1.Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial
Ji-Jung JUNG ; Jong-Ho CHEUN ; Soo-Yeon KIM ; Jiwon KOH ; Jai Min RYU ; Tae-Kyung YOO ; Hee-Chul SHIN ; Sung Gwe AHN ; Seho PARK ; Woosung LIM ; Sang-Eun NAM ; Min Ho PARK ; Ku Sang KIM ; Taewoo KANG ; Jeeyeon LEE ; Hyun Jo YOUN ; Yoo Seok KIM ; Chang Ik YOON ; Hong-Kyu KIM ; Hyeong-Gon MOON ; Wonshik HAN ; Nariya CHO ; Min Kyoon KIM ; Han-Byoel LEE
Journal of Breast Cancer 2024;27(1):61-71
Purpose:
Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies.
Methods
The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuumassisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years.Discussion: This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients.
2.Efficacy and Safety of Sirolimus-Eluting Stent With Biodegradable Polymer Ultimaster™ in Unselected Korean Population: A Multicenter, Prospective, Observational Study From Korean Multicenter Ultimaster Registry
Soohyung PARK ; Seung-Woon RHA ; Byoung Geol CHOI ; Jae-Bin SEO ; Ik Jun CHOI ; Sung-Il WOO ; Soo-Han KIM ; Tae Hoon AHN ; Jae Sang KIM ; Ae-Young HER ; Ji-Hun AHN ; Han Cheol LEE ; Jaewoong CHOI ; Jin Soo BYON ; Markz RMP SINURAT ; Se Yeon CHOI ; Jinah CHA ; Su Jin HYUN ; Cheol Ung CHOI ; Chang Gyu PARK
Korean Circulation Journal 2024;54(6):339-350
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.
3.Uric Acid and Risk of Cardiovascular Disease and Mortality: A Longitudinal Cohort Study
Jae Young KIM ; Changhwan SEO ; Haeyong PAK ; Hyunsun LIM ; Tae Ik CHANG
Journal of Korean Medical Science 2023;38(38):e302-
Background:
This study aimed to examine the association of serum uric acid levels with incident cardiovascular disease and mortality in Korean adults without gout.
Methods:
This large longitudinal cohort study included adults aged > 19 years who had serum uric acid levels measured at least once at the National Health Insurance Service Ilsan Hospital from January 1, 2006 to December 31, 2015. Longitudinal data on person-level cardiovascular disease and cardiovascular mortality were linked to the National Health Insurance Service claims database and National Death Index.
Results:
Among a total of 92,454 study participants with a median follow-up of 4.7 years, 7,670 (8.3%) composite events of cardiovascular disease or cardiovascular mortality were observed. Multivariable Cox proportional-hazards models revealed that each 1 mg/dL increment in uric acid level was associated with a 6% higher risk of composite outcomes.Compared with that for the uric acid level category of 4.0 to < 5.0 mg/dL, adjusted hazard ratios (95% confidence interval) for uric acid level categories of 5.0 to < 6.0, 6.0 to < 7.0, and ≥ 7.0 mg/dL were 1.10 (1.04–1.18), 1.20 (1.11–1.30), and 1.36 (1.25–1.47), respectively. In the secondary analyses for cardiovascular disease or cardiovascular mortality examined separately, a higher uric acid level was similarly associated with a higher risk of each adverse outcome. These associations were generally consistent across clinically relevant subgroups.
Conclusion
A graded association was noted between serum uric acid levels and cardiovascular risk, suggesting that higher uric acid levels may adversely affect cardiovascular health and survival in individuals without gout.
4.Marked Reduction in the Risk of Dementia in Patients with Breast Cancer: A Nationwide Population-Based Cohort Study
Jooyoung OH ; Hye Sun LEE ; Soyoung JEON ; Jeong-Ho SEOK ; Tae-Kyung YOO ; Woo-Chan PARK ; Chang Ik YOON
Cancer Research and Treatment 2023;55(2):551-561
Purpose:
An inverse relationship between cancer and neurodegenerative disease, which presents the possibility of a reduced risk of dementia in cancer patients, has been suggested previously. However, a nationwide longitudinal population-based study of specific types of cancer with due consideration of treatment effects has not been conducted.
