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1. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, Zurawski, Bogdan, Spicer, Jonathan D, Garassino, Marina C, Majem, Margarita, Martinengo, Gastón L, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, and Samkari, Ayman

Published
2024
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2. Sunvozertinib, a selective EGFR inhibitor for previously treated non-small cell lung cancer with EGFR exon 20 insertion mutationsSunvozertinib for NSCLC with EGFR Exon20ins

Author

Wang, Mengzhao, Yang, James Chih-Hsin, Mitchell, Paul L, Fang, Jian, Camidge, D Ross, Nian, Weiqi, Chiu, Chao-Hua, Zhou, Jianying, Zhao, Yanqiu, Su, Wu-Chou, Yang, Tsung-Ying, Zhu, Viola W, Millward, Michael, Fan, Yun, Huang, Wen-Tsung, Cheng, Ying, Jiang, Liyan, Brungs, Daniel, Bazhenova, Lyudmila, Lee, Chee Khoon, Gao, Bo, Xu, Yan, Hsu, Wei-Hsun, Zheng, Li, and Janne, Pasi A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Lung Cancer, Clinical Research, Lung, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Antibodies, Bispecific, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, ErbB Receptors, Exons, Humans, Lung Neoplasms, Mutagenesis, Insertional, Mutation, Protein Kinase Inhibitors, Biochemistry and cell biology, Oncology and carcinogenesis
Abstract

Epidermal growth factor receptor exon 20 insertion mutations (EGFRexon20ins) are detected in approximately 2% of patients with non-small cell lung cancer (NSCLC). Due to a lack of effective therapy, the prognosis of these patients is typically poor. Sunvozertinib (DZD9008) was designed as an oral, potent, irreversible, and selective EGFR tyrosine kinase inhibitor, showing activity against EGFRexon20ins and other mutations. In both cell lines and xenograft models, sunvozertinib shows potent antitumor activity. In the two ongoing phase I clinical studies, sunvozertinib was tolerated up to 400 mg once daily. The most common drug-related adverse events included diarrhea and skin rash. Antitumor efficacy was observed at the doses of 100 mg and above in patients with EGFRexon20ins NSCLC across different subtypes, with prior amivantamab treatment as well as with baseline brain metastasis. The median duration of response has not been reached.SignificanceWe report the discovery and early clinical development of sunvozertinib, a potential treatment option for the unmet medical need of EGFRexon20ins NSCLC. This article is highlighted in the In This Issue feature, p. 1599.

Published
2022

3. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With NTRK Fusion-Positive Solid TumorsEntrectinib in NTRK+ Solid Tumors: Updated Efficacy/Safety

Author

Demetri, George D, De Braud, Filippo, Drilon, Alexander, Siena, Salvatore, Patel, Manish R, Cho, Byoung Chul, Liu, Stephen V, Ahn, Myung-Ju, Chiu, Chao-Hua, Lin, Jessica J, Goto, Koichi, Lee, Jeeyun, Bazhenova, Lyudmila, John, Thomas, Fakih, Marwan, Chawla, Sant P, Dziadziuszko, Rafal, Seto, Takashi, Heinzmann, Sebastian, Pitcher, Bethany, Chen, David, Wilson, Timothy R, and Rolfo, Christian

Subjects
Cancer, Clinical Trials and Supportive Activities, Brain Disorders, Neurosciences, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Benzamides, Carcinoma, Non-Small-Cell Lung, Child, Humans, Indazoles, Lung Neoplasms, Protein-Tyrosine Kinases, Proto-Oncogene Proteins, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeEntrectinib potently inhibits tropomyosin receptor kinases (TRKAs)/B/C and ROS1, and previously induced deep [objective response rate (ORR) 57.4%] and durable [median duration of response (DoR) 10.4 months] responses in adults with NTRK fusion-positive solid tumors from three phase I/II trials. This article expands prior reports with additional patients and longer follow-up.Patients and methodsPatients with locally advanced/metastatic NTRK fusion-positive solid tumors and ≥12 months' follow-up were included. Primary endpoints were ORR and DoR by blinded independent central review (BICR); secondary endpoints included progression-free survival (PFS), intracranial efficacy, and safety. The safety-evaluable populations included all patients who had received ≥1 entrectinib dose.ResultsAt clinical cut-off (August 31, 2020), the efficacy-evaluable population comprised 121 adults with 14 tumor types and ≥30 histologies. Median follow-up was 25.8 months; 61.2% of patients had a complete (n = 19) or partial response (n = 55). Median DoR was 20.0 months [95% confidence interval (CI), 13.0-38.2]; median PFS was 13.8 months (95% CI, 10.1-19.9). In 11 patients with BICR-assessed measurable central nervous system (CNS) disease, intracranial ORR was 63.6% (95% CI, 30.8-89.1) and median intracranial DoR was 22.1 (95% CI, 7.4-not estimable) months. The safety profile of entrectinib in adults and pediatric patients was aligned with previous reports. Most treatment-related adverse events (TRAEs) were grade 1/2 and manageable/reversible with dose modifications. TRAE-related discontinuations occurred in 8.3% of patients.ConclusionsWith additional clinical experience, entrectinib continues to demonstrate durable systemic and intracranial responses and can address the unmet need of a CNS-active treatment in patients with NTRK fusion-positive solid tumors.

