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3. Nivolumab plus chemotherapy in patients with HER2-negative, previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: 3-year follow-up of the ATTRACTION-4 randomized, double-blind, placebo-controlled, phase 3 trial

Author

Boku, Narikazu, Omori, Takeshi, Shitara, Kohei, Sakuramoto, Shinichi, Yamaguchi, Kensei, Kato, Ken, Kadowaki, Shigenori, Tsuji, Kunihiro, Ryu, Min-Hee, Oh, Do-Youn, Oh, Sang Cheul, Rha, Sun Young, Lee, Keun-Wook, Chung, Ik-Joo, Sym, Sun Jin, Chen, Li-Tzong, Chen, Jen-Shi, Bai, Li-Yuan, Nakada, Takashi, Hagihara, Shunsuke, Makino, Reina, Nishiyama, Eiji, and Kang, Yoon-Koo

Published
2024
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10. Clinical practice guidelines for esophagogastric junction cancer: Upper GI Oncology Summit 2023

Author

Kitagawa, Yuko, Matsuda, Satoru, Gotoda, Takuji, Kato, Ken, Wijnhoven, Bas, Lordick, Florian, Bhandari, Pradeep, Kawakubo, Hirofumi, Kodera, Yasuhiro, Terashima, Masanori, Muro, Kei, Takeuchi, Hiroya, Mansfield, Paul F., Kurokawa, Yukinori, So, Jimmy, Mönig, Stefan Paul, Shitara, Kohei, Rha, Sun Young, Janjigian, Yelena, Takahari, Daisuke, Chau, Ian, Sharma, Prateek, Ji, Jiafu, de Manzoni, Giovanni, Nilsson, Magnus, Kassab, Paulo, Hofstetter, Wayne L., Smyth, Elizabeth Catherine, Lorenzen, Sylvie, Doki, Yuichiro, Law, Simon, Oh, Do-Youn, Ho, Khek Yu, Koike, Tomoyuki, Shen, Lin, van Hillegersberg, Richard, Kawakami, Hisato, Xu, Rui-Hua, Wainberg, Zev, Yahagi, Naohisa, Lee, Yeong Yeh, Singh, Rajvinder, Ryu, Min-Hee, Ishihara, Ryu, Xiao, Zili, Kusano, Chika, Grabsch, Heike Irmgard, Hara, Hiroki, Mukaisho, Ken-ichi, Makino, Tomoki, Kanda, Mitsuro, Booka, Eisuke, Suzuki, Sho, Hatta, Waku, Kato, Motohiko, Maekawa, Akira, Kawazoe, Akihito, Yamamoto, Shun, Nakayama, Izuma, Narita, Yukiya, Yang, Han-Kwang, Yoshida, Masahiro, and Sano, Takeshi

Published
2024
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12. Rivoceranib, a VEGFR-2 inhibitor, monotherapy in previously treated patients with advanced or metastatic gastric or gastroesophageal junction cancer (ANGEL study): an international, randomized, placebo-controlled, phase 3 trial

Author

Kang, Yoon-Koo, Ryu, Min-Hee, Di Bartolomeo, Maria, Chau, Ian, Yoon, Harry, Kim, Jong Gwang, Lee, Keun-Wook, Oh, Sang Chul, Takashima, Atsuo, Kryzhanivska, Anna, Chao, Yee, Evesque, Ludovic, Schenker, Michael, McGinn, Arlo, Zhao, Yufan, Lee, Jennifer, Wyrwicz, Lucjan, and Boku, Narikazu

Published
2024
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13. Association between gene expression signatures and clinical outcomes of pembrolizumab versus paclitaxel in advanced gastric cancer: exploratory analysis from the randomized, controlled, phase III KEYNOTE-061 trial.

Author

Shitara, Kohei, Di Bartolomeo, Maria, Mandala, Mario, Ryu, Min-Hee, Caglevic, Christian, Olesinski, Tomasz, Chung, Hyun, Muro, Kei, Goekkurt, Eray, McDermott, Raymond, Mansoor, Wasat, Shih, Chie-Schin, Kobie, Julie, Nebozhyn, Michael, Cristescu, Razvan, Cao, Z, Loboda, Andrey, Özgüroğlu, Mustafa, and Wainberg, Zev

Subjects
Gastrointestinal Neoplasms, Gene Expression Profiling, Genetic Markers, Immunotherapy, Programmed Cell Death 1 Receptor, Humans, Paclitaxel, Stomach Neoplasms, Transcriptome, Antibodies, Monoclonal, Humanized
Abstract

