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5. Genome-wide association study of lung adenocarcinoma in East Asia and comparison with a European population

Author

Shi, Jianxin, Shiraishi, Kouya, Choi, Jiyeon, Matsuo, Keitaro, Chen, Tzu-Yu, Dai, Juncheng, Hung, Rayjean J, Chen, Kexin, Shu, Xiao-Ou, Kim, Young Tae, Landi, Maria Teresa, Lin, Dongxin, Zheng, Wei, Yin, Zhihua, Zhou, Baosen, Song, Bao, Wang, Jiucun, Seow, Wei Jie, Song, Lei, Chang, I-Shou, Hu, Wei, Chien, Li-Hsin, Cai, Qiuyin, Hong, Yun-Chul, Kim, Hee Nam, Wu, Yi-Long, Wong, Maria Pik, Richardson, Brian Douglas, Funderburk, Karen M, Li, Shilan, Zhang, Tongwu, Breeze, Charles, Wang, Zhaoming, Blechter, Batel, Bassig, Bryan A, Kim, Jin Hee, Albanes, Demetrius, Wong, Jason YY, Shin, Min-Ho, Chung, Lap Ping, Yang, Yang, An, She-Juan, Zheng, Hong, Yatabe, Yasushi, Zhang, Xu-Chao, Kim, Young-Chul, Caporaso, Neil E, Chang, Jiang, Ho, James Chung Man, Kubo, Michiaki, Daigo, Yataro, Song, Minsun, Momozawa, Yukihide, Kamatani, Yoichiro, Kobayashi, Masashi, Okubo, Kenichi, Honda, Takayuki, Hosgood, Dean H, Kunitoh, Hideo, Patel, Harsh, Watanabe, Shun-ichi, Miyagi, Yohei, Nakayama, Haruhiko, Matsumoto, Shingo, Horinouchi, Hidehito, Tsuboi, Masahiro, Hamamoto, Ryuji, Goto, Koichi, Ohe, Yuichiro, Takahashi, Atsushi, Goto, Akiteru, Minamiya, Yoshihiro, Hara, Megumi, Nishida, Yuichiro, Takeuchi, Kenji, Wakai, Kenji, Matsuda, Koichi, Murakami, Yoshinori, Shimizu, Kimihiro, Suzuki, Hiroyuki, Saito, Motonobu, Ohtaki, Yoichi, Tanaka, Kazumi, Wu, Tangchun, Wei, Fusheng, Dai, Hongji, Machiela, Mitchell J, Su, Jian, Kim, Yeul Hong, Oh, In-Jae, Lee, Victor Ho Fun, Chang, Gee-Chen, Tsai, Ying-Huang, Chen, Kuan-Yu, Huang, Ming-Shyan, Su, Wu-Chou, Chen, Yuh-Min, Seow, Adeline, Park, Jae Yong, and Kweon, Sun-Seog

Subjects
Genetics, Cancer, Clinical Research, Human Genome, Prevention, Lung, Lung Cancer, Tobacco, Tobacco Smoke and Health, 2.1 Biological and endogenous factors, Aetiology, Respiratory, Humans, Genome-Wide Association Study, Genetic Predisposition to Disease, Adenocarcinoma of Lung, Asia, Eastern, Lung Neoplasms, Polymorphism, Single Nucleotide
Abstract

Lung adenocarcinoma is the most common type of lung cancer. Known risk variants explain only a small fraction of lung adenocarcinoma heritability. Here, we conducted a two-stage genome-wide association study of lung adenocarcinoma of East Asian ancestry (21,658 cases and 150,676 controls; 54.5% never-smokers) and identified 12 novel susceptibility variants, bringing the total number to 28 at 25 independent loci. Transcriptome-wide association analyses together with colocalization studies using a Taiwanese lung expression quantitative trait loci dataset (n = 115) identified novel candidate genes, including FADS1 at 11q12 and ELF5 at 11p13. In a multi-ancestry meta-analysis of East Asian and European studies, four loci were identified at 2p11, 4q32, 16q23, and 18q12. At the same time, most of our findings in East Asian populations showed no evidence of association in European populations. In our studies drawn from East Asian populations, a polygenic risk score based on the 25 loci had a stronger association in never-smokers vs. individuals with a history of smoking (Pinteraction = 0.0058). These findings provide new insights into the etiology of lung adenocarcinoma in individuals from East Asian populations, which could be important in developing translational applications.

