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7. Impact of Bevacizumab Being Skipped due to Adverse Events of Special Interest for Bevacizumab in Patients with Unresectable Hepatocellular Carcinoma Treated with Atezolizumab plus Bevacizumab: An Exploratory Analysis of the Phase III IMbrave150 Study.

Author

Kudo, Masatoshi, Tsuchiya, Kaoru, Shao, Yu-Yun, Finn, Richard S., Galle, Peter R., Ducreux, Michel, Cheng, Ann-Lii, Yamashita, Tatsuya, Koga, Hironori, Take, Ryosuke, Yamada, Kyoko, Asakawa, Takashi, Nakagawa, Yuki, and Ikeda, Masafumi

Subjects
HEPATOCELLULAR carcinoma, OVERALL survival, PROGRESSION-free survival, BEVACIZUMAB, SPECIAL events
Abstract

Introduction: The phase III IMbrave150 study established atezolizumab + bevacizumab as the global standard of care in patients with unresectable hepatocellular carcinoma (HCC). This exploratory analysis examined the impact of bevacizumab interruption due to bevacizumab adverse events of special interest (AESIs). Methods: Patients in IMbrave150 who were randomized to atezolizumab + bevacizumab and received treatment for ≥6 months (to reduce immortal time bias) were included in group A-1 if bevacizumab had ever been skipped due to bevacizumab AESIs or to group A-2 otherwise. Efficacy analyses included overall survival (OS) and progression-free survival (PFS) by whether bevacizumab was skipped (group A-1 vs. A-2). PFS was evaluated per independent review facility (IRF)-assessed Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 and HCC-modified RECIST (IRF-HCC mRECIST). Safety was also evaluated. Results: Of the 210 patients who received ≥6 months of atezolizumab + bevacizumab, 69 were assigned to group A-1 and 141 to A-2. At data cutoff (August 20, 2020), hazard ratio (HR) for OS was 1.04 (95% CI: 0.64, 1.69) for group A-1 versus A-2. HR for PFS was 1.07 (95% CI: 0.74, 1.55) per IRF-assessed RECIST 1.1 and 1.10 (95% CI: 0.76, 1.59; 15.5 vs. 9.7 months) per IRF-HCC mRECIST for group A-1 versus A-2. Safety profiles for atezolizumab and bevacizumab were largely similar between groups. More group A-1 patients had grade 3/4 adverse events. A separate analysis investigating the impact of immortal time bias in patients who received ≥3 months of atezolizumab + bevacizumab supported the appropriateness of the ≥6-month landmark analysis. Discussion/Conclusion: Efficacy was similar between patients who skipped bevacizumab due to bevacizumab AESIs and those who did not. Although this comparison was nonrandomized and exploratory, results suggest that skipping bevacizumab due to bevacizumab AESIs did not considerably impact the efficacy and safety of atezolizumab + bevacizumab. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Impact of Bevacizumab Being Skipped due to Adverse Events of Special Interest for Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab: An Exploratory Analysis of the Phase III IMbrave150 study

Author

Kudo, Masatoshi, primary, Tsuchiya, Kaoru, additional, Shao, Yu-Yun, additional, Finn, Richard S., additional, Galle, Peter R., additional, Ducreux, Michel, additional, Cheng, Ann-Lii, additional, Yamashita, Tatsuya, additional, Koga, Hironori, additional, Take, Ryosuke, additional, Yamada, Kyoko, additional, Asakawa, Takashi, additional, Nakagawa, Yuki, additional, and Ikeda, Masafumi, additional

Published
2023
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15. Cancer-Associated Thrombosis: A Taiwanese Perspective on Therapeutic Options with Focus on Non-Vitamin K Antagonist Oral Anticoagulants

Author

Shao, Yu-Yun, Ho, Ching-Liang, Chang, Cheng-Shyong, Chang, Chia-Lun, Lee, Jen-Kuang, Lin, Hung-Ju, Hsiao, Hui-Hua, Chao, Ta-Chung, Lin, Ching-Yeh, and Liaw, Chuang-Chi

Subjects
Review Article
Abstract

Cancer-associated thrombosis (CAT) is a common complication of malignancies. Patients with CAT are at risk of venous thromboembolism recurrence, but also at risk of bleeding while anticoagulated. Taiwanese patients are perceived to have a lower incidence of CAT, likely leading to false reassurance for Taiwanese patients with cancer. Because of this, oncologists and cardiologists from multiple medical institutions in Taiwan have set forth to provide clinical consensus guidelines on the management of CAT, based on local clinical practices and guided by predominant international clinical practice guidelines. This paper aims to describe the current disease burden of cancer-associated venous thromboembolism in Taiwanese cancer patients, and discusses the unmet needs and gaps in the management of this medical complication. It also outlines diagnostic and management strategies relevant to the different treatment options available, such as non-vitamin K antagonist oral anticoagulants.

