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2. Durvalumab or placebo plus gemcitabine and cisplatin in participants with advanced biliary tract cancer (TOPAZ-1): updated overall survival from a randomised phase 3 study

Author

Oh, Do-Youn, He, Aiwu Ruth, Bouattour, Mohamed, Okusaka, Takuji, Qin, Shukui, Chen, Li-Tzong, Kitano, Masayuki, Lee, Choong-kun, Kim, Jin Won, Chen, Ming-Huang, Suksombooncharoen, Thatthan, Ikeda, Masafumi, Lee, Myung Ah, Chen, Jen-Shi, Potemski, Piotr, Burris, Howard A, III, Ostwal, Vikas, Tanasanvimon, Suebpong, Morizane, Chigusa, Zaucha, Renata E, McNamara, Mairéad G, Avallone, Antonio, Cundom, Juan E, Breder, Valeriy, Tan, Benjamin, Shimizu, Satoshi, Tougeron, David, Evesque, Ludovic, Petrova, Mila, Zhen, David B, Gillmore, Roopinder, Gupta, Vineet Govinda, Dayyani, Farshid, Park, Joon Oh, Buchschacher, Gary L, Jr, Rey, Felipe, Kim, Hyosung, Wang, Julie, Morgan, Claire, Rokutanda, Nana, Żotkiewicz, Magdalena, Vogel, Arndt, and Valle, Juan W

Published
2024
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3. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer (TOPAZ-1): patient-reported outcomes from a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Burris, Howard A, III, Okusaka, Takuji, Vogel, Arndt, Lee, Myung Ah, Takahashi, Hidenori, Breder, Valeriy, Blanc, Jean-Frédéric, Li, Junhe, Bachini, Melinda, Żotkiewicz, Magdalena, Abraham, Jayne, Patel, Nikunj, Wang, Julie, Ali, Muzammil, Rokutanda, Nana, Cohen, Gordon, and Oh, Do-Youn

Published
2024
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6. Safety and effectiveness of aflibercept in combination with FOLFIRI in Korean patients with metastatic colorectal cancer who received oxaliplatin-containing regimen

Author

Beom, Seung-Hoon, Kim, Jong Gwang, Baik, Seung Hyuk, Shin, Seong Hoon, Park, Inkeun, Park, Young Suk, Lee, Myung-Ah, Lee, Soohyeon, Jeon, So-Yeon, Han, Sae-Won, Kang, Myoung Hee, Oh, Jisu, Kim, Jin Soo, Kim, Jin Young, Ahn, Mi Sun, Zang, Dae Young, Bae, Byung-Noe, Jo, Hong Jae, Kim, Hee Kyung, Kim, Jung-Han, Yoon, Ji Ae, and Kim, Dong Han

Published
2023
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7. Meta-analysis examining overall survival in patients with pancreatic cancer treated with second-line 5-fluorouracil and oxaliplatin-based therapy after failing first-line gemcitabine-containing therapy: effect of performance status and comparison with other regimens

Author

Wainberg, Zev A, Feeney, Kynan, Lee, Myung Ah, Muñoz, Andrés, Gracián, Antonio Cubillo, Lonardi, Sara, Ryoo, Baek-Yeol, Hung, Annie, Lin, Yong, Bendell, Johanna, and Hecht, J Randolph

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Patient Safety, Cancer, Clinical Research, Digestive Diseases, Rare Diseases, Pancreatic Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Combined Chemotherapy Protocols, Deoxycytidine, Drug Resistance, Neoplasm, Drug-Related Side Effects and Adverse Reactions, Fluorouracil, Humans, Karnofsky Performance Status, Leucovorin, Organoplatinum Compounds, Oxaliplatin, Pancreatic Neoplasms, Prognosis, Randomized Controlled Trials as Topic, Risk Factors, Survival Analysis, Treatment Outcome, Gemcitabine, Pancreatic cancer, Metastatic, Performance status, FOLFOX, Meta-analysis, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Epidemiology
Abstract

BackgroundPancreatic cancer has a poor prognosis and few choices of therapy. For patients with adequate performance status, FOLFIRINOX or gemcitabine plus nab-paclitaxel are preferred first-line treatment. 5-Fluorouracil (5-FU)-based therapy (e.g. FOLFIRI, OFF, or FOLFOX) are often used in patients who previously received gemcitabine-based regimens. A systematic review was conducted of the safety and efficacy of FOLFOX for metastatic pancreatic cancer following prior gemcitabine-based therapy. A Bayesian fixed-effect meta-analysis with adjustment of patient performance status (PS) was conducted to evaluate overall survival (OS) and compare outcomes with nanoliposomal irinotecan combination therapy.MethodsPubMed.gov , FDA.gov , ClinicalTrials.gov , congress abstracts, Cochrane.org library, and EMBASE database searches were conducted to identify randomized controlled trials of advanced/metastatic disease, prior gemcitabine-based therapy, and second-line treatment with 5-FU and oxaliplatin. The database search dates were January 1, 1990-June 30, 2019. Endpoints were OS and severe treatment-related adverse events (TRAEs). Trial-level PS scores were standardized by converting Karnofsky grade scores to Eastern Cooperative Oncology Group (ECOG) Grade, and overall study-weighted PS was calculated based on weighted average of all patients.ResultsOf 282 studies identified, 11 randomized controlled trials (N = 454) were included in the meta-analysis. Baseline weighted PS scores predicted OS in 10 of the 11 studies, and calculated PS scores of 1.0 were associated with a median OS of 6.3 months (95% posterior interval, 5.4-7.4). After adjusting for baseline PS, FOLFOX had a similar treatment effect profile (median OS, range 2.6-6.7 months) as 5-FU/leucovorin plus nanoliposomal irinotecan therapy (median OS, 6.1 months; 95% confidence interval 4.8-8.9). Neutropenia and fatigue were the most commonly reported Grade 3-4 TRAEs associated with FOLFOX.ConclusionsBaseline PS is a strong prognostic factor when interpreting the efficacy of 5-FU and oxaliplatin-based therapy of pancreatic cancer after progression on first-line gemcitabine-based regimens. When baseline PS is considered, FOLFOX has a similar treatment effect as 5-FU and nanoliposomal irinotecan therapy and a comparable safety profile. These findings suggest that 5-FU and oxaliplatin-based therapies remain an acceptable and alternative second-line treatment option for patients with pancreatic cancer and adequate PS (e.g. ECOG 0-1) following gemcitabine treatment.

