Article
Oncology
Qi Sun, Qi Li, Fuping Gao, Hongyan Wu, Yao Fu, Jun Yang, Xiangshan Fan, Xiaobin Cui, Xiaohong Pu
Summary: In this study, the HER2 scoring system in colorectal cancer (CRC) was evaluated using five immunohistochemical (IHC) scoring criteria and two fluorescence in situ hybridization (FISH) criteria. The study found that the IRS-p criterion was more suitable for assessing the HER2 status in CRC patients, while the FISH scoring system could identify subgroups with unique clinicopathological characteristics.
JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY
(2023)
Article
Oncology
Yoshiya Horimoto, Yumiko Ishizuka, Yuko Ueki, Toru Higuchi, Atsushi Arakawa, Mitsue Saito
Summary: For HER2-positive tumors, there was no difference in disease-free survival between IHC(2+)/FISH(+) tumors and IHC(3+) tumors, but there was a difference in survival after developing metastasis.
Article
Oncology
Joseph Kattan, Fady El Karak, Fadi Farhat, Dany Abi Gerges, Walid Mokaddem, Georges Chahine, Saad Khairallah, Najla Fakhruddin, Jawad Makarem, Fadi Nasr
Summary: This study reports on the prevalence of HER2-neu in newly diagnosed gastric cancer patients in Lebanon, as well as the correlation between IHC and ISH results. The study found a relatively high prevalence of HER2-neu over expression in these patients.
Article
Oncology
Laura Morsberger, Aparna Pallavajjala, Patty Long, Melanie Hardy, Rebecca Park, Rebecca Parish, Azin Nozari, Ying S. Zou
Summary: This study reviewed the results of HER2 IHC and FISH testing in 4884 cases of HER2-positive breast carcinomas and found a small percentage of patients with discordant results. Additionally, determining HER2 amplification status using NGS can provide a more comprehensive genetic analysis for breast carcinomas. This is particularly important for HER2-positive breast carcinomas with negative HER2 IHC results.
CANCER CELL INTERNATIONAL
(2022)
Article
Pathology
Antonio Polonia, Carolina Canelas, Ana Caramelo
Summary: This study aimed to characterize the pathological features of breast cancer cases with different HER2 scores by IHC and establish a relationship between HER2 expression and HER2 amplification by ISH. The findings revealed that HER2-equivocal cases could have HER2 gene amplification, and quantifying the 2+ score could predict the ISH classification. Furthermore, a logistic regression model using HER2 quantification and nuclear score improved the prediction of HER2 amplification.
Article
Medicine, General & Internal
Yiming Chu, Hongbo Li, Dan Wu, Qingqu Guo
Summary: This study analyzed the clinicopathological characteristics of HER2 protein expression in gastric carcinoma and found that HER2 protein expression is correlated with tumor features and P53 expression, and associated with higher survival rates.
Article
Medicine, General & Internal
Zubaria Mukhtar, Amina Faisal, Ghazala Mudassir, Nadira Mamoon
Summary: This study aimed to correlate the HER2/neu protein overexpression on immunohistochemistry (IHC) and gene amplification on fluorescence in situ hybridization (FISH) and document the challenges in performing the FISH procedure. The results showed that HER2/neu amplification was observed in a majority of HER2/neu 3+ cases and approximately one-third of HER2/neu 2+ cases. Poor fixation, inadequate amount of tumor, and dye application issues were identified as the causes of sample rejection. This study highlights the importance of proper fixation, sufficient biopsy material, and standardized processing for obtaining meaningful results in FISH.
PAKISTAN JOURNAL OF MEDICAL SCIENCES
(2023)
Article
Pathology
William R. Sukov, Jain Zhou, Katherine B. Geiersbach, Gary L. Keeney, Jodi M. Carter, J. Kenneth Schoolmeester
Summary: HER2 overexpression and gene amplification have been well established in several tumors, and HER2 targeted therapy may be effective in these cases. However, interpreting data regarding HER2 in clear cell endometrial carcinoma (CCC) is challenging due to various issues. A study of hysterectomy specimens from CCC patients showed that HER2 overexpression and amplification occur in a subset of cases, suggesting the potential benefit of HER2 targeted therapy in CCC patients.
