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1,151 results on '"Lee, Kyung-Hun"'

1. A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer

Author

Noguchi, Emi, Yamanaka, Takashi, Mukai, Hirofumi, Yamamoto, Naohito, Chung, Chi-Feng, Lu, Yen-Shen, Chang, Dwan-Ying, Sohn, Joohyuk, Kim, Gun Min, Lee, Kyung-Hun, Lee, Soo-Chin, Iwasa, Tsutomu, Iwata, Hiroji, Watanabe, Kenichi, Jung, Kyung Hae, Tanabe, Yuko, Kang, Seok Yun, Yasojima, Hiroyuki, Aogi, Kenjiro, Tokunaga, Eriko, Sim, Sung Hoon, Yap, Yoon Sim, Matsumoto, Koji, Tseng, Ling-Ming, Umeyama, Yoshiko, Sudo, Kazuki, Kojima, Yuki, Hata, Tomomi, Kuchiba, Aya, Shibata, Taro, Nakamura, Kenichi, Fujiwara, Yasuhiro, Tamura, Kenji, and Yonemori, Kan

Published
2024
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8. Determinants of Response to Talazoparib in Patients with HER2-Negative, Germline BRCA1/2-Mutated Breast CancerTalazoparib in Germline BRCA1/2-Mutated Breast Cancer

Author

Blum, Joanne L, Laird, A Douglas, Litton, Jennifer K, Rugo, Hope S, Ettl, Johannes, Hurvitz, Sara A, Martin, Miguel, Roché, Henri H, Lee, Kyung-Hun, Goodwin, Annabel, Chen, Ying, Lanzalone, Silvana, Chelliserry, Jijumon, Czibere, Akos, Hopkins, Julia F, Albacker, Lee A, and Mina, Lida A

Subjects
Clinical Research, Breast Cancer, Human Genome, Genetics, Cancer, Good Health and Well Being, BRCA1 Protein, BRCA2 Protein, Breast Neoplasms, Female, Germ Cells, Germ-Line Mutation, Humans, Phthalazines, Poly(ADP-ribose) Polymerase Inhibitors, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposePARP inhibitors (PARPi) have demonstrated efficacy in tumors with germline breast cancer susceptibility genes (gBRCA) 1 and 2 mutations, but further factors influencing response to PARPi are poorly understood.Experimental designBreast cancer tumor tissue from patients with gBRCA1/2 mutations from the phase III EMBRACA trial of the PARPi talazoparib versus chemotherapy was sequenced using FoundationOne CDx.ResultsIn the evaluable intent-to-treat population, 96.1% (296/308) had ≥1 tumor BRCA (tBRCA) mutation and there was strong concordance (95.3%) between tBRCA and gBRCA mutational status. Genetic/genomic characteristics including BRCA loss of heterozygosity (LOH; identified in 82.6% of evaluable patients), DNA damage response (DDR) gene mutational burden, and tumor homologous recombination deficiency [assessed by genomic LOH (gLOH)] demonstrated no association with talazoparib efficacy.ConclusionsOverall, BRCA LOH status, DDR gene mutational burden, and gLOH were not associated with talazoparib efficacy; however, these conclusions are qualified by population heterogeneity and low patient numbers in some subgroups. Further investigation in larger patient populations is warranted.

Published
2022

10. Pemetrexed plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer (KCSG-BR15-17): A randomized, open-label, multicenter, phase II trial

Author

Lee, Dae-Won, Jung, Kyung Hae, Lee, Kyung-Hun, Park, Yeon Hee, Lee, Keun Seok, Sohn, Joohyuk, Ahn, Hee Kyung, Jeong, Jae Ho, Koh, Su-Jin, Kim, Jee Hyun, Kim, Han Jo, Lee, Kyoung Eun, Kim, Hee-Jun, Yang, Yae-Won, Park, Kyong Hwa, Lee, Jieun, Won, Hye Sung, Kim, Tae-Yong, and Im, Seock-Ah

Published
2024
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13. Longitudinal multi-omics study of palbociclib resistance in HR-positive/HER2-negative metastatic breast cancer

