論文種別 原著(症例報告除く)
言語種別 英語
査読の有無 その他(不明)
表題 Molecular Residual Disease and Recurrence in Rectal Cancer Patients Undergoing Upfront Surgery: A Prospective Cohort Study.
掲載誌名 正式名:Annals of surgery
略  称:Ann Surg
ISSNコード:15281140/00034932
掲載区分国外
巻・号・頁 pp.Online ahead of print
著者・共著者 Koji Ando, Atsushi Hamabe, Yoshiaki Nakamura, Jun Watanabe, Keiji Hirata, Kozo Kataoka, Masaaki Miyo, Kentaro Kato, Naoya Akazawa, Yoshinori Kagawa, Mitsuru Yokota, Kentaro Yamazaki, Saori Mishima, Hiroki Yukami, Daisuke Kotani, Hideaki Bando, George Laliotis, Shruti Sharma, Charuta C Palsuledesai, Matthew Rabinowitz, Adham Jurdi, Minetta C Liu, Alexey Aleshin, Hiroya Taniguchi, Ichiro Takemasa, Takeshi Kato, Takayuki Yoshino, Eiji Oki
発行年月 2025/09
概要 OBJECTIVE:To evaluate the prognostic utility of postoperative circulating tumor DNA (ctDNA) for recurrence and treatment response in patients with rectal cancer undergoing upfront surgery.SUMMARY BACKGROUND DATA:ctDNA-based molecular residual disease (MRD) testing shows promise in colorectal cancer, but its role in patients with rectal cancer not receiving neoadjuvant therapy is unclear. This study evaluates whether postoperative ctDNA predicts disease-free survival (DFS) and guides adjuvant chemotherapy (ACT) decisions.METHODS:We analyzed ctDNA from patients with stage II-III rectal cancer (N=250) enrolled in the GALAXY study, multi-center registry in Japan. A clinically validated, personalized, tumor-informed 16-plex PCR-NGS assay (SignateraTM) was used to detect and quantify ctDNA. The primary outcome was DFS, defined as time from landmark to recurrence, death, or latest radiological assessment.RESULTS:In the MRD window (2-10 wks post-surgery, before ACT), 14.2% (35/246) of patients were ctDNA-positive and had significantly shorter DFS (HR: 9.96, 95% CI: 5.76-17.2, P<0.0001). Among patients who were ctDNA-positive in the MRD window, a significant benefit from ACT was observed (HR: 0.28, 95% CI: 0.09-0.89, P=0.031), whereas no benefit was seen in ctDNA-negative patients (HR: 0.59, 95% CI: 0.26-1.35, P=0.211). When analyzing ctDNA dynamics from MRD window to 6-months post-surgery, recurrence risk was higher in patients who converted from ctDNA-negative to positive (HR: 8.22, 95% CI: 1.86-36.32, P=0.0055) and who remained ctDNA-positive (HR: 45.48, 95% CI: 14.31-144.57, P<0.0001) compared to serially ctDNA-negative patients.CONCLUSIONS:Postoperative ctDNA status is a robust biomarker predicting recurrence risk and ACT benefit in patients with rectal cancer undergoing upfront surgery.
DOI 10.1097/SLA.0000000000006948
PMID 41002143