Published
2023

6. Efficacy of immune checkpoint inhibitors plus platinum-based chemotherapy as 1st line treatment for patients with non-small cell lung cancer harboring HER2 mutations: Results from LC-SCRUM-Asia

Author

Kato, Yuki, Udagawa, Hibiki, Matsumoto, Shingo, Izumi, Hiroki, Ohe, Yuichiro, Kato, Terufumi, Nishino, Kazumi, Miyamoto, Shingo, Kawana, Sachiko, Chikamori, Kenichi, Shingyoji, Masato, Sato, Yuki, Takada, Yuji, Toyozawa, Ryo, Azuma, Koichi, Tanaka, Yu, Sakai, Tetsuya, Shibata, Yuji, Sugiyama, Eri, Nosaki, Kaname, Zenke, Yoshitaka, Umemura, Shigeki, Yoh, Kiyotaka, Seike, Masahiro, and Goto, Koichi

Published
2024
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12. Hypersensitivity Reactions to Selpercatinib Treatment With or Without Prior Immune Checkpoint Inhibitor Therapy in Patients With NSCLC in LIBRETTO-001.

Author

Rolfo, Christian, Drilon, Alexander, Lacouture, Mario, Besse, Benjamin, Goto, Koichi, Zhu, Viola, Tan, Daniel, Farajian, Stephanie, Potter, Laura, Kherani, Jennifer, Soldatenkova, Victoria, Olek, Elizabeth, Muehlenbein, Catherine, Park, Keunchil, and Mccoach, Caroline

Subjects
Hypersensitivity, Immune checkpoint inhibitor, Non–small-cell lung cancer, Selpercatinib, Supportive care, Carcinoma, Non-Small-Cell Lung, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Humans, Immune Checkpoint Inhibitors, Lung Neoplasms, Protein Kinase Inhibitors, Proto-Oncogene Proteins c-ret, Pyrazoles, Pyridines
Abstract

INTRODUCTION: Immune checkpoint inhibitor (ICI) therapy has been found to increase the risk/severity of immune-mediated adverse events with subsequent kinase inhibitor treatment in oncogenically driven cancers. We explored the risk for hypersensitivity with selpercatinib, a first-in-class highly selective and potent, central nervous system-active RET inhibitor, in prior ICI-treated patients with RET fusion-positive NSCLC compared with their ICI-naive counterparts. METHODS: Data from patients enrolled by December 16, 2019, in the ongoing phase 1/2 LIBRETTO-001 (NCT03157128) trial were analyzed for hypersensitivity reactions reported using preferred terms of hypersensitivity/drug hypersensitivity and defined as a constellation of symptoms/findings characterized by maculopapular rash, often preceded by fever with arthralgias/myalgias, followed by greater than or equal to 1 of the following signs/symptoms: thrombocytopenia, increased aspartate aminotransferase or alanine aminotransferase, hypotension, tachycardia, or increased creatinine. RESULTS: Of 329 patients, 22 (7%) who experienced a grade 1 to 3 hypersensitivity reaction that met the defined constellation of events were attributed to selpercatinib by investigators, and more often in prior ICI-treated (n = 17, 77%) than ICI-naive (n = 5, 23%) patients. There were 19 patients with selpercatinib-related hypersensitivity who resumed selpercatinib post-hypersensitivity with dose modification/supportive care. Furthermore, 17 patients, of whom 14 received prior ICI therapy, were still on treatment at twice daily doses of 40 mg (n = 5), 80 mg (n = 4), 120 mg (n = 4), and 160 mg (n = 4). CONCLUSIONS: Rates of selpercatinib-related hypersensitivity were low overall and, as with other kinase inhibitors, occurred predominantly in prior ICI-treated patients. Hypersensitivity to selpercatinib can be managed with supportive care measures regardless of prior ICI status and is reversible.