Author

Park, Yeon Hee, Im, Seock-Ah, Park, Kyunghee, Wen, Ji, Lee, Kyung-Hun, Choi, Yoon-La, Lee, Won-Chul, Min, Ahrum, Bonato, Vinicius, Park, Seri, Ram, Sripad, Lee, Dae-Won, Kim, Ji-Yeon, Lee, Su Kyeong, Lee, Won-Woo, Lee, Jisook, Kim, Miso, Kim, Hyun Seon, Weinrich, Scott L., Ryu, Han Suk, Kim, Tae Yong, Dann, Stephen, Kim, Yu-Jin, Fernandez, Diane R., Koh, Jiwon, Wang, Shuoguo, Park, Song Yi, Deng, Shibing, Powell, Eric, Ravi, Rupesh Kanchi, Bienkowska, Jadwiga, Rejto, Paul A., Park, Woong-Yang, and Kan, Zhengyan

Published
2023
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17. Talazoparib in Patients with a Germline BRCA‐Mutated Advanced Breast Cancer: Detailed Safety Analyses from the Phase III EMBRACA Trial

Author

Hurvitz, Sara A, Gonçalves, Anthony, Rugo, Hope S, Lee, Kyung‐Hun, Fehrenbacher, Louis, Mina, Lida A, Diab, Sami, Blum, Joanne L, Chakrabarti, Jayeta, Elmeliegy, Mohamed, DeAnnuntis, Liza, Gauthier, Eric, Czibere, Akos, Tudor, Iulia Cristina, Quek, Ruben GW, Litton, Jennifer K, and Ettl, Johannes

Subjects
Cancer, Breast Cancer, Patient Safety, Clinical Trials and Supportive Activities, Clinical Research, Hematology, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Germ Cells, Germ-Line Mutation, Humans, Phthalazines, Poly(ADP-ribose) Polymerase Inhibitors, BRCA1, BRCA2, Breast cancer, Talazoparib, Chemotherapy, BRCA1, BRCA2, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BACKGROUND:In the EMBRACA phase III study (NCT01945775), talazoparib was associated with a significantly prolonged progression-free survival (PFS) compared with physician's choice of chemotherapy (PCT) in germline BRCA1/2-mutated HER2-negative advanced breast cancer (ABC). Herein, the safety profile of talazoparib is explored in detail. MATERIALS AND METHODS:Overall, 412 patients received ≥1 dose of talazoparib (n = 286) or PCT (n = 126). Adverse events (AEs) were evaluated, including timing, duration, and potential overlap of selected AEs. The relationship between talazoparib plasma exposure and grade ≥3 anemia was analyzed. Time-varying Cox proportional hazard models assessed the impact of dose reductions on PFS. Patient-reported outcomes (PROs) in patients with common AEs and health resource utilization (HRU) were assessed in both treatment arms. RESULTS:The most common AEs with talazoparib were hematologic (195 [68.2%] patients) and typically occurred within the first 3-4 months of receiving talazoparib. Grade 3-4 anemia lasted approximately 7 days for both arms. Overlapping grade 3-4 hematologic AEs were infrequent with talazoparib. Higher talazoparib exposure was associated with grade ≥3 anemia. Permanent discontinuation of talazoparib due to hematologic AEs was low (

Published
2020

18. Outcomes in Clinically Relevant Patient Subgroups From the EMBRACA Study: Talazoparib vs Physician's Choice Standard-of-Care Chemotherapy.