Article
Pathology
Emad A. Rakha, Puay Hoon Tan, Cecily Quinn, Elena Provenzano, Abeer M. Shaaban, Rahul Deb, Grace Callagy, Jane Starczynski, Andrew H. S. Lee, Ian O. Ellis, Sarah E. Pinder
Summary: This article provides a comprehensive update on the UK guidelines for HER2 status evaluation in breast cancer, addressing key areas such as HER2 equivocal cases, low IHC scores for HER2, HER2 heterogeneity, and HER2 testing in specific settings. The article also considers the potential role of next generation sequencing and image analysis in HER2 testing.
JOURNAL OF CLINICAL PATHOLOGY
(2023)
Article
Veterinary Sciences
L. Muscatello, F. Gobbo, E. Di Oto, G. Sarli, R. De Maria, A. De Leo, G. Tallini, B. Brunetti
Summary: HER2 amplification was found in a subgroup of canine mammary carcinomas, with the HER2 gene copy number correlated with HER2 protein overexpression but not with tumor behavior. Additionally, a possible translocation of HER2/CRYBA1 was discovered. This study highlights the potential for different amplification patterns in studying HER2 in canine mammary tumors.
VETERINARY SCIENCES
(2022)
Article
Oncology
Sarah Anderson, Brooke Baxter Bartow, Gene P. Siegal, Xiao Huang, Shi Wei
Summary: This study aimed to explore the dynamic changes of HER2 expression during the progression of breast cancer. The results showed that HER2-low breast cancers are a heterogeneous group of tumors, with significant discordance between primary tumors and advanced disease as well as the distant sites of relapse. Therefore, further biomarker studies are needed in the pursuit of precision medicine.
BREAST CANCER RESEARCH AND TREATMENT
(2023)
Article
Oncology
Aswin Shanmugalingam, Kerry Hitos, Nirmala Pathmanathan, Senarath Edirimmane, T. Michael Hughes, Nicholas K. Ngui
Summary: The study aimed to analyze the concordance between HER2 immunohistochemistry (IHC) and in situ hybridization (ISH) and evaluate the benefit of repeating HER2 testing on the same breast cancer specimens. The results showed perfect positive concordance and agreement between non-equivocal IHC and ISH results, indicating that IHC alone can be reliably used for HER2 status testing based on the 2018 ASCO/CAP guidelines.
BREAST CANCER RESEARCH AND TREATMENT
(2023)
Article
Pathology
Yen-Ying Chen, Ching-Fen Yang, Chih-Yi Hsu
Summary: Current HER2 testing algorithms are unsatisfactory in detecting HER2-low cases. Using ISH to detect tumors with HER2 signals and HER2:CEP17 ratio higher than the upper bound of benign glands can be an alternative method.
JOURNAL OF CLINICAL PATHOLOGY
(2022)
Article
Oncology
Katharina Kolbe, Ivonne Haffner, Katrin Schierle, Dieter Maier, Birgitta Geier, Birgit Luber, Hendrik Blaeker, Christian Wittekind, Florian Lordick
Summary: This prospective multicenter study aimed to identify resistance biomarkers for HER2-targeted treatment in advanced gastric and esophago-gastric junction cancer. The study found that HER2 test deviations were associated with a negative impact on survival for trastuzumab-treated patients. Methodological and biological variables that may contribute to deviating HER2 test results were investigated.
JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY
(2023)
Article
Pathology
Chen Chen, Xin He, Min Chen, Tianhai Du, Weiji Qin, Wenyi Jing, Hongying Zhang
Summary: The diagnostic value of MDM2 RNA in situ hybridization (RNA-ISH) was evaluated in distinguishing low-grade osteosarcoma (LGOS) and compared with MDM2 FISH and IHC. MDM2 RNA-ISH showed high sensitivity and specificity, with higher sensitivity than IHC.