BACKGROUND: In the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit a longer duration of response and offered a favorable safety profile. This prespecified exploratory analysis was conducted to evaluate associations between tumor gene expression signatures and clinical outcomes in the phase III KEYNOTE-061 trial. METHODS: Using RNA sequencing data obtained from formalin-fixed, paraffin-embedded baseline tumor tissue samples, we evaluated the 18-gene T-cell-inflamed gene expression profile (TcellinfGEP) and 10 non-TcellinfGEP signatures (angiogenesis, glycolysis, granulocytic myeloid-derived suppressor cell (gMDSC), hypoxia, monocytic MDSC (mMDSC), MYC, proliferation, RAS, stroma/epithelial-to-mesenchymal transition/transforming growth factor-β, WNT). The association between each signature on a continuous scale and outcomes was analyzed using logistic (objective response rate (ORR)) and Cox proportional hazards regression (progression-free survival (PFS) and OS). One-sided (pembrolizumab) and two-sided (paclitaxel) p values were calculated for TcellinfGEP (prespecified α=0.05) and the 10 non-TcellinfGEP signatures (multiplicity-adjusted; prespecified α=0.10). RESULTS: RNA sequencing data were available for 137 patients in each treatment group. TcellinfGEP was positively associated with ORR (p=0.041) and PFS (p=0.026) for pembrolizumab but not paclitaxel (p>0.05). The TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR (p=0.077), PFS (p=0.057), and OS (p=0.033) for pembrolizumab, while the TcellinfGEP-adjusted glycolysis (p=0.018), MYC (p=0.057), and proliferation (p=0.002) signatures were negatively associated with OS for paclitaxel. CONCLUSIONS: This exploratory analysis of tumor TcellinfGEP showed associations with ORR and PFS for pembrolizumab but not for paclitaxel. TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR, PFS, and OS for pembrolizumab but not paclitaxel. These data suggest myeloid-driven suppression may play a role in resistance to PD-1 inhibition in G/GEJ cancer and support a strategy of considering immunotherapy combinations which target this myeloid axis. TRIAL REGISTRATION NUMBER: NCT02370498.

Published
2023

17. Adjuvant nivolumab plus chemotherapy versus placebo plus chemotherapy for stage III gastric or gastro-oesophageal junction cancer after gastrectomy with D2 or more extensive lymph-node dissection (ATTRACTION-5): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial

Author

Kang, Yoon-Koo, Terashima, Masanori, Kim, Young-Woo, Boku, Narikazu, Chung, Hyun Cheol, Chen, Jen-Shi, Ji, Jiafu, Yeh, Ta-Sen, Chen, Li-Tzong, Ryu, Min-Hee, Kim, Jong Gwang, Omori, Takeshi, Rha, Sun Young, Kim, Tae Yong, Ryu, Keun Won, Sakuramoto, Shinichi, Nishida, Yasunori, Fukushima, Norimasa, Yamada, Takanobu, Bai, Li-Yuan, Hirashima, Yoshinori, Hagihara, Shunsuke, Nakada, Takashi, and Sasako, Mitsuru

Published
2024
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22. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100

Author

Moehler, Markus, Dvorkin, Mikhail, Boku, Narikazu, Özgüroğlu, Mustafa, Ryu, Min-Hee, Muntean, Alina S, Lonardi, Sara, Nechaeva, Marina, Bragagnoli, Arinilda C, Coşkun, Hasan S, Gracian, Antonio Cubillo, Takano, Toshimi, Wong, Rachel, Safran, Howard, Vaccaro, Gina M, Wainberg, Zev A, Silver, Matthew R, Xiong, Huiling, Hong, Janet, Taieb, Julien, and Bang, Yung-Jue

Subjects
Rare Diseases, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Capecitabine, Female, Fluorouracil, Follow-Up Studies, Humans, Induction Chemotherapy, Maintenance Chemotherapy, Male, Middle Aged, Oxaliplatin, Prognosis, Stomach Neoplasms, Survival Rate, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe role of maintenance therapy for gastric (GC) or gastroesophageal junction cancer (GEJC) is unclear. We investigated avelumab (anti-programmed death ligand-1 [PD-L1]) maintenance after first-line induction chemotherapy for GC/GEJC.Patients and methodsJAVELIN Gastric 100 was a global, open-label, phase III trial. Eligible patients had untreated, unresectable, human epidermal growth factor receptor 2-negative, locally advanced or metastatic GC or GEJC. Patients without progressive disease after 12 weeks of first-line chemotherapy with oxaliplatin plus a fluoropyrimidine were randomly assigned 1:1 to avelumab 10 mg/kg every 2 weeks or continued chemotherapy, stratified by region (Asia v non-Asia). The primary end point was overall survival (OS) after induction chemotherapy in all randomly assigned patients or the PD-L1-positive randomly assigned population (≥ 1% of tumor cells; 73-10 assay).ResultsA total of 805 patients received induction; 499 were randomly assigned to avelumab (n = 249) or continued chemotherapy (n = 250). Median OS was 10.4 months (95% CI, 9.1 to 12.0 months) versus 10.9 months (95% CI, 9.6 to 12.4 months) and 24-month OS rate was 22.1% versus 15.5% with avelumab versus chemotherapy, respectively (hazard ratio [HR], 0.91; 95% CI, 0.74 to 1.11; P = .1779). In the PD-L1-positive population (n = 54), the HR for OS was 1.13 (95% CI, 0.57 to 2.23; P = .6352). In an exploratory analysis of the PD-L1-positive population, defined as combined positive score ≥ 1 (22C3 assay; n = 137), median OS was 14.9 months (95% CI, 8.7 to 17.3 months) with avelumab versus 11.6 months (95% CI, 8.4 to 12.6 months) with chemotherapy (unstratified HR, 0.72; 95% CI, 0.49 to 1.05). With avelumab and chemotherapy, treatment-related adverse events (TRAEs) occurred in 149 (61.3%) and 184 (77.3%) patients, including grade ≥ 3 TRAEs in 31 (12.8%) and 78 (32.8%) patients, respectively.ConclusionJAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1-positive population.

