1.A Phase II Study to Evaluate the Efficacy of Bortezomib in Combination with Thalidomide in Treatment-Naïve Waldenstrom Macroglobulinemia Patients
Ja Min BYUN ; Junghoon SHIN ; Sang-A KIM ; Hyunkyung PARK ; Jiyun LEE ; Dong-Yeop SHIN ; Junshik HONG ; Jeong-Ok LEE ; Soo-Mee BANG ; Inho KIM ; Sung-Soon YOON ; Youngil KOH
Cancer Research and Treatment 2024;56(2):675-680
Purpose:
Despite the recent success of Bruton’s tyrosine kinase (BTK) inhibitors for the treatment of Waldenstrom macroglobulinemia (WM), their indefinite treatment duration ultimately tantamount to substantial financial and emotional burden. On the other hand, fixed duration of proteasome inhibitors (PI) have shown rapid and reasonable response in WM treatment. Despite the well-known synergism between PI and immunomodulatory drugs (IMiD), there is no trials evaluating such combination in WM.
Materials and Methods:
Based on above, we designed this phase II study to investigate the efficacy and safety of 6 cycles of 28-day bortezomib-thalidomide-dexamethasone (VTD) regimen for treatment-naïve WM.
Results:
A total of 15 patients were enrolled: major response rate was 64.3%, and overall response rate was 78.6%. During the median follow-up of 41 months, median progression-free survival (PFS) was 13 months and overall survival 40 months. For responders, median duration of response was 13 months and median PFS 19 months. The most common adverse event (AE) of any grade was constipation (57.1%). The most common grade ≥ 3 AE was anemia (21.4%).
Conclusion
All in all, we hereby provide proof-of-concept that PI + IMiD may be an attractive backbone for fixed duration treatment. It should be noted that granting the same level of access to newer drugs globally is virtually impossible. Thus efforts to develop regimens using readily available drugs to yield similar or adequate treatment outcomes should not be disregarded. In this sense, we believe our study holds its place for its novelty and eloquently addresses achieving the daunting societal quest of health equity.
2.Early Neurodevelopmental Assessments of Neonates Discharged From the Neonatal Intensive Care Unit: A Physiatrist’s Perspective
Sung Eun HYUN ; Jeong-Yi KWON ; Bo Young HONG ; Jin A YOON ; Ja Young CHOI ; Jiyeon HONG ; Seong-Eun KOH ; Eun Jae KO ; Seung Ki KIM ; Min-Keun SONG ; Sook-Hee YI ; AhRa CHO ; Bum Sun KWON
Annals of Rehabilitation Medicine 2023;47(3):147-161
The survival rate of children admitted in the neonatal intensive care unit (NICU) after birth is on the increase; hence, proper evaluation and care of their neurodevelopment has become an important issue. Neurodevelopmental assessments of individual domains regarding motor, language, cognition, and sensory perception are crucial in planning prompt interventions for neonates requiring immediate support and rehabilitation treatment. These assessments are essential for identifying areas of weakness and designing targeted interventions to improve future functional outcomes and the quality of lives for both the infants and their families. However, initial stratification of risk to select those who are in danger of neurodevelopmental disorders is also important in terms of cost-effectiveness. Efficient and robust functional evaluations to recognize early signs of developmental disorders will help NICU graduates receive interventions and enhance functional capabilities if needed. Several age-dependent, domain-specific neurodevelopmental assessment tools are available; therefore, this review summarizes the characteristics of these tools and aims to develop multidimensional, standardized, and regular follow-up plans for NICU graduates in Korea.
3.TNM-Based Head-to-Head Comparison of Urachal Carcinoma and Urothelial Bladder Cancer: Stage-Matched Analysis of a Large Multicenter National Cohort
Sang Hun SONG ; Jaewon LEE ; Young Hwii KO ; Jong Wook KIM ; Seung Il JUNG ; Seok Ho KANG ; Jinsung PARK ; Ho Kyung SEO ; Hyung Joon KIM ; Byong Chang JEONG ; Tae-Hwan KIM ; Se Young CHOI ; Jong Kil NAM ; Ja Yoon KU ; Kwan Joong JOO ; Won Sik JANG ; Young Eun YOON ; Seok Joong YUN ; Sung-Hoo HONG ; Jong Jin OH
Cancer Research and Treatment 2023;55(4):1337-1345
Purpose:
Outcome analysis of urachal cancer (UraC) is limited due to the scarcity of cases and different staging methods compared to urothelial bladder cancer (UroBC). We attempted to assess survival outcomes of UraC and compare to UroBC after stage-matched analyses.