Published
2020

8. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study

Author

Abou-Alfa, Ghassan, Alfonso, Jorge Adeva, Aglietta, Massimo, Baron, Ari, Beg, Muhammad, Aguirre, Paula Carrasco, Chen, Eric, Cheng, Ying, Gracián, Antonio Cubillo, Dahan, Laetitia, De Braud, Filippo, Fenocchio, Elisabetta, Gbolohon, Olumide, Gillmore, Roopinder, Jary, Marine, Javle, Milind, Jiang, Yixing, Kang, Jung Hun, King, Gentry George, Kundranda, Madappa, Layos, Laura, Li, Daneng, Liang, Tingbo, Lonardi, Sara, Marathe, Omkar, Mondaca, Sebastian, Martin, Andrés J. Muñoz, Park, Joon Oh, Pazo Cid, Roberto, Fernandez, Paula Ribera, Rimassa, Lorenza, Alonso, Rosa Rodriguez, Sadeghi, Saeed, Scott, Aaron, Tan, Benjamin, Tougeron, David, Yan, Qiang, Yin, Xiaoyu, Zhao, Haitao, Harding, James J, Fan, Jia, Oh, Do-Youn, Choi, Hye Jin, Kim, Jin Won, Chang, Heung-Moon, Bao, Lequn, Sun, Hui-Chuan, Macarulla, Teresa, Xie, Feng, Metges, Jean-Phillippe, Ying, Jie'er, Bridgewater, John, Lee, Myung-Ah, Tejani, Mohamedtaki A, Chen, Emerson Y, Kim, Dong Uk, Wasan, Harpreet, Ducreux, Michel, Bao, Yuanyuan, Boyken, Lisa, Ma, Jiafang, Garfin, Phillip, and Pant, Shubham

