Article
Oncology
Jing Zhu, Wenwen Wu, Yukiko Togashi, Naoe Taira Nihira, Yoshikazu Johmura, Dajiang Zhu, Makoto Nakanishi, Yasuo Miyoshi, Tomohiko Ohta
Summary: This study found that the effectiveness of sacituzumab govitecan, a promising drug for breast cancer, could be altered by concomitant treatment. Tamoxifen, in particular, may be a favorable agent for combined therapy.
Article
Oncology
Laura M. Spring, Erika Nakajima, Jennifer Hutchinson, Elene Viscosi, Gayle Blouin, Colin Weekes, Hope Rugo, Beverly Moy, Aditya Bardia
Summary: Patients with metastatic triple-negative breast cancer have a poor prognosis. Sacituzumab govitecan has shown promising therapeutic activity and received accelerated approval for the treatment of these patients. Limited information is available regarding adverse event management with this agent.
Article
Oncology
Anna R. Schreiber, Michelle Andress, Jennifer R. Diamond
Summary: Sacituzumab govitecan has demonstrated promising survival benefits in patients with previously treated mTNBC based on data from the ASCENT trial. Common adverse effects include neutropenia, diarrhea, and nausea, which are manageable with supportive care. In addition to TNBC, Sacituzumab govitecan has shown potential in cancers such as urothelial and lung, and is being studied in HR-positive breast cancers. The therapy is likely to be used in combination with other novel targeted agents as ongoing clinical trials progress.
EXPERT REVIEW OF ANTICANCER THERAPY
(2021)
Review
Oncology
S. Michaleas, A. Moreno Oliver, J. Mueller-Berghaus, S. B. Sarac, M. E. van der Elst, S. Mueller-Egert, H. Zander, H. Enzmann, F. Pignatti
Summary: Sacituzumab govitecan (SG) is an antineoplastic agent approved as a monotherapy for the treatment of unresectable or metastatic triple-negative breast cancer (mTNBC). SG combines a humanized monoclonal antibody binding to tropoblast cell surface antigen-2 (Trop-2)-expressing cancer cells with a cytotoxic moiety SN-38 (govitecan) that acts as a topoisomerase I inhibitor. A phase III trial showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) with SG compared to treatment of physician's choice (TPC) in patients with mTNBC. Common side effects of SG include diarrhea, neutropenia, nausea, fatigue, alopecia, anemia, constipation, and vomiting.
Article
Oncology
Yitian Lang, Qingqing Chai, Wenqi Tao, Yahui Liao, Xiaoyan Liu, Bin Wu
Summary: The ASCENT trial demonstrated the efficacy of sacituzumab govitecan for the treatment of advanced or metastatic triple-negative breast cancer (TNBC). The study evaluated the cost-effectiveness of receiving sacituzumab govitecan compared with standard chemotherapy from the United States payer perspective. The cost-effectiveness analysis suggests that sacituzumab govitecan, at the current price, is unlikely to be the preferred option for patients with advanced or metastatic TNBC from a US payer's point of view at a threshold of $150,000/QALY.
Article
Medicine, General & Internal
Shao-Xian Cheng, Qiu-Chi Chen, Guo-He Lin, Yan-Hong Han, Bi-Cheng Wang, Yi Dai, Yan-Xia Zhao
Summary: This study evaluated the efficacy and safety of Sacituzumab govitecan (SG) in patients with relapsed or refractory metastatic triple-negative breast cancer (RM-TNBC). The results showed that SG had a certain effectiveness in these patients, and the main treatment-related adverse events were myelosuppression and diarrhea.
Article
Oncology
Sakar Wahby, Lola Fashoyin-Aje, Christy L. Osgood, Joyce Cheng, Mallorie H. Fiero, Lijun Zhang, Shenghui Tang, Salaheldin S. Hamed, Pengfei Song, Rosane Charlab, Sarah E. Dorff, Tiffany K. Ricks, Kimberly Barnett-Ringgold, Jeannette Dinin, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Laleh Amiri-Kordestani, Julia A. Beaver
Summary: FDA granted accelerated approval to Sacituzumab Govitecan-hziy for the treatment of metastatic triple-negative breast cancer. Data showed an objective response rate of 33.3% and a median duration of response of 7.7 months, supporting the approval.
CLINICAL CANCER RESEARCH
(2021)
Article
Oncology
Hope S. Rugo, Sara M. Tolaney, Delphine Loirat, Kevin Punie, Aditya Bardia, Sara A. Hurvitz, Joyce O'Shaughnessy, Javier Cortes, Veronique Dieras, Lisa A. Carey, Luca Gianni, Martine J. Piccart, Sibylle Loibl, David M. Goldenberg, Quan Hong, Martin Olivo, Loretta M. Itri, Kevin Kalinsky
Summary: Sacituzumab govitecan has shown manageable safety profile in patients with mTNBC, with neutropenia and diarrhea being the main adverse events. Patients with UGT1A1 *28/*28 genotype have a higher risk of adverse reactions, including neutropenia, febrile neutropenia, anemia, and diarrhea, and should be closely monitored and managed.
