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1. 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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2. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Azevedo, Sergio, Braghiroli, Maria Ignez, Girotto, Gustavo, Bragagnoli, Arinilda, Branco, Ricardo, Faccio, Adilson, Moretto, Andrea, Skare, Nils, Dutra, Jamille, Viola, Luciana, Vianna, Karina, Meton, Fernando, Sette, Claudia, Faulhaber, Amanda, Tam, Vincent C., Couture, Felix, Biagi, Jim, Castel, Helene, Mulder, Karen, Ko, Yoo-Joung, Zbuk, Kevin, Welch, Stephen, Beaudoin, Annie, Heurgué, Alexandra, Assenat, Eric, Archambeaud, Isabelle, Tougeron, David, Peron, Jean-Marie, Gilabert, Marine, Bronowicki, Jean-Pierre, Cattan, Stephane, Blanc, Jean-Frederic, Bouattour, Mohamed, Phelip, Jean-Marc, Boige, Valerie, Michel, Pierre, Frin, Anne-Claire, De Toni, Enrico N., Berres, Marie-Luise, Vogel, Arndt, Berg, Thomas, Ettrich, Thomas, Waldschmidt, Dirk, Wedemeyer, Hans Heinrich, Worns, Marcus-Alexander, Bitzer, Michael, Weiss, Karl-Heinz, Lau, George, Chan, Stephen L., Yau, Thomas, Tai, Yin Ping, Lee, Ann Shing, Thungappa, Satheesh Chiradoni, N, Lokesh K., Sureshchand Ostwal, Vikas, Ashok, Kattimani Kiran, Mittal, Sushant, Goyal, Hari, Srinivasan, Sankar, Biswas, Ghanashyam, Mohan, Mallavarapu, Limaye, Sewanti, Asarawala, Nirav, Rimassa, Lorenza, Falcone, Alfredo, Gianni, Luca, Gasbarrini, Antonio, Daniele, Bruno, Avallone, Antonio, Paolo Frassineti, Giovanni Luca, Roila, Fausto, Kudo, Masatoshi, Kawaoka, Tomokazu, Morimoto, Manabu, Takikawa, Yasuhiro, Kato, Naoya, Yamashita, Tatsuya, Osaki, Yukio, Motomura, Kenta, Tateishi, Ryosuke, Ohkawa, Kazuyoshi, Wada, Yoshiyuki, Onishi, Hideki, Sasahira, Naoki, Inaba, Yoshitaka, Kurosaki, Masayuki, Tsuji, Kunihiko, Takei, Yoshiyuki, Aramaki, Takeshi, Hagihara, Atsushi, Furuse, Junji, Kioka, Kiyohide, Koga, Hironori, Sasaki, Yutaka, Numata, Kazushi, Tada, Toshifumi, Kawaguchi, Yasunori, Nadano, Seijin, Vasilyev, Alexander, Breder, Valery, Lipatov, Oleg, Dvorkin, Mikhail, Zarubenkov, Oleg, Kutukova, Svetlana, Ponomarev, Roman, Shostka, Kirill, Alyasova, Anna, Topuzov, Eldar, Severtsev, Alexey, Petrov, Yuryi, Erygin, Dmitriy, Berdov, Boris, Kang, Yoon-Koo, Tak, Won-Young, Park, Joong-Won, Lim, Ho Yeong, Heo, Jeong, Kim, Jee Hyun, Kim, Tae-You, Choi, Hye Jin, Varela, María, Reig Monzon, María Elisa, Sangro, Bruno, Martin, Carlos Gómez, Ponce, Carmen Guillén, López, Carlos, Cheng, Ann-Lii, Chao, Yee, Feng, Yin-Hsun, Jeng, Long-Bin, Hung, Chao-Hung, Hou, Ming-Mo, Wang Tsang-En Wang, Jing-Houng, Yen, Chia-Jui, Sukeepaisarnjaroen, Wattana, Sunpaweravong, Patrapim, Charoentum, Chaiyut, Tanasanvimon, Suebpong, Sirachainan, Ekaphop, Ungtrakul, Teerapat, Prasongsook, Naiyarat, Maneenil, Kunlatida, Jitpewngarm, Wittawat, Ostapenko, Yurii, Skoryi, Denys, Bondarenko, Igor, Shparyk, Yaroslav, Trukhin, Dmytro, Hotko, Yevhen, Ursol, Grygorii, Kryzhanivska, Anna, Abou-Alfa, Ghassan K., Mody, Kabir, Dayyani, Farshid, Al-Rajabi, Raed, Yarchoan, Mark, Gandhi, Sunil, Crysler, Oxana, He, Aiwu Ruth, Reeves, James, Bahary, Nathan, Mahipal, Amit, Kelley, Robin Kate, Dasgupta, Anirudha, Rowe, Julie, Thota, Ramya, Beg, Muhammad, Morse, Michael, Choi, Sung-hee, Crocenzi, Todd, Somer, Bradley, Abrams, Thomas, Denlinger, Crystal, Zhang, Yue, Sharma, Nisha, Dao, Tu V., Thinh, Nguyen Tien, Tuyet Phuong, Le Thi, Sangro, B., Chan, S.L., Kelley, R.K., Lau, G., Kudo, M., Sukeepaisarnjaroen, W., Yarchoan, M., De Toni, E.N., Furuse, J., Kang, Y.K., Galle, P.R., Rimassa, L., Heurgué, A., Tam, V.C., Van Dao, T., Thungappa, S.C., Breder, V., Ostapenko, Y., Reig, M., Makowsky, M., Paskow, M.J., Gupta, C., Kurland, J.F., Negro, A., and Abou-Alfa, G.K.

