In recent years, next-generation sequencing (NGS)–based genetic testing has become crucial in cancer care. While its primary objective is to identify actionable genetic alterations to guide treatment decisions, its scope has broadened to encompass aiding in pathological diagnosis and exploring resistance mechanisms. With the ongoing expansion in NGS application and reliance, a compelling necessity arises for expert consensus on its application in solid cancers. To address this demand, the forthcoming recommendations not only provide pragmatic guidance for the clinical use of NGS but also systematically classify actionable genes based on specific cancer types. Additionally, these recommendations will incorporate expert perspectives on crucial biomarkers, ensuring informed decisions regarding circulating tumor DNA panel testing.

Purpose: Notable effectiveness of trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2 (HER2)–low advanced breast cancer (BC) has focused pathologists’ attention. We studied the incidence and clinicopathologic characteristics of HER2-low BC, and the effects of immunohistochemistry (IHC) associated factors on HER2 IHC results. Materials and Methods: The Breast Pathology Study Group of the Korean Society of Pathologists conducted a nationwide study using real-world data on HER2 status generated between January 2022 and December 2022. Information on HER2 IHC protocols at each participating institution was also collected. Results: Total 11,416 patients from 25 institutions included in this study. Of these patients, 40.7% (range, 6.0% to 76.3%) were classified as HER2-zero, 41.7% (range, 10.5% to 69.1%) as HER2-low, and 17.5% (range, 6.7% to 34.0%) as HER2-positive. HER2-low tumors were associated with positive estrogen receptor and progesterone receptor statuses (p < 0.001 and p < 0.001, respectively). Antigen retrieval times (≥ 36 minutes vs. < 36 minutes) and antibody incubation times (≥ 12 minutes vs. < 12 minutes) affected on the frequency of HER2 IHC 1+ BC at institutions using the PATHWAY HER2 (4B5) IHC assay and BenchMark XT or Ultra staining instruments. Furthermore, discordant results between core needle biopsy and subsequent resection specimen HER2 statuses were observed in 24.1% (787/3,259) of the patients. Conclusion The overall incidence of HER2-low BC in South Korea concurs with those reported in previously published studies. Significant inter-institutional differences in HER2 IHC protocols were observed, and it may have impact on HER2-low status. Thus, we recommend standardizing HER2 IHC conditions to ensure precise patient selection for targeted therapy.

Background: Since the emergence of hypervirulent strains of Clostridioides difficile, the incidence of C. difficile infections (CDI) has increased significantly. Methods: To assess the incidence of CDI in Korea, we conducted a prospective multicentre observational study from October 2020 to October 2021. Additionally, we calculated the incidence of CDI from mass data obtained from the Health Insurance Review and Assessment Service (HIRA) from 2008 to 2020. Results: In the prospective study with active surveillance, 30,212 patients had diarrhoea and 907 patients were diagnosed with CDI over 1,288,571 patient-days and 193,264 admissions in 18 participating hospitals during 3 months of study period; the CDI per 10,000 patientdays was 7.04 and the CDI per 1,000 admission was 4.69. The incidence of CDI was higher in general hospitals than in tertiary hospitals: 6.38 per 10,000 patient-days (range: 3.25–12.05) and 4.18 per 1,000 admissions (range: 1.92–8.59) in 11 tertiary hospitals, vs. 9.45 per 10,000 patient-days (range: 5.68–13.90) and 6.73 per 1,000 admissions (range: 3.18–15.85) in seven general hospitals. With regard to HIRA data, the incidence of CDI in all hospitals has been increasing over the 13-year-period: from 0.3 to 1.8 per 10,000 patient-days, 0.3 to 1.6 per 1,000 admissions, and 6.9 to 56.9 per 100,000 population, respectively. Conclusion The incidence of CDI in Korea has been gradually increasing, and its recent value is as high as that in the United State and Europe. CDI is underestimated, particularly in general hospitals in Korea.

In recent years, next-generation sequencing (NGS)–based genetic testing has become crucial in cancer care. While its primary objective is to identify actionable genetic alterations to guide treatment decisions, its scope has broadened to encompass aiding in pathological diagnosis and exploring resistance mechanisms. With the ongoing expansion in NGS application and reliance, a compelling necessity arises for expert consensus on its application in solid cancers. To address this demand, the forthcoming recommendations not only provide pragmatic guidance for the clinical use of NGS but also systematically classify actionable genes based on specific cancer types. Additionally, these recommendations will incorporate expert perspectives on crucial biomarkers, ensuring informed decisions regarding circulating tumor DNA panel testing.