Article
Oncology
Charles S. Fuchs, Mustafa Ozguroglu, Yung-Jue Bang, Maria Di Bartolomeo, Mario Mandala, Min-Hee Ryu, Lorenzo Fornaro, Tomasz Olesinski, Christian Caglevic, Hyun C. Chung, Kei Muro, Eric Van Cutsem, Anneli Elme, Peter Thuss-Patience, Ian Chau, Atsushi Ohtsu, Pooja Bhagia, Anran Wang, Chie-Schin Shih, Kohei Shitara
Summary: In this long-term analysis, second-line pembrolizumab did not significantly improve overall survival but was associated with higher 24-month OS rates than paclitaxel in the CPS>=1 population. Pembrolizumab also increased overall survival benefit with PD-L1 enrichment among patients with PD-L1-positive gastric/GEJ cancer and led to fewer treatment-related adverse events (TRAEs) compared to paclitaxel.
Meeting Abstract
Oncology
Manish A. Shah, Jaffer A. Ajani, Salah-Eddin Al-Batran, Yung-Jue Bang, Daniel V. T. Catenacci, Peter C. Enzinger, David H. Ilson, Sunnie S. Kim, Florian Lordick, Kohei Shitara, Eric Van Cutsem, Ahsan Arozullah, Jeffrey J. Raizer, Jung Wook Park, Rui-hua Xu
JOURNAL OF CLINICAL ONCOLOGY
(2022)
Meeting Abstract
Oncology
Kensei Yamaguchi, Yung-Jue Bang, Satoru Iwasa, Naotoshi Sugimoto, Min-Hee Ryu, Daisuke Sakai, Hyun Cheol Cheol Chung, Hisato Kawakami, Hiroshi Yabusaki, Jeeyun Lee, Kaku Saito, Yoshinori Kawaguchi, Takahiro Kamio, Akihito Kojima, Masahiro Sugihara, Kohei Shitara
JOURNAL OF CLINICAL ONCOLOGY
(2022)
Meeting Abstract
Oncology
Kohei Shitara, Yung-Jue Bang, Satoru Iwasa, Naotoshi Sugimoto, Min-Hee Ryu, Daisuke Sakai, Hyun Cheol Cheol Chung, Yasushi Omuro, Hisato Kawakami, Hiroshi Yabusaki, Yasuhiro Sakamoto, Tomohiro Nishina, Koichiro Inaki, Yusuke Kuwahara, Fumitaka Suto, Masahiro Sugihara, Kaku Saito, Akihito Kojima, Kensei Yamaguchi
JOURNAL OF CLINICAL ONCOLOGY
(2022)
Meeting Abstract
Oncology
Deirdre Jill Cohen, Josep Tabernero, Eric Van Cutsem, Yelena Y. Janjigian, Yung-Jue Bang, Shukui Qin, Zev A. Wainberg, Anran Wang, Natalyn Nicole Hawk, Chie-Schin Shih, Pooja Bhagia, Kohei Shitara
JOURNAL OF CLINICAL ONCOLOGY
(2022)
Article
Oncology
Manish A. Shah, Kohei Shitara, Florian Lordick, Yung-Jue Bang, Niall C. Tebbutt, Jean-Phillippe Metges, Kei Muro, Keun-Wook Lee, Lin Shen, Sergei Tjulandin, John L. Hays, Naureen Starling, Rui-Hua Xu, Keren Sturtz, Marilyn Fontaine, Cindy Oh, Emily M. Brooks, Bo Xu, Wei Li, Chiang J. Li, Laura Borodyansky, Eric Van Cutsem
Summary: Adding napabucasin to paclitaxel did not improve survival in patients with second-line advanced gastric or gastroesophageal junction adenocarcinoma. The safety profile of napabucasin was driven by manageable gastrointestinal events, with grade >= 3 diarrhea occurring at a higher frequency with napabucasin plus paclitaxel versus placebo plus paclitaxel.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Sehhoon Park, Chan-Young Ock, Hyojin Kim, Sergio Pereira, Seonwook Park, Minuk Ma, Sangjoon Choi, Seokhwi Kim, Seunghwan Shin, Brian Jaehong Aum, Kyunghyun Paeng, Donggeun Yoo, Hongui Cha, Sunyoung Park, Koung Jin Suh, Hyun Ae Jung, Se Hyun Kim, Yu Jung Kim, Jong-Mu Sun, Jin-Haeng Chung, Jin Seok Ahn, Myung-Ju Ahn, Jong Seok Lee, Keunchil Park, Sang Yong Song, Yung-Jue Bang, Yoon-La Choi, Tony S. Mok, Se-Hoon Lee
