1.Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset
Ki Hyeong LEE ; Byoung Chul CHO ; Myung-Ju AHN ; Yun-Gyoo LEE ; Youngjoo LEE ; Jong-Seok LEE ; Joo-Hang KIM ; Young Joo MIN ; Gyeong-Won LEE ; Sung Sook LEE ; Kyung-Hee LEE ; Yoon Ho KO ; Byoung Yong SHIM ; Sang-We KIM ; Sang Won SHIN ; Jin-Hyuk CHOI ; Dong-Wan KIM ; Eun Kyung CHO ; Keon Uk PARK ; Jin-Soo KIM ; Sang Hoon CHUN ; Jangyoung WANG ; SeokYoung CHOI ; Jin Hyoung KANG
Cancer Research and Treatment 2024;56(1):48-60
Purpose:
This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non–small cell lung cancer (NSCLC).
Materials and Methods:
Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS).
Results:
In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment–related AEs occurred with lazertinib than gefitinib.
Conclusion
Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population.
2.Efficacy of the granisetron transdermal system for the control of nausea and vomiting induced by highly emetogenic chemotherapy: a multicenter, randomized, controlled trial
Der Sheng SUN ; Yoon Ho KO ; Jong Youl JIN ; In Sook WOO ; Suk Young PARK ; Yun Ae EOM ; Jin Hyoung KANG ; Hoon Kyo KIM
The Korean Journal of Internal Medicine 2023;38(3):406-416
Background/Aims:
We compared the efficacy of the granisetron transdermal system (GTS) with that of ondansetron for controlling chemotherapy-induced nausea and vomiting (CINV) in patients treated with highly emetogenic chemotherapy (HEC).
Methods:
We randomized a total of 389 patients to groups treated by GTS and ondansetron before HEC. The primary endpoint was the percentage of patients achieving complete response (CR; no retching/vomiting/rescue medication) of CINV from the time of chemotherapy initiation to 24 hours after the last administration of chemotherapy (prespecified non-inferiority margin of 15%). Quality of life (QoL) was also assessed using the Functional Living Index-Emesis (FLIE).
Results:
The per protocol analysis included 152 (47.80%) and 166 patients (52.20%) in the GTS and ondansetron groups, respectively. In the full analysis set, the most common diagnosis, regimen, and period of chemotherapy were lung cancer (149 patients, 40.27%), cisplatin-based regimen (297 patients, 80.27%), and 1 day chemotherapy (221 patients, 59.73%). The CR rates were 86.84% and 90.36% in the GTS and ondansetron groups, respectively; the treatment difference was −3.52% (95% confidence interval, −10.52 to 3.48) and met the primary endpoint, indicating that GTS was not inferior to ondansetron. Patient satisfaction, assessed on the FLIE, showed significantly higher scores in the GTS group compared to the ondansetron group (mean ± standard deviation, 1,547.38 ± 306.00 and 1,494.07 ± 312.05 mm, respectively; p = 0.0449).
Conclusions
GTS provided effective, safe, and well-tolerated control of CINV and improved the QoL in HEC.
3.First Case of Atypical, Generalized Skin Rash after Transarterial Chemoembolization in a Patient with Hepatocellular Carcinoma
Yohan LEE ; Eunae CHO ; Chang Hwan PARK ; Jae Hyun YOON ; Sung Kyu CHOI ; Hyoung Ook KIM ; Chan PARK ; Sook Jung YUN
The Korean Journal of Gastroenterology 2023;81(4):173-177
Transarterial chemoembolization (TACE) is a widely used hepatocellular carcinoma (HCC) treatment. Some cases of supraumbilical skin rash after TACE in patients with HCC have been reported. To the best of the authors’ knowledge, there are no reports on atypical, generalized rashes caused by doxorubicin systemic absorption after TACE. This paper presents the case of a 64-year-old male with HCC who developed generalized macules and patches one day after a successful TACE procedure. A histology examination of a skin biopsy of a dark reddish patch on the knee revealed severe interface dermatitis. He was treated with a topical steroid, and all skin rashes improved within a week with no side effects. This report presents this rare case with a literature review on skin rash after TACE.
