1.Real-World Clinical Data of Palbociclib in Asian Metastatic Breast Cancer Patients: Experiences from Eight Institutions
Jieun LEE ; Hyung Soon PARK ; Hye Sung WON ; Ji Hyun YANG ; Hee Yeon LEE ; In Sook WOO ; Kabsoo SHIN ; Ji Hyung HONG ; Young Joon YANG ; Sang Hoon CHUN ; Jae Ho BYUN
Cancer Research and Treatment 2021;53(2):409-423
Purpose:
Use of cyclin-dependent kinase 4/6 inhibitors improved survival outcome of hormone receptor (HR) positive metastatic breast cancer (MBC) patients, including Asian population. However, Asian real-world data of palbociclib is limited. We analyzed the real-world clinical practice patterns and outcome in HR-positive, MBC Asian patients treated with palbociclib.
Materials and Methods:
Between April 2017 to November 2019, 169 HR-positive, human epidermal growth factor-2–negative MBC patients treated with letrozole or fulvestrant plus palbocilib were enrolled from eight institutions. Survival outcome (progression-free survival [PFS]), treatment response and toxicity profiles were analyzed.
Results:
Median age of letrozole plus palbociclib (145 patients, 85.8%) and fulvestrant plus palbociclib (24 patients, 14.2%) was 58 and 53.5 years, with median follow-up duration of 14.63 months (range 0.2 to 33.9 months). Median PFS (mPFS) of letrozole plus palbociclib and fulvestrant plus palbociclib was 25.6 (95% confidence interval [CI], 19.1 to not reached) and 6.37 months (95% CI, 5.33 to not reached), comparable to previous phase 3 trials. In letrozole plus palbociclib arm, luminal A (hazard ratio, 2.86; 95% CI, 1.20 to 6.80; p=0.017) and patients with good performance (Eastern Cooperative Oncology Group 0-1 [hazard ratio, 3.68; 95% CI, 1.70 to 7.96]) showed better mPFS. In fulvestrant plus palbociclib group, chemotherapy naïve patients showed better mPFS (hazard ratio, 12.51, 95% CI, 1.59 to 99.17; p=0.017). The most common grade 3 or 4 adverse event was neutropenia (letrozole 86.3%, fulvestrant 88.3%).
Conclusion
To our knowledge, this is the first real-world data of palbociclib reported in Asia. Palbociclib showed comparable benefit to previous phase 3 trials in Asian patients during daily clinical practice.
2.Real-World Clinical Data of Palbociclib in Asian Metastatic Breast Cancer Patients: Experiences from Eight Institutions
Jieun LEE ; Hyung Soon PARK ; Hye Sung WON ; Ji Hyun YANG ; Hee Yeon LEE ; In Sook WOO ; Kabsoo SHIN ; Ji Hyung HONG ; Young Joon YANG ; Sang Hoon CHUN ; Jae Ho BYUN
Cancer Research and Treatment 2021;53(2):409-423
Purpose:
Use of cyclin-dependent kinase 4/6 inhibitors improved survival outcome of hormone receptor (HR) positive metastatic breast cancer (MBC) patients, including Asian population. However, Asian real-world data of palbociclib is limited. We analyzed the real-world clinical practice patterns and outcome in HR-positive, MBC Asian patients treated with palbociclib.
Materials and Methods:
Between April 2017 to November 2019, 169 HR-positive, human epidermal growth factor-2–negative MBC patients treated with letrozole or fulvestrant plus palbocilib were enrolled from eight institutions. Survival outcome (progression-free survival [PFS]), treatment response and toxicity profiles were analyzed.
Results:
Median age of letrozole plus palbociclib (145 patients, 85.8%) and fulvestrant plus palbociclib (24 patients, 14.2%) was 58 and 53.5 years, with median follow-up duration of 14.63 months (range 0.2 to 33.9 months). Median PFS (mPFS) of letrozole plus palbociclib and fulvestrant plus palbociclib was 25.6 (95% confidence interval [CI], 19.1 to not reached) and 6.37 months (95% CI, 5.33 to not reached), comparable to previous phase 3 trials. In letrozole plus palbociclib arm, luminal A (hazard ratio, 2.86; 95% CI, 1.20 to 6.80; p=0.017) and patients with good performance (Eastern Cooperative Oncology Group 0-1 [hazard ratio, 3.68; 95% CI, 1.70 to 7.96]) showed better mPFS. In fulvestrant plus palbociclib group, chemotherapy naïve patients showed better mPFS (hazard ratio, 12.51, 95% CI, 1.59 to 99.17; p=0.017). The most common grade 3 or 4 adverse event was neutropenia (letrozole 86.3%, fulvestrant 88.3%).