Author

Rugo, Hope S, Ettl, Johannes, Hurvitz, Sara A, Gonçalves, Anthony, Lee, Kyung-Hun, Fehrenbacher, Louis, Mina, Lida A, Diab, Sami, Woodward, Natasha E, Yerushalmi, Rinat, Goodwin, Annabel, Blum, Joanne L, Martin, Miguel, Quek, Ruben GW, Tudor, Iulia Cristina, Bhattacharyya, Helen, Gauthier, Eric, Litton, Jennifer K, and Eiermann, Wolfgang

Subjects
Clinical Research, Breast Cancer, Clinical Trials and Supportive Activities, Cancer, Comparative Effectiveness Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals
Abstract

BackgroundTalazoparib is a poly(adenosine diphosphate-ribose) polymerase inhibitor that causes death in cells with breast cancer susceptibility gene 1 or 2 (BRCA1/2) mutations.MethodsEMBRACA (NCT01945775) was a randomized phase III study comparing efficacy, safety, and patient-reported outcomes (PROs) of talazoparib (1 mg) with physician's choice of chemotherapy (PCT: capecitabine, eribulin, gemcitabine, vinorelbine) in locally advanced or metastatic breast cancer with a germline BRCA1/2 (gBRCA1/2) mutation. Prespecified patient subgroups were analyzed for progression-free survival, objective response, clinical benefit, duration of response, and safety. PROs were evaluated in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) or triple-negative breast cancer (TNBC) subgroups.ResultsOf 431 patients, 287 were randomly assigned to talazoparib and 144 to PCT. Prespecified subgroup analyses showed prolonged progression-free survival with talazoparib (HR+/HER2-: hazard ratio = 0.47, 95% confidence interval = 0.32 to 0.71; TNBC: hazard ratio = 0.60, 95% confidence interval = 0.41 to 0.87) and greater objective response rate (odds ratio = 1.97 to 11.89), clinical benefit rate (odds ratio = 2.05 to 7.77), and duration of response with talazoparib in all subgroups. PROs in HR+/HER2- and TNBC subgroups showed consistent overall improvement and delay in time to definitive clinically meaningful deterioration with talazoparib vs PCT. Across subgroups, common adverse events included anemia, fatigue, and nausea with talazoparib and neutropenia, fatigue, and nausea with PCT. Seven patients (2.4%) receiving talazoparib had grade II alopecia and 22.7% had grade I alopecia.ConclusionsAcross all patient subgroups with gBRCA-mutated advanced breast cancer, talazoparib demonstrated clinically significant superiority in outcomes compared with PCT.

Published
2020

21. Talazoparib in Patients with a Germline BRCA-Mutated Advanced Breast Cancer: Detailed Safety Analyses from the Phase III EMBRACA Trial.

Author

Hurvitz, Sara A, Gonçalves, Anthony, Rugo, Hope S, Lee, Kyung-Hun, Fehrenbacher, Louis, Mina, Lida A, Diab, Sami, Blum, Joanne L, Chakrabarti, Jayeta, Elmeliegy, Mohamed, DeAnnuntis, Liza, Gauthier, Eric, Czibere, Akos, Tudor, Iulia Cristina, Quek, Ruben GW, Litton, Jennifer K, and Ettl, Johannes

Subjects
BRCA1, BRCA2, Breast cancer, Chemotherapy, Talazoparib, BRCA1, BRCA2, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BACKGROUND:In the EMBRACA phase III study (NCT01945775), talazoparib was associated with a significantly prolonged progression-free survival (PFS) compared with physician's choice of chemotherapy (PCT) in germline BRCA1/2-mutated HER2-negative advanced breast cancer (ABC). Herein, the safety profile of talazoparib is explored in detail. MATERIALS AND METHODS:Overall, 412 patients received ≥1 dose of talazoparib (n = 286) or PCT (n = 126). Adverse events (AEs) were evaluated, including timing, duration, and potential overlap of selected AEs. The relationship between talazoparib plasma exposure and grade ≥3 anemia was analyzed. Time-varying Cox proportional hazard models assessed the impact of dose reductions on PFS. Patient-reported outcomes (PROs) in patients with common AEs and health resource utilization (HRU) were assessed in both treatment arms. RESULTS:The most common AEs with talazoparib were hematologic (195 [68.2%] patients) and typically occurred within the first 3-4 months of receiving talazoparib. Grade 3-4 anemia lasted approximately 7 days for both arms. Overlapping grade 3-4 hematologic AEs were infrequent with talazoparib. Higher talazoparib exposure was associated with grade ≥3 anemia. Permanent discontinuation of talazoparib due to hematologic AEs was low (

Published
2019

24. DNA Damage Repair Inhibitor for Breast Cancer Treatment

Author

Min, Ahrum, Lee, Kyung-Hun, Im, Seock-Ah, Crusio, Wim E., Series Editor, Dong, Haidong, Series Editor, Radeke, Heinfried H., Series Editor, Rezaei, Nima, Series Editor, Xiao, Junjie, Series Editor, Noh, Dong-Young, editor, Han, Wonshik, editor, and Toi, Masakazu, editor

Published
2021
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25. Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation.

