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Observational Study
. 2024 Jan 3;8(1):zrad146.
doi: 10.1093/bjsopen/zrad146.

Assessment of postoperative circulating tumour DNA to predict early recurrence in patients with stage I-III right-sided colon cancer: prospective observational study

Kristin B Lygre  1   2   3 , Rakel B Forthun  4   5 , Trude Høysæter  5   6 , Sigrun M Hjelle  4 , Geir E Eide  7   8 , Bjørn T Gjertsen  4 , Frank Pfeffer  2   3 , Randi Hovland  5   6   9
Affiliations
Observational Study

Assessment of postoperative circulating tumour DNA to predict early recurrence in patients with stage I-III right-sided colon cancer: prospective observational study

Kristin B Lygre et al. BJS Open. .

Abstract

Background: Right-sided colon cancer (RCC) differs in mutation profile and risk of recurrence compared to distal colon cancer. Circulating tumour DNA (ctDNA) present after surgery can identify patients with residual disease after curative surgery and predict risk of early recurrence.

Methods: This is a prospective observational biomarker trial with exploration of ctDNA in 50 non-metastatic RCC patients for which oncological right-sided colectomy was performed. Blood samples were collected preoperatively, within 1 month post surgery, 3 months (not mandatory), 6 months and every 6 months thereafter. Plasma cell free DNA and/or tumour was investigated for cancer-related mutations by the next-generation sequencing (NGS) panel AVENIO surveillance specifically designed for ctDNA analysis. Detected mutations were quantified using digital droplet PCR (ddPCR) for follow-up. Recurrence-free survival was explored.

Results: 50 patients were recruited. Somatic cancer-related mutations were detected in 47/50 patients. ddPCR validated results from NGS for 27/34 (plasma) and 72/72 samples (tumour). Preoperative ctDNA was detected in 31/47 of the stage I/III patients and the majority of ctDNA positive patients showed reduction of ctDNA after surgery (27/31). ctDNA-positive patients at first postoperative sample had high recurrence risk compared to patients without measurable ctDNA (adjusted hazard ratio: 172.91; 95% c.i.: 8.70 to 3437.24; P: 0.001).

Conclusion: ctDNA was detectable in most patients with non-metastatic RCC before surgery. Positive postoperative ctDNA was strongly associated with early recurrence. Detectable postoperative ctDNA is a prognostic factor with high (100%) positive predictive value for recurrence in this cohort of non-metastatic RCC.

Clinical trial registration: ClinicalTrials.gov ID: NCT03776591.

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Figures

Fig. 1
Fig. 1
Kaplan–Meier plot for days from postoperative sampling (liquid biopsy) until postoperative recurrence in 50 patients operated for right-sided non-metastatic colon cancer in the D3/CME-study at Haraldsplass Deaconess Hospital or Haukeland University Hospital, Bergen (Norway) between September 2017 and July 2019 according to postoperative ctDNA status (P = 0.001)
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