2026-06-12 国立がん研究センター,関西医科大学,大阪医療センター
図1
＜関連情報＞
- https://www.ncc.go.jp/jp/information/pr_release/2026/0612/index.html
- https://www.nature.com/articles/s41591-026-04428-0
切除された結腸直腸癌のctDNA陽性患者における術後補助化学療法：ランダム化第3相試験 Post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial
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,… Takeshi Kato
Nature Medicine Published:08 June 2026
DOI:https://doi.org/10.1038/s41591-026-04428-0
Abstract
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.