Conclusion
To our knowledge, this is the first real-world data of palbociclib reported in Asia. Palbociclib showed comparable benefit to previous phase 3 trials in Asian patients during daily clinical practice.
3.Impact on Bisphosphonate Persistence and Compliance: Daily Postprandial Administration
Chan Ho PARK ; Ki Jin JUNG ; Jae Hwi NHO ; Ja Hyung KIM ; Sung Hun WON ; Dong Il CHUN ; Dong Won BYUN
Journal of Bone Metabolism 2019;26(1):39-44
BACKGROUND: Bisphosphonate (BP) is an effective drug for the prevention and treatment of osteoporosis. However, gastrointestinal distress caused by BP is a well-known side effect for low compliance. The aim of our study was to compare the 1-year persistence, compliance and T-scores between the aperitif medication group and the postprandial medication group. METHODS: Three hundred patients were included in this study to determine their persistence and compliance with the prescribed daily BP (Maxmarvil®, alendronate 5 mg and calcitriol 0.5 µg; YuYu Pharm) following distal radius fractures. Patients in Group 1 (aperitif medication) were asked to adhere to the general guidelines for BPs before breakfast. Patients in Group 2 (postprandial medication) were recommended medication after breakfast. We compared the persistence and compliance of this daily BP therapy using the medication possession ratio (MPR) and T-scores between the 2 groups after 1 year. RESULTS: Bone mineral density in hip and lumbar spine was improved significantly in 2 groups (P < 0.001). Significant differences existed between 2 groups, including 73 of 150 patients (48.7%) in Group 1, and 111 of 150 patients (73.3%) in Group 2 for 1-year persistence (P=0.001). The mean MPR is 0.66 in Group 1 (range, 0.50–0.86) and 0.71 in Group 2 (range, 0.54–0.87). A significant difference was detected between the 2 groups (P=0.002). CONCLUSIONS: Postprandial administration improved persistence and compliance with daily BP therapy, resulting in better clinical outcomes.
Alendronate
;
Bone Density
;
Breakfast
;
Calcitriol
;
Compliance
;
Hip
;
Humans
;
Osteoporosis
;
Radius Fractures
;
Spine
4.The Comparison of Seasonal Ginsenoside Composition Contents in Korean Wild Simulated Ginseng (Panax ginseng) which were Cultivated in Different Areas and Various Ages
Byung Wook YANG ; Jae Bum LEE ; Jung Min LEE ; Min Su JO ; Jae Kyung BYUN ; Hyoung Chun KIM ; Sung Kwon KO
Natural Product Sciences 2019;25(1):1-10
The ginsenoside content was compared with wild simulated ginseng (Panax ginseng) collected every season at 11 wild simulated ginseng plantations in Korea. As a result, the total saponin of 7 years old wild simulated ginseng showed the highest content of 4.5% in spring sampling wild simulated ginseng, 2.0% in summer sampling wild simulated ginseng, 1.2% in winter sampling wild simulated ginseng and 1.0% in autumn sampling wild simulated ginseng. And also, the total saponin of 10 years old wild simulated ginseng showed the highest content of 3.9% in spring sampling wild simulated ginseng, summer sampling wild simulated ginseng (1.8%), winter sampling wild simulated ginseng (1.6%) and autumn sampling wild simulated ginseng (0.6%). Therefore, the total saponin of spring sampling wild simulated ginseng was about 4.5 – 6.5 times higher than that of autumn sampling wild simulated ginseng regardless of cultivation period.
Korea
;
Panax
;
Saponins
;
Seasons
5.Erratum: Complications of Central Venous Totally Implantable Access Port: Internal Jugular Versus Subclavian Access.
Pil Young JUNG ; Hoon RYU ; Jae Hung JUNG ; Eunbi LEE ; Joong Hwan OH ; Chun Sung BYUN ; Il Hwan PARK
Korean Journal of Critical Care Medicine 2015;30(4):365-365
We found an error in this article. The author's affiliation.
6.Complications of Central Venous Totally Implantable Access Port: Internal Jugular Versus Subclavian Access.