Published
2024
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5. 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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7. Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study

Author

Carranza, Omar, Greco, Martin Alberto, Coward, Jim, Joshua, Anthony, Karapetis, Christos, Hart, Christopher, Zhang, Alison, Prenen, Hans, Goeminne, Jean-Charles, Machiels, Jean-Pascal, Rottey, Sylvie, Corassa, Marcelo, Molin, Graziela Zibetti Dal, Tiscoski, Katsuki, Jardim, Denis Leonardo Fontes, Mak, Milena, Fu, Wei, Yao, Herui, Huang, Jing, Jiang, Haiping, Qin, Shukui, Chen, Baoshi, Yan, Dong, Yang, Yu, Loriot, Yohann, Le Tourneau, Christophe, Penel, Nicolas, Salas, Sébastien, Blay, Jean-Yves, Brachet, Pierre-Emmanuel, Durando, Xavier, Emambux, Sheik, Ravaud, Alain, Folprecht, Gunnar, Arnold, Dirk, Schuler, Martin, Ahrens, Marit, Golf, Alexander, Haag, Georg Martin, Lordick, Florian, Desuki, Alexander, Cazzaniga, Marina, Ciardiello, Fortunato, Milella, Michele, Koyama, Takafumi, Hirooka, Yoshiki, Okamoto, Wataru, Aogi, Kenjiro, Kuboki, Yasutoshi, Lee, Jungyun, Kim, Sung-Bae, Ahn, Myung-Ju, Chang, Jong Hee, Kim, Yong-Man, Nam, Do-Hyun, Park, Jae-Sung, Lugowska, Iwona, Paz-Ares, Luis, Moreno, Victor, Cervantes, Andres, Calvo, Mariona, Falcon, Alejandro, Gonzalez, Antonio, Tabernero, Josep, Martinez Bueno, Alejandro, García-Corbacho, Javier, Longo, Federico, Yen, Chia-Jui, Chen, Jen-Shi, Hou, Ming-Feng, Chao, Yee, Rau, Kun-Ming, Chiu, Tai-Jan, Feng, Yin-Hsun, Hsu, Chih-Hung, Huang, Wen-Tsung, Lai, Kuan-Ming, Yeh, Su-peng, Palmer, Daniel, Minchom, Anna, Winter, Helen, Welsh, Liam, Plummer, Ruth, Iyer, Gopakumar, Gutierrez, Martin, Bilen, Mehmet, Arrowsmith, Edward, Pant, Shubham, Spigel, David Robert, Zandberg, Dan Paul, Doroshow, Deborah, Lu-Emerson, Christine, Moezi, Mehdi, Paulson, Scott, Reardon, David, Ward, Patrick, Chaves, Jorge, Grigg, Claud, Hussein, Atif, Manda, Sudhir, Monticelli, Michael, Qamar, Rubina, Richey, Stephen L, Tamura, David, Wilks, Sharon, Iyer, Gopa, Witt, Olaf, Doi, Toshihiko, Reardon, David A, Massard, Christophe, Stuyckens, Kim, Crow, Lauren, Najmi, Saltanat, Hammond, Constance, Thomas, Shibu, Santiago-Walker, Ademi, Triantos, Spyros, and Sweiti, Hussein

Published
2023
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8. Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/Gastroesophageal Adenocarcinoma

Author

Catenacci, Daniel V.T., Kang, Yoon-Koo, Uronis, Hope E., Lee, Keun-Wook, Ng, Matthew C.H., Enzinger, Peter C., Park, Se Hoon, Gold, Philip J., Lacy, Jill, Hochster, Howard S., Oh, Sang Cheul, Kim, Yeul Hong, Marrone, Kristen A., Kelly, Ronan J., Juergens, Rosalyn A., Kim, Jong Gwang, Alcindor, Thierry, Sym, Sun Jin, Song, Eun-Kee, Chee, Cheng Ean, Chao, Yee, Kim, Sunnie, Oh, Do-Youn, Yen, Jennifer, Odegaard, Justin I., Lagow, Errin, Li, Daner, Sun, Jichao, Kaminker, Patrick, Moore, Paul A., Rosales, Minori Koshiji, and Park, Haeseong

Subjects
Merck KGaA, MacroGenics Inc., Bayer AG, AstraZeneca PLC, Medical research, Medicine, Experimental, Immunohistochemistry, Tumors -- Patient outcomes, DNA, Adenocarcinoma -- Patient outcomes, Pharmaceutical industry, Health
Abstract