Article
Oncology
Lisa A. Carey, Delphine Loirat, Kevin Punie, Aditya Bardia, Veronique Dieras, Florence Dalenc, Jennifer R. Diamond, Christel Fontaine, Grace Wang, Hope S. Rugo, Sara A. Hurvitz, Kevin Kalinsky, Joyce O'Shaughnessy, Sibylle Loibl, Luca Gianni, Martine Piccart, Yanni Zhu, Rosemary Delaney, See Phan, Javier Cortes
Summary: Sacituzumab govitecan (SG) improves progression-free survival and overall survival in patients with metastatic triple-negative breast cancer (mTNBC), with manageable safety profile.
Article
Multidisciplinary Sciences
Peng Guo, Jing Huang, Bing Zhu, Andrew C. Huang, Lingxiao Jiang, Jianmin Fang, Marsha A. Moses
Summary: In this study, a rationally designed antibody drug conjugate (ADC) was developed for the treatment of late-stage and refractory triple-negative breast cancer (TNBC). The overexpression of intercellular adhesion molecule-1 (ICAM1) in TNBC was found to efficiently facilitate receptor-mediated antibody internalization. Four ICAM1 ADCs with different chemical linkers and warheads were constructed and their efficacy was evaluated in vitro and in vivo using multiple human TNBC cell lines and TNBC animal models. An ICAM1 antibody conjugated with monomethyl auristatin E (MMAE) via a protease-cleavable valine-citrulline linker was identified as the optimal ADC formulation due to its outstanding efficacy and safety, and could serve as an effective ADC candidate for TNBC therapy.
Article
Oncology
Jigang Chen, Mingyang Han, Aihua Liu, Bo Shi
Summary: The study evaluated the cost-effectiveness of Sacituzumab Govitecan for metastatic triple-negative breast cancer from the perspectives of China and the United States. Results showed that the current price of SG is unlikely to be cost-effective in both countries. Sensitivity analysis indicated that the price of SG has the greatest impact on cost-effectiveness.
FRONTIERS IN ONCOLOGY
(2021)
Article
Oncology
Pierluigi di Mauro, Greta Schivardi, Rebecca Pedersini, Lara Laini, Andrea Esposito, Vito Amoroso, Marta Lagana, Salvatore Grisanti, Deborah Cosentini, Alfredo Berruti
Summary: This article reports a case of a TNBC patient who achieved significant results after receiving sacituzumab govitecan treatment. This treatment can improve the survival rate of early recurrent and BRCA-mutant TNBC patients.
FRONTIERS IN ONCOLOGY
(2023)
Article
Oncology
A. Bardia, S. M. Tolaney, K. Punie, D. Loirat, M. Oliveira, K. Kalinsky, A. Zelnak, P. Aftimos, F. Dalenc, S. Sardesai, E. Hamilton, P. Sharma, S. Recalde, E. C. Gil, T. Traina, J. O'Shaughnessy, J. Cortes, M. Tsai, L. Vahdat, V Dieras, L. A. Carey, H. S. Rugo, D. M. Goldenberg, Q. Hong, M. Olivo, L. M. Itri, S. A. Hurvitz
Summary: The biomarker analysis from the ASCENT trial demonstrates that sacituzumab govitecan (SG) provides improved survival outcomes and objective response rates in previously treated mTNBC patients with high/medium Trop-2 expression compared to standard-of-care chemotherapy (TPC), regardless of germline BRCA1/2 mutation status. The efficacy outcomes were consistently higher with SG compared to TPC in patients with both high/medium Trop-2 expression and those without germline BRCA1/2 mutations.
ANNALS OF ONCOLOGY
(2021)
Article
Oncology
Sibylle Loibl, Delphine Loirat, Sara M. Tolaney, Kevin Punie, Mafalda Oliveira, Hope S. Rugo, Aditya Bardia, Sara A. Hurvitz, Adam M. Brufsky, Kevin Kalinsky, Javier Cortes, Joyce A. O'Shaughnessy, Veronique Dieras, Lisa A. Carey, Luca Gianni, Mahdi Gharaibeh, Luciana Preger, See Phan, Lawrence Chang, Ling Shi, Martine J. Piccart
Summary: This study investigated the effect of the antibody-drug conjugate sacituzumab govitecan (SG) on the health-related quality of life (HRQoL) in patients with metastatic triple-negative breast cancer (mTNBC). The results showed that SG was associated with greater improvements and delayed worsening of HRQoL scores compared with other treatment options chosen by physicians.