Published
2022

13. 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

14. Clinicopathological significance of peritumoral alveolar macrophages in patients with resected early-stage lung squamous cell carcinoma

Author

Tanaka, Yu, Nakai, Tokiko, Suzuki, Ayako, Kagawa, Yosuke, Noritake, Osamu, Taki, Tetsuro, Hashimoto, Hiroko, Sakai, Tetsuya, Shibata, Yuji, Izumi, Hiroki, Nosaki, Kaname, Udagawa, Hibiki, Zenke, Yoshitaka, Matsumoto, Shingo, Yoh, Kiyotaka, Miyazaki, Saori, Sakamoto, Naoya, Sakashita, Shingo, Kojima, Motohiro, Watanbe, Reiko, Tsuboi, Masahiro, Goto, Koichi, and Ishii, Genichiro

Published
2023
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15. Clinical outcomes in patients with non-small cell lung cancer harboring EGFR Exon20 in-frame insertions in the near-loop and far-loop: Results from LC-SCRUM-Asia

Author

Okahisa, Masanobu, Udagawa, Hibiki, Matsumoto, Shingo, Kato, Terufumi, Yokouchi, Hiroshi, Furuya, Naoki, Kanemaru, Ryota, Toyozawa, Ryo, Nishiyama, Akihiro, Ohashi, Kadoaki, Miyamoto, Shingo, Nishino, Kazumi, Nakamura, Atsushi, Iwama, Eiji, Niho, Seiji, Oi, Hajime, Sakai, Tetsuya, Shibata, Yuji, Izumi, Hiroki, Sugiyama, Eri, Nosaki, Kaname, Umemura, Shigeki, Zenke, Yoshitaka, Yoh, Kiyotaka, Kah Mun Low, Grace, Zhuo, Jianmin, and Goto, Koichi

Published
2024
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18. Clinical Significance of a Prospective Large Genomic Screening for SCLC: The Genetic Classification and a Biomarker-Driven Phase 2 Trial of Gedatolisib

Author

Umemura, Shigeki, Udagawa, Hibiki, Ikeda, Takaya, Murakami, Haruyasu, Daga, Haruko, Toyozawa, Ryo, Kozuki, Toshiyuki, Sakakibara-Konishi, Jun, Ohe, Yuichiro, Morise, Masahiro, Kato, Terufumi, Shingyoji, Masato, Hara, Satoshi, Furuya, Naoki, Teranishi, Shuhei, Takata, Saori, Miyamoto, Shingo, Nakachi, Ichiro, Wakabayashi, Masashi, Nomura, Shogo, Sato, Akihiro, Ishii, Genichiro, Tsuchihara, Katsuya, Sugiyama, Eri, Kirita, Keisuke, Sakai, Tetsuya, Shibata, Yuji, Izumi, Hiroki, Nosaki, Kaname, Zenke, Yoshitaka, Matsumoto, Shingo, Yoh, Kiyotaka, Niho, Seiji, and Goto, Koichi

Published
2024
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21. A novel Menin-MLL1 inhibitor, DS-1594a, prevents the progression of acute leukemia with rearranged MLL1 or mutated NPM1

Author

Numata, Masashi, Haginoya, Noriyasu, Shiroishi, Machiko, Hirata, Tsuyoshi, Sato-Otsubo, Aiko, Yoshikawa, Kenji, Takata, Yoshimi, Nagase, Reina, Kashimoto, Yoshinori, Suzuki, Makoto, Schulte, Nina, Polier, Gernot, Kurimoto, Akiko, Tomoe, Yumiko, Toyota, Akiko, Yoneyama, Tomoko, Imai, Emi, Watanabe, Kenji, Hamada, Tomoaki, Kanada, Ryutaro, Watanabe, Jun, Kagoshima, Yoshiko, Tokumaru, Eri, Murata, Kenji, Baba, Takayuki, Shinozaki, Taeko, Ohtsuka, Masami, Goto, Koichi, Karibe, Tsuyoshi, Deguchi, Takao, Gocho, Yoshihiro, Yoshida, Masanori, Tomizawa, Daisuke, Kato, Motohiro, Tsutsumi, Shinji, Kitagawa, Mayumi, and Abe, Yuki