4.Clinical Characteristics and Long-term Outcomes of Pediatric Ulcerative Colitis: A Single-Center Experience in Korea
Jooyoung JANG ; Sung Hee LEE ; In Sook JEONG ; Jinmin CHO ; Hyun Jin KIM ; Seak Hee OH ; Dae Yeon KIM ; Ho-Su LEE ; Sang Hyoung PARK ; Byong Duk YE ; Suk-Kyun YANG ; Kyung Mo KIM
Gut and Liver 2022;16(2):236-245
Background/Aims:
Although pediatric ulcerative colitis (UC) has a different phenotype and clinical course than adult UC, its clinical features and outcomes are poorly defined, especially in Asian populations. This study investigated the clinical features and long-term outcomes of pediatric UC in a Korean population.
Methods:
We retrospectively analyzed 208 patients aged <18 years diagnosed with UC between 1987 and 2013. The patient characteristics at diagnosis according to the Paris classification and the clinical course were analyzed.
Results:
The male-to-female ratio was 1.3:1, and the median patient age was 15.5 years. At diagnosis, 28.8% of patients had proctitis (E1), 27.8%, left-sided colitis (E2); 5.2%, extensive colitis (E3); and 38.2%, pancolitis (E4). The cumulative probabilities of extension after 5, 10, 15, and 20 years were 32.7%, 40.4%, 52.5%, and 65.8%, respectively. Eighteen patients underwent colectomy, and three patients had colorectal cancer. The cumulative probabilities of colectomy after 5, 10, 15, and 20 years were 7.1%, 8.9%, 12.6%, and 15.6%, and those of colorectal cancer after 10, 15, and 20 years were 0%, 2.1%, and 12.0%, respectively. The disease extent, Pediatric Ulcerative Colitis Activity Index severity, and systemic corticosteroid therapy were significant risk factors for colectomy. The development of primary sclerosing cholangitis was significantly associated with colorectal cancer.
Conclusions
This study provides detailed information on the disease phenotype and long-term clinical outcomes in a large cohort of Korean children with UC. They have extensive disease at diagnosis, a high rate of disease extension, and a low rate of cumulative colectomy.
5.Influence of Communication Competence and Communication Style on the Nurse-Parent Partnership in Pediatric Nurses
Hyun Jin CHO ; Hyoung Sook PARK
Journal of Korean Academy of Fundamental Nursing 2022;29(2):170-180
Purpose:
The purpose of this study was to examine the relationship of communication competence and communication style with nurse-parent partnership among pediatric nurses.
Methods:
This study had a descriptive, correlational design. Data were collected from 169 pediatric nurses in B metropolitan city and Y city, from January 2018 to February 2018. A structured questionnaire was administered. Data were analyzed using descriptive statistics, the t-test, one-way analysis of variance, the Scheffé test, the Kruskal-Wallis test, and multiple regression analysis with SPSS version 23.0.
Results:
Nurse-parent partnership was correlated with communication competence (r=.59, p<.001), an informative communication style (r=.65, p<.001), an affective communication style (r=.68, p<.001), and an authoritative communication style (r=-.30, p<.001). The factors influencing nurse-parent partnership among the study subjects were an affective communication style, an informative communication style, communication competence, and the nurses’ current position. The overall explanatory power of this model was 61.0%, and the most influential factor was an affective communication style.
Conclusion
Nurse-parent partnership showed significant correlations with communication competence and affective and informative communication styles. The study may serve as a basic resource for promoting nurse-parent partnership, which increases the effectiveness of treatment for children in pediatric wards and will ultimately help improve the quality of child care.
6.A Survey on Undergraduate Nursing Students Safety during Fundamentals of Nursing Practicum
Seung-Kyo CHAUNG ; Yun Hee SHIN ; Youngmi KANG ; Dongwon CHOI ; Hye Sun JEONG ; Youngshin SONG ; Hyun-Ju KIM ; Ji-Su KIM ; Kyeong-Yae SOHNG ; Hyoung Sook PARK ; Soohyun PARK
Journal of Korean Academy of Fundamental Nursing 2021;28(3):320-330
Purpose:
This study was done to investigate the experience of physical and emotional safety in nursing students during fundamentals of nursing practicum.