Human Q fever, a zoonosis caused by Coxiella burnetii, presents with diverse clinical manifestations ranging from mild self-limited febrile illnesses to life-threatening complications such as endocarditis or vascular infection. Although acute Q fever is a benign illness with a low mortality rate, a large-scale outbreak of Q fever in the Netherlands led to concerns about the possibility of blood transfusion-related transmission or obstetric complications in pregnant women. Furthermore, a small minority (< 5%) of patients with asymptomatic or symptomatic infection progress to chronic Q fever. Chronic Q fever is fatal in 5–50% of patients if left untreated. In South Korea, Q fever in humans was designated as a notifiable infectious disease in 2006, and the number of Q fever cases has increased sharply since 2015. Nonetheless, it is still considered a neglected and under-recognized infectious disease. In this review, recent trends of human and animal Q fever in South Korea, and public health concerns regarding Q fever outbreaks are reviewed, and we consider how a One Health approach could be applied as a preventive measure to prepare for zoonotic Q fever outbreaks.

Background: Gaucher disease (GD) is an autosomal recessive disorder characterized by excessive accumulation of glucosylceramide in multiple organs. This study was performed to determine the detection rate of GD in a selected patient population with unexplained splenomegaly in Korea. Methods: This was a multicenter, observational study conducted at 18 sites in Korea between December 2016 and February 2020. Adult patients with unexplained splenomegaly were enrolled and tested for β-glucosidase enzyme activity on dried blood spots (DBS) and in peripheral blood leukocytes. Mutation analysis was performed if the test was positive or indeterminate for the enzyme assay. The primary endpoint was the percentage of patients with GD in patients with unexplained splenomegaly. Results: A total of 352 patients were enrolled in this study (male patients, 199; mean age, 48.42 yr). Amongst them, 14.77% of patients had concomitant hepatomegaly. The most common sign related to GD was splenomegaly (100%), followed by thrombocytopenia (44.32%) and, anemia (40.91%). The β-glucosidase activity assay on DBS and peripheral leukocytes showed abnormal results in sixteen and six patients, respectively. Eight patients were tested for the mutation, seven of whom were negative and one patient showed a positive mutation analysis result. One female patient who presented with splenomegaly and thrombocytopenia was diagnosed with type 1 GD. The detection rate of GD was 0.2841% (exact 95% CI, 0.0072‒). Conclusion The detection rate of GD in probable high-risk patients in Korea was lower than expected.However, the role of hemato-oncologists is still important in the diagnosis of GD.

Background/Aims: Recently, 1-L polyethylene glycol-ascorbic acid (PEG-Asc) has been used to reduce the volume of preparation agents in colonoscopy. This clinical trial aimed to compare the efficacy and safety of two types of 1-L PEG-Asc (CleanViewAL ® [Tae Joon Pharmaceutical Company, Seoul, Korea] and Plenvu ® [Norgine, Harefield, United Kingdom]) in average-aged adults. Methods: This study was a prospective, randomized, non-inferiority, open-label, phase 4 clinical trial. The primary endpoint was the efficacy evaluated using the Boston bowel preparation scale (BBPS), and the secondary endpoint was clinical safety. Results: In total, 173 patients were assigned to either the CleanViewAL ® (n=84) or Plenvu ® (n=89) group. Overall cleansing successes of 97.6% (82/84) and 98.8% (88/89) were achieved in the CleanViewAL ® group and in the Plenvu ® group, respectively, showing that CleanViewAL ® has similar bowel cleansing efficacy to Plenvu ® (95% CI, -0.052 to 0.027; p=0.207). The total BBPS score was 8.67±1.00 and 8.70±0.76 in the CleanViewAL ® group and Plenvu ® group, respectively (p=0.869). The most common adverse symptom was nausea, and no adverse symptoms requiring hospitalization were reported in either group. There were no cases of critical hypernatremia and liver dysfunction exceeding the common terminology criteria for adverse events grade I. An overall satisfaction score (scale of 1 to 10) showed no difference between the two groups (p=0.289). However, the CleanViewAL ® group showed a higher taste satisfaction score (scale of 1 to 5) than the Plenvu ® group (CleanViewAL ® : 2.90±0.91, Plenvu ® : 2.60±0.86, p=0.028). Conclusions Both types of 1-L PEG-Asc, CleanViewAL ® and Plenvu ® , are effective and safe bowel cleansing agents in average-aged adults. CleanViewAL ® was preferred in terms of taste satisfaction.

