Cited by 1,011Cancer Genomics and DiagnosticsColorectal Cancer Treatments and StudiesGenetic factors in colorectal cancer

Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer

Open access
Reinert, Thomas, Henriksen, Tenna Vesterman, Christensen, Emil, Sharma, Shruti, Salari, Raheleh, Sethi, Himanshu, Knudsen, Michael, Nordentoft, Iver +30 more·2019·JAMA Oncology

Abstract

IMPORTANCE: Novel sensitive methods for detection and monitoring of residual disease can improve postoperative risk stratification with implications for patient selection for adjuvant chemotherapy (ACT), ACT duration, intensity of radiologic surveillance, and, ultimately, outcome for patients with colorectal cancer (CRC). OBJECTIVE: To investigate the association of circulating tumor DNA (ctDNA) with recurrence using longitudinal data from ultradeep sequencing of plasma cell-free DNA in patients with CRC before and after surgery, during and after ACT, and during surveillance. DESIGN, SETTING, AND PARTICIPANTS: In this prospective, multicenter cohort study, ctDNA was quantified in the preoperative and postoperative settings of stages I to III CRC by personalized multiplex, polymerase chain reaction-based, next-generation sequencing. The study enrolled 130 patients at the surgical departments of Aarhus University Hospital, Randers Hospital, and Herning Hospital in Denmark from May 1, 2014, to January 31, 2017. Plasma samples (n = 829) were collected before surgery, postoperatively at day 30, and every third month for up to 3 years. MAIN OUTCOMES AND MEASURES: Outcomes were ctDNA measurement, clinical recurrence, and recurrence-free survival. RESULTS: A total of 130 patients with stages I to III CRC (mean [SD] age, 67.9 [10.1] years; 74 [56.9%] male) were enrolled in the study; 5 patients discontinued participation, leaving 125 patients for analysis. Preoperatively, ctDNA was detectable in 108 of 122 patients (88.5%). After definitive treatment, longitudinal ctDNA analysis identified 14 of 16 relapses (87.5%). At postoperative day 30, ctDNA-positive patients were 7 times more likely to relapse than ctDNA-negative patients (hazard ratio [HR], 7.2; 95% CI, 2.7-19.0; P < .001). Similarly, shortly after ACT ctDNA-positive patients were 17 times (HR, 17.5; 95% CI, 5.4-56.5; P < .001) more likely to relapse. All 7 patients who were ctDNA positive after ACT experienced relapse. Monitoring during and after ACT indicated that 3 of the 10 ctDNA-positive patients (30.0%) were cleared by ACT. During surveillance after definitive therapy, ctDNA-positive patients were more than 40 times more likely to experience disease recurrence than ctDNA-negative patients (HR, 43.5; 95% CI, 9.8-193.5 P < .001). In all multivariate analyses, ctDNA status was independently associated with relapse after adjusting for known clinicopathologic risk factors. Serial ctDNA analyses revealed disease recurrence up to 16.5 months ahead of standard-of-care radiologic imaging (mean, 8.7 months; range, 0.8-16.5 months). Actionable mutations were identified in 81.8% of the ctDNA-positive relapse samples. CONCLUSIONS AND RELEVANCE: Circulating tumor DNA analysis can potentially change the postoperative management of CRC by enabling risk stratification, ACT monitoring, and early relapse detection.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1001/jamaoncol.2019.0528

Cites

30 of 30 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Authors
Reinert, T., Henriksen, T. V., Christensen, E., Sharma, S., Salari, R., Sethi, H., Knudsen, M., Nordentoft, I., Wu, H.-T., Tin, A. S., Heilskov Rasmussen, M., Vang, S., Shchegrova, S., Frydendahl Boll Johansen, A., Srinivasan, R., Assaf, Z., Balcioglu, M., Olson, A., Dashner, S., Hafez, D., Navarro, S., Goel, S., Rabinowitz, M., Billings, P., Sigurjonsson, S., Dyrskjøt, L., Swenerton, R., Aleshin, A., Laurberg, S., Husted Madsen, A., Kannerup, A.-S., Stribolt, K., Palmelund Krag, S., Iversen, L. H., Gotschalck Sunesen, K., Lin, C.-H. J., Zimmermann, B. G., & Lindbjerg Andersen, C.
Affiliations
  • Aarhus University Hospital (DK)
  • Natera (United States) (US)
  • Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark
  • Department of Surgery, Regional Hospital Herning, Herning, Denmark
  • Regional Hospital Randers (DK)
  • Department of Pathology, Aarhus University Hospital, Aarhus, Denmark
  • Department of Surgery, Regional Hospital Randers, Randers, Denmark
Venue
JAMA Oncology
Published
2019-08-01
Volume
5
Issue
8
Pages
1124
ISSN
2374-2437 (ISSN-L)
OpenAlex
W2944044607
Cited by
1,011
References
30
Citations by year
2026: 150 · 2025: 159 · 2024: 145 · 2023: 173 · 2022: 137 · 2021: 140 · 2020: 87 · 2019: 18
FWCI
30.45
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • JAMA Oncology (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • Strategiske Forskningsråd
  • Lundbeckfonden (R180-2014-3998)
  • Danmarks Frie Forskningsfond
  • Novo Nordisk Fonden (NNF17OC0025052, NNF17OC0024464, NNF14OC0012747)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
  • Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
Keywords
colorectal cancer, circulating tumor DNA, cell-free DNA, ultra-deep sequencing, liquid biopsy, tumor recurrence, adjuvant chemotherapy, postoperative follow-up, recurrence-free survival, residual disease monitoring, early colorectal cancer, postoperative risk stratification, prognostic factors, treatment response monitoring

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review