Published
2022

6. Low-dose CT screening among never-smokers with or without a family history of lung cancer in Taiwan: a prospective cohort study

Author

Chan, Chang-Chuan, Chan, Si-Wa, Chang, I-Shou, Chang, Jer-Hwa, Chao, Kun-San, Chen, Chi-Jen, Chen, Huei-Wen, Chiang, Chun-Ju, Chiou, Hung-Yi, Chou, Mei-Chun, Chung, Chi-Li, Chung, Ta-Jung, Guo, Yue Leon, Hsiao, Chin-Fu, Huang, Chien-Sheng, Ko, Sheung-Fat, Lee, Mei-Hsuan, Li, Yao-Jen, Liao, Yu-San, Lu, Yueh-Hsun, Ou, Hsin-You, Wu, Ping-An, Yang, Hwai-I, Yang, Shi-Yi, Yang, Szu-Chun, Chang, Gee-Chen, Chiu, Chao-Hua, Yu, Chong-Jen, Chang, Yeun-Chung, Chang, Ya-Hsuan, Hsu, Kuo-Hsuan, Wu, Yu-Chung, Chen, Chih-Yi, Hsu, Hsian-He, Wu, Ming-Ting, Yang, Cheng-Ta, Chong, Inn-Wen, Lin, Yu-Ching, Hsia, Te-Chun, Lin, Meng-Chih, Su, Wu-Chou, Lin, Chih-Bin, Lee, Kang-Yun, Wei, Yu-Feng, Lan, Gong-Yau, Chan, Wing P, Wang, Kao-Lun, Wu, Mei-Han, Tsai, Hao-Hung, Chian, Chih-Feng, Lai, Ruay-Sheng, Shih, Jin-Yuan, Wang, Chi-Liang, Hsu, Jui-Sheng, Chen, Kun-Chieh, Chen, Chun-Ku, Hsia, Jiun-Yi, Peng, Chung-Kan, Tang, En-Kuei, Hsu, Chia-Lin, Chou, Teh-Ying, Shen, Wei-Chih, Tsai, Ying-Huang, Tsai, Chun-Ming, Chen, Yuh-Min, Lee, Yu-Chin, Chen, Hsuan-Yu, Yu, Sung-Liang, Chen, Chien-Jen, Wan, Yung-Liang, Hsiung, Chao Agnes, and Yang, Pan-Chyr

Published
2024
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8. Evaluation of combination treatment with DS-1205c, an AXL kinase inhibitor, and osimertinib in metastatic or unresectable EGFR-mutant non-small cell lung cancer: results from a multicenter, open-label phase 1 study

Author

Yang, James Chih-Hsin, Su, Wu-Chou, Chiu, Chao-Hua, Shiah, Her-Shyong, Lee, Kang-Yun, Hsia, Te-Chun, Uno, Makiko, Crawford, Nigel, Terakawa, Hiroshi, Chen, Wen-Chi, Takayama, Gensuke, Hsu, Ching, Hong, Ying, Saintilien, Carline, McGill, Joseph, and Chang, Gee-Chen

Published
2023
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11. Asian Subgroup Analysis of the Randomized Phase 3 CROWN Study of First-Line Lorlatinib Versus Crizotinib in Advanced ALK-Positive NSCLC

Author

Zhou, Qing, Soo, Ross A., Chang, Gee-Chen, Chiu, Chao-Hua, Hayashi, Hidetoshi, Kim, Sang-We, Teraoka, Shunsuke, Goto, Yasushi, Zhou, Jianying, Ho-Fun Lee, Victor, Kim, Dong-Wan, Han, Baohui, Chung Man Ho, James, Lin, Chia-Chi, Lu, Shun, Polli, Anna, Calella, Anna Maria, Martini, Jean-François, Wong, Chew Hooi, Mok, Tony, Kim, Hye Ryun, and Wu, Yi-Long

Published
2023
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15. Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial

Author

Lu, Shun, Wang, Qiming, Zhang, Guojun, Dong, Xiaorong, Yang, Cheng-Ta, Song, Yong, Chang, Gee-Chen, Lu, You, Pan, Hongming, Chiu, Chao-Hua, Wang, Zhehai, Feng, Jifeng, Zhou, Jianying, Xu, Xingxiang, Guo, Renhua, Chen, Jianhua, Yang, Haihua, Chen, Yuan, Yu, Zhuang, Shiah, Her-Shyong, Wang, Chin-Chou, Yang, Nong, Fang, Jian, Wang, Ping, Wang, Kai, Hu, Yanping, He, Jianxing, Wang, Ziping, Shi, Jianhua, Chen, Shaoshui, Wu, Qiong, Sun, Changan, Li, Chuan, Wei, Hongying, Cheng, Ying, Su, Wu-Chou, Hsia, Te-Chun, Cui, Jiuwei, Sun, Yuping, Ou, Sai-Hong Ignatius, Zhu, Viola W., and Chih-Hsin Yang, James

Published
2022
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16. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Spicer, Jonathan D, Garassino, Marina C, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, Samkari, Ayman, Gao, Shugeng, Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, and Zurawski, Bogdan

Abstract

At the first interim analysis of the KEYNOTE-671 trial, adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival in participants with early-stage non-small-cell lung cancer (NSCLC). We report overall survival and health-related quality of life outcomes from the second interim analysis.