Methods:
A descriptive cross-sectional study was conducted from March to September 2019. A total of 553 nursing students, who had completed fundamental nursing laboratories, participated in this study. Data were collected using self-report questionnaires which included questions about general characteristics, physical and emotional safety during fundamental nursing laboratories along with an informed consent given prior to the practicum.
Results:
Of the students, 26 experienced physical safety accidents, and 18 reported emotional safety accidents. Students' mean stress score for physical safety was 1.95, and the mean score for emotional safety was 1.92. Of the students, more than 59.1% agreed to volunteer as practice models in certain nursing procedures’ training. Of the students, 55.8% were satisfied with using their bodies to train fundamental nursing skills. 61.8% of students reported that informed consent was obtained during the nursing laboratory, and 88.6% of students thought that informed consent needs to be obtained.
Conclusion
To prevent safety accidents during the fundamentals of nursing practicum and systematically manage accidents, standardized safety guidelines for nursing practicum should be developed. Establishing various training strategies using advanced models or simulators to increase education efficiency and satisfaction is necessary.
7.A Study on Breast Cancer Patients’ Commitment to a Plan for Exercise based on Health Beliefs
Hyoung Sook PARK ; Yun Seo JUNG ; Young Mi KIM ; Jae Hyun HWANG
Journal of Korean Academy of Fundamental Nursing 2020;27(1):64-72
Purpose:
The purpose of this study was to identify the factors relating to commitment to a plan for exercise in the breast cancer patient following a mastectomy and to examine the relationship between these factors.
Methods:
This study was a correlational research and the participants were 152 patients with breast cancer. Data were collected using a structured questionnaire from June to October, 2015.
Results:
The final regression model showed that income, experience of exercise and current exercise were significant predictors related to commitment to a plan for exercise in patients with breast cancer and explained for 65.9% of the variance in commitment to a plan for exercise.
Conclusion
The findings indicate that patients in breast cancer-oriented intervention programs have an enhancing experience of exercise. Current exercise should be provided for patients with breast cancer in order to promote health and quality of life.
8.The Influence of Awareness regarding Particulate Matter, Perceived Respiratory Symptoms, and Physical Activities on Health Promotion Behavior of Elementary School Children
Hyoung Sook PARK ; Myoung Soo KIM ; Sang Hee KIM ; Ryewon MA ; Myo Sung KIM
Journal of Korean Academy of Fundamental Nursing 2020;27(2):95-105
Purpose:
The purpose of this study was to identify the influence of awareness regarding particulate matter, perceived respiratory symptoms, and physical activities on health promotion behavior in elementary school children.
Methods:
Data were collected from 639 4th~6th grades students from 8 elementary schools in Busan and analyzed using independent t-test and ANOVA, Pearson correlation coefficients and multiple regression analysis.
Results:
The average for awareness regarding particulate matter was 29.84±5.63, for perceived respiratory symptoms, 0.66±0.95, and for health promotion behavior, 7.85±1.76. The mean amount of time the students spent in sleeping or sitting on an easy chair and/or activity while sitting were 10.71±3.04 and 6.60±2.84 hours a day. Factors influencing health promotion behavior in elementary school children were being a girl (β=.09, p=.015), in 4th grade (β=-.09, p=.025), residence in Busanjingu (β=-.10, p=.005), residence in Bukgu (β=-.12, p=.001), more than 10 years residence period (β=-.09, p=.020) and awareness regarding particulate matter (β=.42, p<.001). The explanation power of these variables was 23% (F=22.21, p<.001).
Conclusion
It is recommended that for health education programs, gender, grade, length of residence and area’s air pollution level be considered and education program including guideline for particulate matter be provided continuously to elementary students to increase their level of awareness regarding particulate matter and proper physical activity.
