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Peer-reviewedCC BY-NC-ND 4.0ESMO Open

Risk stratification by circulating tumor DNA-based pretreatment genomic profile and post-operative molecular residual disease detection in resectable colorectal oligometastases: PRECISION, a prospective multicenter study

  • S. Kobayashi1
  • T. Takamoto2
  • A. Shiomi3
  • A. Takahashi4
  • M. Shiozawa5
  • H. Taniguchi6
  • Y. Nishizawa7
  • D. Nobuoka8
  • S. Yasuta9
  • T. Kato10
  • K. Ando11
  • A. Taketomi12
8 more authors
  • Y. Takahashi13
  • S. Natsume14
  • T. Kojima15
  • T. Nakamura16
  • R. Mitani16
  • M. Wakabayashi17
  • T. Yoshino18
  • Y. Nakamura18
18 affiliations
  1. 1Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan
  2. 2Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, Tokyo, Japan
  3. 3Division of Colon and Rectal Surgery, Shizuoka Cancer Center, Nagaizumicho, Japan
  4. 4Department of Gastroenterological Surgery, Saitama Cancer Center, Ina, Japan
  5. 5Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan
  6. 6Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
  7. 7Department of Gastroenterological Surgery, Osaka General Medical Center, Osaka, Japan
  8. 8Department of Surgery, Kagawa Prefectural Central Hospital, Takamatsu, Japan
  9. 9Department of Gastroenterological Surgery, Sendai Kousei Hospital, Sendai, Japan
  10. 10Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan
  11. 11Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
  12. 12Department of Gastroenterological Surgery I, Hokkaido University Hospital, Sapporo, Japan
  13. 13Division of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
  14. 14Department of Surgery, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan
  15. 15Department of Surgery, Okayama Saiseikai Hospital, Okayama, Japan
  16. 16Translational Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan
  17. 17Biostatistics Division, Center for Research Administration and Support, National Cancer Center Hospital East, Kashiwa, Japan
  18. 18Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan
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Abstract

Background: The role of a comprehensive genomic profile (CGP) and molecular residual disease (MRD) in circulating tumor DNA (ctDNA) for risk stratification of resectable colorectal oligometastases (CRMs) remains unclear. This study aimed to investigate the feasibility of ctDNA analysis in patients with CRM and to conduct an exploratory assessment of its recurrence risk.

Patients and methods: This study assessed ctDNA in patients with previously untreated resectable CRM scheduled for curative resection, before starting treatment and 4 weeks postoperatively. Pretreatment samples were prospectively tested for genomic alteration using a 74-gene CGP assay (Guardant360). The pathogenic mutations in BRAF, KRAS, PIK3CA, SMAD4, or TP53 were defined as poor genomic profiles. Postoperative samples were retrospectively analyzed for MRD using a methylation-based MRD assay (Guardant Reveal).

Results: Among 118 eligible patients, pretreatment ctDNA was detected in 114 (96.6%) patients, 75 (63.6%) of whom had poor profiles. MRD was detected in 34 (31.2%) patients out of 109 evaluable patients who underwent surgery. Using multivariable analysis, pretreatment poor profiles and post-operative MRD were significantly associated with shorter recurrence-free survival (RFS) [hazard ratio (HR) 3.28, 95% confidence interval (CI) 1.72-6.25; HR 4.07, 95% CI 2.40-6.90, respectively] and time to surgical failure (TSF) (HR 2.76, 95% CI 1.35-5.64; HR 3.05, 95% CI 1.70-5.45, respectively). Patients with both poor pretreatment profiles and post-operative MRD demonstrated the worst prognosis in RFS (HR 13.28, 95% CI 5.86-30.10), TSF (HR 8.98, 95% CI 3.77-21.40), and overall survival (HR 9.21, 95% CI 2.06-41.18).

Conclusions: Combining pretreatment CGP and post-operative MRD in ctDNA showed potential for improved prognostic stratification after CRM resection.