Published
2024
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17. SKYSCRAPER-02:Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer

Author

Rudin, Charles M., Liu, Stephen V., Soo, Ross A., Lu, Shun, Hong, Min Hee, Lee, Jong Seok, Bryl, Maciej, Dumoulin, Daphne W., Rittmeyer, Achim, Chiu, Chao Hua, Ozyilkan, Ozgur, Johnson, Melissa, Navarro, Alejandro, Novello, Silvia, Ozawa, Yuichi, Tam, Sammi Hiu, Patil, Namrata S., Wen, Xiaohui, Huang, Meilin, Hoang, Tien, Meng, Raymond, Reck, Martin, Rudin, Charles M., Liu, Stephen V., Soo, Ross A., Lu, Shun, Hong, Min Hee, Lee, Jong Seok, Bryl, Maciej, Dumoulin, Daphne W., Rittmeyer, Achim, Chiu, Chao Hua, Ozyilkan, Ozgur, Johnson, Melissa, Navarro, Alejandro, Novello, Silvia, Ozawa, Yuichi, Tam, Sammi Hiu, Patil, Namrata S., Wen, Xiaohui, Huang, Meilin, Hoang, Tien, Meng, Raymond, and Reck, Martin

Abstract

PURPOSE: The phase III SKYSCRAPER-02 study determined whether the benefits of atezolizumab plus carboplatin and etoposide (CE) could be enhanced by the addition of tiragolumab in untreated extensive-stage small-cell lung cancer (ES-SCLC). We report final progression-free survival (PFS) and overall survival (OS) analyses. METHODS: Patients received tiragolumab 600 mg/placebo, plus atezolizumab 1,200 mg and CE (four cycles), then maintenance tiragolumab/placebo plus atezolizumab. Primary end points were investigator-assessed PFS and OS in patients without history/presence of brain metastases (primary analysis set [PAS]). Additional end points included PFS and OS in all patients regardless of brain metastases status (full analysis set [FAS]), response, and safety. RESULTS: Four hundred ninety patients were randomly assigned (FAS): 243 to tiragolumab arm and 247 to control arm. At the cutoff date (February 6, 2022; median duration of follow-up, 14.3 months [PAS] and 13.9 months [FAS]), final analysis of PFS in the PAS (n = 397) did not reach statistical significance (stratified hazard ratio [HR], 1.11; P = .3504; median, 5.4 months tiragolumab v 5.6 months control). At the cutoff date (September 6, 2022; median duration of follow-up, 21.2 months [FAS]), median OS in the PAS at final OS analysis was 13.1 months in both arms (stratified HR, 1.14; P = .2859). Median PFS and OS in the FAS were consistent with the PAS. The proportion of patients with immune-mediated adverse events (AEs) in the tiragolumab and control arms was 54.4% and 49.2%, respectively (grade 3/4: 7.9% and 7.7%). AEs leading to treatment withdrawal occurred in 8.4% and 9.3% of tiragolumab- and control-treated patients, respectively.CONCLUSION: Tiragolumab did not provide additional benefit over atezolizumab and CE in untreated ES-SCLC. The combination was well tolerated with no new safety signals.

Published
2024

18. Safety, Efficacy, and Pharmacokinetics of Almonertinib (HS-10296) in Pretreated Patients With EGFR-Mutated Advanced NSCLC: A Multicenter, Open-label, Phase 1 Trial

Author

Yang, James Chih-Hsin, Camidge, D. Ross, Yang, Cheng-Ta, Zhou, Jianying, Guo, Renhua, Chiu, Chao-Hua, Chang, Gee-Chen, Shiah, Her-Shyong, Chen, Yuan, Wang, Chin-Chou, Berz, David, Su, Wu-Chou, Yang, Nong, Wang, Ziping, Fang, Jian, Chen, Jianhua, Nikolinakos, Petros, Lu, You, Pan, Hongming, Maniam, Ajit, Bazhenova, Lyudmila, Shirai, Keisuke, Jahanzeb, Mohammad, Willis, Maurice, Masood, Nehal, Chowhan, Naveed, Hsia, Te-Chun, Jian, Hong, and Lu, Shun

Published
2020
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21. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1–2 trials

