [CI], 2.56–9.11) and recurrencefree survival rate (log-rank p < 0.001; HR, 3.00; 95% CI, 1.94–4.63) than those in the ENG.After adjusting for other variables, focal breast edema remained a significant factor affecting the OS rate, regardless of the edema type. Specifically, the presence of subcutaneous edema emerged as the strongest predictor for OS with the highest HR (p < 0.001; HR, 9.10; 95% CI, 3.05–27.15).
Conclusion
Focal breast edema on preoperative breast MRI implies a higher possibility of LVI and axillary lymph node metastasis, which can lead to a poor prognosis. A detailed description of focal breast edema, especially subcutaneous edema, on preoperative breast MRI may provide prognostic predictions. More intensive surveillance is required for patients with breast cancer and focal preoperative breast edema.

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