Summary: This study developed an AI-powered WSI analyzer of tumor-infiltrating lymphocytes (TIL) to predict the effectiveness of immune checkpoint inhibitors (ICI). The results showed that the inflamed immune phenotype (IP) correlated with enrichment in local immune cytolytic activity, higher response rate, and prolonged progression-free survival.
JOURNAL OF CLINICAL ONCOLOGY
(2022)
Article
Oncology
Keun-Wook Lee, Eric Van Cutsem, Yung-Jue Bang, Charles S. Fuchs, Iveta Kudaba, Marcelo Garrido, Hyun Cheol Chung, Jeeyun Lee, Hugo R. Castro, Joseph Chao, Zev A. Wainberg, Z. Alexander Cao, Deepti Aurora-Garg, Julie Kobie, Razvan Cristescu, Pooja Bhagia, Sukrut Shah, Josep Tabernero, Kohei Shitara, Lucjan Wyrwicz
Summary: This analysis of KEYNOTE-062 suggests an association between tumor mutational burden (TMB) and clinical efficacy with first-line pembrolizumab-based therapy in patients with advanced gastric/gastroesophageal junction adenocarcinoma. However, the clinical utility of TMB was attenuated after excluding patients with MSI-H tumors.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Tae Won Kim, Howard A. Burris, Maria J. de Miguel Luken, Michael J. Pishvaian, Yung-Jue Bang, Michael Gordon, Ahmad Awada, D. Ross Camidge, F. Stephen Hodi, Grant A. McArthur, Wilson H. Miller, Andres Cervantes, Laura Q. Chow, Alexander M. Lesokhin, Annemie Rutten, Mario Sznol, Deepali Rishipathak, Shang-Chiung Chen, Eric Stefanich, Tony Pourmohamad, Maria Anderson, Jeong Kim, Mahrukh Huseni, Ina Rhee, Lillian L. Siu
Summary: This study evaluated the first-in-human use of MOXR0916, a humanized monoclonal antibody, in the treatment of advanced solid tumors. The results showed that MOXR0916 was well tolerated and demonstrated evidence of tumor immune activation. Although objective responses were rare with monotherapy, further investigation in combination with PD-1/PD-L1 antagonists is warranted.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Kensei Yamaguchi, Yung-Jue Bang, Satoru Iwasa, Naotoshi Sugimoto, Min-Hee Ryu, Daisuke Sakai, Hyun Cheol Chung, Hisato Kawakami, Hiroshi Yabusaki, Jeeyun Lee, Tatsu Shimoyama, Keun-Wook Lee, Kaku Saito, Yoshinori Kawaguchi, Takahiro Kamio, Akihito Kojima, Masahiro Sugihara, Kohei Shitara
Summary: This study aimed to investigate the efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-low gastric or gastroesophageal junction adenocarcinoma. The results showed that T-DXd has clinical activity in heavily pretreated patients with HER2-low gastric/GEJ adenocarcinoma.