Author

Drilon, Alexander, Siena, Salvatore, Dziadziuszko, Rafal, Barlesi, Fabrice, Krebs, Matthew G, Shaw, Alice T, de Braud, Filippo, Rolfo, Christian, Ahn, Myung-Ju, Wolf, Jürgen, Seto, Takashi, Cho, Byoung Chul, Patel, Manish R, Chiu, Chao-Hua, John, Thomas, Goto, Koichi, Karapetis, Christos S, Arkenau, Hendrick-Tobias, Kim, Sang-We, Ohe, Yuichiro, Li, Yu-Chung, Chae, Young K, Chung, Christine H, Otterson, Gregory A, Murakami, Haruyasu, Lin, Chia-Chi, Tan, Daniel S W, Prenen, Hans, Riehl, Todd, Chow-Maneval, Edna, Simmons, Brian, Cui, Na, Johnson, Ann, Eng, Susan, Wilson, Timothy R, and Doebele, Robert C

Published
2020
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23. Nivolumab Plus Chemotherapy in Epidermal Growth Factor Receptor–Mutated Metastatic Non–Small-Cell Lung Cancer After Disease Progression on Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: Final Results of CheckMate 722

Author

Mok, Tony, primary, Nakagawa, Kazuhiko, additional, Park, Keunchil, additional, Ohe, Yuichiro, additional, Girard, Nicolas, additional, Kim, Hye Ryun, additional, Wu, Yi-Long, additional, Gainor, Justin, additional, Lee, Se-Hoon, additional, Chiu, Chao-Hua, additional, Kim, Sang-We, additional, Yang, Cheng-Ta, additional, Wu, Chien Liang, additional, Wu, Lin, additional, Lin, Meng-Chih, additional, Samol, Jens, additional, Ichikado, Kazuya, additional, Wang, Mengzhao, additional, Zhang, Xiaoqing, additional, Sylvester, Judi, additional, Li, Sunney, additional, Forslund, Ann, additional, and Yang, James Chih-Hsin, additional

Published
2024
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24. Brief Report: Updated Efficacy and Safety Data From an Integrated Analysis of Entrectinib in Locally Advanced/Metastatic ROS1 Fusion-Positive Non-Small Cell Lung Cancer

Author

Fan, Yun, primary, Drilon, Alexander, additional, Chiu, Chao-Hua, additional, Loong, Herbert H.F., additional, Siena, Salvatore, additional, Krzakowski, Maciej, additional, Dziadziuszko, Rafal, additional, Zeuner, Harald, additional, Xue, Cloris, additional, and Krebs, Matthew G., additional

Published
2023
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27. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Chu, Quincy, Cortot, Alexis, Pujol, Jean-Louis, Moro-Sibilot, Denis, Fabre, Elizabeth, Lamour, Corinne, Bischoff, Helge, Kollmeier, Jens, Reck, Martin, Kimmich, Martin, Engel-Riedel, Walburga, Hammerschmidt, Stefan, Schütte, Wolfgang, Syrigos, Konstantinos, Ho, James Chung Man, Au, Kwok-Hung, Novello, Silvia, Ardizzoni, Andrea, Pasello, Giulia, Gregorc, Vanessa, Del Conte, Alessandro, Galetta, Domenico, Takahashi, Toshiaki, Nakagawa, Kazuhiko, Nishio, Makoto, Yoh, Kiyotaka, Seto, Takashi, Imamura, Fumio, Kumagai, Toru, Hotta, Katsuyuki, Goto, Yasushi, Hosomi, Yukio, Sakai, Hiroshi, Takiguchi, Yuichi, Kim, Young Hak, Kurata, Takayasu, Yamaguchi, Hiroyuki, Daga, Haruko, Okamoto, Isamu, Satouchi, Miyako, Ikeda, Satoshi, Kasahara, Kazuo, Atagi, Shinji, Azuma, Koichi, Aoe, Keisuke, Horio, Yoshitsugu, Yamamoto, Nobuyuki, Tanaka, Hiroshi, Watanabe, Satoshi, Nogami, Naoyuki, Ozaki, Tomohiro, Koyama, Ryo, Hirashima, Tomonori, Kaneda, Hiroyasu, Tomii, Keisuke, Fujita, Yuka, Seike, Masahiro, Nishimura, Naoki, Kato, Terufumi, Ichiki, Masao, Saka, Hideo, Hirano, Katsuya, Nakahara, Yasuharu, Sugawara, Shunichi, Park, Keunchil, Kim, Sang-We, Min, Young Joo, Lee, Hyun Woo, Kang, Jin-Hyoung, An, Ho Jung, Lee, Ki Hyeong, Kim, Jin-Soo, Lee, Gyeong-Won, Lee, Sung Yong, Alexandru, Aurelia, Udrea, Anghel Adrian, Juan-Vidal, Óscar, Nadal-Alforja, Ernest, Gil-Bazo, Ignacio, Ponce-Aix, Santiago, Paz-Ares, Luis, Rubio-Viqueira, Belén, Alonso Garcia, Miriam, Felip Font, Enriqueta, Fuentes Pradera, Jose, Coves Sarto, Juan, Lin, Meng-Chih, Su, Wu-Chou, Hsia, Te-Chun, Chang, Gee-Chen, Wei, Yu-Feng, Chiu, Chao-Hua, Shih, Jin-Yuan, Su, Jian, Cicin, Irfan, Goksel, Tuncay, Harputluoglu, Hakan, Ozyilkan, Ozgur, Henning, Ivo, Popat, Sanjay, Hatcher, Olivia, Mileham, Kathryn, Acoba, Jared, Garon, Edward, Jung, Gabriel, Raj, Moses, Martin, William, Dakhil, Shaker, Garon, Edward B, Ponce Aix, Santiago, Nadal, Ernest, Au, Kwok Hung, Enatsu, Sotaro, Zimmermann, Annamaria, Frimodt-Moller, Bente, and Visseren-Grul, Carla