Published
2023
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9. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Akce, Mehmet, Ales Diaz, Inmaculada, Alves, Gustavo, Anand, Sumitra, Arslan, Cagatay, Asselah, Jamil, Assenat, Eric, Aubin, Francine, Bai, Li-Yuan, Bai, Yuxian, Barajas, Olga, Bates, Susan, Begbie, Stephen, Ben-Aharon, Irit, Beri, Nina, Berres, Marie-Luise, Blanc, Jean-Frederic, Borbath, Ivan, Bordonaro, Robert, Bouattour, Mohamed, Brandi, Giovanni, Burgoyne, Adam, Butthongkomvong, Kritiya, Camandaroba, Marcos, Cao, Ke, Carballido, Marcela, Chan, Stephan Lam, Chen, Jen-Shi, Chen, Ming-Huang, Chen, Xiaoming, Cheng, Ashley, Chiu, Tai-Jan, Choi, Hye Jin, Chon, Hong Jae, Collignon, Joelle, Cubillo Gracian, Antonio, Davis, Sarah, de Carvalho, Ricardo Saraiva, de Groot, D.J.A., Demols, Anne, De Vos, Judith, Diab, Maria, Easaw, Jacob, Eatock, Martin, Edeline, Julien, Elias, Rawad, Eskens, Fredericus, Falcone, Alfredo, Fernandez, Plinio, Finn, Richard, Franke, Fabio, Furukawa, Masayuki, Furuse, Junji, Gbolahan, Olumide, Geboes, Karen, Geneser, Keri-Lee, Geng, Zhimin, Geva, Ravit, Gillmore, Roopinder, Goetze, Thorsten, Gou, Hongfeng, Grasselli, Julieta, Gu, Shanzhi, Gumus, Mahmut, Haj Mohammad, Nadia, Hao, Chunyi, Harputluoglu, Hakan, Hatoum, Hassan, Heinemann, Volker, Ho, Wang Kwong, Hsu, Chiun, Hubert, Ayala, Hwang, Juneul, Inanc, Mevlude, Iseas, Soledad, Jeyasingam, Vaishnavi, Jimenez Fonseca, Paula, Joubert, Warren, Juengsamarn, Jitlada, Kaen, Diego, Kanai, Masashi, Kasper-Virchow, Stefan, Kazemi, Ghazaleh, Kelleher, Fergal, Kelley, Robin, Kim, Jin Won, Kim, Jong Gwang, Kinupe Abrahao, Ana Beatriz, Klumpen, Heinz, Kochenderfer, Mark, Kose, Fatih, Lam, Ho Ching, Lee, Choong-kun, Lee, Hyun Woo, Lee, Margaret, Lee, Myung Ah, Lee, Wai Man Sarah, Le Sourd, Samuel, Li, Dongliang, Li, Wei, Liang, Houjie, Liang, Tingbo, Lim, Chun Sen, Lingerfelt, Brian, Lopez, Charles, Low, John, Macarulla Mercade, Teresa, Malka, David, Mao, Yimin, Masi, Gianluca, McCune, Steven, McDermott, Ray, McWhirter, Elaine, Mendez, Guillermo, Milella, Michele, Mizuno, Nobumasa, Mizutani, Tomonori, Moniz, Camila, Morales, Luisa, Munoz Martin, Andres Jesús, Nervi, Bruno, Ngamphaiboon, Nuttapong, Oh, Sang Cheul, Oksuzoglu, Berna, Outlaw, Darryl, Ozaka, Masato, Ozguroglu, Mustafa, Ozyilkan, Ozgur, Painemal, Claudio, Pan, Yueyin, Park, Joon Oh, Pelzer, Uwe, Peng, Chuang, Petorin, Caroline, Pezet, Denis, Power, Derek, Qin, Shukui, Ren, Zhenggang, Roohullah, Aflah, Ryu, Hyewon, Salman, Pamela, Sasaki, Mitsuhito, Sasidharan, Rita, Satoh, Taroh, Schulze, Kornelius, Scott-Brown, Martin, Segovia, Ruben, Seufferlein, Thomas, Siena, Salvatore, Sinapi, Isabelle, Smolenschi, Cristina, Song, Tianqiang, Sookprasert, Aumkhae, Soparattanapaisarn, Nopadol, Starling, Naureen, Stein, Stacey, Stemmer, Salomon, Su, Haichuan, Sugimoto, Rie, Suksombooncharoen, Thatthan, Tam, Vincent, Tan, Ai Lian, Tan, Chih Kiang, Tanasanvimon, Suebpong, Tonini, Giuseppe, Tortora, Giampaolo, Tsuji, Akihito, Ueno, Makoto, Uribe, Rodrigo, Venerito, Marino, Verdaguer Mata, Helena, Verslype, Chris, Victorino, Ana Paula, Vogel, Arndt, Wade, James, Waldschmidt, Dirk Thomas, Wang, Lu, Wan Isahk, Wan Zamaniah, Wasan, Harpeet, Weschenfelder, Rui, Wong, Chun Yin, Wong, Yoke Fui, Yalcin, Suayib, Yanez Weber, Patricio, Yang, Xuezhong, Yasui, Hisateru, Yau, Thomas, Yazici, Ozan, Yen, Chia-Jui, Ying, Jieer, Yoo, Changhoon, Yu, Wenchang, Zhao, Haitao, Kelley, Robin Kate, Finn, Richard S, Klümpen, Heinz-Josef, Chan, Stephen L, Valle, Juan W, Yu, Li, Malhotra, Usha, and Siegel, Abby B

Published
2023
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12. Sotorasib for previously treated colorectal cancers with KRASG12C mutation (CodeBreaK100): a prespecified analysis of a single-arm, phase 2 trial

Author

Fakih, Marwan G, Kopetz, Scott, Kuboki, Yasutoshi, Kim, Tae Won, Munster, Pamela N, Krauss, John C, Falchook, Gerald S, Han, Sae-Won, Heinemann, Volker, Muro, Kei, Strickler, John H, Hong, David S, Denlinger, Crystal S, Girotto, Gustavo, Lee, Myung-Ah, Henary, Haby, Tran, Qui, Park, Joseph K, Ngarmchamnanrith, Gataree, Prenen, Hans, and Price, Timothy J

Published
2022
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15. GX-I7(rhIL-7-hyFc, efineptakin alfa), a long-acting IL-7, safely and effectively increased peripheral CD8+ and CD4+ T cells and TILs in patients with solid tumors

Author

Sohn, Joohyuk, primary, Kim, Tae Won, additional, Park, Su-Hyung, additional, Kim, Gun Min, additional, Kim, Sojeong, additional, Lee, Myung Ah, additional, Byun, Mi-Sun, additional, Choi, Donghoon, additional, Yang, Se Hwan, additional, Woo, JungWon, additional, Sung, Young Chul, additional, and Shin, Eui-Cheol, additional

Published
2024
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16. The Impact of a Summer Camp-Based Science Methods Course on Preservice Teachers' Self-Efficacy in Teaching Science as Inquiry