EUROPEAN JOURNAL OF CANCER
(2023)
Review
Pharmacology & Pharmacy
Alessandro Rizzo, Angela Dalia Ricci, Laura Lanotte, Lucia Lombardi, Alessandro Di Federico, Giovanni Brandi, Gennaro Gadaleta-Caldarola
Summary: The authors provide an overview of current immune-based combinations for metastatic triple negative breast cancer (mTNBC) and discuss future prospects. Clinical trials suggest ICI monotherapy may benefit a minority of mTNBC patients, while various immune-based combinations have shown promising results in recent studies. Numerous trials are ongoing to explore novel ICI-based combinations.
EXPERT OPINION ON INVESTIGATIONAL DRUGS
(2022)
Review
Oncology
Neelima Vidula, Leif W. Ellisen, Aditya Bardia
Summary: Metastatic triple-negative breast cancer is being subtyped based on advances in genomics and molecular profiling, guiding the development of targeted therapies. New agents such as AKT inhibitors, checkpoint inhibitors, and PARP inhibitors are crucial for improving the treatment landscape for TNBC patients.
JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK
(2021)
Article
Oncology
Neelima Vidula, Andrzej Niemierko, Giuliana Malvarosa, Megan Yuen, Jochen Lennerz, A. John Iafrate, Seth A. Wander, Laura Spring, Dejan Juric, Steven Isakoff, Jerry Younger, Beverly Moy, Leif W. Ellisen, Aditya Bardia
Summary: Plasma-based genotyping can identify high rates of actionable mutations, leading to significant application of matched therapy and improved overall survival in patients with metastatic breast cancer.
CLINICAL CANCER RESEARCH
(2021)
Article
Oncology
Jing Xu, Tanya E. Keenan, Beth Overmoyer, Nadine M. Tung, Rebecca S. Gelman, Karleen Habin, Judy E. Garber, Leif W. Ellisen, Eric P. Winer, Paul E. Goss, Beow Y. Yeap, Bruce A. Chabner, Steven J. Isakoff
Summary: The study evaluated the efficacy and safety of the PARP inhibitors veliparib and temozolomide in metastatic breast cancer patients with or without germline BRCA1/2 mutations. While the primary endpoint was not met in unselected or BRCA-associated breast cancer, the combination showed clinical activity in platinum-naive BRCA-associated metastatic breast cancer with manageable toxicity at lower doses than the single-agent active dose. This regimen was further evaluated in a subsequent study.
BREAST CANCER RESEARCH AND TREATMENT
(2021)
Article
Oncology
Siang-Boon Koh, Kenneth Ross, Steven J. Isakoff, Nsan Melkonjan, Lei He, Karina J. Matissek, Andrew Schultz, Erica L. Mayer, Tiffany A. Traina, Lisa A. Carey, Hope S. Rugo, Minetta C. Liu, Vered Stearns, Adam Langenbucher, Srinivas Vinod Saladi, Sridhar Ramaswamy, Michael S. Lawrence, Leif W. Ellisen
Summary: This study identifies high levels of RASAL2 as predictors of chemotherapy response and long-term outcomes in TNBC. RASAL2 rewires MAPK feedback and cross-talk to confer resistance to MEK1/2 and EGFR inhibitors while also indicating sensitivity to these inhibitors.
CLINICAL CANCER RESEARCH
(2021)
Article
Oncology
Siang-Boon Koh, Brian N. Dontchos, Veerle Bossuyt, Christine Edmonds, Simona Cristea, Nsan Melkonjan, Lindsey Mortensen, Annie Ma, Kassidy Beyerlin, Elyssa Denault, Elizabeth Niehoff, Taghreed Hirz, David B. Sykes, Franziska Michor, Michelle Specht, Constance Lehman, Leif W. Ellisen, Laura M. Spring
Summary: Systematic collection of fresh tissues for research during diagnostic breast biopsy is safe, feasible, and efficient, providing a high-yield mechanism for diverse interdisciplinary research. The study demonstrated high diagnostic concordance between research and clinical specimens, consistent cell recovery, and potential clinical relevance in analyzing HER2 levels and immune microenvironment diversity.
NPJ PRECISION ONCOLOGY
(2021)
Editorial Material
Oncology
Siang-Boon Koh, Leif W. Ellisen
Summary: Zhang et al. conducted extensive single-cell immune compartment analyses of pre- and post-therapy triple-negative breast cancer and revealed potential mechanisms of T cell activation and patterns of immune evolution, which may inform future biomarkers of response and clinical benefit.