Published
2019
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30. Low-dose CT screening among never-smokers with or without a family history of lung cancer in Taiwan: a prospective cohort study

Author

Chang, Gee-Chen, primary, Chiu, Chao-Hua, additional, Yu, Chong-Jen, additional, Chang, Yeun-Chung, additional, Chang, Ya-Hsuan, additional, Hsu, Kuo-Hsuan, additional, Wu, Yu-Chung, additional, Chen, Chih-Yi, additional, Hsu, Hsian-He, additional, Wu, Ming-Ting, additional, Yang, Cheng-Ta, additional, Chong, Inn-Wen, additional, Lin, Yu-Ching, additional, Hsia, Te-Chun, additional, Lin, Meng-Chih, additional, Su, Wu-Chou, additional, Lin, Chih-Bin, additional, Lee, Kang-Yun, additional, Wei, Yu-Feng, additional, Lan, Gong-Yau, additional, Chan, Wing P, additional, Wang, Kao-Lun, additional, Wu, Mei-Han, additional, Tsai, Hao-Hung, additional, Chian, Chih-Feng, additional, Lai, Ruay-Sheng, additional, Shih, Jin-Yuan, additional, Wang, Chi-Liang, additional, Hsu, Jui-Sheng, additional, Chen, Kun-Chieh, additional, Chen, Chun-Ku, additional, Hsia, Jiun-Yi, additional, Peng, Chung-Kan, additional, Tang, En-Kuei, additional, Hsu, Chia-Lin, additional, Chou, Teh-Ying, additional, Shen, Wei-Chih, additional, Tsai, Ying-Huang, additional, Tsai, Chun-Ming, additional, Chen, Yuh-Min, additional, Lee, Yu-Chin, additional, Chen, Hsuan-Yu, additional, Yu, Sung-Liang, additional, Chen, Chien-Jen, additional, Wan, Yung-Liang, additional, Hsiung, Chao Agnes, additional, Yang, Pan-Chyr, additional, Chan, Chang-Chuan, additional, Chan, Si-Wa, additional, Chang, I-Shou, additional, Chang, Jer-Hwa, additional, Chao, Kun-San, additional, Chen, Chi-Jen, additional, Chen, Huei-Wen, additional, Chiang, Chun-Ju, additional, Chiou, Hung-Yi, additional, Chou, Mei-Chun, additional, Chung, Chi-Li, additional, Chung, Ta-Jung, additional, Guo, Yue Leon, additional, Hsiao, Chin-Fu, additional, Huang, Chien-Sheng, additional, Ko, Sheung-Fat, additional, Lee, Mei-Hsuan, additional, Li, Yao-Jen, additional, Liao, Yu-San, additional, Lu, Yueh-Hsun, additional, Ou, Hsin-You, additional, Wu, Ping-An, additional, Yang, Hwai-I, additional, Yang, Shi-Yi, additional, and Yang, Szu-Chun, additional

Published
2023
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32. Personalized cancer avatars for patients with thymic malignancies: A pilot study with circulating tumor cell‐derived organoids

Author

Wu, Yuan‐Hung, primary, Chao, Heng‐sheng, additional, Chiang, Chi‐Lu, additional, Luo, Yung‐Hung, additional, Chiu, Chao‐Hua, additional, Yen, Sang‐Hue, additional, Liu, Chun‐Yu, additional, Chiou, Jeng‐Fong, additional, Burnouf, Thierry, additional, Chen, Yin‐Ju, additional, Wang, Peng‐Yuan, additional, Chao, Tsu‐Yi, additional, Hsu, Shih‐Ming, additional, and Lu, Long‐Sheng, additional

Published
2023
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34. Low-dose CT screening among never-smokers with or without a family history of lung cancer in Taiwan: a prospective cohort study.