Published
2021

23. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial

Author

Mendez, Guillermo, O'Connor, Juan Manuel, Yanzi Castilla, Alvaro, Cundom, Juan, Kaen, Diego, Wong, Rachel, Ng, Weng, Aghmesheh, Morteza, Peressoni, Mauricio, Andrade, Carlos, Franke, Fabio, Alves, Gustavo, Cruz, Felipe Jose, Vianna, Karina, Monteiro, Maria Marcela, Raphael, Michael, Berry, Scott, Jang, Raymond, Tan, Ann, Asselah, Jamil, Yanez Weber, Patricio, Mahave, Mauricio, Sanchez, Cesar, Salman, Pamela, Bai, Yuxian, Li, Jin, Zhang, Xiaochun, Liu, Tianshu, Lin, Xiaoyan, Qin, Shukui, Yang, Jianwei, Luo, Suxia, Li, Wei, Ying, Jieer, Chen, Xi, Zeng, Shan, Qu, Yanli, Yang, Lin, Zhao, Lin, Chen, Ping, Pan, Hongming, Li, Enxiao, Ye, Feng, Lu, Jianwei, Liang, Xinjun, Zhao, Qun, Yin, Xianli, Li, Junhe, Ling, Yang, Lv, Guoqing, Li, Shouguo, Guerrero, Alvaro, Rubiano, Juan, Gonzalez Fernandez, Manuel, Manneh Kopp, Ray, Guzman Ramirez, Adrian, Corrales, Luis, Gonzalez Herrera, Ileana, Melichar, Bohuslav, Buchler, Tomas, Svoboda, Tomas, Obermannova, Radka, Vrana, David, Cvek, Jakub, Pfeiffer, Per, Baeksgaard, Lene, Yilmaz, Mette, Boige, Valerie, Lopez-Trabada, Daniel, Borg, Christophe, Pannier, Diane, Hiret, Sandrine, Di Fiore, Frederic, Metges, Jean-Philippe, Arnold, Dirk, Martens, Uwe, Lordick, Florian, Stein, Alexander, Castro, Hugo, Lopez, Karla, Ramirez, Julio, Aguilar, Mynor, Chivalan, Marco, Chan, Wendy, Cheng, Ashley, Yeo, Winnie, Arkosy, Peter, Csoszi, Tibor, Hitre, Erika, Horvath, Zsolt, Lowery, Maeve, McDermott, Ray, Morris, Patrick, Hubert, Ayala, Brenner, Baruch, Ben-Aharon, Irit, Shacham-Shmueli, Einat, Man, Sofia, Pelles Avraham, Sharon, Brenner, Ronen, Mishaeli, Moshe, Di Bartolomeo, Maria, Fazio, Nicola, Lonardi, Sara, Garufi, Carlo, Satoh, Taroh, Hara, Hiroki, Iwagami, Shiro, Yasui, Hisateru, Tsuda, Masahiro, Shimoyama, Tatsu, Shoji, Hirokazu, Sugimoto, Naotoshi, Shibata, Nobuhiro, Yamaguchi, Kensei, Amagai, Kenji, Choda, Yasuhiro, Esaki, Taito, Yabusaki, Hiroshi, Oshima, Takashi, Tsuji, Akihito, Kawakami, Hisato, Kawazoe, Akihito, Ishido, Kenji, Kadowaki, Shigenori, Martinez Rodriguez, Jorge, Herrera Martinez, Marytere, Huitzil Melendez, Fidel, Ramirez Godinez, Francisco, Balancan, Paola, Damianovich, Dragan, Castro Oliden, Victor, Grados, Julio, Torres, Cesar, Wyrwicz, Lucjan, Wysocki, Piotr, Hajac, Lukasz, Zolnierek, Jakub, Karaszewska, Boguslawa, Rha, Sun Young, Lee, Jeeyun, Ryu, Min-Hee, Oh, Do-Youn, Orlova, Rashida, Tjulandin, Sergey, Fadeeva, Natalia, Makarycheva, Yulia, Nosov, Dmitry, Smagina, Maria, Chan, Sze, Jacobs, Conrad, Kraus, Peter, Landers, Gregory, Robertson, Barbara, Ruff, Paul, Schoeman, Elizabeth, Maurel, Jean-Marc, Diez Garcia, Marc, Jimenez Fonseca, Paula, Gallego Plazas, Javier, Rivera Herrero, Fernando, Miranda Poma, Jesus, Layos Romero, Laura, Fritsch, Ralph, Bastian, Sara, Winterhalder, Ralph, Dosso, Sara De, Kossler, Thibaud, Yeh, Kun-Huei, Yen, Chia-Jui, Chen, Yen-Yang, Lin, Johnson, Bilici, Mehmet, Ozguroglu, Mustafa, Cil, Timucin, Oksuzoglu, Berna, Harputluoglu, Hakan, Karaoglu, Aziz, Hacibekiroglu, Ilhan, Erdogan, Bulent, Yalcin, Suayib, Adamchuk, Hryhoriy, Bondarenko, Igor, Kolesnik, Oleksii, Ostapenko, Yuriy, Kryzhanivska, Anna, Leshchenko, Lurii, Ilin, Ievgen, Shparyk, Yaroslav, Trukhin, Dmytro, Voitko, Nataliia, Roy, Rajarshi, Young, Anna-Mary, Medley, Louise, Shiu, Kai-Keen, Celano, Paul, Overton, Lindsay, Raj, Moses, Dunne, Richard, Wainberg, Zev, Dayyani, Farshid, Larson, Timothy, Kochenderfer, Mark, Yañez, Patricio, Rivera, Fernando, Alves, Gustavo Vasconcelos, Garrido, Marcelo, Fernández, Manuel González, Lowery, Maeve A, Çil, Timuçin, Cruz, Felipe Melo, Wainberg, Zev A, Yin, Lina, Bordia, Sonal, Bhagia, Pooja, and Wyrwicz, Lucjan S