Published
2023
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27. Carboplatin and irinotecan (CI) vs. carboplatin and etoposide (CE) for the treatment of extended-stage small-cell lung cancer in an elderly population: A phase II/III randomized control trial

Author

Shimokawa, Tsuneo, Okamoto, Hiroaki, Machida, Ryunosuke, Misumi, Yuki, Hosomi, Yukio, Yoneshima, Yasuto, Tanaka, Hiroshi, Okishio, Kyoichi, Simizu, Junichi, Goto, Koichi, Akamatsu, Hiroaki, Kubota, Kaoru, Nakagawa, Kazuhiko, Horinouchi, Hidehito, Ando, Masahiko, Kataoka, Tomoko, and Ohe, Yuichiro

Published
2023
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28. Efficacy of Selpercatinib in RET Fusion–Positive Non–Small-Cell Lung Cancer

Author

Drilon, Alexander, Oxnard, Geoffrey R, Tan, Daniel SW, Loong, Herbert HF, Johnson, Melissa, Gainor, Justin, McCoach, Caroline E, Gautschi, Oliver, Besse, Benjamin, Cho, Byoung C, Peled, Nir, Weiss, Jared, Kim, Yu-Jung, Ohe, Yuichiro, Nishio, Makoto, Park, Keunchil, Patel, Jyoti, Seto, Takashi, Sakamoto, Tomohiro, Rosen, Ezra, Shah, Manisha H, Barlesi, Fabrice, Cassier, Philippe A, Bazhenova, Lyudmila, De Braud, Filippo, Garralda, Elena, Velcheti, Vamsidhar, Satouchi, Miyako, Ohashi, Kadoaki, Pennell, Nathan A, Reckamp, Karen L, Dy, Grace K, Wolf, Jürgen, Solomon, Benjamin, Falchook, Gerald, Ebata, Kevin, Nguyen, Michele, Nair, Binoj, Zhu, Edward Y, Yang, Luxi, Huang, Xin, Olek, Elizabeth, Rothenberg, S Michael, Goto, Koichi, and Subbiah, Vivek

Subjects
Lung Cancer, Clinical Research, Lung, Cancer, Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, Female, Humans, Hypertension, Intention to Treat Analysis, Lung Neoplasms, Male, Middle Aged, Mutation, Progression-Free Survival, Protein Kinase Inhibitors, Proto-Oncogene Proteins c-ret, Pyrazoles, Pyridines, Transaminases, Treatment Outcome, Young Adult, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundRET fusions are oncogenic drivers in 1 to 2% of non-small-cell lung cancers (NSCLCs). In patients with RET fusion-positive NSCLC, the efficacy and safety of selective RET inhibition are unknown.MethodsWe enrolled patients with advanced RET fusion-positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated separately in a phase 1-2 trial of selpercatinib. The primary end point was an objective response (a complete or partial response) as determined by an independent review committee. Secondary end points included the duration of response, progression-free survival, and safety.ResultsIn the first 105 consecutively enrolled patients with RET fusion-positive NSCLC who had previously received at least platinum-based chemotherapy, the percentage with an objective response was 64% (95% confidence interval [CI], 54 to 73). The median duration of response was 17.5 months (95% CI, 12.0 to could not be evaluated), and 63% of the responses were ongoing at a median follow-up of 12.1 months. Among 39 previously untreated patients, the percentage with an objective response was 85% (95% CI, 70 to 94), and 90% of the responses were ongoing at 6 months. Among 11 patients with measurable central nervous system metastasis at enrollment, the percentage with an objective intracranial response was 91% (95% CI, 59 to 100). The most common adverse events of grade 3 or higher were hypertension (in 14% of the patients), an increased alanine aminotransferase level (in 12%), an increased aspartate aminotransferase level (in 10%), hyponatremia (in 6%), and lymphopenia (in 6%). A total of 12 of 531 patients (2%) discontinued selpercatinib because of a drug-related adverse event.ConclusionsSelpercatinib had durable efficacy, including intracranial activity, with mainly low-grade toxic effects in patients with RET fusion-positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated. (Funded by Loxo Oncology and others; LIBRETTO-001 ClinicalTrials.gov number, NCT03157128.).