Author

Litton, Jennifer, Gonçalves, Anthony, Lee, Kyung-Hun, Fehrenbacher, Louis, Yerushalmi, Rinat, Mina, Lida, Martin, Miguel, Roché, Henri, Im, Young-Hyuck, Quek, Ruben, Markova, Denka, Tudor, Iulia, Hannah, Alison, Eiermann, Wolfgang, Blum, Joanne, Ettl, Johannes, Hurvitz, Sara, and Rugo, Hope

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Breast Neoplasms, Disease-Free Survival, Female, Genes, BRCA1, Genes, BRCA2, Germ-Line Mutation, Humans, Middle Aged, Patient Reported Outcome Measures, Phthalazines, Poly(ADP-ribose) Polymerase Inhibitors, Quality of Life, Survival Analysis
Abstract

BACKGROUND: The poly(adenosine diphosphate-ribose) inhibitor talazoparib has shown antitumor activity in patients with advanced breast cancer and germline mutations in BRCA1 and BRCA2 ( BRCA1/2). METHODS: We conducted a randomized, open-label, phase 3 trial in which patients with advanced breast cancer and a germline BRCA1/2 mutation were assigned, in a 2:1 ratio, to receive talazoparib (1 mg once daily) or standard single-agent therapy of the physicians choice (capecitabine, eribulin, gemcitabine, or vinorelbine in continuous 21-day cycles). The primary end point was progression-free survival, which was assessed by blinded independent central review. RESULTS: Of the 431 patients who underwent randomization, 287 were assigned to receive talazoparib and 144 were assigned to receive standard therapy. Median progression-free survival was significantly longer in the talazoparib group than in the standard-therapy group (8.6 months vs. 5.6 months; hazard ratio for disease progression or death, 0.54; 95% confidence interval [CI], 0.41 to 0.71; P

Published
2018

26. HER2 expression, copy number variation and survival outcomes in HER2-low non-metastatic breast cancer: an international multicentre cohort study and TCGA-METABRIC analysis

Author

Tan, Ryan Shea Ying Cong, Ong, Whee Sze, Lee, Kyung-Hun, Lim, Abner Herbert, Park, Seri, Park, Yeon Hee, Lin, Ching-Hung, Lu, Yen-Shen, Ono, Makiko, Ueno, Takayuki, Naito, Yoichi, Onishi, Tatsuya, Lim, Geok-Hoon, Tan, Su-Ming, Lee, Han-Byoel, Ryu, Han Suk, Han, Wonshik, Tan, Veronique Kiak Mien, Wong, Fuh-Yong, Im, Seock-Ah, Tan, Puay Hoon, Chan, Jason Yongsheng, and Yap, Yoon-Sim

Published
2022
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27. A first-in-human phase 1/2 study of FGF401 and combination of FGF401 with spartalizumab in patients with hepatocellular carcinoma or biomarker-selected solid tumors

Author

Chan, Stephen L., Schuler, Martin, Kang, Yoon-Koo, Yen, Chia-Jui, Edeline, Julien, Choo, Su Pin, Lin, Chia-Chi, Okusaka, Takuji, Weiss, Karl-Heinz, Macarulla, Teresa, Cattan, Stéphane, Blanc, Jean-Frederic, Lee, Kyung-Hun, Maur, Michela, Pant, Shubham, Kudo, Masatoshi, Assenat, Eric, Zhu, Andrew X., Yau, Thomas, Lim, Ho Yeong, Bruix, Jordi, Geier, Andreas, Guillén-Ponce, Carmen, Fasolo, Angelica, Finn, Richard S., Fan, Jia, Vogel, Arndt, Qin, Shukui, Riester, Markus, Katsanou, Vasiliki, Chaudhari, Monica, Kakizume, Tomoyuki, Gu, Yi, Porta, Diana Graus, Myers, Andrea, and Delord, Jean-Pierre