Published
2023
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24. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study

Author

Qin, Shukui, Chan, Stephen L, Cheng, Ann-Lii, Kaseb, Ahmed, Vogel, Arndt, Gu, Shanzhi, Bai, Yuxian, Ren, Zhenggang, Lin, Xiaoyan, Chen, Zhendong, Jia, Weidong, Jin, Yongdong, Guo, Yabing, Hu, Xiaohua, Meng, Zhiqiang, Liang, Jun, Cheng, Ying, Xiong, Jianping, Ren, Hong, Yang, Fang, Li, Wei, Chen, Yajin, Zeng, Yong, Sultanbaev, Alexander, Pazgan-Simon, Monika, Pisetska, Margaryta, Melisi, Davide, Ponomarenko, Dmitriy, Osypchuk, Yurii, Sinielnikov, Ivan, Yang, Tsai-Sheng, Liang, Xiao, Chen, Chunxia, Wang, Linna, Zhang, Mingxiang, Xu, Li, Yuan, Xianglin, Li, Da, Ying, Jierer, Zhang, Jingdong, Zhang, Tao, Gu, Kangsheng, He, Yifu, Hao, Ping, Jiang, Da, Zhang, Shu, Xing, Baocai, Zhang, Baihong, Wang, Dong, Zhai, Xiaofeng, Liang, Houjie, Cybulska-Stopa, Bozena, Dvorkin, Mikhail, Stroyakovskiy, Daniil, Nechaeva, Marina, Yen, Chia-Jui, Su, Wei-Wen, Chen, Yen-Hao, Bondarenko, Igor, Yang, Lin, Fang, Weijia, Gomez-Martin, Carlos, Ryu, Min-Hee, Kim, Han-Sang, Kim, Jee-Hyun, Zarubenkov, Oleg, Orlova, Rashida, Poddubskaya, Elena, Fadeeva, Natalia, Makarova, Yulia, Chao, Yee, Hung, Chao-Hung, Neffa, Maryna, Vynnychenko, Oleksandr, Burgoyne, Adam, Hao, Chunyi, Mohr, Raphael U, Diaz-Beveridge, Roberto, Feliu-Batlle, Jaime, Cubillo-Gracian, Antonio, Lee, Ann-Shing, Daniele, Bruno, Antonuzzo, Lorenzo, Sangiovanni, Angelo, Gasbarrini, Antonio, Scartozzi, Mario, Ahn, Mi Sun, Oh, Sung-Yong, Orlov, Sergey, Harputluoglu, Hakan, Oksuzoglu, Berna, Hsu, Chiun, Rau, Kun-Ming, Krechkovskyi, Oleksandr, Yareshko, Vladimir, Xiong, Henry, Lee, Fa-Chyi, Jiang, Yixing, Gabayan, Afshin, Crow, Mary, Van Steenkiste, Christophe, and Verset, Gontran

Published
2023
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25. Determinants of clinical outcomes of gastric cancer patients treated with neoadjuvant chemotherapy: a sub-analysis of the PRODIGY study

Author

Kim, Hyung-Don, Lee, Jong Seok, Park, Young Soo, Yook, Jeong Hwan, Noh, Sung Hoon, Park, Young-Kyu, Kim, Young-Woo, Oh, Sang Cheul, Kim, Jong Gwang, Ryu, Min-Hee, Cheong, Jae-Ho, Kim, HyunKi, Lim, Joon Seok, Lee, Jae-Hyuk, Heo, Suk Hee, Kim, Jin Young, Heo, Mi Hwa, Park, Young Iee, Kim, In-Ho, and Kang, Yoon-Koo

Published
2022
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30. Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2–Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2–Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial.

Author

Yao, Herui, Yan, Min, Tong, Zhongsheng, Wu, Xinhong, Ryu, Min-Hee, Park, John J., Kim, Jee Hyun, Zhong, Yahua, Zhao, Yiming, Voskoboynik, Mark, Yin, Yongmei, Liu, Kan, Kaubisch, Andreas, Liu, Caigang, Zhang, Jian, Wang, Shouman, Im, Seock-Ah, Ganju, Vinod, Barve, Minal, and Li, Hui

Published
2024
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31. Impact of systemic steroids on the efficacy of first line imatinib treatment of patients with advanced gastrointestinal stromal tumors (GISTs).