BACKGROUND: The i-gel™ (i-gel) and Laryngeal Mask Airway Supreme™ (LMA Supreme) have been safely used in children. We compared the airway performance of the i-gel and LMA Supreme in infants undergoing general anesthesia. METHODS: Sixty infants with American Society of Anesthesiologists physical status I or II were randomly assigned to place either the i-gel or the LMA Supreme. The size 1 or 1.5 of each airway was selected by the weight of infants. The primary outcome variable was oropharyngeal leak pressure (OLP). We also assessed insertion success rate, insertion time, fiberoptic view of the larynx, airway quality, airway manipulations, and perioperative complications. RESULTS: Demographic data did not differ between the two groups. Insertion success rate was similar in both groups. OLP for the i-gel (26.0 ± 3.8 cmH2O) was higher than for the LMA Supreme (23.7 ± 3.2 cmH2O) (P = 0.016). Insertion time for the i-gel (16.4 ± 2.8 s) was shorter than for the LMA Supreme (18.5 ± 2.7 s) (P = 0.002). There were no differences in fiberoptic view of the larynx, airway quality, airway manipulations, and complications between the two groups. CONCLUSIONS: This study demonstrated that the i-gel and LMA Supreme provided a similar performance of airway in infants. Compared with the LMA Supreme, the i-gel provided shorter insertion time and higher OLP in infants.
Anesthesia, General ; Child ; Humans ; Infant ; Laryngeal Masks ; Larynx

BACKGROUND: The i-gel™ (i-gel) and Laryngeal Mask Airway Supreme™ (LMA Supreme) have been safely used in children. We compared the airway performance of the i-gel and LMA Supreme in infants undergoing general anesthesia. METHODS: Sixty infants with American Society of Anesthesiologists physical status I or II were randomly assigned to place either the i-gel or the LMA Supreme. The size 1 or 1.5 of each airway was selected by the weight of infants. The primary outcome variable was oropharyngeal leak pressure (OLP). We also assessed insertion success rate, insertion time, fiberoptic view of the larynx, airway quality, airway manipulations, and perioperative complications. RESULTS: Demographic data did not differ between the two groups. Insertion success rate was similar in both groups. OLP for the i-gel (26.0 ± 3.8 cmH2O) was higher than for the LMA Supreme (23.7 ± 3.2 cmH2O) (P = 0.016). Insertion time for the i-gel (16.4 ± 2.8 s) was shorter than for the LMA Supreme (18.5 ± 2.7 s) (P = 0.002). There were no differences in fiberoptic view of the larynx, airway quality, airway manipulations, and complications between the two groups. CONCLUSIONS This study demonstrated that the i-gel and LMA Supreme provided a similar performance of airway in infants. Compared with the LMA Supreme, the i-gel provided shorter insertion time and higher OLP in infants.

BACKGROUND: Limited data are available on the current status of cytology practices in Korea. This nationwide study presents Korean cytology statistics from 2015. METHODS: A nationwide survey was conducted in 2016 as a part of the mandatory quality-control program by the Korean Society for Cytopathology. The questionnaire was sent to 208 medical institutions performing cytopathologic examinations in Korea. Individual institutions were asked to submit their annual cytology statistical reports and gynecologic cytology-histology correlation data for 2015. RESULTS: Responses were obtained from 206 medical institutions including 83 university hospitals, 87 general hospitals, and 36 commercial laboratories. A total of 8,284,952 cytologic examinations were performed in 2015, primarily in commercial laboratories (74.9%). The most common cytology specimens were gynecologic samples (81.3%). Conventional smears and liquid-based cytology were performed in 6,190,526 (74.7%) and 2,094,426 (25.3%) cases, respectively. The overall diagnostic concordance rate between cytologic and histologic diagnoses of uterine cervical samples was 70.5%. Discordant cases were classified into three categories: category A (minimal clinical impact, 17.4%), category B (moderate clinical impact, 10.2%), and category C (major clinical impact, 1.9%). The ratio of atypical squamous cells of undetermined significance to squamous intraepithelial lesion was 1.6 in university hospitals, 2.9 in general hospitals, and 4.9 in commercial laboratories. CONCLUSIONS: This survey reveals the current status and trend of cytology practices in Korea. The results of this study can serve as basic data for the establishment of nationwide cytopathology policies and quality improvement guidelines in Korean medical institutions.
Atypical Squamous Cells of the Cervix ; Diagnosis ; Hospitals, General ; Hospitals, University ; Korea* ; Quality Improvement ; Squamous Intraepithelial Lesions of the Cervix