Author

Chang, Gee-Chen, Chiu, Chao-Hua, Yu, Chong-Jen, Chang, Yeun-Chung, Chang, Ya-Hsuan, Hsu, Kuo-Hsuan, Wu, Yu-Chung, Chen, Chih-Yi, Hsu, Hsian-He, Wu, Ming-Ting, Yang, Cheng-Ta, Chong, Inn-Wen, Lin, Yu-Ching, Hsia, Te-Chun, Lin, Meng-Chih, Su, Wu-Chou, Lin, Chih-Bin, Lee, Kang-Yun, Wei, Yu-Feng, and Lan, Gong-Yau

Subjects
FAMILY history (Medicine), MEDICAL screening, LUNG cancer, TUBERCULOSIS, PASSIVE smoking, VIRTUAL colonoscopy, ARTIFICIAL respiration
Abstract

In Taiwan, lung cancers occur predominantly in never-smokers, of whom nearly 60% have stage IV disease at diagnosis. We aimed to assess the efficacy of low-dose CT (LDCT) screening among never-smokers, who had other risk factors for lung cancer. The Taiwan Lung Cancer Screening in Never-Smoker Trial (TALENT) was a nationwide, multicentre, prospective cohort study done at 17 tertiary medical centres in Taiwan. Eligible individuals had negative chest radiography, were aged 55–75 years, had never smoked or had smoked fewer than 10 pack-years and stopped smoking for more than 15 years (self-report), and had one of the following risk factors: a family history of lung cancer; passive smoke exposure; a history of pulmonary tuberculosis or chronic obstructive pulmonary disorders; a cooking index of 110 or higher; or cooking without using ventilation. Eligible participants underwent LDCT at baseline, then annually for 2 years, and then every 2 years up to 6 years thereafter, with follow-up assessments at each LDCT scan (ie, total follow-up of 8 years). A positive scan was defined as a solid or part-solid nodule larger than 6 mm in mean diameter or a pure ground-glass nodule larger than 5 mm in mean diameter. Lung cancer was diagnosed through invasive procedures, such as image-guided aspiration or biopsy or surgery. Here, we report the results of 1-year follow-up after LDCT screening at baseline. The primary outcome was lung cancer detection rate. The p value for detection rates was estimated by the χ2 test. Univariate and multivariable logistic regression analyses were used to assess the association between lung cancer incidence and each risk factor. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of LDCT screening were also assessed. This study is registered with ClinicalTrials.gov , NCT02611570 , and is ongoing. Between Dec 1, 2015, and July 31, 2019, 12 011 participants (8868 females) were enrolled, of whom 6009 had a family history of lung cancer. Among 12 011 LDCT scans done at baseline, 2094 (17·4%) were positive. Lung cancer was diagnosed in 318 (2·6%) of 12 011 participants (257 [2·1%] participants had invasive lung cancer and 61 [0·5%] had adenocarcinomas in situ). 317 of 318 participants had adenocarcinoma and 246 (77·4%) of 318 had stage I disease. The prevalence of invasive lung cancer was higher among participants with a family history of lung cancer (161 [2·7%] of 6009 participants) than in those without (96 [1·6%] of 6002 participants). In participants with a family history of lung cancer, the detection rate of invasive lung cancer increased significantly with age, whereas the detection rate of adenocarcinoma in situ remained stable. In multivariable analysis, female sex, a family history of lung cancer, and age older than 60 years were associated with an increased risk of lung cancer and invasive lung cancer; passive smoke exposure, cumulative exposure to cooking, cooking without ventilation, and a previous history of chronic lung diseases were not associated with lung cancer, even after stratification by family history of lung cancer. In participants with a family history of lung cancer, the higher the number of first-degree relatives affected, the higher the risk of lung cancer; participants whose mother or sibling had lung cancer were also at an increased risk. A positive LDCT scan had 92·1% sensitivity, 84·6% specificity, a PPV of 14·0%, and a NPV of 99·7% for lung cancer diagnosis. TALENT had a high invasive lung cancer detection rate at 1 year after baseline LDCT scan. Overdiagnosis could have occurred, especially in participants diagnosed with adenocarcinoma in situ. In individuals who do not smoke, our findings suggest that a family history of lung cancer among first-degree relatives significantly increases the risk of lung cancer as well as the rate of invasive lung cancer with increasing age. Further research on risk factors for lung cancer in this population is needed, particularly for those without a family history of lung cancer. Ministry of Health and Welfare of Taiwan. [ABSTRACT FROM AUTHOR]

Published
2024
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35. SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer.

Author

Rudin, Charles M., Liu, Stephen V., Soo, Ross A., Lu, Shun, Hong, Min Hee, Lee, Jong-Seok, Bryl, Maciej, Dumoulin, Daphne W., Rittmeyer, Achim, Chiu, Chao-Hua, Ozyilkan, Ozgur, Johnson, Melissa, Navarro, Alejandro, Novello, Silvia, Ozawa, Yuichi, Tam, Sammi Hiu, Patil, Namrata S., Wen, Xiaohui, Huang, Meilin, and Hoang, Tien

Published
2024
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38. Data from Sunvozertinib, a Selective EGFR Inhibitor for Previously Treated Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Author