Author

Kim, Sejin, Kim, Hyung-Don, Kim, Eo Jin, Ryu, Min-Hee, and Kang, Yoon-Koo

Subjects
GASTROINTESTINAL stromal tumors, PROGRESSION-free survival, ADVERSE health care events, EXANTHEMA, OVERALL survival
Abstract

Background: Effective management of adverse events is required to maintain sufficient imatinib dosing when treating patients with gastrointestinal stromal tumors (GISTs). Skin rash is a common adverse event of imatinib, which can be effectively controlled by systemic steroid treatment without imatinib dose modification or interruption. However, the impact of the use of systemic steroids on the efficacy of imatinib treatment remains unclear. Methods: Between October 2014 and February 2022, 277 consecutive patients from a prospective registry of GIST patients were included as the study population. Patients who started systemic steroids due to grade ≥ 3 skin rash or grade 2 skin rash with grade 2 pruritis were classified as the steroid group, whereas patients who did not develop a skin rash or those who did not require steroids for a mild skin rash were classified as the control group. Efficacy outcomes were compared between the two groups. Results: Among the 277 patients, 30 (10.8%) were treated with systemic steroids for skin rash. There was no significant difference in progression free survival (PFS) or overall survival (OS) between the steroid and control groups (3-year PFS, 67.7% vs. 65.1%, p = 0.53; 3-year OS, 91% vs. 89.9%, p = 0.67, respectively). The use of systemic steroids was not an independent factor associated with PFS (hazard ratio 0.73, 95% confidence interval 0.36–1.49, p = 0.39) and OS (hazard ratio 0.37, 95% confidence interval 0.12–1.18, p = 0.09). In the steroid group, patients who successfully maintained the imatinib dosage showed a trend toward more favorable survival outcomes than those who did not (3-year PFS, 73.3% vs. 44.4%, p = 0.34; 3-year OS, 95.8% vs. 75.0%, p = 0.15, respectively). Conclusions: The use of systemic steroids for the control of imatinib induced severe skin rash did not adversely affect the efficacy outcomes of imatinib in patients with advanced GIST. [ABSTRACT FROM AUTHOR]

Published
2024
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32. Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer: Updated Overall Survival Outcomes From Phase III PRODIGY.

Author

Kang, Yoon-Koo, Kim, Hyung-Don, Yook, Jeong Hwan, Park, Young-Kyu, Lee, Jong Seok, Kim, Young-Woo, Kim, Jin Young, Ryu, Min-Hee, Rha, Sun Young, Chung, Ik Joo, Kim, In-Ho, Oh, Sang Cheul, Park, Young Soo, Cheong, Jae-Ho, Jeong, Oh, Heo, Mi Hwa, Kim, Hark Kyun, Park, ChoHyun, Yoo, Chang Hak, and Kang, Seok Yun

Published
2024
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33. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial

Author

Kang, Yoon-Koo, Chen, Li-Tzong, Ryu, Min-Hee, Oh, Do-Youn, Oh, Sang Cheul, Chung, Hyun Cheol, Lee, Keun-Wook, Omori, Takeshi, Shitara, Kohei, Sakuramoto, Shinichi, Chung, Ik-Joo, Yamaguchi, Kensei, Kato, Ken, Sym, Sun Jin, Kadowaki, Shigenori, Tsuji, Kunihiro, Chen, Jen-Shi, Bai, Li-Yuan, Oh, Sung-Yong, Choda, Yasuhiro, Yasui, Hisateru, Takeuchi, Kentaro, Hirashima, Yoshinori, Hagihara, Shunsuke, and Boku, Narikazu

Published
2022
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36. Exploration of predictors of benefit from nivolumab monotherapy for patients with pretreated advanced gastric and gastroesophageal junction cancer: post hoc subanalysis from the ATTRACTION-2 study

Author

Kang, Yoon-Koo, Morita, Satoshi, Satoh, Taroh, Ryu, Min-Hee, Chao, Yee, Kato, Ken, Chung, Hyun Cheol, Chen, Jen-Shi, Muro, Kei, Kang, Won Ki, Yeh, Kun-Huei, Yoshikawa, Takaki, Oh, Sang Cheul, Bai, Li-Yuan, Tamura, Takao, Lee, Keun-Wook, Hamamoto, Yasuo, Kim, Jong Gwang, Chin, Keisho, Oh, Do-Youn, Minashi, Keiko, Cho, Jae Yong, Tsuda, Masahiro, Sameshima, Hiroki, Chen, Li-Tzong, and Boku, Narikazu

Published
2022
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37. Pembrolizumab versus paclitaxel for previously treated PD-L1-positive advanced gastric or gastroesophageal junction cancer: 2-year update of the randomized phase 3 KEYNOTE-061 trial

Author

Fuchs, Charles S., Özgüroğlu, Mustafa, Bang, Yung-Jue, Di Bartolomeo, Maria, Mandala, Mario, Ryu, Min-Hee, Fornaro, Lorenzo, Olesinski, Tomasz, Caglevic, Christian, Chung, Hyun C., Muro, Kei, Van Cutsem, Eric, Elme, Anneli, Thuss-Patience, Peter, Chau, Ian, Ohtsu, Atsushi, Bhagia, Pooja, Wang, Anran, Shih, Chie-Schin, and Shitara, Kohei

Published
2022
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38. Regorafenib versus cabozantinb as second-line treatment after sorafenib for unresectable hepatocellular carcinoma: matching-adjusted indirect comparison analysis

Author

Casadei-Gardini, Andrea, Rimassa, Lorenza, Rimini, Margherita, Yoo, Changhoon, Ryoo, Baek-Yeol, Lonardi, Sara, Masi, Gianluca, Kim, Hyung-Don, Vivaldi, Caterina, Ryu, Min-Hee, Rizzato, Mario Domenico, Salani, Francesca, Bang, Yeonghak, Pellino, Antonio, Catanese, Silvia, Burgio, Valentina, Cascinu, Stefano, and Cucchetti, Alessandro

Published
2021
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39. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma

