DENEB: Development of new criteria for curability after local excision of pathological T1 colorectal cancer using liquid biopsy

Abstract

According to the current international guidelines, high-risk patients diagnosed with pathological T1 (pT1) colorectal cancer (CRC) who underwent complete local resection but may have risk of developing lymph node metastasis (LNM) are recommended additional intestinal resection with lymph node dissection. However, around 90% of the patients without LNM are exposed to the risk of being overtreated due to the insufficient pathological criteria for risk stratification of LNM. Circulating tumor DNA (ctDNA) is a noninvasive biomarker for molecular residual disease and relapse detection after treatments including surgical and endoscopic resection of solid tumors. The CIRCULATE-Japan project includes a large-scale patient-screening registry of the GALAXY study to track ctDNA status of patients with stage II to IV or recurrent CRC that can be completely resected. Based on the CIRCULATE-Japan platform, we launched DENEB, a new prospective study, within the GALAXY study for patients with pT1 CRC who underwent complete local resection and were scheduled for additional intestinal resection with lymph node dissection based on the standard How to cite this article: Miyo M, Kato T, Nakamura Y, et al. DENEB: Development of new criteria for curability after local excision of pathological T1 colorectal cancer using liquid biopsy.

Essential updates 2020/2021: Advancing precision medicine for comprehensive rectal cancer treatment

“…A new prospective study, DENEB, was launched for patients with pT1 colorectal cancer who underwent complete local resection and were scheduled for additional intestinal resection to investigate the predictive ability of LNM using ctDNA analysis compared to standard pathological criteria. 158 As described above, the global standard treatment for locally advanced rectal cancer is neoadjuvant CRT followed by resection of the rectum, but there are currently no criteria for TNT. Considering adverse events and high medical costs, the application of TNT for all locally advanced rectal cancers can be excessive.…”

“…However, due to insufficient pathological criteria for risk stratification of LNMs, ~90% of patients without LNM are at risk of overtreatment that may impair their quality of life (QoL) due to the stoma or deterioration of defecation function, especially in rectal cancer patients. A new prospective study, DENEB, was launched for patients with pT1 colorectal cancer who underwent complete local resection and were scheduled for additional intestinal resection to investigate the predictive ability of LNM using ctDNA analysis compared to standard pathological criteria 158 . As described above, the global standard treatment for locally advanced rectal cancer is neoadjuvant CRT followed by resection of the rectum, but there are currently no criteria for TNT.…”