PURPOSE. To assess the ability of circulating tumor DNA (ctDNA)-based testing to identify patients with HER2 (encoded by ERBB2)-positive gastric/gastroesophageal adenocarcinoma (GEA) who progressed on or after trastuzumab-containing treatments were treated with combination therapy of anti-HER2 and anti-PD-1 agents. METHODS. ctDNA analysis was performed retrospectively using plasma samples collected at study entry from 86 patients participating in the phase 1/2 CP-MGAH22-05 study (NCT02689284). RESULTS. Objective response rate (ORR) was significantly higher in evaluable ERBB2 amplification-positive vs negative patients based on ctDNA analysis at study entry (37% vs 6%, respectively; P = .00094). ORR was 23% across all patients who were evaluable for response. ERBB2 amplification was detected at study entry in 57% of patients (all HER2 positive at diagnosis), and detection was higher (88%) when HER2 status was determined by immunohistochemistry fewer than 6 months before study entry. ctDNA was detected in 98% (84/86) of patients tested at study entry. Codetected ERBB2-activating mutations were not associated with response. CONCLUSIONS. Current ERBB2 status may be more effective than archival status at predicting clinical benefit from margetuximab plus pembrolizumab therapy. ctDNA testing for ERBB2 status prior to treatment will spare patients from repeat tissue biopsies, which may be reserved for reflex testing when ctDNA is not detected. KEYWORDS. gastric/gastroesophageal adenocarcinoma; HER2; ctDNA; and margetuximab plus pembrolizumab, BACKGROUND The human epidermal growth factor receptor 2 (HER2) protein is a receptor tyrosine-protein kinase, encoded by erythroblastic oncogene B2 (ERBB2), normally involved in the proliferation and division of cells. [...]

Published
2023

9. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial

Author

Qiu, Miao-Zhen, primary, Oh, Do-Youn, additional, Kato, Ken, additional, Arkenau, Tobias, additional, Tabernero, Josep, additional, Correa, Marcia Cruz, additional, Zimina, Anastasia V, additional, Bai, Yuxian, additional, Shi, Jianhua, additional, Lee, Keun-Wook, additional, Wang, Jufeng, additional, Poddubskaya, Elena, additional, Pan, Hongming, additional, Rha, Sun Young, additional, Zhang, Ruixing, additional, Hirano, Hidekazu, additional, Spigel, David, additional, Yamaguchi, Kensei, additional, Chao, Yee, additional, Wyrwicz, Lucjan, additional, Disel, Umut, additional, Cid, Roberto Pazo, additional, Fornaro, Lorenzo, additional, Evesque, Ludovic, additional, Wang, Hongwei, additional, Xu, Yaling, additional, Li, Jiang, additional, Sheng, Tao, additional, Yang, Silu, additional, Li, Liyun, additional, Moehler, Markus, additional, and Xu, Rui-Hua, additional

Published
2024
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13. Safety and Efficacy of Durvalumab and Tremelimumab Alone or in Combination in Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

Author

Kelly, Ronan J, Lee, Jeeyun, Bang, Yung-Jue, Almhanna, Khaldoun, Blum-Murphy, Mariela, Catenacci, Daniel VT, Chung, Hyun Cheol, Wainberg, Zev A, Gibson, Michael K, Lee, Keun-Wook, Bendell, Johanna C, Denlinger, Crystal S, Chee, Cheng Ean, Omori, Takeshi, Leidner, Rom, Lenz, Heinz-Josef, Chao, Yee, Rebelatto, Marlon C, Brohawn, Philip Z, He, Peng, McDevitt, Jennifer, Sheth, Siddharth, Englert, Judson M, and Ku, Geoffrey Y

Subjects
Clinical Research, Cancer, Rare Diseases, Clinical Trials and Supportive Activities, Digestive Diseases, Patient Safety, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, B7-H1 Antigen, CTLA-4 Antigen, Circulating Tumor DNA, Esophagogastric Junction, Female, Humans, Interferon-gamma, Male, Middle Aged, Prospective Studies, Stomach Neoplasms, Transcriptome, Young Adult, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThis randomized, multicenter, open-label, phase Ib/II study assessed durvalumab and tremelimumab in combination or as monotherapy for chemotherapy-refractory gastric cancer or gastroesophageal junction (GEJ) cancer.Patients and methodsSecond-line patients were randomized 2:2:1 to receive durvalumab plus tremelimumab (arm A), or durvalumab (arm B) or tremelimumab monotherapy (arm C), and third-line patients received durvalumab plus tremelimumab (arm D). A tumor-based IFNγ gene signature was prospectively evaluated as a potential predictive biomarker in second- and third-line patients receiving the combination (arm E). The coprimary endpoints were objective response rate and progression-free survival (PFS) rate at 6 months.ResultsA total of 113 patients were treated: 6 in phase Ib and 107 (arm A, 27; arm B, 24; arm C, 12; arm D, 25; arm E, 19) in phase II. Overall response rates were 7.4%, 0%, 8.3%, 4.0%, and 15.8% in the five arms, respectively. PFS rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 4%, 42%, 16%, and 11% of patients, respectively.ConclusionsResponse rates were low regardless of monotherapy or combination strategies. No new safety signals were identified. Including use of a tumor-based IFNγ signature and change in baseline and on-treatment circulating tumor DNA are clinically feasible and may be novel strategies to improve treatment response in this difficult-to-treat population.