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Article
Oncology
Lyn Ley Lam, Nick Pavlakis, Kohei Shitara, Katrin M. Sjoquist, Andrew J. Martin, Sonia Yip, Yoon-Koo Kang, Yung-Jue Bang, Li-Tzong Chen, Markus Moehler, Tanios Bekaii-Saab, Thierry Alcindor, Christopher J. O'Callaghan, Niall C. Tebbutt, Wendy Hague, Howard Chan, Sun Young Rha, Keun-Wook Lee, Val Gebski, Anthony Jaworski, John Zalcberg, Timothy Price, John Simes, David Goldstein
Summary: This study aims to evaluate the efficacy and safety of regorafenib alone and in combination with nivolumab in advanced gastro-oesophageal cancer patients. The study consists of two international randomized controlled trials, comparing the efficacy of regorafenib versus placebo, and the efficacy of regorafenib plus nivolumab versus chemotherapy. The primary endpoint of the study is overall survival.
Article
Medicine, General & Internal
Kohei Shitara, Florian Lordick, Yung-Jue Bang, Peter Enzinger, David Ilson, Manish A. Shah, Eric Van Cutsem, Rui-Hua Xu, Giuseppe Aprile, Jianming Xu, Joseph Chao, Roberto Pazo-Cid, Yoon-Koo Kang, Jianning Yang, Diarmuid Moran, Pranob Bhattacharya, Ahsan Arozullah, Jung Wook Park, Mok Oh, Jaffer A. Ajani
Summary: Zolbetuximab in combination with mFOLFOX6 significantly prolongs progression-free survival and overall survival in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma, with good safety profile.
Article
Biochemistry & Molecular Biology
Vivek Subbiah, Robert J. Kreitman, Zev A. Wainberg, Anas Gazzah, Ulrik Lassen, Alexander Stein, Patrick Y. Wen, Sascha Dietrich, Maja J. A. de Jonge, Jean-Yves Blay, Antoine Italiano, Kan Yonemori, Daniel C. Cho, Filip Y. F. L. de Vos, Philippe Moreau, Elena Elez Fernandez, Jan H. M. Schellens, Christoph C. Zielinski, Suman Redhu, Aislyn Boran, Vanessa Q. Passos, Palanichamy Ilankumaran, Yung-Jue Bang
Summary: This study is a phase 2 basket trial evaluating the efficacy and safety of dabrafenib plus trametinib in patients with BRAFV600E-mutated advanced rare cancers. The overall response rates in different tumor types ranged from 56% to 89%. Secondary endpoints included duration of response, progression-free survival, overall survival, and safety.
Article
Oncology
Fortunato Ciardiello, Yung-Jue Bang, Andres Cervantes, Mikhail Dvorkin, Charles D. Lopez, Jean-Philippe Metges, Antonio Sanchez Ruiz, Mariona Calvo, Andrew H. Strickland, George Kannourakis, Kei Muro, Hisato Kawakami, Jia Wei, Christophe Borg, Zhaoyin Zhu, Neal Gupta, Robert J. Pelham, Lin Shen
Summary: The study investigated the efficacy and safety of maintenance therapy with Pamiparib in gastric cancer. The results showed that Pamiparib did not demonstrate a significant superiority in progression-free survival (PFS) compared to placebo, but it was well tolerated with few adverse events.
Article
Biochemistry & Molecular Biology
Manish A. Shah, Kohei Shitara, Jaffer A. Ajani, Yung-Jue Bang, Peter Enzinger, David Ilson, Florian Lordick, Eric Van Cutsem, Javier Gallego Plazas, Jing Huang, Lin Shen, Sang Cheul Oh, Patrapim Sunpaweravong, Hwoei Fen Soo Hoo, Haci Mehmet Turk, Mok Oh, Jung Wook Park, Diarmuid Moran, Pranob Bhattacharya, Ahsan Arozullah, Rui-Hua Xu
Summary: The GLOW trial demonstrated that zolbetuximab, a monoclonal antibody targeting CLDN18.2, combined with CAPOX, significantly improved progression-free survival and overall survival in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.