Published
2020

29. Gumarontinib in patients with non-small-cell lung cancer harbouring MET exon 14 skipping mutations: a multicentre, single-arm, open-label, phase 1b/2 trial

Author

Yu, Yongfeng, Zhou, Jianya, Li, Xingya, Goto, Koichi, Min, Xuhong, Nishino, Kazumi, Cui, Jiuwei, Wu, Lin, Sakakibara, Jun, Shu, Yongqian, Dong, Xiaorong, Li, Lu, Yoneshima, Yasuto, Zhou, Chengzhi, Li, Xiaoling, Zhang, Yiping, Huang, Dingzhi, Zang, Aimin, Zhang, Wei, Wang, Xiuwen, Zhang, Li, Bai, Chong, Fang, Jian, Cao, Lejie, Zhao, Yanqiu, Yu, Yan, Shi, Meiqi, Zhong, Diansheng, Li, Fugen, Li, Meng, Wu, Qiuxia, Zhou, Jun, Sun, Minghui, and Lu, Shun

Published
2023
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33. Large-scale clinico-genomic profile of non-small cell lung cancer with KRAS G12C: Results from LC-SCRUM-Asia study

Author

Tamiya, Yutaro, Matsumoto, Shingo, Zenke, Yoshitaka, Yoh, Kiyotaka, Ikeda, Takaya, Shibata, Yuji, Kato, Terufumi, Nishino, Kazumi, Nakamura, Atsushi, Furuya, Naoki, Miyamoto, Shingo, Kuyama, Shoichi, Nomura, Shogo, Ikeno, Takashi, Udagawa, Hibiki, Sugiyama, Eri, Nosaki, Kaname, Izumi, Hiroki, Sakai, Tetsuya, Hashimoto, Naozumi, and Goto, Koichi

Published
2023
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34. A splice-switching oligonucleotide treatment ameliorates glycogen storage disease type 1a in mice with G6PC c.648G>T

Author

Ito, Kentaro, Tajima, Go, Kamisato, Chikako, Tsumura, Miyuki, Iwamoto, Mitsuhiro, Sekiguchi, Yukiko, Numata, Yukinobu, Watanabe, Kyoko, Yabe, Yoshiyuki, Kanki, Satomi, Fujieda, Yusuke, Goto, Koichi, Sogawa, Yoshitaka, Oitate, Masataka, Nagase, Hiroyuki, Tsuji, Shinnosuke, Nishizawa, Tomohiro, Kakuta, Masayo, Masuda, Takeshi, Onishi, Yoshiyuki, Koizumi, Makoto, Nakamura, Hidefumi, Okada, Satoshi, Matsuo, Masafumi, and Takaishi, Kiyosumi

Subjects
Thermo Fisher Scientific Inc., Charles River Laboratories Corp., Scientific equipment and supplies industry, Agricultural industry, Dextrose, Diabetes therapy, Phosphatases, RNA, Glucose, Liver, Glycogen, Health care industry
Abstract