Published
2020

15. Multicenter evaluation of the safety and efficacy of selective internal radiation therapy with yttrium‐90 resin microspheres in Taiwan: data from the RESIN registry

Author

Lee, Rheun‐Chuan, primary, Liang, Po‐Chin, additional, Liang, Huei‐Lung, additional, Chen, Yung‐Fang, additional, Yu, Chun‐Yen, additional, Cheng, Pin‐Nan, additional, Hung, Chien‐Fu, additional, Hsia, Cheng‐Yuan, additional, Lai, Hsueh‐Chou, additional, Ho, Ming‐Chih, additional, Cheng, Yu‐Fan, additional, Liu, Yi‐Sheng, additional, Chao, Yee, additional, and Chen, Chien‐Hung, additional

Published
2024
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16. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Sangro, B., primary, Chan, S.L., additional, Kelley, R.K., additional, Lau, G., additional, Kudo, M., additional, Sukeepaisarnjaroen, W., additional, Yarchoan, M., additional, De Toni, E.N., additional, Furuse, J., additional, Kang, Y.K., additional, Galle, P.R., additional, Rimassa, L., additional, Heurgué, A., additional, Tam, V.C., additional, Van Dao, T., additional, Thungappa, S.C., additional, Breder, V., additional, Ostapenko, Y., additional, Reig, M., additional, Makowsky, M., additional, Paskow, M.J., additional, Gupta, C., additional, Kurland, J.F., additional, Negro, A., additional, Abou-Alfa, G.K., additional, Azevedo, Sergio, additional, Braghiroli, Maria Ignez, additional, Girotto, Gustavo, additional, Bragagnoli, Arinilda, additional, Branco, Ricardo, additional, Faccio, Adilson, additional, Moretto, Andrea, additional, Skare, Nils, additional, Dutra, Jamille, additional, Viola, Luciana, additional, Vianna, Karina, additional, Meton, Fernando, additional, Sette, Claudia, additional, Faulhaber, Amanda, additional, Tam, Vincent C., additional, Couture, Felix, additional, Biagi, Jim, additional, Castel, Helene, additional, Mulder, Karen, additional, Ko, Yoo-Joung, additional, Zbuk, Kevin, additional, Welch, Stephen, additional, Beaudoin, Annie, additional, Heurgué, Alexandra, additional, Assenat, Eric, additional, Archambeaud, Isabelle, additional, Tougeron, David, additional, Peron, Jean-Marie, additional, Gilabert, Marine, additional, Bronowicki, Jean-Pierre, additional, Cattan, Stephane, additional, Blanc, Jean-Frederic, additional, Bouattour, Mohamed, additional, Phelip, Jean-Marc, additional, Boige, Valerie, additional, Michel, Pierre, additional, Frin, Anne-Claire, additional, Enrico N De Toni, Germany, additional, Berres, Marie-Luise, additional, Vogel, Arndt, additional, Berg, Thomas, additional, Ettrich, Thomas, additional, Waldschmidt, Dirk, additional, Wedemeyer, Hans Heinrich, additional, Worns, Marcus-Alexander, additional, Bitzer, Michael, additional, Weiss, Karl-Heinz, additional, Lau, George, additional, Chan, Stephen L., additional, Yau, Thomas, additional, Tai, Yin Ping, additional, Lee, Ann Shing, additional, Thungappa, Satheesh Chiradoni, additional, N, Lokesh K., additional, Ostwal, Vikas Sureshchand, additional, Ashok, Kattimani Kiran, additional, Mittal, Sushant, additional, Goyal, Hari, additional, Srinivasan, Sankar, additional, Biswas, Ghanashyam, additional, Mohan, Mallavarapu, additional, Limaye, Sewanti, additional, Asarawala, Nirav, additional, Rimassa, Lorenza, additional, Falcone, Alfredo, additional, Gianni, Luca, additional, Gasbarrini, Antonio, additional, Daniele, Bruno, additional, Avallone, Antonio, additional, Paolo Frassineti, Giovanni Luca, additional, Roila, Fausto, additional, Kudo, Masatoshi, additional, Kawaoka, Tomokazu, additional, Morimoto, Manabu, additional, Takikawa, Yasuhiro, additional, Kato, Naoya, additional, Yamashita, Tatsuya, additional, Osaki, Yukio, additional, Motomura, Kenta, additional, Tateishi, Ryosuke, additional, Ohkawa, Kazuyoshi, additional, Wada, Yoshiyuki, additional, Onishi, Hideki, additional, Sasahira, Naoki, additional, Inaba, Yoshitaka, additional, Kurosaki, Masayuki, additional, Tsuji, Kunihiko, additional, Takei, Yoshiyuki, additional, Aramaki, Takeshi, additional, Hagihara, Atsushi, additional, Furuse, Junji, additional, Kioka, Kiyohide, additional, Koga, Hironori, additional, Sasaki, Yutaka, additional, Numata, Kazushi, additional, Tada, Toshifumi, additional, Kawaguchi, Yasunori, additional, Nadano, Seijin, additional, Alexander Vasilyev, Russian Federation, additional, Breder, Valery, additional, Lipatov, Oleg, additional, Dvorkin, Mikhail, additional, Zarubenkov, Oleg, additional, Kutukova, Svetlana, additional, Ponomarev, Roman, additional, Shostka, Kirill, additional, Alyasova, Anna, additional, Topuzov, Eldar, additional, Severtsev, Alexey, additional, Petrov, Yuryi, additional, Erygin, Dmitriy, additional, Berdov, Boris, additional, Kang, Yoon-Koo, additional, Tak, Won-Young, additional, Park, Joong-Won, additional, Lim, Ho Yeong, additional, Heo, Jeong, additional, Kim, Jee Hyun, additional, Kim, Tae-You, additional, Choi, Hye Jin, additional, Varela, María, additional, Reig Monzon, María Elisa, additional, Sangro, Bruno, additional, Martin, Carlos Gómez, additional, Ponce, Carmen Guillén, additional, López, Carlos, additional, Cheng, Ann-Lii, additional, Chao, Yee, additional, Feng, Yin-Hsun, additional, Jeng, Long-Bin, additional, Hung, Chao-Hung, additional, Hou, Ming-Mo, additional, Wang Tsang-En Wang, Jing-Houng, additional, Yen, Chia-Jui, additional, Sukeepaisarnjaroen, Wattana, additional, Sunpaweravong, Patrapim, additional, Charoentum, Chaiyut, additional, Tanasanvimon, Suebpong, additional, Sirachainan, Ekaphop, additional, Ungtrakul, Teerapat, additional, Prasongsook, Naiyarat, additional, Maneenil, Kunlatida, additional, Jitpewngarm, Wittawat, additional, Ostapenko, Yurii, additional, Skoryi, Denys, additional, Bondarenko, Igor, additional, Shparyk, Yaroslav, additional, Trukhin, Dmytro, additional, Hotko, Yevhen, additional, Ursol, Grygorii, additional, Kryzhanivska, Anna, additional, Abou-Alfa, Ghassan K., additional, Mody, Kabir, additional, Dayyani, Farshid, additional, Al-Rajabi, Raed, additional, Yarchoan, Mark, additional, Gandhi, Sunil, additional, Crysler, Oxana, additional, He, Aiwu Ruth, additional, Reeves, James, additional, Bahary, Nathan, additional, Mahipal, Amit, additional, Kelley, Robin Kate, additional, Dasgupta, Anirudha, additional, Rowe, Julie, additional, Thota, Ramya, additional, Beg, Muhammad, additional, Morse, Michael, additional, Choi, Sung-hee, additional, Crocenzi, Todd, additional, Somer, Bradley, additional, Abrams, Thomas, additional, Denlinger, Crystal, additional, Zhang, Yue, additional, Sharma, Nisha, additional, Dao, Tu V., additional, Thinh, Nguyen Tien, additional, and Tuyet Phuong, Le Thi, additional