Pil Young JUNG ; Hoon RYU ; Jae Hung JUNG ; Eunbi LEE ; Joong Hwan OH ; Chun Sung BYUN ; Il Hwan PARK
Korean Journal of Critical Care Medicine 2015;30(1):13-17
BACKGROUND: Totally implantable access port (TIAP) provides reliable, long term vascular access with minimal risk of infection and allows patients normal physical activity. With wide use of ports, new complications have been encountered. We analyzed TIAP related complications and evaluated the outcomes of two different percutaneous routes of access to superior vena cava. METHODS: All 172 patients who underwent port insertion with internal jugular approach (Group 1, n = 92) and subclavian approach (Group 2, n = 79) between August 2011 and May 2013 in a single center were analyzed, retrospectively. Medical records were analyzed to compare the outcomes and the occurrence of port related complications between two different percutaneous routes of access to superior vena cava. RESULTS: Median follow-up for TIAP was 278 days (range, 1-1868). Twenty four complications were occurred (14.0%), including pneumothorax (n = 1, 0.6%), migration/malposition (n = 4, 2.3%), pinch-off syndrome (n = 4, 2.3%), malfunction (n = 2, 1.1%), infection (n = 8, 4.7%), and venous thrombosis (n = 5, 2.9%). The overall incidence was 8.7% and 20.3% in each group (p = 0.030). Mechanical complications except infectious and thrombotic complications were more often occurred in group 2 (p = 0.033). The mechanical complication free probability is significantly higher in group 1 (p = 0.040). CONCLUSIONS: We suggest that the jugular access should be chosen in patients who need long term catheterization because of high incidence of mechanical complication, such as pinch-off syndrome.
Catheterization
;
Catheters
;
Follow-Up Studies
;
Humans
;
Incidence
;
Jugular Veins
;
Medical Records
;
Motor Activity
;
Pneumothorax
;
Retrospective Studies
;
Subclavian Vein
;
Vascular Access Devices
;
Vena Cava, Superior
;
Venous Thrombosis
7.Complications of Central Venous Totally Implantable Access Port: Internal Jugular Versus Subclavian Access
Pil Young JUNG ; Hoon RYU ; Jae Hung JUNG ; Eunbi LEE ; Joong Hwan OH ; Chun Sung BYUN ; Il Hwan PARK
The Korean Journal of Critical Care Medicine 2015;30(1):13-17
BACKGROUND: Totally implantable access port (TIAP) provides reliable, long term vascular access with minimal risk of infection and allows patients normal physical activity. With wide use of ports, new complications have been encountered. We analyzed TIAP related complications and evaluated the outcomes of two different percutaneous routes of access to superior vena cava. METHODS: All 172 patients who underwent port insertion with internal jugular approach (Group 1, n = 92) and subclavian approach (Group 2, n = 79) between August 2011 and May 2013 in a single center were analyzed, retrospectively. Medical records were analyzed to compare the outcomes and the occurrence of port related complications between two different percutaneous routes of access to superior vena cava. RESULTS: Median follow-up for TIAP was 278 days (range, 1-1868). Twenty four complications were occurred (14.0%), including pneumothorax (n = 1, 0.6%), migration/malposition (n = 4, 2.3%), pinch-off syndrome (n = 4, 2.3%), malfunction (n = 2, 1.1%), infection (n = 8, 4.7%), and venous thrombosis (n = 5, 2.9%). The overall incidence was 8.7% and 20.3% in each group (p = 0.030). Mechanical complications except infectious and thrombotic complications were more often occurred in group 2 (p = 0.033). The mechanical complication free probability is significantly higher in group 1 (p = 0.040). CONCLUSIONS: We suggest that the jugular access should be chosen in patients who need long term catheterization because of high incidence of mechanical complication, such as pinch-off syndrome.
Catheterization
;
Catheters
;
Follow-Up Studies
;
Humans
;
Incidence
;
Jugular Veins
;
Medical Records
;
Motor Activity
;
Pneumothorax
;
Retrospective Studies
;
Subclavian Vein
;
Vascular Access Devices
;
Vena Cava, Superior
;
Venous Thrombosis
8.Erratum: Complications of Central Venous Totally Implantable Access Port: Internal Jugular Versus Subclavian Access
Pil Young JUNG ; Hoon RYU ; Jae Hung JUNG ; Eunbi LEE ; Joong Hwan OH ; Chun Sung BYUN ; Il Hwan PARK
The Korean Journal of Critical Care Medicine 2015;30(4):365-365
We found an error in this article. The author's affiliation.
