Clinical validation of a novel circulating tumor DNA methylation assay for predicting recurrence of colorectal cancer in patients with curative-intent surgery by monitoring minimal residual disease.

• DOI: 10.1200/jco.2024.42.16_suppl.3620
• Publication Date: 2024-06-04T20:28:43Z
• Authors: Jin-Soo Kim; Yun Young Lee; Mi Young Kim; Joon An; Rumi Shin; Jin Hyun Park; Jinil Han; In Sil Choi; Seung Chul Heo; Youngho Moon
• Keywords: Minimal Residual Disease; Circulating tumor DNA

3620 Background: Circulating tumor DNA (ctDNA)-based liquid biopsy has emerged as a promising tool for early detection and monitoring of cancer. In this study, we developed COLO eDX, digital-PCR based colorectal cancer (CRC) diagnostic assay using single CRC-specific methylation biomarker. This study aimed to evaluate the prognostic value universal recurrence in CRC patients with curative-intent surgery. Methods: A total 116 who underwent surgery at Seoul National University Boramae Medical Center were enrolled from Mar 2017 January 2020. For each patient, postoperative plasma specimens collected 7 days regular clinical follow-up visit up 2 years. The followed radiological measures maximally 5 years after primary outcome was recurrence-free survival (RFS) according ctDNA status. Results: majority samples positive by eDX (65/83, 78.3%) status not significantly associated RFS, suggesting that signatures can still be detected most least 1 week However, positivity month or later worse RFS. taken between 1- 9-months surgery, group had higher rate than negative (hazard ratio [HR], 11.4, 95% confidence interval [CI], 3.8-34.4; P<0.0001). Incorporating serial longitudinal samples, (HR, 13.4, CI, 4.3-40.6; Notably, analysis more powerful predictor predicting carcinoembryonic antigen (CEA) assessment 4.0, 1.4-11.8; P=0.0107 HR, 1.5, 0.3-8.2; P=0.5949). Conclusions: Postoperative epigenetic biomarker-based digital PCR is strategy prediction personalized management through minimal residual disease (MRD).