Author

Abou-Alfa, Ghassan K, Meyer, Tim, Cheng, Ann-Lii, El-Khoueiry, Anthony B, Rimassa, Lorenza, Ryoo, Baek-Yeol, Cicin, Irfan, Merle, Philippe, Chen, YenHsun, Park, Joong-Won, Blanc, Jean-Frederic, Bolondi, Luigi, Klümpen, Heinz-Josef, Chan, Stephen L, Zagonel, Vittorina, Pressiani, Tiziana, Ryu, Min-Hee, Venook, Alan P, Hessel, Colin, Borgman-Hagey, Anne E, Schwab, Gisela, and Kelley, Robin K

Subjects
Digestive Diseases, Rare Diseases, Clinical Trials and Supportive Activities, Clinical Research, Liver Disease, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Anilides, Antineoplastic Agents, Carcinoma, Hepatocellular, Disease-Free Survival, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Liver Neoplasms, Male, Middle Aged, Pyridines, Receptor Protein-Tyrosine Kinases, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundCabozantinib inhibits tyrosine kinases, including vascular endothelial growth factor receptors 1, 2, and 3, MET, and AXL, which are implicated in the progression of hepatocellular carcinoma and the development of resistance to sorafenib, the standard initial treatment for advanced disease. This randomized, double-blind, phase 3 trial evaluated cabozantinib as compared with placebo in previously treated patients with advanced hepatocellular carcinoma.MethodsA total of 707 patients were randomly assigned in a 2:1 ratio to receive cabozantinib (60 mg once daily) or matching placebo. Eligible patients had received previous treatment with sorafenib, had disease progression after at least one systemic treatment for hepatocellular carcinoma, and may have received up to two previous systemic regimens for advanced hepatocellular carcinoma. The primary end point was overall survival. Secondary end points were progression-free survival and the objective response rate.ResultsAt the second planned interim analysis, the trial showed significantly longer overall survival with cabozantinib than with placebo. Median overall survival was 10.2 months with cabozantinib and 8.0 months with placebo (hazard ratio for death, 0.76; 95% confidence interval [CI], 0.63 to 0.92; P=0.005). Median progression-free survival was 5.2 months with cabozantinib and 1.9 months with placebo (hazard ratio for disease progression or death, 0.44; 95% CI, 0.36 to 0.52; P

Published
2018

40. Trastuzumab deruxtecan in HER2-positive advanced gastric cancer: exploratory biomarker analysis of the randomized, phase 2 DESTINY-Gastric01 trial

Author

Shitara, Kohei, primary, Bang, Yung-Jue, additional, Iwasa, Satoru, additional, Sugimoto, Naotoshi, additional, Ryu, Min-Hee, additional, Sakai, Daisuke, additional, Chung, Hyun Cheol, additional, Kawakami, Hisato, additional, Yabusaki, Hiroshi, additional, Sakamoto, Yasuhiro, additional, Nishina, Tomohiro, additional, Inaki, Koichiro, additional, Kuwahara, Yusuke, additional, Wada, Naoya, additional, Suto, Fumitaka, additional, Arita, Takeo, additional, Sugihara, Masahiro, additional, Tsuchihashi, Zenta, additional, Saito, Kaku, additional, Kojima, Akihito, additional, and Yamaguchi, Kensei, additional

Published
2024
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42. Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab

Author

Boku, Narikazu, Satoh, Taroh, Ryu, Min-Hee, Chao, Yee, Kato, Ken, Chung, Hyun Cheol, Chen, Jen-Shi, Muro, Kei, Kang, Won Ki, Yeh, Kun-Huei, Yoshikawa, Takaki, Oh, Sang Cheul, Bai, Li-Yuan, Tamura, Takao, Lee, Keun-Wook, Hamamoto, Yasuo, Kim, Jong Gwang, Chin, Keisho, Oh, Do-Youn, Minashi, Keiko, Cho, Jae Yong, Tsuda, Masahiro, Nishiyama, Taihei, Chen, Li-Tzong, and Kang, Yoon-Koo

Published
2021
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43. Clinical practice guidelines for esophagogastric junction cancer: Upper GI Oncology Summit 2023

