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Dynamic circulating tumor DNA (ctDNA) monitoring can predict poor response to neoadjuvant chemotherapy in locally advanced rectal cancer (LARC) patients early in treatment. This tool helps identify patients needing alternative therapies for better outcomes.

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Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Rectal Cancer Research

Background:

  • Neoadjuvant chemotherapy (NCT) is standard for locally advanced rectal cancer (LARC).
  • Predicting pathological response to NCT is crucial due to variable patient outcomes.
  • Early identification of non-responders is needed for treatment adaptation.

Purpose of the Study:

  • To evaluate dynamic circulating tumor DNA (ctDNA) analysis for early response monitoring in LARC patients undergoing NCT.
  • To determine if ctDNA kinetics can predict pathological response and clinical outcomes.
  • To assess ctDNA as a biomarker for treatment stratification.

Main Methods:

  • Biomarker substudy of the multicenter randomized COPEC trial involving 153 LARC patients.
  • Serial plasma sample collection (n=526) during NCT for tumor-informed ctDNA sequencing.
  • Classification of patients into high-risk (delayed/no clearance, recurred positive) and low-risk (early clearance, persistent negative) ctDNA dynamic groups.
  • Correlation of ctDNA status with pathological tumor regression grade (pTRG) and distant metastasis.

Main Results:

  • High-risk ctDNA dynamics were strongly associated with poor pathological response (pTRG 3) and distant metastasis (59.4% vs 12.4%, p<0.001).
  • Dynamic ctDNA status was an independent predictor of poor response (OR=11.69, p<0.001).
  • Delayed/no clearance and recurred ctDNA positivity were significant risk factors; a single preoperative ctDNA-positive result also predicted poor response.

Conclusions:

  • Dynamic ctDNA monitoring effectively identifies LARC patients at high risk for NCT failure as early as two cycles.
  • This approach can guide adaptive trial designs for LARC treatment.
  • ctDNA analysis offers a pathway for personalizing therapy selection in LARC.