Integrating multi-omics features for blood-based multi-cancer early detection.

癌症 医学 乳腺癌 胰腺癌 内科学 肺癌 肿瘤科 人口 阶段(地层学) 胃癌 无症状的 肝癌 生物 环境卫生 古生物学
作者
Mao Mao,Shiyong Li,Qingqi Ren,Yi Luan,Weijie Liang,Shuaipeng Geng,Guolin Zhong,Dandan Zhu,Yinyin Chang,Wei Wu,Yingying Zhang,Linfeng Zhang,Yan Wang,Yukuan Feng,Bing Wei,Jie Ma,Chaohui Duan,Guanghui Long
出处
期刊:JCO global oncology [American Society of Clinical Oncology]
卷期号:9 (Supplement_1): 156-156
标识
DOI:10.1200/go.2023.9.supplement_1.156
摘要

156 Background: The current standard-of-care cancer screening paradigm is constrained to just a few cancer types and has challenges in patient compliance due to the invasive procedures endured from the tests. Recently studies have demonstrated that blood-based multi-cancer detection (MCED) approaches may hold promise for identifying asymptomatic cancer patients from the general population. However, most studies only exploit a single aspect of cancer hallmarks which is challenging for the biological reasons since cancer is a heterogenous disease with a wide spectrum of pathological and clinical behaviors. Methods: Here we report SeekInCare, a CE-IVD Mark MCED test, based on a novel multi-dimensional cancer risk score (CRS) model incorporating copy number aberrations, fragment size, end motifs and oncogenic viruses via shallow whole genome sequencing (sWGS) from cell-free DNA (cfDNA), and seven common tumor markers in a single 8ml blood draw. Results: Our research cohort consisted of 898 healthy subjects and 615 stage I-IV cancer patients that covered eight common cancers and 19 uncommon cancer types. The CRS model identified 427 cancer patients with 69.4% sensitivity at 98.0% specificity, resulting in an AUC (area under the curve) of 0.926. The sensitivities were 50.3%, 64.0%, 73.8% and 86.2% in stage I, II, III and IV cancers respectively. The sensitivities of eight common cancer types, breast, stomach, lung, colorectum, lymphoma, liver, pancreas and leukemia, were 45.1%, 50.0%, 63.4%, 69.4%, 70.5%, 81.4%, 82.4% and 90.9% respectively. We also prospectively evaluated SeekInCare in a real-world cohort consisting of 1212 subjects who received the test as a LDT (laboratory developed test) (median follow-up time: 753 days, range: 78~1669 days). 13 out of 18 cancer cases were detected while 46 subjects tested positive but without cancer. Thus, SeekInCare achieved 72.2% sensitivity, 96.1% specificity, 22.0% PPV and 99.6% NPV in the real-world cohort. Conclusions: In this study, we provided a non-invasive MCED test (SeekInCare) based on the multi-omics and multi-dimensional features. The case-control study demonstrated that SeekInCare could detect >20 cancer types with 69.4% sensitivity at 98.0% specificity. The outstanding real-world performance of SeekInCare warrants future investigation of its clinical utility and health economics as a mass cancer screening test in average-risk populations.

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