PROVIDERS

Minimal residual disease (MRD) screening with RaDaR® is available for breast, colorectal, lung, and head & neck cancers

Colorectal cancer (CRC)

There is growing support in the literature for the use of circulating tumor DNA (ctDNA) detection in the management of colorectal cancer patients, and authoritative bodies continue to assess best-practice guidelines. Recognizing this interest and potential, the Colon and Rectal-Anal Task Forces of the United States National Cancer Institute (US NCI) have published guidance on the promotion, development, and integration of this technology into clinical care.1

RaDaR applicability in CRC

  • Risk stratification: How likely is it for your patient’s tumor to recur? Positive ctDNA result can mean your patient has a high risk of recurrence 
  • Adjuvant decision-making: Should your patient receive adjuvant therapy after curative-intent treatment, such as surgery? Patients with detectable ctDNA post-surgery are more likely to recur. Recent data (DYNAMIC II) showed that patients with stage II colon cancer were able to avoid chemotherapy based on negative MRD results, without inferior outcomes 
  • Surveillance: Regular monitoring with ctDNA may give you an indication of tumor recurrence, often before standard of care (SOC) imaging results: 
    • Even with monitoring tools like carcinoembryonic antigen (CEA), ctDNA offers greater sensitivity and specificity, meaning you can detect recurrence sooner

Clinical support for MRD testing in CRC

ADJUVANT DECISION MAKING AND RISK ASSESSMENT IN STAGE II COLON CANCER

In stage II colon cancer, approximately 80% of patients are cured by surgery alone.2 You must rely on clinical and pathologic features to determine which patients are at high risk for recurrence, and which might benefit from adjuvant chemotherapy. MRD tests can help reveal which patients have residual disease after surgery and are therefore at high risk for disease recurrence. 

In 2016, Tie J, et al. evaluated the ability of ctDNA to detect MRD in patients with resected stage II colon cancer, to help inform the need for subsequent adjuvant chemotherapy (ACT).3 The study found that the detection of ctDNA after surgery was associated with a markedly reduced recurrence-free survival (RFS) compared to patients with ctDNA-negative status.3

The follow-up study – DYNAMIC II (Tie J, et al. 2022) – demonstrated that patients with resected stage II colon cancer who are ctDNA-negative post-surgery may avoid adjuvant chemotherapy without compromising outcomes.4

Graph showing recurrence-free rates of subjects who tested ctDNA negative (n=164) vs. subjects who tested ctDNA positive (n=14) over time (months since surgery), as measured by RaDaR. The hazard ratio for ctDNA negative vs. ctDNA positive was 18 (95% CI: 7.9-40).

ctDNA detection after resection provides direct evidence of MRD, and identifies recurrence risk

RISK ASSESSMENT AFTER SURGERY IN STAGE III COLON CANCER

In stage III colon cancer, approximately 50% of patients are cured by surgery alone. MRD tests can help reveal which patients have residual cancer and are at high risk for disease recurrence.5

In 2019, Tie J, et al. evaluated the ability of ctDNA to detect MRD in patients with resected stage III colon cancer to assess a patient’s risk of disease recurrence. The study found that the detection of ctDNA after surgery was associated with a reduced RFS compared to patients where ctDNA was not detected.6

Graph showing recurrence-free rates of subjects who were ctDNA negative vs. subjects who were ctDNA positive over time (months since surgery), as measured by RaDaR. The hazard ratio for ctDNA negative vs. ctDNA positive was 3.8 (95% CI: 2.4-21.0), with a log-rank p value of

ctDNA detection after resection shows prognostic significance and identifies recurrence risk.

RISK ASSESSMENT AFTER ADJUVANT THERAPY IN STAGE III COLON CANCER (cont’d)

In stage III colon cancer, nearly all patients are treated with ACT. Despite this, approximately 30% of patients will go on to experience a disease recurrence. There is a clear need for additional tools to help determine which patients could potentially benefit from additional therapeutic intervention.

In 2021, Chen G, et al. investigated the ability of ctDNA to detect residual disease in patients with stage II and III colon cancer after ACT.7 The study found that patients with ctDNA detected after ACT were 12 times more likely to experience disease recurrence compared to patients where ctDNA was not detected.

Graph showing recurrence-free survival rates of subjects who were ctDNA negative vs. subjects who were ctDNA positive over time (months since surgery), as measured by RaDaR. The hazard ratio for ctDNA negative vs. ctDNA positive was 12.76 (95% CI: 5.39-30.0), p value

ctDNA detection after adjuvant chemotherapy is prognostic and identifies recurrence risk.

References: 1. Dasari A, et al. Nat Rev Clin Oncol. 2020;17:757-770. doi.org/10.1038/s41571-020-0392-0. 2. Rebuzzi SE, et al. Cancers. 2020;12(9):2584. 3. Tie J, et al. Sci Transl Med. 2016;8(346):346ra92. doi:10.1126/scitranslmed.aaf6219. 4. Tie J, et al. N Engl J Med. 2022;386:2261-2272. 5. Taieb J, et al. Cancers. 2020;12:2679. doi:10.3390/cancers12092679. 6. Tie J, et al. JAMA Oncol. 2019;5(12):1710-1717. doi:10.1001/jamaoncol.2019.3616. 7. Chen G, et al. J Hematol Oncol. 2021;14:80. doi.org/10.1186/s13045-021-01089-z.

RaDaR has been carefully designed to help you detect tumor DNA in the blood with exceptional sensitivity and specificity

  • Increased accuracy with a tumor-informed, personalized panel design: RaDaR sequencing assays monitor up to 48 tumor-specific mutations, unique to each patient’s tumor, to help detect circulating tumor DNA (ctDNA)
  • Earlier detection with high sensitivity: RaDaR can detect extremely low levels of ctDNA in the blood, with a demonstrated LoD95 = 0.001% VAF. This can give additional time for important treatment management decisions
  • Fewer false positives with high specificity: RaDaR has a demonstrated analytical specificity of 100% in validation studies, giving you the confidence that comes from having more reliable results 

NeoGenomics has been supporting oncologists and pathologists in their goal to provide patients with the best care possible since 2002.

LoD95 = limit of detection, working at a confidence of 95%; VAF = variant allele fraction.

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