Glycogen storage disease type 1a (GSD1a) is caused by a congenital deficiency of glucose-6-phosphatase-[alpha] (G6Pase-[alpha], encoded by G6PC), which is primarily associated with life-threatening hypoglycemia. Although strict dietary management substantially improves life expectancy, patients still experience intermittent hypoglycemia and develop hepatic complications. Emerging therapies utilizing new modalities such as adeno- associated virus and mRNA with lipid nanoparticles are under development for GSD1a but potentially require complicated glycemic management throughout life. Here, we present an oligonucleotide-based therapy to produce intact G6Pase-[alpha] from a pathogenic human variant, G6PC c.648G>T, the most prevalent variant in East Asia causing aberrant splicing of G6PC. DS-4108b, a splice-switching oligonucleotide, was designed to correct this aberrant splicing, especially in liver. We generated a mouse strain with homozygous knockin of this variant that well reflected the pathophysiology of patients with GSD1a. DS-4108b recovered hepatic G6Pase activity through splicing correction and prevented hypoglycemia and various hepatic abnormalities in the mice. Moreover, DS-4108b had long-lasting efficacy of more than 12 weeks in mice that received a single dose and had favorable pharmacokinetics and tolerability in mice and monkeys. These findings together indicate that this oligonucleotide- based therapy could provide a sustainable and curative therapeutic option under easy disease management for GSD1a patients with G6PC c.648G>T., Introduction Glycogen storage diseases are rare genetic disorders characterized by the dysfunction of enzymes involved in glycogen metabolism (1). Glycogen storage disease type 1a (GSD1a, OMIM: 232200) is an autosomal [...]

Published
2023
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35. The impact of tertiary lymphoid structures on clinicopathological, genetic and gene expression characteristics in lung adenocarcinoma

Author

Tamiya, Yutaro, Nakai, Tokiko, Suzuki, Ayako, Mimaki, Sachiyo, Tsuchihara, Katsuya, Sato, Kei, Yoh, Kiyotaka, Matsumoto, Shingo, Zenke, Yoshitaka, Nosaki, Kaname, Izumi, Hiroki, Shibata, Yuji, Sakai, Tetsuya, Taki, Tetsuro, Miyazaki, Saori, Watanabe, Reiko, Sakamoto, Naoya, Sakashita, Shingo, Kojima, Motohiro, Hashimoto, Naozumi, Tsuboi, Masahiro, Goto, Koichi, and Ishii, Genichiro

Published
2022
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38. Nurse‐Led Screening‐Triggered Early Specialized Palliative Care Program for Patients With Advanced Lung Cancer: A Multicenter Randomized Controlled Trial.

Author

Matsumoto, Yoshihisa, Umemura, Shigeki, Okizaki, Ayumi, Fujisawa, Daisuke, Yamaguchi, Takuhiro, Oyamada, Shunsuke, Miyaji, Tempei, Mashiko, Tomoe, Kobayashi, Naoko, Satomi, Eriko, Kiuchi, Daisuke, Morita, Tatsuya, Uchitomi, Yosuke, Goto, Koichi, and Ohe, Yuichiro

Abstract

Background: We aimed to examine the effectiveness of a nurse‐led, screening‐triggered early specialized palliative care intervention program for patients with advanced lung cancer. Methods: Patients with advanced lung cancer who underwent initial chemotherapy were randomized to intervention and usual care groups between January 2017 and September 2019. The intervention comprised comprehensive needs assessments, counseling, and service coordination by advanced‐level nurses. Patients in the usual care group received the usual oncological care. The primary end point was a change in the trial outcome index (TOI) scores from baseline to 12 weeks. The secondary end‐points were TOI scores at week 20, depression, anxiety, and survival. Results: In total, 102 patients were assigned to each group. Compared with the usual care group, no significant improvement in TOI scores was observed at 12 weeks in the intervention group (mean group difference: 2.13; 90% confidence interval: −0.70, 4.95; p = 0.107, one‐sided), whereas significant improvement was observed at 20 weeks (3.58; 90% confidence interval: 0.15, 7.00; p = 0.043). There were no significant differences in the change from baseline depression and anxiety between the groups from baseline at week 12 and 20 weeks (depression: p = 0.60 and 0.10, anxiety: p = 0.78 and 0.067). Survival did not significantly differ between the groups (median survival time: 12.1 vs. 11.1 months; p = 0.302). Conclusions: Nurse‐led, screening‐triggered, early specialized palliative care did not show significant superiority over usual care during the 12‐week study period. However, it may have yielded delayed clinical benefits, such as improved quality of life and this feasible model can be acceptable in clinical practice. Trial Registration: The University Hospital Medical Information Network Clinical Trials Registry: UMIN000025491 [ABSTRACT FROM AUTHOR]

Published
2024
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39. BLU-945, a potent and selective next-generation EGFR TKI, has antitumor activity in models of osimertinib-resistant non-small-cell lung cancer.