Materials and Methods:
This nationwide population-based cohort study used data obtained in a 12-year period (January 2007- December 2018) in the Korean National Health Insurance claims database. All female breast cancer patients (age ≥ 50 years) diagnosed between 2009 and 2010 were included after excluding those with physician visits for any cancer during a 2-year period (2007-2008). Patients with senile cataract constituted the control group. The main study outcome was the risk of developing dementia.
Results:
From a total of 90,396 and 85,906 patients with breast cancer and cataract, respectively, patients without behavior codes were excluded. Data for 15,407 breast cancer patients and 7,020 controls were analyzed before matching. After matching for comorbidities and age, either group comprised 2,252 patients. The median follow-up time was 104.1±24.0 months after matching. After matching, breast cancer was a predictor of a lower risk of for dementia (hazard ratio, 0.091; 95% confidence interval, 0.075 to 0.111; p < 0.001). In breast cancer patients, receiving chemotherapy and endocrine therapy did not significantly affect the incidence of dementia.
Conclusion
Breast cancer was associated with a remarkably decreased risk of dementia. The findings strongly suggest an inverse relationship between cancer and neurodegeneration, regardless of the adverse effects of cancer treatment on cognitive function.
5.Comparison of dominant and nondominant C3 deposition in primary glomerulonephritis
Jiwon RYU ; Eunji BAEK ; Hyung-Eun SON ; Ji-Young RYU ; Jong Cheol JEONG ; Sejoong KIM ; Ki Young NA ; Dong-Wan CHAE ; Seong Pyo KIM ; Su Hwan KIM ; Jong Hyun JHEE ; Tae Ik CHANG ; Bum Soon CHOI ; Ho Jun CHIN ;
Kidney Research and Clinical Practice 2023;42(1):98-108
Alternative complement pathway dysregulation plays a key role in glomerulonephritis (GN) and is associated with C3 deposition. Herein, we examined pathological and clinical differences between cases of primary GN with C3-dominant (C3D-GN) and nondominant (C3ND-GN) deposition. Methods: We extracted primary GN data from the Korean GlomeruloNEphritis sTudy (KoGNET). C3D-GN was defined as C3 staining two grades greater than C1q, C4, and immunoglobulin via immunofluorescence analysis. To overcome a large difference in the number of patients between the C3D-GN and C3ND-GN groups (31 vs. 9,689), permutation testing was used for analysis. Results: The C3D-GN group exhibited higher serum creatinine (p ≤ 0.001), a greater prevalence of estimated glomerular filtration rate of <60 mL/min/1.72 m2 (p ≤ 0.001), higher (but not significantly so) C-reactive protein level, and lower serum C3 level (p ≤ 0.001). Serum albumin, urine protein/creatinine ratio, number of patients who progressed to end-stage renal disease, and all-cause mortality were comparable between groups. Interstitial fibrosis and mesangial cellularity were greater in the C3D-GN group (p = 0.04 and p = 0.01, respectively) than in the C3ND-GN group. C3 deposition was dominant in the former group (p < 0.001), in parallel with increased subendothelial deposition (p ≤ 0.001). Conclusion: Greater progression of renal injury and higher mortality occurred in patients with C3D-GN than with C3ND-GN, along with pathologic differences in interstitial and mesangial changes.
6.Perspectives of East Asian patients and physicians on complementary and alternative medicine use for inflammatory bowel disease: results of a cross-sectional, multinational study
Eun Soo KIM ; Chung Hyun TAE ; Sung-Ae JUNG ; Dong Il PARK ; Jong Pil IM ; Chang Soo EUN ; Hyuk YOON ; Byung Ik JANG ; Haruhiko OGATA ; Kayoko FUKUHARA ; Fumihito HIRAI ; Kazuo OHTSUKA ; Jing LIU ; Qian CAO ;
Intestinal Research 2022;20(2):192-202
Background/Aims:
Complementary and alternative medicine (CAM) is prevalent in East Asia. However, information on CAM in East Asian patients with inflammatory bowel disease (IBD) is scarce. We aimed to profile the prevalence and pattern of CAM use among East Asian IBD patients and to identify factors associated with CAM use. We also compared physicians’ perspectives on CAM.