Author

MS CGO, Cancer, Kitagawa, Yuko, Matsuda, Satoru, Gotoda, Takuji, Kato, Ken, Wijnhoven, Bas, Lordick, Florian, Bhandari, Pradeep, Kawakubo, Hirofumi, Kodera, Yasuhiro, Terashima, Masanori, Muro, Kei, Takeuchi, Hiroya, Mansfield, Paul F., Kurokawa, Yukinori, So, Jimmy, Mönig, Stefan Paul, Shitara, Kohei, Rha, Sun Young, Janjigian, Yelena, Takahari, Daisuke, Chau, Ian, Sharma, Prateek, Ji, Jiafu, de Manzoni, Giovanni, Nilsson, Magnus, Kassab, Paulo, Hofstetter, Wayne L., Smyth, Elizabeth Catherine, Lorenzen, Sylvie, Doki, Yuichiro, Law, Simon, Oh, Do Youn, Ho, Khek Yu, Koike, Tomoyuki, Shen, Lin, van Hillegersberg, Richard, Kawakami, Hisato, Xu, Rui Hua, Wainberg, Zev, Yahagi, Naohisa, Lee, Yeong Yeh, Singh, Rajvinder, Ryu, Min Hee, Ishihara, Ryu, Xiao, Zili, Kusano, Chika, Grabsch, Heike Irmgard, Hara, Hiroki, Mukaisho, Ken Ichi, Makino, Tomoki, Kanda, Mitsuro, Booka, Eisuke, Suzuki, Sho, Hatta, Waku, Kato, Motohiko, Maekawa, Akira, Kawazoe, Akihito, Yamamoto, Shun, Nakayama, Izuma, Narita, Yukiya, Yang, Han Kwang, Yoshida, Masahiro, Sano, Takeshi, MS CGO, Cancer, Kitagawa, Yuko, Matsuda, Satoru, Gotoda, Takuji, Kato, Ken, Wijnhoven, Bas, Lordick, Florian, Bhandari, Pradeep, Kawakubo, Hirofumi, Kodera, Yasuhiro, Terashima, Masanori, Muro, Kei, Takeuchi, Hiroya, Mansfield, Paul F., Kurokawa, Yukinori, So, Jimmy, Mönig, Stefan Paul, Shitara, Kohei, Rha, Sun Young, Janjigian, Yelena, Takahari, Daisuke, Chau, Ian, Sharma, Prateek, Ji, Jiafu, de Manzoni, Giovanni, Nilsson, Magnus, Kassab, Paulo, Hofstetter, Wayne L., Smyth, Elizabeth Catherine, Lorenzen, Sylvie, Doki, Yuichiro, Law, Simon, Oh, Do Youn, Ho, Khek Yu, Koike, Tomoyuki, Shen, Lin, van Hillegersberg, Richard, Kawakami, Hisato, Xu, Rui Hua, Wainberg, Zev, Yahagi, Naohisa, Lee, Yeong Yeh, Singh, Rajvinder, Ryu, Min Hee, Ishihara, Ryu, Xiao, Zili, Kusano, Chika, Grabsch, Heike Irmgard, Hara, Hiroki, Mukaisho, Ken Ichi, Makino, Tomoki, Kanda, Mitsuro, Booka, Eisuke, Suzuki, Sho, Hatta, Waku, Kato, Motohiko, Maekawa, Akira, Kawazoe, Akihito, Yamamoto, Shun, Nakayama, Izuma, Narita, Yukiya, Yang, Han Kwang, Yoshida, Masahiro, and Sano, Takeshi

Published
2024

44. Clinical practice guidelines for esophagogastric junction cancer:Upper GI Oncology Summit 2023

Author

Kitagawa, Yuko, Matsuda, Satoru, Gotoda, Takuji, Kato, Ken, Wijnhoven, Bas, Lordick, Florian, Bhandari, Pradeep, Kawakubo, Hirofumi, Kodera, Yasuhiro, Terashima, Masanori, Muro, Kei, Takeuchi, Hiroya, Mansfield, Paul F., Kurokawa, Yukinori, So, Jimmy, Mönig, Stefan Paul, Shitara, Kohei, Rha, Sun Young, Janjigian, Yelena, Takahari, Daisuke, Chau, Ian, Sharma, Prateek, Ji, Jiafu, de Manzoni, Giovanni, Nilsson, Magnus, Kassab, Paulo, Hofstetter, Wayne L., Smyth, Elizabeth Catherine, Lorenzen, Sylvie, Doki, Yuichiro, Law, Simon, Oh, Do Youn, Ho, Khek Yu, Koike, Tomoyuki, Shen, Lin, van Hillegersberg, Richard, Kawakami, Hisato, Xu, Rui Hua, Wainberg, Zev, Yahagi, Naohisa, Lee, Yeong Yeh, Singh, Rajvinder, Ryu, Min Hee, Ishihara, Ryu, Xiao, Zili, Kusano, Chika, Grabsch, Heike Irmgard, Hara, Hiroki, Mukaisho, Ken Ichi, Makino, Tomoki, Kanda, Mitsuro, Booka, Eisuke, Suzuki, Sho, Hatta, Waku, Kato, Motohiko, Maekawa, Akira, Kawazoe, Akihito, Yamamoto, Shun, Nakayama, Izuma, Narita, Yukiya, Yang, Han Kwang, Yoshida, Masahiro, Sano, Takeshi, Kitagawa, Yuko, Matsuda, Satoru, Gotoda, Takuji, Kato, Ken, Wijnhoven, Bas, Lordick, Florian, Bhandari, Pradeep, Kawakubo, Hirofumi, Kodera, Yasuhiro, Terashima, Masanori, Muro, Kei, Takeuchi, Hiroya, Mansfield, Paul F., Kurokawa, Yukinori, So, Jimmy, Mönig, Stefan Paul, Shitara, Kohei, Rha, Sun Young, Janjigian, Yelena, Takahari, Daisuke, Chau, Ian, Sharma, Prateek, Ji, Jiafu, de Manzoni, Giovanni, Nilsson, Magnus, Kassab, Paulo, Hofstetter, Wayne L., Smyth, Elizabeth Catherine, Lorenzen, Sylvie, Doki, Yuichiro, Law, Simon, Oh, Do Youn, Ho, Khek Yu, Koike, Tomoyuki, Shen, Lin, van Hillegersberg, Richard, Kawakami, Hisato, Xu, Rui Hua, Wainberg, Zev, Yahagi, Naohisa, Lee, Yeong Yeh, Singh, Rajvinder, Ryu, Min Hee, Ishihara, Ryu, Xiao, Zili, Kusano, Chika, Grabsch, Heike Irmgard, Hara, Hiroki, Mukaisho, Ken Ichi, Makino, Tomoki, Kanda, Mitsuro, Booka, Eisuke, Suzuki, Sho, Hatta, Waku, Kato, Motohiko, Maekawa, Akira, Kawazoe, Akihito, Yamamoto, Shun, Nakayama, Izuma, Narita, Yukiya, Yang, Han Kwang, Yoshida, Masahiro, and Sano, Takeshi