Author

Seung, Elsun, Park, Soonhye, and Lee, Myung-Ah

Abstract

The purpose of this research is to examine the effect of a summer camp-based science methods course on elementary pre-service teachers' self-efficacy in teaching science as inquiry. The science camp was offered to K-6 students as part of the 4-week, 3-credit science teaching methods course over the summer. The pre-service teachers were asked to teach camp children for two weeks for their practicum requirement. This study utilized a mixed-methods design using both qualitative and quantitative data collected with 55 participants over four years. The TSI (Teaching Science as Inquiry) was administered at the beginning and end of the course to estimate participants' self-efficacy. We only measured PSTEB (Personal Science Teaching Efficacy Belief) using 34 items out of the TSI to reduce test fatigue. We also conducted semi-structured interviews at the end of the course to investigate sources for their self-efficacy. The paired samples t-test of the pre- and post-course survey indicates that pre-service teachers' self-efficacy in teaching science as inquiry increased significantly as a result of participating in the course (p < 0.001). Analysis of the interview data revealed eight main sources of self-efficacy and each one's relative significance compared to other sources. The findings of this study imply that the camp-based course increased pre-service teachers' self-efficacy by providing not only various mastery experiences, but also unique experiences that afforded reflection and mentoring, and drew camp participants' positive reactions. This study highlights the potential of informal science education settings as field experience sites especially for elementary science methods courses.

Published
2019
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17. Impact of COVID-19 Infection and Its Association With Previous Vaccination in Patients With Myasthenia Gravis in Korea: A Multicenter Retrospective Study

Author

Han, Hee Jo, primary, Kim, Seung Woo, additional, Kim, Hyunjin, additional, So, Jungmin, additional, Lee, Eun-Jae, additional, Lim, Young-Min, additional, Lee, Jung Hwan, additional, Lee, Myung Ah, additional, Kim, Byung-Jo, additional, Baek, Seol-Hee, additional, Lee, Hyung-Soo, additional, Sohn, Eunhee, additional, Kim, Sooyoung, additional, Park, Jin-Sung, additional, Kang, Minsung, additional, Park, Hyung Jun, additional, Yoon, Byeol-A, additional, Kim, Jong Kuk, additional, Seok, Hung Youl, additional, Kim, Sohyeon, additional, Min, Ju-Hong, additional, Chung, Yeon Hak, additional, Cho, Jeong Hee, additional, Kim, Jee-Eun, additional, Oh, Seong-il, additional, and Shin, Ha Young, additional

Published
2024
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21. Plain Language Summary of the TOPAZ-1 Study: Durvalumab and Chemotherapy for Advanced Biliary Tract Cancer

Author

Oh, Do-Youn, primary, He, Aiwu Ruth, additional, Qin, Shukui, additional, Chen, Li-Tzong, additional, Okusaka, Takuji, additional, Vogel, Arndt, additional, Kim, Jin Won, additional, Suksombooncharoen, Thatthan, additional, Lee, Myung Ah, additional, Kitano, Masayuki, additional, Burris, Howard, additional, Bouattour, Mohamed, additional, Tanasanvimon, Suebpong, additional, McNamara, Mairead G., additional, Zaucha, Renata, additional, Avallone, Antonio, additional, Tan, Benjamin, additional, Cundom, Juan, additional, Lee, Choong-kun, additional, Takahashi, Hidenori, additional, Ikeda, Masafumi, additional, Chen, Jen-Shi, additional, Wang, Julie, additional, Makowsky, Mallory, additional, Rokutanda, Nana, additional, Żotkiewicz, Magdalena, additional, Kurland, John F., additional, Cohen, Gordon, additional, and Valle, Juan W., additional

Published
2023
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25. Phase I/II study of first-line combination therapy with sorafenib plus resminostat, an oral HDAC inhibitor, versus sorafenib monotherapy for advanced hepatocellular carcinoma in east Asian patients

Author

Tak, Won Young, Ryoo, Baek-Yeol, Lim, Ho Yeong, Kim, Do-Young, Okusaka, Takuji, Ikeda, Masafumi, Hidaka, Hisashi, Yeon, Jong-Eun, Mizukoshi, Eishiro, Morimoto, Manabu, Lee, Myung-Ah, Yasui, Kohichiroh, Kawaguchi, Yasunori, Heo, Jeong, Morita, Sojiro, Kim, Tae-You, Furuse, Junji, Katayama, Kazuhiro, Aramaki, Takeshi, Hara, Rina, Kimura, Takuya, Nakamura, Osamu, and Kudo, Masatoshi

Published
2018
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26. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study

Author

Harding, James J, primary, Fan, Jia, additional, Oh, Do-Youn, additional, Choi, Hye Jin, additional, Kim, Jin Won, additional, Chang, Heung-Moon, additional, Bao, Lequn, additional, Sun, Hui-Chuan, additional, Macarulla, Teresa, additional, Xie, Feng, additional, Metges, Jean-Phillippe, additional, Ying, Jie'er, additional, Bridgewater, John, additional, Lee, Myung-Ah, additional, Tejani, Mohamedtaki A, additional, Chen, Emerson Y, additional, Kim, Dong Uk, additional, Wasan, Harpreet, additional, Ducreux, Michel, additional, Bao, Yuanyuan, additional, Boyken, Lisa, additional, Ma, Jiafang, additional, Garfin, Phillip, additional, Pant, Shubham, additional, Abou-Alfa, Ghassan, additional, Alfonso, Jorge Adeva, additional, Aglietta, Massimo, additional, Baron, Ari, additional, Beg, Muhammad, additional, Aguirre, Paula Carrasco, additional, Chen, Eric, additional, Cheng, Ying, additional, Gracián, Antonio Cubillo, additional, Dahan, Laetitia, additional, De Braud, Filippo, additional, Fenocchio, Elisabetta, additional, Gbolohon, Olumide, additional, Gillmore, Roopinder, additional, Jary, Marine, additional, Javle, Milind, additional, Jiang, Yixing, additional, Kang, Jung Hun, additional, King, Gentry George, additional, Kundranda, Madappa, additional, Layos, Laura, additional, Li, Daneng, additional, Liang, Tingbo, additional, Lonardi, Sara, additional, Marathe, Omkar, additional, Mondaca, Sebastian, additional, Martin, Andrés J. Muñoz, additional, Park, Joon Oh, additional, Pazo Cid, Roberto, additional, Fernandez, Paula Ribera, additional, Rimassa, Lorenza, additional, Alonso, Rosa Rodriguez, additional, Sadeghi, Saeed, additional, Scott, Aaron, additional, Tan, Benjamin, additional, Tougeron, David, additional, Yan, Qiang, additional, Yin, Xiaoyu, additional, and Zhao, Haitao, additional