Author

Lim, Sun Min, Schalm, Stefanie S., Lee, Eun Ji, Park, Sewon, Conti, Chiara, Millet, Yves A., Woessner, Rich, Zhang, Zhuo, Tavera-Mendoza, Luz E., Stevison, Faith, Albayya, Faris, Dineen, Thomas A., Hsieh, John, Oh, Seung Yeon, Zalutskaya, Alena, Rotow, Julia, Goto, Koichi, Lee, Dae-Ho, Yun, Mi Ran, and Cho, Byoung Chul

Abstract

Introduction: Despite the availability of several epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), most patients with non-small-cell lung cancer (NSCLC) eventually develop resistance to these agents. Notably, EGFR _C797S mutations confer resistance to the third-generation EGFR-TKI osimertinib and no approved post-osimertinib targeted pharmacology options are currently available. BLU-945 is a novel, reversible, and orally available next-generation EGFR-TKI that selectively targets EGFR-activating (EGFR m) and resistance mutations (including EGFR_C797S) with nanomolar potency while sparing wild-type EGFR in vitro. Methods: In vitro activity of BLU-945 as a single agent and in combination with osimertinib was tested in engineered EGFR -mutant cell lines as well as patient-derived cells and patient-derived organoids. In vivo activity was evaluated in osimertinib-resistant patient-derived xenograft mouse models. Three patient cases from the global, first-in-human, phase I/II SYMPHONY trial (NCT04862780) demonstrating the clinical efficacy of BLU-945 were reported. Results: In vitro BLU-945 demonstrated inhibited cell viability and growth of EGFR -mutant/osimertinib-resistant cell lines. BLU-945 demonstrated in vivo tumor shrinkage in osimertinib-resistant models of NSCLC (osimertinib second line: EGFR _L858R/C797S and third line: EGFR _ex19del/T790M/C797S and L858R/T790M/C797S) both as monotherapy and in combination with osimertinib. BLU-945 also demonstrated tumor shrinkage in patients from the SYMPHONY trial. Conclusion: Our findings demonstrate the preclinical and early clinical activity of BLU-945 in EGFR m NSCLC progressing on previous EGFR-TKIs. [ABSTRACT FROM AUTHOR]

Published
2024
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40. Safety and anti-tumor activity of BAY 2927088 in patients with HER2-mutant NSCLC: Results from an expansion cohort of the SOHO-01 phase I/II study.

Author

Girard, Nicolas, primary, Kim, Tae Min, additional, Kim, Hye Ryun, additional, Loong, Herbert H., additional, Shinno, Yuki, additional, Lu, Shun, additional, Fang, Yong, additional, Zhao, Jun, additional, Nishino, Kazumi, additional, Lee, Ki Hyeong, additional, Miao, Liyun, additional, Sakamoto, Tomohiro, additional, Felip, Enriqueta, additional, Yang, Tsung-Ying, additional, Dooms, Christophe Alfons, additional, Tan, Daniel Shao-Weng, additional, Le, Xiuning, additional, Brase, Jan Christoph, additional, Grassi, Paolo, additional, and Goto, Koichi, additional

Published
2024
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41. FURVENT: Phase 3 trial of furmonertinib vs chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 20 insertion mutations (FURMO-004).