Published
2024
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20. 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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21. PHOCUS: A Phase 3, Randomized, Open-Label Study of Sequential Treatment with Pexa-Vec (JX-594) and Sorafenib in Patients with Advanced Hepatocellular Carcinoma.

Author

Abou-Alfa, Ghassan K., Galle, Peter R., Chao, Yee, Erinjeri, Joseph, Heo, Jeong, Borad, Mitesh J., Luca, Angelo, Burke, James, Pelusio, Adina, Agathon, Delphine, Lusky, Monika, Breitbach, Caroline, Qin, Shukui, and Gane, Edward

Subjects
HEPATOCELLULAR carcinoma, ONCOLYTIC virotherapy, SORAFENIB, VACCINIA, OVERALL survival
Abstract

Introduction: Intratumoral administration of pexa-vec (pexastimogene devacirepvec), an oncolytic and immunotherapeutic vaccinia virus, given to patients with hepatocellular carcinoma (HCC), is associated with both local and distant tumor responses. We hypothesized subsequent treatment with sorafenib could demonstrate superior efficacy. Methods: This random phase III open-label study evaluated the sequential treatment with pexa-vec followed by sorafenib compared to sorafenib in patients with advanced HCC and no prior systemic treatment. The primary endpoint is overall survival (OS). Key secondary endpoints included time to progression (TTP), progression-free survival, overall response rate (ORR), and disease control rate (DCR). Safety was assessed in all patients who received ≥1 dose of study treatment. Results: The study was conducted at 142 sites in 16 countries. From December 30, 2015, to the interim analysis on August 2, 2019, 459 patients were randomly assigned (pexa-vec plus sorafenib: 234, sorafenib: 225). At the interim analysis, the median OS was 12.7 months (95% CI: 9.89, 14.95) in the pexa-vec plus sorafenib arm and 14.0 months (95% CI: 11.01, 18.00) in the sorafenib arm. This led to the early termination of the study. The median TTP was 2.0 months (95% CI: 1.77, 2.96) and 4.2 months (95% CI: 2.92, 4.63); ORR was 19.2% (45 patients) and 20.9% (47 patients); and DCR was 50.0% (117 patients) and 57.3% (129 patients) in the pexa-vec plus sorafenib and sorafenib arms, respectively. Serious adverse events were reported in 117 (53.7%) patients in the pexa-vec plus sorafenib and 77 (35.5%) patients in the sorafenib arm. Liver failure was the most frequently reported in both groups. Conclusion: Sequential pexa-vec plus sorafenib treatment did not demonstrate increased clinical benefit in advanced HCC and fared worse compared to sorafenib alone. The advent of the added value of checkpoint inhibitors should direct any further development of oncolytic virus therapy strategies. [ABSTRACT FROM AUTHOR]

Published
2024
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25. Network meta-analysis of global trials of 1L therapies in locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma.