Published
2023
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28. Prospective, open‐label, and observational study of cetuximab for metastatic colorectal carcinoma: The OPTIM1SE study.

Author

Yang, Tsai‐Sheng, Chen, Hong‐Hwa, Bo‐Wen, Lin, Kim, Tae Won, Kim, Jong Gwang, Ahn, Joong Bae, Lee, Myung‐Ah, Lin, Johnson, Ho, Gwo Fuang, Anh, Le Tuan, Temraz, Sally, Burge, Matthew, Chua, Clarinda, Huang, Jason, and Park, Young Suk

Subjects
CETUXIMAB, COLORECTAL cancer, ELECTRONIC health records, SCIENTIFIC observation, OXALIPLATIN
Abstract

Aim: The OPTIM1SE study observed long‐term real‐world outcomes of cetuximab‐based infusional 5‐fluorouracil (5‐FU) regimens for first‐line treatment of metastatic colorectal cancer (mCRC) across Asia‐Pacific and Middle East regions, aiming to characterize their use, effectiveness, and safety in routine practice. Methods: OPTIM1SE was a prospective, open‐label, observational study. Patients with untreated KRAS wild‐type mCRC and distant metastases were treated per locally approved labels and monitored for 3 years via electronic medical records. The primary endpoint was the overall response rate (ORR). Secondary endpoints included safety, progression‐free survival (PFS), and overall survival (OS). Results: From November 19, 2013, to June 30, 2016, 520 patients were enrolled in 51 sites. Patients were mostly male (61.2%), with a mean age of 58.5 (±12.0) years; 420 patients received leucovorin, 5‐FU, and irinotecan–based regimens and 94 received leucovorin, 5‐FU, and oxaliplatin. The most common primary tumor site was the rectum (38.8%), with liver metastases (65.0%). ORR was 45.4% (95% CI, 41.1%–49.7%), including 26 patients (5.0%) with a complete response. Median PFS was 9.9 months (95% CI, 8.2–11.0); median OS (mOS) was 30.8 months (95% CI, 27.9–33.6). Higher mOS was associated with tumors of left compared with right‐sided origin (hazard ratio, 0.69 [95% CI, 0.49–0.99]); higher ORR was also associated with liver metastases compared with all other metastases (55.4% vs. 40.2%). Adverse events were consistent with the known safety profile of cetuximab. Conclusion: Cetuximab‐based 5‐FU regimens were effective first‐line treatments for mCRC in routine practice, particularly in patients with left‐sided disease and liver metastases only. [ABSTRACT FROM AUTHOR]

Published
2023
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29. Predicting cumulative incidence of adverse events in older patients with cancer undergoing first-line palliative chemotherapy: Korean Cancer Study Group (KCSG) multicentre prospective study

Author

Kim, Jin Won, Lee, Yun-Gyoo, Hwang, In Gyu, Song, Hong Suk, Koh, Su Jin, Ko, Yoon Ho, Shin, Seong Hoon, Woo, In Sook, Hong, Soojung, Kim, Tae-Yong, Kim, Sun Young, Nam, Byung-Ho, Kim, Hyun Jung, Kim, Hyo Jung, Lee, Myung Ah, Kwon, Jung Hye, Hong, Yong Sang, Bae, Sung Hwa, Koo, Dong-Hoe, Kim, Kwang-Il, and Kim, Jee Hyun