Author

Spira, Alexander I., primary, Cho, Byoung Chul, additional, Felip, Enriqueta, additional, Garon, Edward B., additional, Goto, Koichi, additional, Johnson, Melissa Lynne, additional, Leighl, Natasha B., additional, Passaro, Antonio, additional, Planchard, David, additional, Popat, Sanjay, additional, Yang, James Chih-Hsin, additional, Lu, Xiaoqian, additional, Jiang, Yong, additional, Huang, Jack, additional, Lam, Morgan, additional, Kowanetz, Marcin, additional, Wang, Shirley, additional, Le, John, additional, Hsu, Jerry Y., additional, and Zhou, Caicun, additional

Published
2024
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43. Differential Immune-Related Microenvironment Determines Programmed Cell Death Protein-1/Programmed Death-Ligand 1 Blockade Efficacy in Patients With Advanced NSCLC

Author

Shirasawa, Masayuki, Yoshida, Tatsuya, Shimoda, Yukiko, Takayanagi, Daisuke, Shiraishi, Kouya, Kubo, Takashi, Mitani, Sachiyo, Matsumoto, Yuji, Masuda, Ken, Shinno, Yuki, Okuma, Yusuke, Goto, Yasushi, Horinouchi, Hidehito, Ichikawa, Hitoshi, Kohno, Takashi, Yamamoto, Noboru, Matsumoto, Shingo, Goto, Koichi, Watanabe, Shun-ichi, Ohe, Yuichiro, and Motoi, Noriko

Published
2021
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44. A phase I/II study of osimertinib in EGFR exon 20 insertion mutation-positive non-small cell lung cancer

Author

Yasuda, Hiroyuki, Ichihara, Eiki, Sakakibara-Konishi, Jun, Zenke, Yoshitaka, Takeuchi, Shinji, Morise, Masahiro, Hotta, Katsuyuki, Sato, Mineyoshi, Matsumoto, Shingo, Tanimoto, Azusa, Matsuzawa, Reiko, Kiura, Katuyuki, Takashima, Yuta, Yano, Seiji, Koyama, Junji, Fukushima, Takahiro, Hamamoto, Junko, Terai, Hideki, Ikemura, Shinnosuke, Takemura, Ryo, Goto, Koichi, and Soejima, Kenzo

Published
2021
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45. The CLIP1–LTK fusion is an oncogenic driver in non‐small‐cell lung cancer

Author

Izumi, Hiroki, Matsumoto, Shingo, Liu, Jie, Tanaka, Kosuke, Mori, Shunta, Hayashi, Kumiko, Kumagai, Shogo, Shibata, Yuji, Hayashida, Takuma, Watanabe, Kana, Fukuhara, Tatsuro, Ikeda, Takaya, Yoh, Kiyotaka, Kato, Terufumi, Nishino, Kazumi, Nakamura, Atsushi, Nakachi, Ichiro, Kuyama, Shoichi, Furuya, Naoki, Sakakibara-Konishi, Jun, Okamoto, Isamu, Taima, Kageaki, Ebi, Noriyuki, Daga, Haruko, Yamasaki, Akira, Kodani, Masahiro, Udagawa, Hibiki, Kirita, Keisuke, Zenke, Yoshitaka, Nosaki, Kaname, Sugiyama, Eri, Sakai, Tetsuya, Nakai, Tokiko, Ishii, Genichiro, Niho, Seiji, Ohtsu, Atsushi, Kobayashi, Susumu S., and Goto, Koichi

Published
2021
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46. Comprehensive assessment of PD-L1 expression, tumor mutational burden and oncogenic driver alterations in non-small cell lung cancer patients treated with immune checkpoint inhibitors

Author

Yoh, Kiyotaka, Matsumoto, Shingo, Furuya, Naoki, Nishino, Kazumi, Miyamoto, Shingo, Oizumi, Satoshi, Okamoto, Norio, Itani, Hidetoshi, Kuyama, Shoichi, Nakamura, Atsushi, Nishi, Koichi, Fukuda, Ikue, Tsuta, Koji, Hayashi, Yuichiro, Motoi, Noriko, Ishii, Genichiro, and Goto, Koichi

Published
2021
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