Published
2022
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30. Palbociclib plus exemestane with GnRH agonist vs capecitabine in premenopausal patients with HR+/HER2- metastatic breast cancer: Updated survival results of the randomized phase 2 study Young-PEARL.

Author

Park, Yeon Hee, primary, Lee, Kyung-Hun, additional, Kim, Gun Min, additional, Kang, Seok Yun, additional, Lee, Keun Seok, additional, Kim, Jee Hyun, additional, Lee, Kyoung Eun, additional, Ahn, Hee Kyung, additional, Lee, Moon Hee, additional, Kim, Hee Jun, additional, Kim, Hanjo, additional, Koh, Su-Jin, additional, Kim, Ji-Yeon, additional, Sohn, Joohyuk, additional, Kim, Sung-Bae, additional, Ahn, Jin Seok, additional, Kim, Seonwoo, additional, Cho, Hyun, additional, Jung, Kyung Hae, additional, and Im, Seock-Ah, additional

Published
2024
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31. Outcomes in Nonmetastatic Hormone Receptor–Positive HER2-Negative Pure Mucinous Breast Cancer: A Multicenter Cohort Study

Author

Tan, Ryan Ying Cong, primary, Ong, Whee Sze, additional, Lee, Kyung-Hun, additional, Park, Seri, additional, Iqbal, Jabed, additional, Park, Yeon Hee, additional, Lee, Jeong Eon, additional, Yu, Jong Han, additional, Lin, Ching-Hung, additional, Lu, Yen-Shen, additional, Ono, Makiko, additional, Ueno, Takayuki, additional, Naito, Yoichi, additional, Onishi, Tatsuya, additional, Lim, Geok-Hoon, additional, Tan, Su-Ming, additional, Lee, Han-Byoel, additional, Koh, Jiwon, additional, Han, Wonshik, additional, Im, Seock-Ah, additional, Tan, Veronique Kiak Mien, additional, Phyu, Nitar, additional, Wong, Fuh-Yong, additional, Tan, Puay Hoon, additional, and Yap, Yoon-Sim, additional

Published
2024
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32. Prognostic effects of cytokine levels on patients treated with taxane and zoledronic acid for metastatic breast cancer in bone (BEAT-ZO) (KCSG BR 10-13)

Author

Kim, Ju Won, Lee, Soohyeon, Kim, Hye Sook, Choi, Yoon Ji, Yoo, Jinho, Park, Keon Uk, Kang, Seok Yun, Park, Yeon Hee, Jung, Kyung Hae, Ahn, Jin-Hee, Oh, Ho-suk, Choi, In Sil, Kim, Hee Jun, Lee, Kyung-Hun, Lee, Suee, Seo, Jae Hong, Park, In Hae, Lee, Kyung Eun, Kim, Ho Young, and Park, Kyong Hwa

Published
2021
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35. Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study

Author

Bang, Y-J, Bendell, J, Chao, Y, Chen, J-S, Chung, H C, Davis, S L, Dev, A, Gane, E, George, B, He, A R, Hochster, H, Hsu, C-H, Ikeda, M, Lee, J, Lee, M, Mahipal, A, Manji, G, Morimoto, M, Numata, K, Pishvaian, M, Qin, S, Ryan, D, Ryoo, B-Y, Sasahira, N, Stein, S, Strickler, J, Tebbutt, N, Lee, Michael S, Ryoo, Baek-Yeol, Hsu, Chih-Hung, Numata, Kazushi, Stein, Stacey, Verret, Wendy, Hack, Stephen P, Spahn, Jessica, Liu, Bo, Abdullah, Heba, Wang, Yulei, He, Aiwu Ruth, and Lee, Kyung-Hun