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Cite

BibTeXRIS
BibTeX
@article{kobayashi2026risk,
  title = {{Risk stratification by circulating tumor DNA-based pretreatment genomic profile and post-operative molecular residual disease detection in resectable colorectal oligometastases: PRECISION, a prospective multicenter study}},
  author = {S. Kobayashi and T. Takamoto and A. Shiomi and A. Takahashi and M. Shiozawa and H. Taniguchi and Y. Nishizawa and D. Nobuoka and S. Yasuta and T. Kato and K. Ando and A. Taketomi and Y. Takahashi and S. Natsume and T. Kojima and T. Nakamura and R. Mitani and M. Wakabayashi and T. Yoshino and Y. Nakamura},
  journal = {ESMO Open},
  year = {2026},
  month = oct,
  doi = {10.1016/j.esmoop.2026.108622},
  url = {https://doi.org/10.1016/j.esmoop.2026.108622},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Risk stratification by circulating tumor DNA-based pretreatment genomic profile and post-operative molecular residual disease detection in resectable colorectal oligometastases: PRECISION, a prospective multicenter study
AU  - S. Kobayashi
AU  - T. Takamoto
AU  - A. Shiomi
AU  - A. Takahashi
AU  - M. Shiozawa
AU  - H. Taniguchi
AU  - Y. Nishizawa
AU  - D. Nobuoka
AU  - S. Yasuta
AU  - T. Kato
AU  - K. Ando
AU  - A. Taketomi
AU  - Y. Takahashi
AU  - S. Natsume
AU  - T. Kojima
AU  - T. Nakamura
AU  - R. Mitani
AU  - M. Wakabayashi
AU  - T. Yoshino
AU  - Y. Nakamura
PY  - 2026
DA  - 2026/10/28
JO  - ESMO Open
DO  - 10.1016/j.esmoop.2026.108622
UR  - https://doi.org/10.1016/j.esmoop.2026.108622
AB  - Background: The role of a comprehensive genomic profile (CGP) and molecular residual disease (MRD) in circulating tumor DNA (ctDNA) for risk stratification of resectable colorectal oligometastases (CRMs) remains unclear. This study aimed to investigate the feasibility of ctDNA analysis in patients with CRM and to conduct an exploratory assessment of its recurrence risk.  Patients and methods: This study assessed ctDNA in patients with previously untreated resectable CRM scheduled for curative resection, before starting treatment and 4 weeks postoperatively. Pretreatment samples were prospectively tested for genomic alteration using a 74-gene CGP assay (Guardant360). The pathogenic mutations in BRAF, KRAS, PIK3CA, SMAD4, or TP53 were defined as poor genomic profiles. Postoperative samples were retrospectively analyzed for MRD using a methylation-based MRD assay (Guardant Reveal).  Results: Among 118 eligible patients, pretreatment ctDNA was detected in 114 (96.6%) patients, 75 (63.6%) of whom had poor profiles. MRD was detected in 34 (31.2%) patients out of 109 evaluable patients who underwent surgery. Using multivariable analysis, pretreatment poor profiles and post-operative MRD were significantly associated with shorter recurrence-free survival (RFS) [hazard ratio (HR) 3.28, 95% confidence interval (CI) 1.72-6.25; HR 4.07, 95% CI 2.40-6.90, respectively] and time to surgical failure (TSF) (HR 2.76, 95% CI 1.35-5.64; HR 3.05, 95% CI 1.70-5.45, respectively). Patients with both poor pretreatment profiles and post-operative MRD demonstrated the worst prognosis in RFS (HR 13.28, 95% CI 5.86-30.10), TSF (HR 8.98, 95% CI 3.77-21.40), and overall survival (HR 9.21, 95% CI 2.06-41.18).  Conclusions: Combining pretreatment CGP and post-operative MRD in ctDNA showed potential for improved prognostic stratification after CRM resection.
SN  - 2059-7029
ER  -