Materials and Methods:
Total 203 UraC patients from a multicenter database and 373 UroBC patients in single institution from 2000 to 2018 were enrolled (median follow-up, 32 months). Sheldon stage conversion to corresponding TNM staging for UraC was conducted for head-to-head comparison to UroBC. Perioperative clinical variables and pathological results were recorded. Stage-matched analyses for survival by stage were conducted.
Results:
UraC patients were younger (mean age, 54 vs. 67 years; p < 0.001), with 163 patients (80.3%) receiving partial cystectomy and 23 patients (11.3%) radical cystectomy. UraC was more likely to harbor ≥ pT3a tumors (78.8% vs. 41.8%). While 5-year recurrence-free survival, cancer-specific survival (CSS) and overall survival were comparable between two groups (63.4%, 67%, and 62.1% in UraC and 61.5%, 75.9%, and 67.8% in UroBC, respectively), generally favorable prognosis for UraC in lower stages (pT1-2) but unfavorable outcomes in higher stages (pT4) compared to UroBC was observed, although only 5-year CSS in ≥ pT4 showed statistical significance (p=0.028). Body mass index (hazard ratio [HR], 0.929), diabetes mellitus (HR, 1.921), pathologic T category (HR, 3.846), and lymphovascular invasion (HR, 1.993) were predictors of CSS for all patients.
Conclusion
Despite differing histology, UraC has comparable prognosis to UroBC with relatively favorable outcome in low stages but worse prognosis in higher stages. The presented system may be useful for future grading and risk stratification of UraC.
4.Medication Adherence in Korean Patients with Inflammatory Bowel Disease and Its Associated Factors
Kyunghwan OH ; Eun Ja KWON ; Jeong Hye KIM ; Kyuwon KIM ; Jae Yong LEE ; Hee Seung HONG ; Seung Wook HONG ; Jin Hwa PARK ; Sung Wook HWANG ; Dong-Hoon YANG ; Byong Duk YE ; Jeong-Sik BYEON ; Seung-Jae MYUNG ; Suk-Kyun YANG ; Jeong Yun PARK ; Sang Hyoung PARK
The Ewha Medical Journal 2022;45(2):35-45
Objectives:
It is important that inflammatory bowel disease (IBD) patients adhere to their prescribed medication regimens to avoid the repeat exacerbations, complications, or surgeries associated with this disorder. However, there are few studies on medication adherence in patients with IBD, especially in Asian populations. So, we analyzed the factors associated with medication adherence in Korean IBD patients.
Methods:
Patients who had been diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) more than 6 months previously and receiving oral medications for IBD were enrolled. Medication adherence was measured using the Medical Adherence Reporting Scale (MARS-5), a self-reported medication adherence measurement tool.
Results:
Among 207 patients in the final study population, 125 (60.4%) had CD and 134 (64.7%) were men. The mean age was 39.63 years (SD, 13.16 years) and the mean disease duration was 10.09 years (SD, 6.33 years). The mean medication adherence score was 22.46 (SD, 2.86) out of 25, and 181 (87.4%) patients had score of 20 or higher.In multiple linear regression analysis, self-efficacy (β=0.341, P<0.001) and ≥3 dosing per day (β=–0.192 P=0.016) were revealed to be significant factors associated with medication adherence. Additionally, there was a positive correlation between self-efficacy and medication adherence (r=0.312, P<0.001). However, disease related knowledge, depression, and anxiety were not significantly associated with medication adherence.
Conclusion
To improve medication adherence among patients with IBD, a reduction in the number of doses per day and an improved self-efficacy will be helpful.
