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	Post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial.
掲載誌名	正式名：Nature medicine 略　 称：Nat Med ISSNコード：1546170X/10788956
掲載区分	国外
巻・号・頁	pp.Online ahead of print
著者・共著者	Hideaki Bando, Jun Watanabe, Yusuke Takahashi, Masahito Kotaka, Nobuhisa Matsuhashi, Eiji Oki, Yoshito Komatsu, Manabu Shiozawa, Keiji Hirata, Yuji Miyamoto, Masanobu Takahashi, Kentaro Yamazaki, Dai Manaka, Akiyoshi Kanazawa, Yi-Hsin Liang, Kun-Huei Yeh, Yuko Watsuji, Yuko Yamamoto, Makoto Fukui, Shruti Sharma, Vasily N Aushev, Adham Jurdi, Matthew Rabinowitz, Minetta C Liu, Alexey Aleshin, Ichiro Takemasa, Daisuke Kotani, Akihiro Sato, Toshihiro Misumi, Yoshiaki Nakamura, Qian Shi, Hiroya Taniguchi, Takayuki Yoshino, Takeshi Kato
発行年月	2026/06
概要	Tumor-informed circulating tumor DNA (ctDNA) enables detection of molecular residual disease (MRD) after curative resection of colorectal cancer (CRC), but whether early intervention improves outcomes remains uncertain. ALTAIR was a randomized, double-blind, phase 3 trial embedded in the CIRCULATE-Japan platform evaluating a post-adjuvant ctDNA surveillance strategy with treatment initiation upon molecular recurrence. Patients with resected stage 0-IV CRC who became ctDNA positive after completion of standard-of-care therapy and had no radiological evidence of disease were randomly assigned (1:1) to receive trifluridine/tipiracil (FTD/TPI) or placebo for 6 months. The primary endpoint was investigator-assessed disease-free survival (DFS). Between July 2020 and June 2023, 243 patients were randomized to FTD/TPI (n = 122) or placebo (n = 121). Median DFS was 9.30 months with FTD/TPI and 5.55 months with placebo (hazard ratio = 0.79, 95% confidence interval: 0.60-1.05, P = 0.107), and the primary endpoint was not met. FTD/TPI increased grade 3 or higher hematologic adverse events (73.0% versus 3.3%) without new safety signals. These findings indicate that post-adjuvant intervention with FTD/TPI did not significantly improve DFS in ctDNA-positive patients without radiological disease. ClinicalTrials.gov identifier: NCT04457297 .
DOI	10.1038/s41591-026-04428-0
PMID	42260101