Methods:
Patients with IBD from China, Japan, and South Korea were invited to complete questionnaires on CAM use. Patient demographic and clinical data were collected. Logistic regression analysis was applied for predictors of CAM use. Physicians from each country were asked about their opinion on CAM services or products.
Results:
Overall, 905 patients with IBD participated in this study (China 232, Japan 255, and South Korea 418). Approximately 8.6% of patients with IBD used CAM services for their disease, while 29.7% of patients sought at least 1 kind of CAM product. Current active disease and Chinese or South Korean nationality over Japanese were independent predictors of CAM use. Chinese doctors were more likely to consider CAM helpful for patients with IBD than were Japanese and South Korean doctors.
Conclusions
In 8.6% and 29.7% of East Asian patients with IBD used CAM services and products, respectively, which does not differ from the prevalence in their Western counterparts. There is a significant gap regarding CAM usage among different Asian countries, not only from the patients’ perspective but also from the physicians’ point of view.
7.The Radiological Response Rate Pattern Is Associated With Recurrence Free Survival in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
Juneyoung AHN ; Woo-Chan PARK ; Chang Ik YOON ; Pill Sun PAIK ; Min Kyung CHO ; Tae-Kyung YOO
Journal of Breast Cancer 2022;25(2):106-116
Purpose:
The aim of this study was to evaluate the radiological response rate patterns during neoadjuvant chemotherapy (NAC) in patients with breast cancer.
Methods:
Patients who underwent NAC with two specific chemotherapy regimens (doxorubicin with cyclophosphamide or doxorubicin with docetaxel) and who underwent a response evaluation every two cycles were included in the study. The initial response ratio was defined as the ratio of the largest tumor diameter at diagnosis to that after two cycles of NAC. The latter response ratio was defined as the ratio between the tumor size after two cycles and that after four cycles of NAC. The radiological response rate pattern was divided into three groups: the fast-to-slow response group (F–S group, initial response ratio > latter response ratio + 20%), slow-to-fast response group (S–F group, latter response ratio > initial response ratio + 20%), and constant response group (less than 20% difference between the initial and latter response ratios).
Results:
In total, 177 patients were included in the analysis. Forty-two (23.9%) patients were categorized into the F–S group, 26 (14.8%) into the S–F group, and 108 (61.2%) into the constant group. Clinicopathologic factors did not differ according to radiologic response rate patterns. The median follow-up period was 50 months (range, 3–112) months. In the univariate analysis, the F–S group had a significantly worse recurrence-free survival than the S–F and constant groups (hazard ratio [HR], 3.63; 95% confidence interval [CI], 1.05–12.46; p = 0.041). The F–S group also presented with significantly worse survival than the S–F group in the multivariate analysis (HR, 3.45; 95% CI, 1.00–11.89; p = 0.049).
Conclusion
The F–S group had a poorer survival rate than the S–F group. Radiological response rate patterns may be useful for accurate prognostic assessments, especially when considering post-neoadjuvant therapy.
8.Low incidence of lymph node metastasis in patients with microinvasive breast cancer: a Korean nationwide study
Pill Sun PAIK ; Nam Sun PAIK ; Eun Sook LEE ; Jung Eun CHOI ; Joon JEONG ; Hyun Jo YOUN ; Chang Ik YOON ; Soo Youn BAE ; Tae-Kyung YOO ; Korean Breast Cancer Society
Annals of Surgical Treatment and Research 2022;102(6):306-312
Purpose:
Microinvasive breast cancer (MIBC) is an invasive carcinoma with a tumor dimension not exceeding 1 mm. Owing to its low incidence, the rate of axillary node metastasis and its management are not well established. The aim of this study was to assess the incidence of lymph node metastasis (LNM) and identify variables associated with LNM, as well as to evaluate the need for axillary staging in MIBC patients by analyzing nationwide data.