Author

Shah, Manish A., primary, Shitara, Kohei, additional, Lonardi, Sara, additional, Chao, Yee, additional, Yamaguchi, Kensei, additional, Kukielka-Budny, Bozena, additional, Ryu, Min-Hee, additional, Ungureanu, Andrei, additional, Oh, Mok, additional, Chang, Lawrence, additional, Yang, Hongbo, additional, Chai, Xinglei, additional, Bhattacharya, Pranob P., additional, Matsangou, Maria, additional, Ranganath, Radhika, additional, Ajani, Jaffer A., additional, and Xu, Rui-Hua, additional

Published
2024
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26. MORPHEUS-EC: A phase Ib/II open-label, randomized study of first-line tiragolumab (tira) + atezolizumab (atezo) + chemotherapy (CT) in patients (pts) with esophageal cancer (EC).

Author

Sun, Jong-Mu, primary, Chao, Yee, additional, Kim, Sung-Bae, additional, Rha, Sun Young, additional, Evans, T.R. Jeffry, additional, Strickland, Andrew, additional, Wainberg, Zev A., additional, Chau, Ian, additional, Pelles-Avraham, Sharon, additional, Ajani, Jaffer A., additional, Malhotra, Ritu, additional, Liu, Qingyuan, additional, Li, Sijing, additional, Cha, Edward, additional, Rahalkar, Swapna, additional, Allen, Simon, additional, and Hsu, Chih-Hung, additional

Published
2024
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28. Preclinical and Clinical Observations Implying Combination Therapy to Enhance the Efficacy of the Her-2/neu B-Cell Peptide-Based Vaccine HER-Vaxx and to Prevent Immune Evasion

Author

Tobias, Joshua, primary, Högler, Sandra, additional, Raigel, Martin, additional, Lin, Diego Shih-Chieh, additional, Chao, Yee, additional, Kenner, Lukas, additional, Garner-Spitzer, Erika, additional, Yavrom, Sharon, additional, Ede, Nicholas J., additional, Zielinski, Christoph C., additional, Kundi, Michael, additional, and Wiedermann, Ursula, additional

Published
2023
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29. 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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32. Margetuximab plus pembrolizumab in patients with previously treated, HER2-positive gastro-oesophageal adenocarcinoma (CP-MGAH22–05): a single-arm, phase 1b–2 trial

Author

Catenacci, Daniel V T, Kang, Yoon-Koo, Park, Haeseong, Uronis, Hope E, Lee, Keun-Wook, Ng, Matthew C H, Enzinger, Peter C, Park, Se Hoon, Gold, Philip J, Lacy, Jill, Hochster, Howard S, Oh, Sang Cheul, Kim, Yeul Hong, Marrone, Kristen A, Kelly, Ronan J, Juergens, Rosalyn A, Kim, Jong Gwang, Bendell, Johanna C, Alcindor, Thierry, Sym, Sun Jin, Song, Eun-Kee, Chee, Cheng Ean, Chao, Yee, Kim, Sunnie, Lockhart, A Craig, Knutson, Keith L, Yen, Jennifer, Franovic, Aleksandra, Nordstrom, Jeffrey L, Li, Daner, Wigginton, Jon, Davidson-Moncada, Jan K, Rosales, Minori Koshiji, and Bang, Yung-Jue

Published
2020
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34. PHOCUS: A Phase 3, Randomized, Open-Label Study of Sequential Treatment with Pexa-Vec (JX-594) and Sorafenib in Patients with Advanced Hepatocellular Carcinoma

Author

Abou-Alfa, Ghassan K., primary, Galle, Peter R., additional, Chao, Yee, additional, Erinjeri, Joseph, additional, Heo, Jeong, additional, Borad, Mitesh J., additional, Luca, Angelo, additional, Burke, James, additional, Pelusio, Adina, additional, Agathon, Delphine, additional, Lusky, Monika, additional, Breitbach, Caroline, additional, Qin, Shukui, additional, and Gane, Edward, additional

Published
2023
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35. Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study