Published
2018
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31. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Kelley, Robin Kate, primary, Ueno, Makoto, additional, Yoo, Changhoon, additional, Finn, Richard S, additional, Furuse, Junji, additional, Ren, Zhenggang, additional, Yau, Thomas, additional, Klümpen, Heinz-Josef, additional, Chan, Stephen L, additional, Ozaka, Masato, additional, Verslype, Chris, additional, Bouattour, Mohamed, additional, Park, Joon Oh, additional, Barajas, Olga, additional, Pelzer, Uwe, additional, Valle, Juan W, additional, Yu, Li, additional, Malhotra, Usha, additional, Siegel, Abby B, additional, Edeline, Julien, additional, Vogel, Arndt, additional, Akce, Mehmet, additional, Ales Diaz, Immaculada, additional, Alves, Gustavo, additional, Anand, Sumitra, additional, Arslan, Cagatay, additional, Asselah, Jamil, additional, Assenat, Eric, additional, Aubin, Francine, additional, Bai, Li-Yuan, additional, Bai, Yuxian, additional, Bates, Susan, additional, Begbie, Stephen, additional, Ben-Aharon, Irit, additional, Beri, Nina, additional, Berres, Marie-Luise, additional, Blanc, Jean-Frederic, additional, Borbath, Ivan, additional, Bordonaro, Robert, additional, Brandi, Giovanni, additional, Burgoyne, Adam, additional, Butthongkomvong, Kritiya, additional, Cao, Ke, additional, Carballido, Marcela, additional, Camandaroba, Marcos, additional, Chang, Stephan Lam, additional, Chen, Jen-Shi, additional, Chen, Ming-Huang, additional, Chen, Xiaoming, additional, Cheng, Ashley, additional, Chiu, Tai-Jan, additional, Choi, Hye Jin, additional, Chon, Hong Jae, additional, Collignon, Joelle, additional, Cubillo Gracian, Antonio, additional, Davis, Sarah, additional, de Carvalho, Ricardo Saraiva, additional, de Groot, D.J.A., additional, Demols, Anne, additional, De Vos, Judith, additional, Diab, Maria, additional, Easaw, Jacob, additional, Eatock, Martin, additional, Elias, Rawad, additional, Eskens, Fredericus, additional, Falcone, Alfredo, additional, Fernandez, Plinio, additional, Finn, Richard, additional, Franke, Fabio, additional, Furukawa, Masayuki, additional, Gbolahan, Olumide, additional, Geboes, Karen, additional, Geneser, Keri-Lee, additional, Geng, Zhimin, additional, Geva, Ravit, additional, Gillmore, Roopinder, additional, Goetze, Thorsten, additional, Gou, Hongfeng, additional, Grasselli, Julieta, additional, Gu, Shanzhi, additional, Gumus, Mahmut, additional, Haj Mohammad, Nadia, additional, Hao, Chunyi, additional, Harputluoglu, Hakan, additional, Hatoum, Hassan, additional, Heinemann, Volker, additional, Ho, Wang Kwong, additional, Hsu, Chiun, additional, Hubert, Ayala, additional, Hwang, Juneul, additional, Inanc, Mevlude, additional, Iseas, Soledad, additional, Jeyasingam, Vaishnavi, additional, Jimenez Fonseca, Paula, additional, Joubert, Warren, additional, Juengsamarn, Jitlada, additional, Kaen, Diego, additional, Kanai, Masahi, additional, Kasper-Virchow, Stefan, additional, Kazemi, Ghazaleh, additional, Kelleher, Fergal, additional, Kelley, Robin, additional, Kim, Jin Won, additional, Kim, Jong Gwang, additional, Kinupe Abrahao, Ana Beatriz, additional, Klumpen, Heinz, additional, Kochenderfer, Mark, additional, Kose, Fatih, additional, Lam, Ho Ching, additional, Lee, Choong-kun, additional, Lee, Hyun Woo, additional, Lee, Margaret, additional, Lee, Myung Ah, additional, Lee, Wai Man Sarah, additional, Le Sourd, Samuel, additional, Li, Dongliang, additional, Li, Wei, additional, Liang, Houjie, additional, Liang, Tingbo, additional, Lim, Chun Sen, additional, Lingerfelt, Brian, additional, Lopez, Charles, additional, Low, John, additional, Macarulla Mercade, Teresa, additional, Malka, David, additional, Mao, Yimin, additional, Masi, Gianluca, additional, McCune, Steven, additional, McDermott, Ray, additional, McWhirter, Elaine, additional, Mendez, Guillermo, additional, Milella, Michele, additional, Mizutani, Tomonori, additional, Moniz, Camila, additional, Morales, Luisa, additional, Munoz Martin, Andres Jesús, additional, Nervi, Bruno, additional, Ngamphaiboon, Nuttapong, additional, Oh, Sang Cheul, additional, Oksuzoglu, Berna, additional, Outlaw, Darryl, additional, Ozguroglu, Mustafa, additional, Ozyilkan, Ozgur, additional, Painemeal, Claudio, additional, Pan, Yueyin, additional, Peng, Chuang, additional, Petorin, Caroline, additional, Pezet, Denis, additional, Power, Derek, additional, Qin, Shukui, additional, Roohullah, Aflah, additional, Ryu, Hyewon, additional, Salman, Pamela, additional, Sasidharan, Rita, additional, Satho, Taroh, additional, Schulze, Kornelius, additional, Scott-Brown, Martin, additional, Segovia, Ruben, additional, Seufferlin, Thomas, additional, Siena, Salvatore, additional, Sinapi, Isabelle, additional, Smolenschi, Cristina, additional, Song, Tianqiang, additional, Sookprasert, Aumkhae, additional, Soparattanapaisarn, Nopadol, additional, Starling, Naureen, additional, Stein, Stacey, additional, Stemmer, Salomon, additional, Su, Haichuan, additional, Sugimoto, Rie, additional, Suksombooncharoen, Thatthan, additional, Tam, Vincent, additional, Tan, Ai Lian, additional, Tan, Chih Kiang, additional, Tanasanvimon, Suebpong, additional, Tonini, Giuseppe, additional, Tortora, Giampaolo, additional, Tsuji, Akihito, additional, Uribe, Rodrigo, additional, Venerito, Marino, additional, Verdaguer Mata, Helena, additional, Victorino, Ana Paula, additional, Wade, James, additional, Waldschmidt, Dirk Thomas, additional, Wang, Lu, additional, Wan Isahk, Wan Zamaniah, additional, Wasan, Harpeet, additional, Weschenfelder, Rui, additional, Wong, Chun Yin, additional, Wong, Yoke Fui, additional, Yalcin, Suayib, additional, Yanez Weber, Patricio, additional, Yang, Xuezhong, additional, Yasui, Hisateru, additional, Yazici, Ozan, additional, Yen, Chia-Jui, additional, Ying, Jieer, additional, Yu, Wenchang, additional, and Zhao, Haitao, additional