Published
2023

16. Different immune contextures underlie tumor site‐specific responses to immune checkpoint blockade in esophageal cancer.

Author

Guo, Jhe‐Cyuan, Hsu, Chia‐Lang, Hsieh, Min‐Shu, Lin, Chia‐Chi, Huang, Ta‐Chen, Kuo, Hung‐Yang, Shao, Yu‐Yun, and Hsu, Chih‐Hung

Subjects
DRUG efficacy, IMMUNE checkpoint inhibitors, IMMUNOHISTOCHEMISTRY, TREATMENT effectiveness, GENE expression, COMPUTED tomography, TUMOR markers, ESOPHAGEAL tumors
Abstract

Immune checkpoint inhibitors (ICIs) have demonstrated efficacy in advanced esophageal squamous cell carcinoma (ESCC). Heterogeneous responses to ICIs have been reported previously. Here, we describe a patient with advanced ESCC exhibiting a response to durvalumab plus tremelimumab for more than 6 months except primary resistant esophageal tumor. The esophageal tumor had higher regulatory T cells, neutrophils, and mast cells scores estimated by NanoString platform than hepatic tumor. The immunohistochemistry study confirmed higher expression levels of Foxp3, and myeloperoxidase (MPO) in the esophageal tumor. The different immune contextures may underlie the heterogeneous responses to ICI combination in this ESCC patient. [ABSTRACT FROM AUTHOR]

Published
2023
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21. Management consensus guideline for hepatocellular carcinoma: 2020 update on surveillance, diagnosis, and systemic treatment by the Taiwan Liver Cancer Association and the Gastroenterological Society of Taiwan

Author

Shao, Yu-Yun, primary, Wang, Shen-Yung, additional, Lin, Shi-Ming, additional, Chen, Kuan-Yang, additional, Tseng, Jeng-Hwei, additional, Ho, Ming-Chih, additional, Lee, Rheun-Chuan, additional, Liang, Po-Chin, additional, Liao, Li-Ying, additional, Huang, Kai-Wen, additional, Hu, Jui-Ting, additional, Liang, Ja-Der, additional, Kee, Kwong-Ming, additional, Lin, Chih-Lin, additional, Wang, Chung-Kwe, additional, Lu, Sheng-Nan, additional, Wang, Jing-Houng, additional, Lee, Wei-Chen, additional, Chen, Chien-Hung, additional, Liu, Chun-Jen, additional, Huang, Yi-Hsiang, additional, Wang, Chia-Chi, additional, Wang, Tsang-En, additional, Chuang, Po-Heng, additional, Dai, Chia-Yen, additional, Hsu, Chiun, additional, Shao, Yu-Yun, additional, Chen, San-Chi, additional, and Hsieh, Chia-Hsun, additional

Published
2021
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24. Limited Predictive or Prognostic Role of Tumor-Infiltrating Tissue-Resident Memory CD8 T Cells in Patients with Hepatocellular Carcinoma Receiving Immunotherapy

Author

Shen, Ying-Chun, primary, Yeh, Ching-Ping, additional, Jeng, Yung-Ming, additional, Hsu, Chiun, additional, Hsu, Chih-Hung, additional, Lin, Zhong-Zhe, additional, Shao, Yu-Yun, additional, Lu, Li-Chun, additional, Liu, Tsung-Hao, additional, Chen, Chien-Hung, additional, and Cheng, Ann-Lii, additional

Published
2021
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29. An Exploratory Study for the Association of Gut Microbiome with Efficacy of Immune Checkpoint Inhibitor in Patients with Hepatocellular Carcinoma

Author

Shen, Ying-Chun, primary, Lee, Pei-Chang, additional, Kuo, Yu-Lun, additional, Wu, Wei-Kai, additional, Chen, Chieh-Chang, additional, Lei, Chengh-Hau, additional, Yeh, Ching-Ping, additional, Hsu, Chiun, additional, Hsu, Chih-Hung, additional, Lin, Zhong-Zhe, additional, Shao, Yu-Yun, additional, Lu, Li-Chun, additional, Liu, Tsung-Hao, additional, Chen, Chien-Hung, additional, Wu, Ming-Shiang, additional, Huang, Yi-Hsiang, additional, and Cheng, Ann-Lii, additional