Methods:
The Korean Breast Cancer Society registry was searched to identify MIBC patients diagnosed between January 1996 and April 2020. Patients without neoadjuvant chemotherapy experiences, systemic metastasis, and missing or discordant data were eligible for the analysis. The incidence rate of LNM was determined, and variables associated with LNM were identified by multivariable regression analysis.
Results:
Of 2,427 MIBC patients identified, 98 (4.0%) had LNM and 12 (0.5%) had N2/3 disease. Type of breast operation (odds ratio [OR], 2.093; 95% confidence interval [CI], 1.332–3.290; P = 0.001), age (OR, 2.091; 95% CI, 1.326–3.298; P = 0.002), hormone receptor status (OR, 2.220; 95% CI, 1.372–3.594; P = 0.001), and lymphovascular invasion (OR, 11.143; 95% CI, 6.354–19.540; P < 0.001) were significantly related to LNM.
Conclusion
The incidence of LNM in MIBC patients was only 4.0% in our study, suggesting that de-escalation of axillary surgical interventions could be carefully considered. The indications for axillary staging should be individualized considering tumor volume, age, hormone receptor status, and lymphovascular invasion to improve the quality of life of MIBC survivors.
9.Avoiding unnecessary intraoperative sentinel lymph node frozen section biopsy of patients with early breast cancer
Jongwon KANG ; Tae-Kyung YOO ; Ahwon LEE ; Jun KANG ; Chang Ik YOON ; Bong Joo KANG ; Sung Hun KIM ; Woo Chan PARK
Annals of Surgical Treatment and Research 2022;102(5):241-247
Purpose:
After the publication of the ACOSOG (American College of Surgeons Oncology Group) Z0011 trial, the rate of axillary lymph node dissection has reduced. Thus, the need for intraoperative frozen section biopsy of sentinel lymph nodes (SLNs) has become controversial. We identified patients for whom intraoperative SLN frozen section biopsy could be omitted and found that frozen section biopsy rate can be reduced.
Methods:
We reviewed the records of patients with tumors ≤5 cm in diameter who underwent breast-conserving surgery between January 2013 and December 2019 at Seoul St. Mary’s Hospital. Clinicopathological and imaging characteristics were compared according to number of positive SLNs (0–2 SLNs positive vs. ≥3 SLNs positive).
Results:
A total of 1,983 patients were included in this study. Thirty-two patients (1.6%) had at least 3 positive SLNs. Patients with ≥3 positive SLNs had significantly larger tumors and were more frequently high-grade tumors (P < 0.001 and P = 0.002, respectively). Identification of suspicious lymph nodes on imaging studies was also associated with the presence of ≥3 positive SLNs (hazard ratio, 11.54; 95% confidence interval, 4.42–30.10). All patients with none or only 1 suspicious lymph node on any imaging modality (n = 647, 32.6%) had 0–2 positive SLNs. Also, among patients with clinical T1-stage tumors and at least 2 suspicious lymph nodes on only 1 imaging modality (n = 514, 25.9%), only 2 cases had ≥3 positive SLNs.
Conclusion
We found that intraoperative SLN frozen biopsy could be omitted in patients using tumor size and axillary lymph node status on imaging modality.
10.CORRIGENDUM: Low incidence of lymph node metastasis in patients with microinvasive breast cancer: a Korean nationwide study
Pill Sun PAIK ; Nam Sun PAIK ; Eun Sook LEE ; Jung Eun CHOI ; Joon JEONG ; Hyun Jo YOUN ; Chang Ik YOON ; Soo Youn BAE ; Tae-Kyung YOO ;
Annals of Surgical Treatment and Research 2022;103(5):312-312

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