Published
2023
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33. A randomized, multi-center phase III trial of adjuvant chemotherapy with gemcitabine and capecitabine (GemCap) compared to capecitabine (Cap) alone in curatively resected biliary tract cancer (BilGemCap Study): KCSG HB20-14.

Author

Park, Joon Oh, primary, Park, Joon Seong, additional, Lee, Choong-kun, additional, Chon, Hong Jae, additional, Choi, Sae Byeol, additional, Hwang, Dae Wook, additional, Oh, Do-Youn, additional, Lee, Myung Ah, additional, Jang, Jin-Young, additional, and Ryoo, Baek-Yeol, additional

Published
2023
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35. Real-World Study of Systemic Treatment after First-Line Atezolizumab plus Bevacizumab for Hepatocellular Carcinoma in Asia-Pacific Countries

Author

Lee, Choong-kun, Yoo, Changhoon, Hong, Jung Yong, Park, Se Jun, Kim, Jin Won, Tai, David Wai Meng, Kim, Hyeyeong, Korphaisarn, Krittiya, Tanasanvimon, Suebpong, Chen, San-Chi, Kim, Ju Won, Kim, Ilhwan, Kim, Moonho, Choo, Joan, Oh, Sang-Bo, Chen, Ching-Tso, Bae, Woo Kyun, Kim, Hongsik, Huh, Seok Jae, Yen, Chia-Jui, Park, Sejung, Lee, Dong Ki, Chan, Landon Long, Kang, Beodeul, Kang, Minsu, Sundar, Raghav, Choi, Hye Jin, Chan, Stephen Lam, Chon, Hong Jae, and Lee, Myung-Ah

Abstract

Introduction:Atezolizumab plus bevacizumab is a commonly used first-line regimen for advanced hepatocellular carcinoma (HCC) treatment owing to its superior outcomes compared to sorafenib. However, optimal subsequent treatment options for patients with HCC who progressed on first-line atezolizumab plus bevacizumab remain unclear. Methods:This multinational, multi-institutional, retrospective study included patients with HCC from 22 centers in five Asia-Pacific countries who were treated with first-line atezolizumab plus bevacizumab, which was discontinued for any reason. The endpoints included progression-free survival (PFS) and overall survival (OS) according to patient characteristics and second-line regimens. Results:Between June 2016 and May 2023, 1,141 patients were treated with first-line atezolizumab plus bevacizumab, of whom 629 (55.1%) received subsequent treatment. Sorafenib and lenvatinib were the most commonly administered second-line regimens (53.9% and 25.6%, respectively). Overall, the median PFS and OS were 2.9 and 8.0 months, respectively. Lenvatinib had longer PFS (4.0 vs. 2.3 months) and OS (8.0 vs. 6.3 months) than sorafenib. Patients treated with tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) (n= 50, 8.3%) showed PFS and OS of 5.4 and 12.6 months, respectively. Lower tumor burden and lenvatinib or TKI plus ICI use were associated with longer second-line PFS. Preserved liver function was associated with improved OS. Conclusions:In patients with HCC who progressed on first-line atezolizumab plus bevacizumab, sorafenib and lenvatinib were the most commonly used second-line regimens in Asia-Pacific countries, with lenvatinib resulting in longer OS than sorafenib. The second-line TKI plus ICI combination exhibited promising efficacy, suggesting the potential role of continuing ICIs beyond disease progression.

Published
2024
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36. Early Increase in Circulating PD-1 + CD8 + T Cells Predicts Favorable Survival in Patients with Advanced Gastric Cancer Receiving Chemotherapy.

Author

Shin, Kabsoo, Kim, Joori, Park, Se Jun, Kim, Hyunho, Lee, Myung Ah, Kim, Okran, Park, Juyeon, Kang, Nahyeon, and Kim, In-Ho

Subjects
STOMACH tumors, PROGRAMMED cell death 1 receptors, CANCER chemotherapy, MULTIVARIATE analysis, RETROSPECTIVE studies, PLATINUM, GENE expression, SURVIVAL analysis (Biometry), RESEARCH funding, T cells, TUMOR markers, PROGRESSION-free survival, BLOOD
Abstract