9.The health-related quality-of-life of chronic obstructive pulmonary disease patients anddisease-related indirect burdens
Hye Sook CHOI ; Dong-Wook YANG ; Chin Kook RHEE ; Hyoung Kyu YOON ; Jin Hwa LEE ; Seong Yong LIM ; Yu-Il KIM ; Kwang Ha YOO ; Yong-Il HWANG ; Sang Haak LEE ; Yong Bum PARK
The Korean Journal of Internal Medicine 2020;35(5):1136-1144
Background/Aims:
Many chronic obstructive pulmonary disease (COPD) patientshave physical limitations. We investigated EuroQol five-dimensions five-level (EQ-5D-5L) of COPD patients to assess quality of life, and assessed indirect burden including time expenditure to visit doctor, home care rate, and caregiver related burden.
Methods:
We recruited 355 COPD patients according to severity of airflow limitationthat severity was set at 10% mild, 40% moderate, 30% severe, and 20% very severe in two primary and 11 secondary/tertiary hospitals. Eligible patients were aged ≥ 40 years, who have been diagnosed with COPD for more than 1 year. Patients were recruited between June 2015 and October 2016.
Results:
The quality of life tended to decline with age, from mild to very severe impairment, as revealed by the EQ-5D-5L scores and the EQ visual analog scale.Family caregivers accompanied 22.6% of patients who visited outpatient clinics,and 25% of stage IV COPD patients. During emergency visits and hospitalization,this figure increased to > 60%. The home care rates were 28.5% for stage I patients, and 34.4, 31.8, and 52% for stage II to IV patients, respectively. The percentage of caregivers who stopped working was 13.6%. The EQ-5D index was strongly associated with the dyspnea scale (r = –0.64, p < 0.001). The average required time to see a doctor and visit the pharmacy was 154 minutes.
Conclusions
In patients with COPD, the EQ-5D index decreased and disease-relatedhome caregiving increased with airflow limitation. We considered the caregiver-related burden when making a strategy for COPD managemen
10.Comparing the Procedural and Clinical Outcomes of Sapien XT and Sapien 3Valves in Transcatheter Aortic Valve Replacement in Korean Patients
Hyungdon KOOK ; Duck Hyun JANG ; Kyung-Sook YANG ; Hyung Joon JOO ; Jae Hyoung PARK ; Soon Jun HONG ; Do-Sun LIM ; Seung-Hyuk CHOI ; Young Jin CHOI ; Kiyuk CHANG ; Cheol Woong YU
Korean Circulation Journal 2020;50(10):907-922
Background and Objectives:
The Sapien 3 (S3) valve has not been compared to the Sapien XT (SXT) valve in Korea. We compared procedural and clinical outcomes between the 2 devices.
Methods:
A total of 189 patients who underwent transcatheter aortic valve replacement (TAVR) with S3 (n=95) or SXT (n=94) valve was analyzed. The primary endpoint was cardiovascular mortality at 1 year. The median follow-up duration was 438 days.
Results:
The Society of Thoracic Surgeons score was similar between the 2 groups. The device success rate (90.4% vs. 97.9%; p=0.028) was higher in the S3 than in the SXT. The S3 showed significantly fewer cases of moderate or severe paravalvular leakage (PVL) (16.7% vs.0.0%; p=0.001) than the SXT. However, effective orifice area (EOA) (2.07±0.61 vs. 1.70±0.49 cm2 ; p<0.001) was smaller in the S3. Multivariable Cox regression analysis showed the S3 was associated with significantly fewer cardiovascular mortality at 1 year compared to the SXT (5.4% vs. 1.1%; hazard ratio, 0.031; 95% confidence interval, 0.001–0.951; p=0.047). Periprocedural complication rates, composite of disabling stroke or all-cause mortality, allcause mortality, and disabling stroke at 1 year were similar between the 2 groups.
Conclusions
Cardiovascular mortality was lower in the S3 group than in the SXT group over 1 year of follow-up. The reduction in PVL was attributed to the higher device success rate of TAVR with the S3 valve. However, the benefit of S3 obtained at the expense of reduced EOA should be meticulously re-evaluated in larger studies during long-term follow-up.

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