5.Enteroscopy in Crohn’s Disease: Are There Any Changes in Role or Outcomes Over Time? A KASID Multicenter Study
Seong Ran JEON ; Jin-Oh KIM ; Jeong-Sik BYEON ; Dong-Hoon YANG ; Bong Min KO ; Hyeon Jeong GOONG ; Hyun Joo JANG ; Soo Jung PARK ; Eun Ran KIM ; Sung Noh HONG ; Jong Pil IM ; Seong-Eun KIM ; Ja Seol KOO ; Chang Soo EUN ; Dong Kyung CHANG ;
Gut and Liver 2021;15(3):375-382
Background/Aims:
Although balloon-assisted enteroscopy (BAE) enables endoscopic visualization of small bowel (SB) involvement in Crohn’s disease (CD), there is no data on the changes in outcomes over time. We therefore investigated the changes in BAE use on CD patients over different time periods in terms of its role and clinical outcomes.
Methods:
We used a multicenter enteroscopy database to identify CD patients with SB involvement who underwent BAE (131 procedures, 116 patients). We compared BAE-related factors and outcomes between the first period (70 procedures, 60 patients) and the second period (61procedures, 56 patients). The specific cutoff point for dividing the two periods was 2007, when BAE guidelines were introduced.
Results:
Initial diagnosis of SB involvement in CD was the most common indication for BAE during each period (50.0% vs 31.1%, p=0.034). The largest change was in the number of BAE uses for stricture evaluation and/or treatment, which increased significantly in the latter period (2.9% vs 21.3%, p=0.002). The diagnostic yield in patients with suspected CD was 90.7% in the first period and 95.0% in the second (p=0.695). More endoscopic interventions were performed in the second period than in the first (5.1% vs 17.6%, p=0.041). Enteroscopic success rates were high throughout (100% in the first period vs 80.0% in the second period, p>0.999). In the first and second periods, therapeutic plans were adjusted in 62.7% and 61.4% of patients, respectively.
Conclusions
The overall clinical indications, outcomes, and effectiveness of BAE were constant over time in CD patients with SB involvement, with the exception that the frequency of enteroscopic intervention increased remarkably.
6.A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol
Eun Kyung LEE ; Yea Eun KANG ; Young Joo PARK ; Bon Seok KOO ; Ki-Wook CHUNG ; Eu Jeong KU ; Ho-Ryun WON ; Won Sang YOO ; Eonju JEON ; Se Hyun PAEK ; Yong Sang LEE ; Dong Mee LIM ; Yong Joon SUH ; Ha Kyoung PARK ; Hyo-Jeong KIM ; Bo Hyun KIM ; Mijin KIM ; Sun Wook KIM ; Ka Hee YI ; Sue K. PARK ; Eun-Jae JUNG ; June Young CHOI ; Ja Seong BAE ; Joon Hwa HONG ; Kee-Hyun NAM ; Young Ki LEE ; Hyeong Won YU ; Sujeong GO ; Young Mi KANG ;
Endocrinology and Metabolism 2021;36(3):574-581
Background:
Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.
Methods:
This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.
Conclusion
The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
7.Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study
Gwang Ha KIM ; Hang Lak LEE ; Moon Kyung JOO ; Hong Jun PARK ; Sung Woo JUNG ; Ok-Jae LEE ; Hyungkil KIM ; Hoon Jai CHUN ; Soo Teik LEE ; Ji Won KIM ; Han Ho JEON ; Il-Kwun CHUNG ; Hyun-Soo KIM ; Dong Ho LEE ; Kyoung-Oh KIM ; Yun Jeong LIM ; Seun-Ja PARK ; Soo-Jeong CHO ; Byung-Wook KIM ; Kwang Hyun KO ; Seong Woo JEON ; Jae Gyu KIM ; In-Kyung SUNG ; Tae Nyeun KIM ; Jae Kyu SUNG ; Jong-Jae PARK
Gut and Liver 2021;15(6):841-850
Background/Aims:
The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis.
Methods:
This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated.
Results:
According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates.
Conclusions
The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.