Simple Summary: There is a lack of biomarkers for predicting the response to chemotherapy in gastric cancer (GC). This study investigates the prognostic significance of PD-1 expression in CD8+ T cells in the blood of 68 patients with advanced GC receiving platinum-based chemotherapy. Patients were divided based on baseline frequencies of PD-1+CD8+ T cells and whether these frequencies increased or decreased on day 7 after treatment. While baseline frequencies of PD-1+CD8+ T cells had no impact on survival, the patients whose frequencies of PD-1+CD8+ T cells increased on day 7 from the treatment initiation showed significantly longer survival than those whose frequencies of PD-1+CD8+ T cells decreased. This difference was also reflected in the mean duration of response between the groups. These findings suggest that an early increase in frequencies of PD-1+CD8+ T cells could predict favorable prognoses and durable responses in patients with advanced GC receiving chemotherapy. The clinical significance of PD-1 expression in circulating CD8+ T cells in patients with gastric cancer (GC) receiving chemotherapy remains unelucidated. Therefore, we aimed to examine its prognostic significance in blood samples of 68 patients with advanced GC who received platinum-based chemotherapy. The correlation between peripheral blood mononuclear cells, measured using fluorescence-activated cell sorting, was evaluated. Patients were divided into two groups according to the changes in PD-1+CD8+ T-cell frequencies between day 0 and 7. They were categorized as increased or decreased PD-1+CD8+ T-cell groups. The increased PD-1+CD8+ T-cell group showed longer progression-free survival (PFS) and overall survival (OS) than the decreased PD-1+CD8+ T-cell group (PFS: 8.7 months vs. 6.1 months, p = 0.007; OS: 20.7 months vs. 10.8 months, p = 0.003). The mean duration of response was significantly different between the groups (5.7 months vs. 2.5 months, p = 0.041). Multivariate analysis revealed that an increase in PD-1+CD8+ T-cell frequency was an independent prognostic factor. We concluded that the early increase in PD-1+CD8+ T-cell frequency is a potential predictor of favorable prognoses and durable responses in patients with advanced GC receiving chemotherapy. [ABSTRACT FROM AUTHOR]

Published
2023
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37. Adjuvant gemcitabine plus cisplatin versus capecitabine in node-positive extrahepatic cholangiocarcinoma: the STAMP randomized trial

Author

Jeong, Hyehyun, primary, Kim, Kyu-pyo, additional, Jeong, Jae Ho, additional, Hwang, Dae Wook, additional, Lee, Jae Hoon, additional, Kim, Ki-Hun, additional, Moon, Deok-Bog, additional, Lee, Myung Ah, additional, Park, Se Jun, additional, Chon, Hong Jae, additional, Park, Jin-hong, additional, Lee, Ji Sung, additional, Ryoo, Baek-Yeol, additional, and Yoo, Changhoon, additional

Published
2023
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43. Prognostic implication of serum AFP in patients with hepatocellular carcinoma treated with regorafenib

Author

Lim, Dong-Hoon, primary, Casadei-Gardini, Andrea, additional, Lee, Myung Ah, additional, Lonardi, Sara, additional, Kim, Jin Won, additional, Masi, Gianluca, additional, Chon, Hong Jae, additional, Rimini, Margherita, additional, Kim, Ilhwan, additional, Cheon, Jaekyung, additional, Hwang, Jun-Eul, additional, Kang, Jung Hun, additional, Lim, Ho Yeong, additional, and Yoo, Changhoon, additional

Published
2022
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46. Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer.

Author

Burris III, Howard A., primary, Okusaka, Takuji, additional, Vogel, Arndt, additional, Lee, Myung Ah, additional, Takahashi, Hidenori, additional, Breder, Valeriy Vladimirovich, additional, Blanc, Jean-Frédéric, additional, Li, Junhe, additional, Watras, Magdalena, additional, Xiong, Julia, additional, Abraham, Jayne, additional, Patel, Nikunj, additional, Wang, Julie, additional, Rokutanda, Nana, additional, Cohen, Gordon, additional, and Oh, Do-Youn, additional

Published
2022
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47. Adjuvant gemcitabine plus cisplatin (GemCis) versus capecitabine (CAP) in patients (pts) with resected lymph node (LN)-positive extrahepatic cholangiocarcinoma (CCA): A multicenter, open-label, randomized, phase 2 study (STAMP).

Author

Yoo, Changhoon, primary, Jeong, Hyehyun, additional, Kim, Kyu-Pyo, additional, Hwang, Dae Wook, additional, Lee, Jae-Hoon, additional, Kim, Ki-Hun, additional, Moon, Deok Bok, additional, Lee, Myung Ah, additional, Park, Se Jun, additional, Chon, Hong Jae, additional, Park, Jin-hong, additional, Lee, Ji Sung, additional, and Ryoo, Baek-Yeol, additional

Published
2022
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48. Trastuzumab plus FOLFOX for gemcitabine/cisplatin refractory HER2-positive biliary tract cancer: A multi-institutional phase II trial of the Korean Cancer Study Group (KCSG-HB19-14).

Author

Lee, Choong-kun, primary, Chon, Hong Jae, additional, Cheon, Jaekyung, additional, Lee, Myung Ah, additional, Im, Hyeon-Su, additional, Jang, Joung-Soon, additional, Kim, Min Hwan, additional, Ock, Chan-Young, additional, Kim, Jin Won, additional, Park, Hyung Soon, additional, Kang, Myoung Joo, additional, and Choi, Hye Jin, additional

Published
2022
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