Wang, Mengzhao, primary, Yang, James Chih-Hsin, primary, Mitchell, Paul L., primary, Fang, Jian, primary, Camidge, D. Ross, primary, Nian, Weiqi, primary, Chiu, Chao-Hua, primary, Zhou, Jianying, primary, Zhao, Yanqiu, primary, Su, Wu-Chou, primary, Yang, Tsung-Ying, primary, Zhu, Viola W., primary, Millward, Michael, primary, Fan, Yun, primary, Huang, Wen-Tsung, primary, Cheng, Ying, primary, Jiang, Liyan, primary, Brungs, Daniel, primary, Bazhenova, Lyudmila, primary, Lee, Chee Khoon, primary, Gao, Bo, primary, Xu, Yan, primary, Hsu, Wei-Hsun, primary, Zheng, Li, primary, and Jänne, Pasi A., primary

Published
2023
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39. Supplementary Table from Sunvozertinib, a Selective EGFR Inhibitor for Previously Treated Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Author

Wang, Mengzhao, primary, Yang, James Chih-Hsin, primary, Mitchell, Paul L., primary, Fang, Jian, primary, Camidge, D. Ross, primary, Nian, Weiqi, primary, Chiu, Chao-Hua, primary, Zhou, Jianying, primary, Zhao, Yanqiu, primary, Su, Wu-Chou, primary, Yang, Tsung-Ying, primary, Zhu, Viola W., primary, Millward, Michael, primary, Fan, Yun, primary, Huang, Wen-Tsung, primary, Cheng, Ying, primary, Jiang, Liyan, primary, Brungs, Daniel, primary, Bazhenova, Lyudmila, primary, Lee, Chee Khoon, primary, Gao, Bo, primary, Xu, Yan, primary, Hsu, Wei-Hsun, primary, Zheng, Li, primary, and Jänne, Pasi A., primary

Published
2023
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40. Supplementary Data from Sunvozertinib, a Selective EGFR Inhibitor for Previously Treated Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Author

Wang, Mengzhao, primary, Yang, James Chih-Hsin, primary, Mitchell, Paul L., primary, Fang, Jian, primary, Camidge, D. Ross, primary, Nian, Weiqi, primary, Chiu, Chao-Hua, primary, Zhou, Jianying, primary, Zhao, Yanqiu, primary, Su, Wu-Chou, primary, Yang, Tsung-Ying, primary, Zhu, Viola W., primary, Millward, Michael, primary, Fan, Yun, primary, Huang, Wen-Tsung, primary, Cheng, Ying, primary, Jiang, Liyan, primary, Brungs, Daniel, primary, Bazhenova, Lyudmila, primary, Lee, Chee Khoon, primary, Gao, Bo, primary, Xu, Yan, primary, Hsu, Wei-Hsun, primary, Zheng, Li, primary, and Jänne, Pasi A., primary

Published
2023
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41. Supplementary Figure from Sunvozertinib, a Selective EGFR Inhibitor for Previously Treated Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Author

Wang, Mengzhao, primary, Yang, James Chih-Hsin, primary, Mitchell, Paul L., primary, Fang, Jian, primary, Camidge, D. Ross, primary, Nian, Weiqi, primary, Chiu, Chao-Hua, primary, Zhou, Jianying, primary, Zhao, Yanqiu, primary, Su, Wu-Chou, primary, Yang, Tsung-Ying, primary, Zhu, Viola W., primary, Millward, Michael, primary, Fan, Yun, primary, Huang, Wen-Tsung, primary, Cheng, Ying, primary, Jiang, Liyan, primary, Brungs, Daniel, primary, Bazhenova, Lyudmila, primary, Lee, Chee Khoon, primary, Gao, Bo, primary, Xu, Yan, primary, Hsu, Wei-Hsun, primary, Zheng, Li, primary, and Jänne, Pasi A., primary

Published
2023
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43. Supplementary Figure from ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non–Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges

Author

Chow, Laura Q.M., primary, Barlesi, Fabrice, primary, Bertino, Erin M., primary, van den Bent, Martin J., primary, Wakelee, Heather A., primary, Wen, Patrick Y., primary, Chiu, Chao-Hua, primary, Orlov, Sergey, primary, Chiari, Rita, primary, Majem, Margarita, primary, McKeage, Mark, primary, Yu, Chong-Jen, primary, Garrido, Pilar, primary, Hurtado, Felipe K., primary, Arratia, Pilar Cazorla, primary, Song, Yuanbo, primary, Branle, Fabrice, primary, Shi, Michael, primary, and Kim, Dong-Wan, primary

Published
2023
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44. Supplementary Data from ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non–Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges

Author

Chow, Laura Q.M., primary, Barlesi, Fabrice, primary, Bertino, Erin M., primary, van den Bent, Martin J., primary, Wakelee, Heather A., primary, Wen, Patrick Y., primary, Chiu, Chao-Hua, primary, Orlov, Sergey, primary, Chiari, Rita, primary, Majem, Margarita, primary, McKeage, Mark, primary, Yu, Chong-Jen, primary, Garrido, Pilar, primary, Hurtado, Felipe K., primary, Arratia, Pilar Cazorla, primary, Song, Yuanbo, primary, Branle, Fabrice, primary, Shi, Michael, primary, and Kim, Dong-Wan, primary