Published
2020
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39. Comparison of atezolizumab plus bevacizumab and lenvatinib for hepatocellular carcinoma with portal vein tumor thrombosis

Author

Park, Jeayeon, primary, Lee, Yun Bin, additional, Ko, Yunmi, additional, Park, Youngsu, additional, Shin, Hyunjae, additional, Hur, Moon Haeng, additional, Park, Min Kyung, additional, Lee, Dae-Won, additional, Cho, Eun Ju, additional, Lee, Kyung-Hun, additional, Lee, Jeong-Hoon, additional, Yu, Su Jong, additional, Kim, Tae-Yong, additional, Kim, Yoon Jun, additional, Kim, Tae-You, additional, and Yoon, Jung-Hwan, additional

Published
2024
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42. Prediction of pathologic complete response using image-guided biopsy after neoadjuvant chemotherapy in breast cancer patients selected based on MRI findings: a prospective feasibility trial

Author

Lee, Han-Byoel, Han, Wonshik, Kim, Soo-Yeon, Cho, Nariya, Kim, Kyoung-Eun, Park, Jung Hyun, Ju, Young Wook, Lee, Eun-Shin, Lim, Sung-Joon, Kim, Jung Ho, Ryu, Han Suk, Lee, Dae-Won, Kim, Miso, Kim, Tae-Yong, Lee, Kyung-Hun, Shin, Sung Ui, Lee, Su Hyun, Chang, Jung Min, Moon, Hyeong-Gon, Im, Seock-Ah, Moon, Woo Kyung, Park, In-Ae, and Noh, Dong-Young

Published
2020
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45. Predictive biomarkers for 5-fluorouracil and oxaliplatin-based chemotherapy in gastric cancers via profiling of patient-derived xenografts

Author

Na, Deukchae, Chae, Jeesoo, Cho, Sung-Yup, Kang, Wonyoung, Lee, Ahra, Min, Seoyeon, Kang, Jinjoo, Kim, Min Jung, Choi, Jaeyong, Lee, Woochan, Shin, Dongjin, Min, Ahrum, Kim, Yu-Jin, Lee, Kyung-Hun, Kim, Tae-Yong, Suh, Yun-Suhk, Kong, Seong-Ho, Lee, Hyuk-Joon, Kim, Woo-Ho, Park, Hansoo, Im, Seock-Ah, Yang, Han-Kwang, Lee, Charles, and Kim, Jong-Il

Published
2021
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49. Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial

Author

Ahn, HK, Cho, EK, Park, IH, Lee, KS, Sim, SS, Hong, SJ, Chang, MH, Kim, JH, Kim, YJ, Kim, SH, Suh, KJ, Park, YH, Park, WY, Choi, YL, Yu, JH, Im, YH, Ahn, JS, Hur, JY, Park, SH, Kim, JY, Nam, SJ, Lee, JE, Kim, SW, Lee, SK, Im, SA, Kim, MS, Kim, TY, Oh, DY, Lee, KH, Lee, DW, Kim, HJ, Jung, KH, Kim, SB, Ahn, JH, Kim, JE, Jung, JH, Kang, SY, Ahn, MS, Choi, YW, Kim, GM, Sohn, JH, Kim, MH, Koh, SJ, Cheon, JK, Lee, JI, Lim, ST, Hyun, SY, Lee, KE, Lee, MH, Cho, JH, Lim, JH, Park, Yeon Hee, Kim, Tae-Yong, Kim, Gun Min, Kang, Seok Yun, Park, In Hae, Kim, Jee Hyun, Lee, Kyoung Eun, Ahn, Hee Kyung, Lee, Moon Hee, Kim, Hee-Jun, Kim, Han Jo, Lee, Jong In, Koh, Su-Jin, Kim, Ji-Yeon, Lee, Kyung-Hun, Sohn, Joohyuk, Kim, Sung-Bae, Ahn, Jin-Seok, Im, Young-Hyuck, Jung, Kyung Hae, and Im, Seock-Ah

Published
2019
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