Author

Pant, Shubham, primary, Schuler, Martin, additional, Iyer, Gopa, additional, Witt, Olaf, additional, Doi, Toshihiko, additional, Qin, Shukui, additional, Tabernero, Josep, additional, Reardon, David A, additional, Massard, Christophe, additional, Minchom, Anna, additional, Lugowska, Iwona, additional, Carranza, Omar, additional, Arnold, Dirk, additional, Gutierrez, Martin, additional, Winter, Helen, additional, Stuyckens, Kim, additional, Crow, Lauren, additional, Najmi, Saltanat, additional, Hammond, Constance, additional, Thomas, Shibu, additional, Santiago-Walker, Ademi, additional, Triantos, Spyros, additional, Sweiti, Hussein, additional, Loriot, Yohann, additional, Greco, Martin Alberto, additional, Coward, Jim, additional, Joshua, Anthony, additional, Karapetis, Christos, additional, Hart, Christopher, additional, Zhang, Alison, additional, Prenen, Hans, additional, Goeminne, Jean-Charles, additional, Machiels, Jean-Pascal, additional, Rottey, Sylvie, additional, Corassa, Marcelo, additional, Molin, Graziela Zibetti Dal, additional, Tiscoski, Katsuki, additional, Jardim, Denis Leonardo Fontes, additional, Mak, Milena, additional, Fu, Wei, additional, Yao, Herui, additional, Huang, Jing, additional, Jiang, Haiping, additional, Chen, Baoshi, additional, Yan, Dong, additional, Yang, Yu, additional, Le Tourneau, Christophe, additional, Penel, Nicolas, additional, Salas, Sébastien, additional, Blay, Jean-Yves, additional, Brachet, Pierre-Emmanuel, additional, Durando, Xavier, additional, Emambux, Sheik, additional, Ravaud, Alain, additional, Folprecht, Gunnar, additional, Ahrens, Marit, additional, Golf, Alexander, additional, Haag, Georg Martin, additional, Lordick, Florian, additional, Desuki, Alexander, additional, Cazzaniga, Marina, additional, Ciardiello, Fortunato, additional, Milella, Michele, additional, Koyama, Takafumi, additional, Hirooka, Yoshiki, additional, Okamoto, Wataru, additional, Aogi, Kenjiro, additional, Kuboki, Yasutoshi, additional, Lee, Jungyun, additional, Kim, Sung-Bae, additional, Ahn, Myung-Ju, additional, Chang, Jong Hee, additional, Kim, Yong-Man, additional, Nam, Do-Hyun, additional, Park, Jae-Sung, additional, Paz-Ares, Luis, additional, Moreno, Victor, additional, Cervantes, Andres, additional, Calvo, Mariona, additional, Falcon, Alejandro, additional, Gonzalez, Antonio, additional, Martinez Bueno, Alejandro, additional, García-Corbacho, Javier, additional, Longo, Federico, additional, Yen, Chia-Jui, additional, Chen, Jen-Shi, additional, Hou, Ming-Feng, additional, Chao, Yee, additional, Rau, Kun-Ming, additional, Chiu, Tai-Jan, additional, Feng, Yin-Hsun, additional, Hsu, Chih-Hung, additional, Huang, Wen-Tsung, additional, Lai, Kuan-Ming, additional, Yeh, Su-peng, additional, Palmer, Daniel, additional, Welsh, Liam, additional, Plummer, Ruth, additional, Iyer, Gopakumar, additional, Bilen, Mehmet, additional, Arrowsmith, Edward, additional, Pant, Shubham, additional, Spigel, David Robert, additional, Zandberg, Dan Paul, additional, Doroshow, Deborah, additional, Lu-Emerson, Christine, additional, Moezi, Mehdi, additional, Paulson, Scott, additional, Reardon, David, additional, Ward, Patrick, additional, Chaves, Jorge, additional, Grigg, Claud, additional, Hussein, Atif, additional, Manda, Sudhir, additional, Monticelli, Michael, additional, Qamar, Rubina, additional, Richey, Stephen L, additional, Tamura, David, additional, and Wilks, Sharon, additional

Published
2023
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36. Secondary Primary Malignancy Risk in Patients With Cervical Cancer in Taiwan

Author

Teng, Chung-Jen, Huon, Leh-Kiong, Hu, Yu-Wen, Yeh, Chiu-Mei, Chao, Yee, Yang, Muh-Hwa, Chen, Tzeng-Ji, Hung, Yi-Ping, and Liu, Chia-Jen

Subjects
Patient Safety, Health Services, Cervical Cancer, Cancer, Clinical Research, Adult, Aged, Antineoplastic Agents, Carboplatin, Comorbidity, Female, Fluorouracil, Humans, Middle Aged, Neoplasms, Second Primary, Radiotherapy, Registries, Taiwan, Uterine Cervical Neoplasms, Young Adult, Clinical Sciences, Arthritis & Rheumatology
Abstract

To evaluate the risk of secondary primary malignancy (SPM) in patients with cervical cancer using a nationwide population-based dataset.Patients newly diagnosed with cervical cancer between 1997 and 2011 were identified using Taiwan's National Health Insurance database. Patients with antecedent malignancies were excluded. Standardized incidence ratios (SIRs) for SPM were calculated by comparing with the cancer incidence in the general population. Risk factors for cancer development were analyzed using Cox proportional hazard models.During the 14-year study period (follow-up of 223,062 person-years), 2004 cancers developed in 35,175 patients with cervical cancer. The SIR for all cancers was 1.56 (95% confidence interval, 1.50-1.63, P 10, 5 to 10, 1 to 5, and

Published
2015

37. Secondary Primary Malignancy Risk in Patients With Ovarian Cancer in Taiwan

Author

Hung, Yi-Ping, Liu, Chia-Jen, Hu, Yu-Wen, Chen, Min-Huang, Li, Chun-Pin, Yeh, Chiu-Mei, Chiou, Tzeon-Jye, Chen, Tzeng-Ji, Yang, Muh-Hwa, and Chao, Yee

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Prevention, Ovarian Cancer, Rare Diseases, Cancer, Clinical Research, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Comorbidity, Female, Fluorouracil, Humans, Incidence, Middle Aged, Neoplasms, Second Primary, Ovarian Neoplasms, Radiotherapy, Retrospective Studies, Risk Assessment, Taiwan, Young Adult
Abstract

To evaluate the incidence of secondary primary malignancy (SPM) in patients with ovarian cancer using a nationwide retrospective population-based dataset. Patients newly diagnosed with ovarian cancer between 1997 and 2010 were identified using Taiwan's National Health Insurance database. Patients with antecedent malignancies were excluded. Standardized incidence ratios (SIRs) for SPM were calculated and compared with the cancer incidence in the general population. Risk factors for cancer development were analyzed using Cox proportional hazard models. Effects of surgery, chemotherapy, and radiotherapy after ovarian cancer diagnosis were regarded as time-dependent variables to prevent immortal time bias. During the 14-year study period (follow-up of 56,214 person-years), 707 cancers developed in 12,127 patients with ovarian cancer. The SIR for all cancers was 2.78 (95% confidence interval 2.58-3.00). SIRs for follow-up periods of >5, 1-5, and

