Abstract CT022: A first-of-its-kind prospective study of a multi-cancer blood test to screen and manage 10,000 women with no history of cancer

Abstract

Abstract One of the most compelling approaches to reduce cancer-specific morbidity and mortality is earlier detection. Minimally-invasive screening tests, such as liquid biopsies, hold much promise in this regard. However, prospective clinical studies of these new methods are required to ensure that the anticipated benefits outweigh the potential risks. We describe an interim analysis of a study that enrolled 10,006 women 65 to 75 years of age who had no prior history of cancer, in a population with a high degree of compliance with standard-of-care screening. Enrollment occurred between September 2017 and May 2019. The study evaluated the prospective implementation of a multi-cancer, multi-analyte screening blood test (DETECT-A blood test) incorporating DNA and protein markers. Participants with positive DETECT-A blood test results were followed by an imaging test (generally PET-CT) to localize the putative cancer. The DETECT-A blood test combined with standard-of-care screening doubled the number of cancers detected by screening. The DETECT-A blood test effectively identified subjects with multiple types of cancer, with a positive predictive value higher than existing non-invasive screening tests for individual cancers. The DETECT-A blood test identified ten different cancer types, including seven types for which there is currently no screening test available. No serious adverse events were observed in any participants enrolled in the study. 65% of the cancers detected by the blood test were classified as local or regional disease. Somatic mutations in TP53, BRAF, KRAS, or PIK3CA were the most common alterations identified in plasma; in all cases where tumor tissue was available, the mutations detected in plasma were confirmed to be present in the primary tumor. These results are the first to demonstrate that a minimally-invasive multi-cancer blood test can be safely incorporated into routine clinical care. Moreover, this is the first study to show that it can be used to guide patient management in real-time, leading to surgery with intent to cure in asymptomatic individuals. Citation Format: Nickolas Papadopoulos. A first-of-its-kind prospective study of a multi-cancer blood test to screen and manage 10,000 women with no history of cancer [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr CT022.