8.Importation and Transmission of SARS-CoV-2 B.1.1.529 (Omicron) Variant of Concern in Korea, November 2021
Ji Joo LEE ; Young June CHOE ; Hyeongseop JEONG ; Moonsu KIM ; Seonggon KIM ; Hanna YOO ; Kunhee PARK ; Chanhee KIM ; Sojin CHOI ; JiWoo SIM ; Yoojin PARK ; In Sil HUH ; Gasil HONG ; Mi Young KIM ; Jin Su SONG ; Jihee LEE ; Eun-Jin KIM ; Jee Eun RHEE ; Il-Hwan KIM ; Jin GWACK ; Jungyeon KIM ; Jin-Hwan JEON ; Wook-Gyo LEE ; Suyeon JEONG ; Jusim KIM ; Byungsik BAE ; Ja Eun KIM ; Hyeonsoo KIM ; Hye Young LEE ; Sang-Eun LEE ; Jong Mu KIM ; Hanul PARK ; Mi YU ; Jihyun CHOI ; Jia KIM ; Hyeryeon LEE ; Eun-Jung JANG ; Dosang LIM ; Sangwon LEE ; Young-Joon PARK
Journal of Korean Medical Science 2021;36(50):e346-
In November 2021, 14 international travel-related severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.1.529 (omicron) variant of concern (VOC) patients were detected in South Korea. Epidemiologic investigation revealed community transmission of the omicron VOC. A total of 80 SARS-CoV-2 omicron VOC-positive patients were identified until December 10, 2021 and 66 of them reported no relation to the international travel.There may be more transmissions with this VOC in Korea than reported.
9.Short-term Comparison of Refractive Errors between Two Different Age Groups after LASEK for Moderate Myopia
Mi Jeong KIM ; Ji Seon AN ; Ja Yoon MOON ; Hee Young KIM ; Jin Seok CHOI ; Kyu Hong PAK ; Sung Kun CHUNG
Journal of the Korean Ophthalmological Society 2021;62(11):1478-1482
Purpose:
To investigate the safety of laser epithelial keratomileusis (LASEK) by drawing a comparison between two groups divided according to age (18-19 vs. 20-21 years old).
Methods:
The study was conducted as a retrospective analysis including 339 patients (678 eyes) who underwent LASEK between January 2017 and April 2020. Patients were divided by age group, group I (18-19 years old) and group II (20-21 years old). The objectives of the study included determination of visual acuity and refractive errors before and at 1, 3, and 6 months after the procedure.
Results:
The preoperative mean spherical equivalents (SEs) were -4.73 ± 0.88 diopters (D) in group I and -4.58 ± 0.87 D in group II (p = 0.34). At 1 month postoperatively, mean SEs were 0.32 ± 0.46 D in group I and 0.26 ± 0.59 D in group II (p = 0.18). At 3 months postoperatively, the mean SEs were 0.30 ± 0.47 D in group I and 0.28 ± 0.50 D in group II (p = 0.67). At 6 months postoperatively, the mean SEs were 0.15 ± 0.47 D in group I and 0.14 ± 0.50 D in group II (p = 0.89). There were no significant differences in postoperative best corrected visual acuity between group I and group II at 1, 3, or 6 months (p = 0.20, p = 0.13, and p = 0.11, respectively).
Conclusions
There were no significant differences in postoperative mean SE or safety of LASEK between moderate myopia patients 18-19 years old and those 20-21 years old.
10.A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol
Eun Kyung LEE ; Yea Eun KANG ; Young Joo PARK ; Bon Seok KOO ; Ki-Wook CHUNG ; Eu Jeong KU ; Ho-Ryun WON ; Won Sang YOO ; Eonju JEON ; Se Hyun PAEK ; Yong Sang LEE ; Dong Mee LIM ; Yong Joon SUH ; Ha Kyoung PARK ; Hyo-Jeong KIM ; Bo Hyun KIM ; Mijin KIM ; Sun Wook KIM ; Ka Hee YI ; Sue K. PARK ; Eun-Jae JUNG ; June Young CHOI ; Ja Seong BAE ; Joon Hwa HONG ; Kee-Hyun NAM ; Young Ki LEE ; Hyeong Won YU ; Sujeong GO ; Young Mi KANG ;
Endocrinology and Metabolism 2021;36(3):574-581
Background:
Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.
Methods:
This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.
Conclusion
The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.

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