Published
2015

39. A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data

Author

Chen, Li-Tzong, 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, Kang, Yoon-Koo, and Boku, Narikazu

Published
2020
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40. Exploratory subgroup analysis of patients with prior trastuzumab use in the ATTRACTION-2 trial: a randomized phase III clinical trial investigating the efficacy and safety of nivolumab in patients with advanced gastric/gastroesophageal junction cancer

Author

Satoh, Taroh, Kang, Yoon-Koo, Chao, Yee, Ryu, Min-Hee, Kato, Ken, Cheol Chung, Hyun, Chen, Jen-Shi, Muro, Kei, Ki Kang, Won, 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, Tanimoto, Mitsunobu, Chen, Li-Tzong, and Boku, Narikazu

Published
2020
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41. Radiologic Patterns Determine the Outcomes of Initial and Subsequent Transarterial Chemoembolization in Intermediate-Stage Hepatocellular Carcinoma

Author

Hung, Ya-Wen, Lee, I-Cheng, Chi, Chen-Ta, Lee, Rheun-Chuan, Liu, Chien-An, Chiu, Nai-Chi, Hwang, Hsuen-En, Chao, Yee, Hou, Ming-Chih, and Huang, Yi-Hsiang

Abstract

Introduction:Outcomes of transarterial chemoembolization (TACE) for intermediate-stage hepatocellular carcinoma (HCC) are diverse because of the heterogeneity of tumor burden. Radiologic pattern is one criterion for determining whether TACE is unsuitable. However, additional evidence is required. This study determined the influence of radiologic morphology on the outcomes of initial and subsequent TACE. Methods:From January 2007 to September 2021, 633 treatment-naive patients with HCC with intermediate-stage HCC undergoing TACE were retrospectively enrolled. Of these patients, 386 patients received repeated TACE. The radiological features of HCC were evaluated by two radiologists and classified into encapsulated nodular type, simple nodular type with extranodular growth, confluent multinodular type, and infiltrative type. The objective response rate (ORR) and survival rate after initial and subsequent TACE among various radiologic morphologies were compared. Results:After initial TACE, encapsulated nodular type HCC had the highest ORR (58%), followed by extranodular type (45.8%), confluent multinodular type (29%), and infiltrative type (19.5%). Notably, radiologic pattern was highly associated with tumor burden. Tumor burden and radiologic morphology were significantly associated with ORR and overall survival (OS) in the multivariate analysis. In 386 patients with subsequent TACE, encapsulated nodular type HCC had the highest ORR (48.7%), followed by extranodular type (37.3%), confluent multinodular type (26.2%), and infiltrative type (10%). In the multivariate analysis, radiologic features were significant independent predictors of ORR and OS after receiving subsequent TACE. Conclusion:Radiologic patterns determine the outcomes of initial and subsequent TACE. Systemic therapy should be considered for patients with intermediate-stage HCC with unfavorable radiologic patterns.

Published
2024
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45. Preclinical and Clinical Observations Implying Combination Therapy to Enhance the Efficacy of the Her-2/neu B-Cell Peptide-Based Vaccine HER-Vaxx and to Prevent Immune Evasion.

Author

Tobias, Joshua, Högler, Sandra, Raigel, Martin, Lin, Diego Shih-Chieh, Chao, Yee, Kenner, Lukas, Garner-Spitzer, Erika, Yavrom, Sharon, Ede, Nicholas J., Zielinski, Christoph C., Kundi, Michael, and Wiedermann, Ursula

Subjects
B cells, TUMOR-infiltrating immune cells, FLUORESCENCE in situ hybridization, PROGRAMMED death-ligand 1, CANCER invasiveness
Abstract

Her-2/neu-targeting therapy by passive application with trastuzumab is associated with acquired resistance and subsequent metastasis development, which is attributed to the upregulation of tumoral PD-L1 expression and the downregulation of Her-2/neu. We aimed to investigate this association, following active immunization with our recently constructed B-cell peptide-based Her-2/neu vaccines in both preclinical and clinical settings. Immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and combined positive score (CPS) were applied to evaluate Her-2/neu and PD-L1 expression using a murine syngeneic tumor model for Her-2/neu lung metastases and tumor biopsies from a gastric cancer patient with disease progression. A significant and concomitant reduction in Her-2/neu and the upregulation of PD-L1 expression was observed in vaccinated mice after 45 days, but not after 30 days, of metastases development. A significant increase in tumor-infiltrating B lymphocytes was observed at both time points. The downregulation of Her-2/neu and the upregulation of PD-L1 were observed in a patient's primary tumor at the disease progression time point but not prior to vaccination (Her-2/neu IHC: 3 to 0, FISH: 4.98 to 1.63; PD-L1 CPS: 0% to 5%). Our results further underline the need for combination therapy by targeting PD-L1 to prevent metastasis formation and immune evasion of Her-2/neu-positive and PD-L1-negative tumor cells. [ABSTRACT FROM AUTHOR]

Published
2024
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