9.L-NAME, a Non Selective Nitric Oxide Synthase, Affects Stress-Related Behaviors and Glial Cell-Derived Neurotrophic Factor Expression in Restrained Adolescent ICR Mice.
Kwang Jun KWON ; Jong Seon BYUN ; Jae Won LEE ; Wanjoo CHUN ; Sung Soo KIM ; Hee Jae LEE
Korean Journal of Psychopharmacology 2012;23(1):5-10
OBJECTIVE: Depending on genetic or environmental effects over adolescent development, typical behavioral responses come out in adolescence. Also, alteration of nitric oxide (NO) levels in the brain has been associated with modifications of stress related behavior. Present study was designed to investigate the possible influence of chronic stress from restraint on the generation of depression in adolescent mice, and also to evaluate whether NO has modulatory roles in the behavioral and biological reactions. METHODS: ICR mice exposed to stressful restraint, 2 h per day, was treated with NG-nitro L-arginine methyl ester (L-NAME) (10 mg/kg), a non-selective NO synthase (NOS) inhibitor. To evaluate depression-like behavior in the mice, forced swim test and open field test were performed after the last restraint. To investigate stress-induced changes in the expression level of glial cell-derived neurotrophic factor (GDNF), free-floating immunohistochemistry was performed. RESULTS: The results showed that stressed group has longer immobility time and less crossing number in forced swimming and open field test, and that these stress responses were significantly prevented by L-NAME. Furthermore, decreased GDNF expression in the hippocampus by stress was prevented to that of controls within the L-NAME treated group. CONCLUSION: The results suggest that stress and NO signaling could be involved in generation of depression in adolescence. It also suggested that GDNF might contribute to prevent stress-related behaviors.
Adolescent
;
Adolescent Development
;
Animals
;
Arginine
;
Brain
;
Depression
;
Glial Cell Line-Derived Neurotrophic Factor
;
Hippocampus
;
Humans
;
Immunohistochemistry
;
Mice
;
Mice, Inbred ICR
;
NG-Nitroarginine Methyl Ester
;
Nitric Oxide
;
Nitric Oxide Synthase
;
Swimming
10.Influenza A (H1N1) 2009 Pandemic Calm Down the Prevalence of Acute Hepatitis A in the Latter Half of 2009: Korean Population Study.
Jin Myung BYUN ; Sang Gyune KIM ; Yuan Yuan ZHANG ; Young Seok KIM ; Soung Won JEONG ; Sae Hwan LEE ; Jae Young JANG ; Soo Jin HONG ; Jong Ho MOON ; Hong Soo KIM ; Moon Sung LEE ; Boo Sung KIM
The Korean Journal of Gastroenterology 2012;59(5):360-365
BACKGROUND/AIMS: There was a spiking incidence of acute hepatitis A (AHA) in 2009 summer, but it went down drastically after an outbreak of influenza A (H1N1). We assessed the relationship between 2009 H1N1 pandemic and AHA prevalence from August to December 2009. METHODS: We compared AHA cases nationwide and in our hospital for the period from the latter half of 2008 to the end of 2010. H1N1 cases in our hospital from August 2009 to December 2009 were included in the study and the correlation between 2009 H1N1 pandemic and AHA prevalence was assessed. RESULTS: The national surveillance system reported 2,233, 7,895, 15,231 and 7,660 AHA cases from 2007 to 2010, respectively. A similar trend was noted in our hospital in the same periods. Although the national total incidence was increased in 2009, it showed steep decreasing trend line in the final 21 weeks of 2009 (weeks 32-52), as compared with 2008 and 2010. The mean weekly incidence percentage (AHA cases in a week/total in a year) in weeks 32-52 of 2009 was 1.17+/-0.55%, significantly lower than that in 2008 and 2010 (1.61+/-0.43% and 1.56+/-0.51%; p<0.001). Furthermore, we found a significant negative correlation between 2009 H1N1 pandemic and AHA in our hospital for weeks 32-52 of 2009 (r=-0.597; p<0.001). CONCLUSIONS: The widespread occurrence of 2009 H1N1 pandemic highlighted the benefits of health care and good hygiene, such as effective hand washing and wearing of masks, which may have also interrupted hepatitis A virus transmission.
Acute Disease
;
Hepatitis A/*epidemiology
;
Humans
;
Influenza A Virus, H1N1 Subtype/*isolation & purification
;
Influenza, Human/*epidemiology/virology
;
Pandemics
;
Prevalence
;
Republic of Korea/epidemiology
;
Seasons

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