{"title":"Testing new anticancer drugs before curative locoregional therapies: MDICT 2024 recommendations","authors":"","doi":"10.1016/j.esmoop.2024.103649","DOIUrl":null,"url":null,"abstract":"<div><p>Advances in the treatment of cancer have resulted in improved outcomes for patients, but improving the cure rate is a major unmet need. While testing new anticancer drugs in the earliest settings may be attractive as the chance of benefit may be greatest, it is also a setting where researchers must ensure patients are not harmed, by either over or undertreatment, or denial of timely standard curative treatments. The Methodology for the Development of Innovative Cancer Therapies Taskforce (MDICT) meets immediately before the ESMO-Targeted Anticancer Therapies (ESMO-TAT) meeting, usually held annually in Paris, France, to address questions that are considered important for early academic clinical trials. The focus of the MDICT 2024 was on early, signal-seeking phase clinical trials of new drugs conducted in the neoadjuvant (NEO) setting (NEO-ECTs) rather than pivotal confirmatory NEO trials (NEO-CONFs), which are typically phase III in design. Recommendations encompass four key concepts: patient engagement, reviewing risk–benefit ratio and clinical/ethical equipoise, the requirement for a randomization to reduce bias and allow robust conclusions to be drawn, and the selection of appropriate endpoints. The careful design of NEO-ECTs will allow the testing of new anticancer treatments in earlier disease settings where activity is hoped to result in higher cure rates, while also ensuring that patients are not harmed by delays to curative/definitive treatments nor by long-term or late-onset toxicity and morbidity. Additional research and investigation are required to further define and refine robust endpoints for use in this setting, including imaging, tissue and blood based endpoints.</p></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":null,"pages":null},"PeriodicalIF":7.1000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2059702924014182/pdfft?md5=0aa00f6fa014781bdfc0ced4a363ff84&pid=1-s2.0-S2059702924014182-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ESMO Open","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2059702924014182","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Advances in the treatment of cancer have resulted in improved outcomes for patients, but improving the cure rate is a major unmet need. While testing new anticancer drugs in the earliest settings may be attractive as the chance of benefit may be greatest, it is also a setting where researchers must ensure patients are not harmed, by either over or undertreatment, or denial of timely standard curative treatments. The Methodology for the Development of Innovative Cancer Therapies Taskforce (MDICT) meets immediately before the ESMO-Targeted Anticancer Therapies (ESMO-TAT) meeting, usually held annually in Paris, France, to address questions that are considered important for early academic clinical trials. The focus of the MDICT 2024 was on early, signal-seeking phase clinical trials of new drugs conducted in the neoadjuvant (NEO) setting (NEO-ECTs) rather than pivotal confirmatory NEO trials (NEO-CONFs), which are typically phase III in design. Recommendations encompass four key concepts: patient engagement, reviewing risk–benefit ratio and clinical/ethical equipoise, the requirement for a randomization to reduce bias and allow robust conclusions to be drawn, and the selection of appropriate endpoints. The careful design of NEO-ECTs will allow the testing of new anticancer treatments in earlier disease settings where activity is hoped to result in higher cure rates, while also ensuring that patients are not harmed by delays to curative/definitive treatments nor by long-term or late-onset toxicity and morbidity. Additional research and investigation are required to further define and refine robust endpoints for use in this setting, including imaging, tissue and blood based endpoints.
期刊介绍:
ESMO Open is the online-only, open access journal of the European Society for Medical Oncology (ESMO). It is a peer-reviewed publication dedicated to sharing high-quality medical research and educational materials from various fields of oncology. The journal specifically focuses on showcasing innovative clinical and translational cancer research.
ESMO Open aims to publish a wide range of research articles covering all aspects of oncology, including experimental studies, translational research, diagnostic advancements, and therapeutic approaches. The content of the journal includes original research articles, insightful reviews, thought-provoking editorials, and correspondence. Moreover, the journal warmly welcomes the submission of phase I trials and meta-analyses. It also showcases reviews from significant ESMO conferences and meetings, as well as publishes important position statements on behalf of ESMO.
Overall, ESMO Open offers a platform for scientists, clinicians, and researchers in the field of oncology to share their valuable insights and contribute to advancing the understanding and treatment of cancer. The journal serves as a source of up-to-date information and fosters collaboration within the oncology community.