Published
2024

45. Sequential Treatment of Sorafenib–Regorafenib Versus Sorafenib–Physician’s Choice: A Propensity Score-Matched Analysis

Author

Bang, Yeonghak, Yoo, Changhoon, Lonardi, Sara, Kim, Hyung-Don, Vivaldi, Caterina, Rimini, Margherita, Frassineti, Giovanni Luca, Park, Sook Ryun, Rizzato, Mario Domenico, Ryu, Min-Hee, Salani, Francesca, Rapposelli, Ilario Giovanni, Ryoo, Baek-Yeol, Zagonel, Vittorina, Massa, Valentina, Valgiusti, Martina, Burgio, Valentina, Scartozzi, Mario, Cascinu, Stefano, and Casadei-Gardini, Andrea

Published
2021
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47. FDA regulatory considerations for oncology drug development.

Author

Moon, Hanlim, Zang, Dae Young, Ryu, Min‐Hee, Seo, YeonSook, Oh, Bitna, Hwang, Sunjin, and Farrand, Lee

Subjects
ANTINEOPLASTIC agents, DRUG development, DRUG accessibility, DRUG approval, SENTINEL lymph nodes
Abstract

The article focuses on the FDA (U.S. Food and Drug Administration) regulatory considerations for oncology drug development, particularly emphasizing the Accelerated Approval (AA) program. It examines the challenges and opportunities within the current competitive oncology landscape, including the need for early dose optimization, representation of ethnic diversity in clinical trials, and the impact of various FDA initiatives such as Project Optimus and Project Equity on drug approval processes.

Published
2024
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48. Heterogeneity of claudin 18.2 expression in metastatic gastric cancer.

Author

Choi, Eugene, Shin, Jinho, Ryu, Min-Hee, Kim, Hyung-Don, and Park, Young Soo

Subjects
CLAUDINS, STOMACH cancer, SURVIVAL rate, MOLECULAR cloning, LYMPH nodes
Abstract

Claudin 18.2 has emerged as a viable therapeutic target in gastric cancer (GC), but little is known about the heterogeneity of its expression in GC. This study investigated the heterogeneity of claudin 18.2 expression in 166 patients with metastatic GC whose surgical or paired primary–metastatic specimens were available. The prevalence of claudin 18.2 positivity (moderate-to-strong expression in ≥ 75% by the 43-14A clone) was 47.0%. Claudin 18.2-positive tumors exhibited more frequent peritoneal metastasis and a lower incidence of hepatic and distant lymph node involvement. Survival outcomes were comparable between patients with claudin 18.2-positive and -negative tumors. Intratumoral heterogeneity was noted in 38.5% of surgical specimens. Paired primary-metastatic site analysis revealed that 25.2% of patients had discordant results for claudin 18.2 positivity. Across different metastatic organ categories, peritoneal lesions showed the highest positivity rate (44.3%) and positive concordance rate (31.4%), whereas liver lesions had the lowest positivity rate (17.9%) and concordance rate (12.8%). In conclusion, claudin 18.2 expression exhibits intratumoral and intrapatient spatial heterogeneity in metastatic GC. Claudin 18.2 positivity is associated with more frequent peritoneal metastasis, and peritoneal lesions are more likely to have positively concordant claudin 18.2 results with the primary site than other metastatic sites. [ABSTRACT FROM AUTHOR]

Published
2024
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49. S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial

Author

Kang, Yoon-Koo, Chin, Keisho, Chung, Hyun Cheol, Kadowaki, Shigenori, Oh, Sang Cheul, Nakayama, Norisuke, Lee, Keun-Wook, Hara, Hiroki, Chung, Ik-Joo, Tsuda, Masahiro, Park, Se Hoon, Hosaka, Hisashi, Hironaka, Shuichi, Miyata, Yoshinori, Ryu, Min-Hee, Baba, Hideo, Hyodo, Ichinosuke, Bang, Yung-Jue, and Boku, Narikazu

Published
2020
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50. Biomarker and pharmacodynamic activity of the transforming growth factor‐beta (TGFβ) inhibitor SAR439459 as monotherapy and in combination with cemiplimab in a phase I clinical study in patients with advanced solid tumors

Author

Robbrecht, Debbie, primary, Grob, Jean‐Jacques, additional, Bechter, Oliver, additional, Simonelli, Matteo, additional, Doger, Bernard, additional, Borbath, Ivan, additional, Butler, Marcus O., additional, Cheng, Tina, additional, Romano, Patricia Martin, additional, Pons‐Tostivint, Elvire, additional, Di Nicola, Massimo, additional, Curigliano, Giuseppe, additional, Ryu, Min‐Hee, additional, Rodriguez‐Vida, Alejo, additional, Schadendorf, Dirk, additional, Garralda, Elena, additional, Abbadessa, Giovanni, additional, Demers, Brigitte, additional, Amrate, Amele, additional, Wang, Hong, additional, Lee, Joon Sang, additional, Pomponio, Robert, additional, and Wang, Rui, additional

Published
2024
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