Published
2021
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34. Abstract 1590: High ICOS/FOXP3 Tregs content in the tumor microenvironment is associated with poorer survival in patients with hepatocellular carcinoma

Author

Lu, Li-Chun, primary, Deantonio, Cecilia, additional, Mitchell, Laura, additional, Lee, Yi-Hsuan, additional, Shao, Yu-Yun, additional, Chen, Ron, additional, Cowan, Marianne, additional, Corser, Matthew, additional, Sherry, Lorcan, additional, Cheng, Ann-Lii, additional, Lin, Chia-Chi, additional, Quaratino, Sonia, additional, Sainson, Richard C., additional, and Hsu, Chih-Hung, additional

Published
2020
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35. A Multicenter Phase II Study of Second-Line Axitinib for Patients with Advanced Hepatocellular Carcinoma Failing First-Line Sorafenib Monotherapy

Author

Lin, Zhong-Zhe, primary, Chen, Bang-Bin, additional, Hung, Yi-Ping, additional, Huang, Po-Hsiang, additional, Shen, Ying-Chun, additional, Shao, Yu-Yun, additional, Hsu, Chih-Hung, additional, Cheng, Ann-Lii, additional, Lee, Rheun-Chuan, additional, Chao, Yee, additional, and Hsu, Chiun, additional

Published
2020
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39. Differential Organ-Specific Tumor Response to Immune Checkpoint Inhibitors in Hepatocellular Carcinoma

Author

Lu, Li-Chun, primary, Hsu, Chiun, additional, Shao, Yu-Yun, additional, Chao, Yee, additional, Yen, Chia-Jui, additional, Shih, I-Lun, additional, Hung, Yi-Ping, additional, Chang, Chun-Jung, additional, Shen, Ying-Chun, additional, Guo, Jhe-Cyuan, additional, Liu, Tsung-Hao, additional, Hsu, Chih-Hung, additional, and Cheng, Ann-Lii, additional

Published
2019
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48. Sorafenib in advanced hepatocellular carcinoma: current status and future perspectives

Author

Cheng, Ann-Lii, Hsu,Chih-Hung, Shen,Ying-Chun, Shao,Yu-Yun, and Hsu,Chiun

Subjects
neoplasms, digestive system diseases, Journal of Hepatocellular Carcinoma
Abstract

Chih-Hung Hsu,1,4 Ying-Chun Shen,1,2 Yu-Yun Shao,1,4 Chiun Hsu,1,4 Ann-Lii Cheng,1,3,41Department of Oncology, 2Department of Medical Research, 3Department of Internal Medicine, National Taiwan University Hospital, 4Graduate Institute of Oncology, College of Medicine, National Taiwan University, Taipei, TaiwanAbstract: The approval of sorafenib, a multikinase inhibitor targeting primarily Raf kinase and the vascular endothelial growth factor receptor, in 2007 for treating advanced hepatocellular carcinoma (HCC) has generated considerable enthusiasm in drug development for this difficult-to-treat disease. However, because several randomized Phase III studies testing new multikinase inhibitors failed, sorafenib remains the standard of first-line systemic therapy for patients with advanced HCC. Field practice studies worldwide have suggested that in daily practice, physicians are adopting either a preemptive dose modification or a ramp-up strategy to improve the compliance of their patients. In addition, accumulating data have suggested that patients with Child–Pugh class B liver function can tolerate sorafenib as well as patients with Child–Pugh class A liver function, although the actual benefit of sorafenib in patients with Child–Pugh class B liver function has yet to be confirmed. Whether sorafenib can be used as an adjunctive therapy to improve the outcomes of intermediate-stage HCC patients treated with transcatheter arterial chemoembolization or early-stage HCC patients after curative therapies is being investigated in several ongoing randomized Phase III studies. An increasing number of studies have reported that sorafenib exerts "off-target" effects, including the modulation of signaling pathways other than Raf/MEK/ERK pathway, nonapoptotic cell death mechanisms, and even immune modulation. Finally, although sorafenib in combination with chemotherapy or other targeted therapies has the potential to improve therapeutic efficacy in treating HCC, it also increases toxicity. Additional clinical studies are warranted to determine useful sorafenib-based combinations for the treatment of advanced HCC.Keywords: HCC, multikinase inhibitor, advanced stage, sorafenib

Published
2014

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