Editorial Material
Medicine, General & Internal
James T. Coates, Christiaan de Koning
JOURNAL OF THE ROYAL SOCIETY OF MEDICINE
(2022)
Article
Oncology
Qibiao Wu, Yuanli Zhen, Lei Shi, Phuong Vu, Patricia Greninger, Ramzi Adil, Joshua Merritt, Regina Egan, Meng-Ju Wu, Xunqin Yin, Cristina R. Ferrone, Vikram Deshpande, Islam Baiev, Christopher J. Pinto, Daniel E. McLoughlin, Charlotte S. Walmsley, James R. Stone, John D. Gordan, Andrew X. Zhu, Dejan Juric, Lipika Goyal, Cyril H. Benes, Nabeel Bardeesy
Summary: This study reveals that feedback activation of EGFR signaling limits the effectiveness of FGFR inhibitor therapy and drives adaptive resistance in patient-derived models of FGFR2 fusion-positive cholangiocarcinoma. Inhibition of wild type EGFR can improve the efficacy of FGFR inhibitors and cause tumor regression in vivo, providing a potential improved treatment for patients with FGFR2-driven cholangiocarcinoma.
Article
Oncology
Ling Yu, Read Allen, Lin Jia, Ting Sun, Steven J. Isakoff, Marielle Scherrer-Crosbie, Allison M. Kehlmann, Hui Zheng, Amy Ly, Charlotte S. Walmsley, Katherine Hesler, Ava N. Varasteh, Christopher J. Pinto, Daniel E. McLoughlin, Wenjin Wu, Xinhui Wang
Summary: This study evaluated the potential of cMLC-1 as a biomarker for predicting TIC, screening breast cancer patients, and monitoring disease progression. The results showed that elevated cMLC-1 levels were associated with TIC and breast cancer, as well as metastasis in breast cancer patients.
FRONTIERS IN ONCOLOGY
(2022)
Review
Oncology
Rachel Occhiogrosso Abelman, Bogang Wu, Laura M. Spring, Leif W. Ellisen, Aditya Bardia
Summary: Antibody-drug conjugates (ADCs) are a promising class of therapies that deliver targeted treatment with fewer side effects. Despite their success, resistance to ADCs in breast cancer and other malignancies remains a challenge. This paper reviews the literature on the mechanisms of resistance to ADCs and discusses potential strategies to overcome them.
Article
Oncology
Neelima Vidula, Andrzej Niemierko, Katherine Hesler, Lianne Ryan, Beverly Moy, Steven Isakoff, Leif Ellisen, Dejan Juric, Aditya Bardia
Summary: We compared the cell-free DNA (cfDNA) results at the time of diagnosis of metastatic breast cancer (MBC) in patients who developed brain metastases (BM) with those who did not, in order to identify genomic predictors of BM. Among patients who underwent cfDNA testing at MBC diagnosis using Guardant360 (R) technology, we found that 21% of them developed BM. Comparing BM patients with non-BM patients, we observed a higher prevalence of specific gene mutations such as BRCA2, APC, CDKN2A, and SMAD4 in the former group. This genomic pattern had a high negative predictive value (85%) and specificity (93%) in excluding BM development.
Article
Orthopedics
Hunter S. Angileri, Daniel E. McLoughlin, Madeline M. Owen, Jared M. May, Michael A. Terry, Vehniah K. Tjong
Summary: A retrospective study of 5 NFL seasons found that factors such as travel distance, overseas games, early season bye weeks, and an expanded regular season do not contribute to increased injury rates in NFL players. However, teams that did not qualify for the playoffs had higher injury rates and more players on injured reserve.
ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE
(2023)
Meeting Abstract
Oncology
Anosheh Afghahi, Sydney Marsh, Alyse Winchester, Dexiang Gao, Hannah Parris, Lisen Axell, Leif W. Ellisen, Erin Wysong Hofstatter, Allison W. Kurian, Marie Wood, Dana Zakalik, Carol-Ann Mullin, Jennifer Lee Caswell-Jin, Virginia F. Borges, Nadine M. Tung
JOURNAL OF CLINICAL ONCOLOGY
(2021)
Meeting Abstract
Oncology
Charles Dai, Andrzej Niemierko, Neelima Vidula, Laura M. Spring, Seth A. Wander, Arielle J. Medford, Katherine A. Hesler, Giuliana Malvarosa, Jeffrey Peppercorn, Dejan Juric, Steven J. Isakoff, Beverly Moy, Leif W. Ellisen, Aditya Bardia
Meeting Abstract
Oncology
Laura M. Spring, Sara M. Tolaney, Neelam Desai, Amy Comander, Therese Mulvey, Ian E. Krop, Eric P. Winer, Elizabeth A. Mittendorf, Leif W. Ellisen, Aditya Bardia