Published
2023
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45. Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With NTRK Fusion-Positive Solid Tumors

Author

Demetri, George D., primary, De Braud, Filippo, primary, Drilon, Alexander, primary, Siena, Salvatore, primary, Patel, Manish R., primary, Cho, Byoung Chul, primary, Liu, Stephen V., primary, Ahn, Myung-Ju, primary, Chiu, Chao-Hua, primary, Lin, Jessica J., primary, Goto, Koichi, primary, Lee, Jeeyun, primary, Bazhenova, Lyudmila, primary, John, Thomas, primary, Fakih, Marwan, primary, Chawla, Sant P., primary, Dziadziuszko, Rafal, primary, Seto, Takashi, primary, Heinzmann, Sebastian, primary, Pitcher, Bethany, primary, Chen, David, primary, Wilson, Timothy R., primary, and Rolfo, Christian, primary

Published
2023
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46. Efficacy of different platforms in detecting EGFR mutations using cerebrospinal fluid cell‐free DNA from non‐small ‐cell lung cancer patients with leptomeningeal metastases

Author

Chiang, Chi‐Lu, primary, Ho, Hsiang‐Ling, additional, Yeh, Yi‐Chen, additional, Lee, Cheng‐Chia, additional, Huang, Hsu‐Ching, additional, Shen, Chia‐I, additional, Luo, Yung‐Hung, additional, Chen, Yuh‐Min, additional, Chiu, Chao‐Hua, additional, and Chou, Teh‐Ying, additional

Published
2023
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48. Entrectinib in ROS1-positive advanced non-small cell lung cancer: the phase 2/3 BFAST trial

Author

Peters, Solange, Gadgeel, Shirish M., Mok, Tony, Nadal, Ernest, Kilickap, Saadettin, Swalduz, Aurélie, Cadranel, Jacques, Sugawara, Shunichi, Chiu, Chao-Hua, Yu, Chong-Jen, Moskovitz, Mor, Tanaka, Tomohiro, Nersesian, Rhea, Shagan, Sarah M., Maclennan, Margaret, Mathisen, Michael, Bhagawati-Prasad, Vijay, Diarra, Cheick, Assaf, Zoe June, Archer, Venice, and Dziadziuszko, Rafal

Abstract

Although comprehensive biomarker testing is recommended for all patients with advanced/metastatic non-small cell lung cancer (NSCLC) before initiation of first-line treatment, tissue availability can limit testing. Genomic testing in liquid biopsies can be utilized to overcome the inherent limitations of tissue sampling and identify the most appropriate biomarker-informed treatment option for patients. The Blood First Assay Screening Trial is a global, open-label, multicohort trial that evaluates the efficacy and safety of multiple therapies in patients with advanced/metastatic NSCLC and targetable alterations identified by liquid biopsy. We present data from Cohort D (ROS1-positive). Patients ≥18 years of age with stage IIIB/IV, ROS1-positive NSCLC detected by liquid biopsies received entrectinib 600 mg daily. At data cutoff (November 2021), 55 patients were enrolled and 54 had measurable disease. Cohort D met its primary endpoint: the confirmed objective response rate (ORR) by investigator was 81.5%, which was consistent with the ORR from the integrated analysis of entrectinib (investigator-assessed ORR, 73.4%; data cutoff May 2019, ≥12 months of follow-up). The safety profile of entrectinib was consistent with previous reports. These results demonstrate consistency with those from the integrated analysis of entrectinib in patients with ROS1-positive NSCLC identified by tissue-based testing, and support the clinical value of liquid biopsies to inform clinical decision-making. The integration of liquid biopsies into clinical practice provides patients with a less invasive diagnostic method than tissue-based testing and has faster turnaround times that may expedite the reaching of clinical decisions in the advanced/metastatic NSCLC setting. ClinicalTrials.gov registration: NCT03178552.

Published
2024
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50. Old age and EGFR mutation status in inoperable early‐stage non‐small cell lung cancer patients receiving stereotactic ablative radiotherapy: A single institute experience of 71 patients in Taiwan

Author

Wu, Yuan‐Hung, primary, Kang, Yu‐Mei, additional, Hu, Yu‐Wen, additional, Lan, Keng‐Li, additional, Yen, Sang‐Hue, additional, Lai, Tzu‐Yu, additional, Lan, Tien‐Li, additional, Chen, Yuh‐Min, additional, Chiu, Chao‐Hua, additional, Luo, Yung‐Hung, additional, Chao, Heng‐sheng, additional, Chiang, Chi‐Lu, additional, Shiao, Tsu‐Hui, additional, Yang, Chao‐Neng, additional, Hsu, Wen‐Hu, additional, Wu, Yu‐Chung, additional, Hsu, Han‐Shui, additional, Hung, Jung‐Jyh, additional, Huang, Chien‐Sheng, additional, Hsu, Po‐Kuei, additional, and Chen, Yi‐Wei, additional

Published
2023
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