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Limitations in surgical options, along with the risk of harming healthy tissues from radiation and chemotherapy, demand new treatment concepts. Tumor-agnostic therapy targets characteristic molecular signatures of transformed cells independent of traditional histopathology, including recurrent DNA alterations, shared metabolic dependencies, and immune-evasion features. FDA-approved advances, enabled by biomarker-driven evidence, are reshaping clinical oncology by reviewing history, current status, and future perspectives.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/tumor-agnostic-therapy-the-final-step-forward-in-the-cure-for-human-neoplasms/332165/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/tumor-agnostic-therapy-the-final-step-forward-in-the-cure-for-human-neoplasms/332165.png","ImageObject",300,407,{"name":92,"@type":93},"Violet","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-27","2026-09-21",true,{"@type":102,"interactionType":103,"userInteractionCount":44},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Why does cancer treatment need a new paradigm beyond conventional therapies?","Question",{"text":112,"@type":113},"Conventional approaches often rely on site-specific histopathology, while also facing toxicity and eventual drug resistance. 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Tumor-Agnostic Therapy—The Final Step Forward in the Cure for Human Neoplasms? Cells 2024, 13, 1071. [https://doi.org/](https://doi.org/)[ ](https://doi.org/)[10.3390/cells13121071](10.3390/cells13121071)  \nAcademic Editors: Kazuyuki Kitatani and Daria A. Chudakova  \nReceived: 1 May 2024  \nRevised: 17 June 2024  \nAccepted: 18 June 2024  \nPublished: 20 June 2024  \nCopyright: © 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ([https://](https://)[ ](https://)[creativecommons.org/licenses/by/](creativecommons.org/licenses/by/)[ ](creativecommons.org/licenses/by/)[4.0/](4.0/)) .  \nSchool of Medicine and Dentistry, Faculty of Clinical and Biomedical Sciences, University of Central Lancashire,  \nPreston PR1 2HE, UK; [mmelsayed@uclan.ac.uk](mmelsayed@uclan.ac.uk) (M.M.E.-S.); [jrbianco@uclan.ac.uk](jrbianco@uclan.ac.uk) (J.R.B.); [yjli4@uclan.ac.uk](yjli4@uclan.ac.uk) (Y.L.)  \n* Correspondence: [zfabian@uclan.ac.uk](zfabian@uclan.ac.uk)  \n† These authors contributed equally to this work.  \nAbstract: Cancer accounted for 10 million deaths in 2020, nearly one in every six deaths annually. Despite advancements, the contemporary clinical management of human neoplasms faces a number of challenges. Surgical removal of tumor tissues is often not possible technically, while radiation and chemotherapy pose the risk of damaging healthy cells, tissues, and organs, presenting complex clinical challenges. These require a paradigm shift in developing new therapeutic modalities moving towards a more personalized and targeted approach. The tumor-agnostic philosophy, one of these new modalities, focuses on characteristic molecular signatures of transformed cells independently of their traditional histopathological classification. These include commonly occurring DNA aberrationsin cancer cells, shared metabolic features of their homeostasis or immune evasion measures of the tumor tissues. The first dedicated, FDA-approved tumor-agnostic agent’s profound progression-free survival of 78% in mismatch repair-deficient colorectal cancer paved the way for the accelerated FDA approvals of novel tumor-agnostic therapeutic compounds. Here, we review the historical background, current status, and future perspectives of this new era of clinical oncology.  \nKeywords: tumor-agnostic philosophy; pan-cancer mutations; biomarkers; next-generation sequencing  \n1. Introduction  \nCancer is among the leading causes of mortality in developed countries due to the high rate of morbidity and limited efficiency of contemporary therapeutic modalities. Indeed, lung cancer, for instance, accounts for an estimated 350 fatalities daily, making it the leading cause of cancer-related mortality across both sexes in 2022 . From 2001 to 2017, an increase from 19% to 31% in 3-year survival outcome was observed. During this period, the median survival increased from 8 to 13 months [1] . Despite conventional chemotherapy being the primary treatment for non-small-cell lung cancer, the success rate was less than 5%[2] .  \nOver the course of several decades, cancer management has predominantly relied on scrutinizing tumor tissue at the cellular and supracellular levels [3] . This has led to a site-specific approach in managing tumors, where guidelines are tailored, primarily, on the basis of their location within the human body. Accordingly, cancer research, clinical trials, and the development of anticancer drugs have, so far, hinged on histopathological classifications rather than addressing genetic alterations, highlighting the inherent limitations of these treatment regimes. Moreover, the lack of specificity of","cbCair6Zn6NTRjZP","https://ap.wps.com/l/cbCair6Zn6NTRjZP","pdf",2310609,38,"English","# Introduction\n# Tumor-Agnostic Philosophy\n## Advances in Understanding the Molecular Events of Tumor Development","[{\"question\":\"Why does cancer treatment need a new paradigm beyond conventional therapies?\",\"answer\":\"Conventional approaches often rely on site-specific histopathology, while also facing toxicity and eventual drug resistance. In addition, surgery may be technically impossible and radiation/chemotherapy can damage healthy cells and organs.\"},{\"question\":\"What does tumor-agnostic therapy focus on instead of tumor location or histopathology?\",\"answer\":\"It targets characteristic molecular signatures of transformed cells regardless of their traditional classification, including DNA aberrations, shared metabolic features, and immune-evasion measures.\"},{\"question\":\"How have biomarker-driven approvals influenced the adoption of tumor-agnostic treatments?\",\"answer\":\"Evidence supporting biomarker-driven, tissue-agnostic therapeutics has been strengthened through regulatory approvals, enabling accelerated FDA approvals of new tumor-agnostic compounds.\"}]","Tumor-Agnostic Therapy - The Final Step Forward in the Cure for Human Neoplasms | PDF",1789997159,96]