The Emerging Role of Liquid Biopsy in the Diagnosis and Management of CRC

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The Emerging Role of Liquid Biopsy in the Diagnosis and Management of CRC
References
  1. Key statistics for colorectal cancer. American Cancer Society. Revised January 13, 2023. Accessed November 30, 2023. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html 

  1. Mazouji O, Ouhajjou A, Incitti R, Mansour H. Updates on clinical use of liquid biopsy in colorectal cancer screening, diagnosis, follow-up, and treatment guidance. Front Cell Dev Biol. 2021;9:660924. doi:10.3389/fcell.2021.660924 

  1. Vacante M, Ciuni R, Basile F, Biondi A. The liquid biopsy in the management of colorectal cancer: an overview. Biomedicines. 2020;8(9):308. doi:10.3390/biomedicines8090308 

  1. American Cancer Society. Colorectal cancer facts & figures 2020-2022. Published 2022. Accessed November 30, 2023. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf 

  1. Johnson & Johnson. FDA clears Cellsearch™ circulating tumor cell test [news release]. Published February 27, 2008. Accessed November 30, 2023. https://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/fda-clears-cellsearchtm-circulating-tumor-cell-test  

  1. US Food and Drug Administration. Summary of safety and effectiveness data, Epi proColon®. PMA number P130001. Published April 12, 2016. Accessed November 30, 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf13/p130001b.pdf  

  1. FDA approves blood tests that can help guide cancer treatment. National Institutes of Health, National Cancer Institute. Published October 15, 2020. Accessed November 30, 2023. https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-guardant-360-foundation-one-cancer-liquid-biopsy  

  1. Foundation Medicine. US Food and Drug Administration (FDA) approves FoundationOne®LiquidCDx as a companion diagnostic for Pfizer’s BRAFTOVI® (encorafenib) in combination with cetuximab to identify patients with BRAF V600E alterations in metastatic colorectal cancer [press release]. Published June 10, 2023. Accessed November 30, 2023. https://www.foundationmedicine.com/press-releases/f9b285eb-db6d-4f61-856c-3f1edb803937 
     

Author and Disclosure Information

David Lieberman, MD, AGAF
Professor
Department of Medicine
Division of Gastroenterology
Oregon Health and Science University
Staff Physician
Department of Medicine
Portland VA Medical Center
Portland, Oregon

Disclosures:
Serve(d) as a consultant for: UDX; Geneoscopy
Received income in an amount equal to or greater than $250 from: Geneoscopy

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Author and Disclosure Information

David Lieberman, MD, AGAF
Professor
Department of Medicine
Division of Gastroenterology
Oregon Health and Science University
Staff Physician
Department of Medicine
Portland VA Medical Center
Portland, Oregon

Disclosures:
Serve(d) as a consultant for: UDX; Geneoscopy
Received income in an amount equal to or greater than $250 from: Geneoscopy

Author and Disclosure Information

David Lieberman, MD, AGAF
Professor
Department of Medicine
Division of Gastroenterology
Oregon Health and Science University
Staff Physician
Department of Medicine
Portland VA Medical Center
Portland, Oregon

Disclosures:
Serve(d) as a consultant for: UDX; Geneoscopy
Received income in an amount equal to or greater than $250 from: Geneoscopy

References
  1. Key statistics for colorectal cancer. American Cancer Society. Revised January 13, 2023. Accessed November 30, 2023. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html 

  1. Mazouji O, Ouhajjou A, Incitti R, Mansour H. Updates on clinical use of liquid biopsy in colorectal cancer screening, diagnosis, follow-up, and treatment guidance. Front Cell Dev Biol. 2021;9:660924. doi:10.3389/fcell.2021.660924 

  1. Vacante M, Ciuni R, Basile F, Biondi A. The liquid biopsy in the management of colorectal cancer: an overview. Biomedicines. 2020;8(9):308. doi:10.3390/biomedicines8090308 

  1. American Cancer Society. Colorectal cancer facts & figures 2020-2022. Published 2022. Accessed November 30, 2023. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf 

  1. Johnson & Johnson. FDA clears Cellsearch™ circulating tumor cell test [news release]. Published February 27, 2008. Accessed November 30, 2023. https://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/fda-clears-cellsearchtm-circulating-tumor-cell-test  

  1. US Food and Drug Administration. Summary of safety and effectiveness data, Epi proColon®. PMA number P130001. Published April 12, 2016. Accessed November 30, 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf13/p130001b.pdf  

  1. FDA approves blood tests that can help guide cancer treatment. National Institutes of Health, National Cancer Institute. Published October 15, 2020. Accessed November 30, 2023. https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-guardant-360-foundation-one-cancer-liquid-biopsy  

  1. Foundation Medicine. US Food and Drug Administration (FDA) approves FoundationOne®LiquidCDx as a companion diagnostic for Pfizer’s BRAFTOVI® (encorafenib) in combination with cetuximab to identify patients with BRAF V600E alterations in metastatic colorectal cancer [press release]. Published June 10, 2023. Accessed November 30, 2023. https://www.foundationmedicine.com/press-releases/f9b285eb-db6d-4f61-856c-3f1edb803937 
     

References
  1. Key statistics for colorectal cancer. American Cancer Society. Revised January 13, 2023. Accessed November 30, 2023. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html 

  1. Mazouji O, Ouhajjou A, Incitti R, Mansour H. Updates on clinical use of liquid biopsy in colorectal cancer screening, diagnosis, follow-up, and treatment guidance. Front Cell Dev Biol. 2021;9:660924. doi:10.3389/fcell.2021.660924 

  1. Vacante M, Ciuni R, Basile F, Biondi A. The liquid biopsy in the management of colorectal cancer: an overview. Biomedicines. 2020;8(9):308. doi:10.3390/biomedicines8090308 

  1. American Cancer Society. Colorectal cancer facts & figures 2020-2022. Published 2022. Accessed November 30, 2023. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf 

  1. Johnson & Johnson. FDA clears Cellsearch™ circulating tumor cell test [news release]. Published February 27, 2008. Accessed November 30, 2023. https://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/fda-clears-cellsearchtm-circulating-tumor-cell-test  

  1. US Food and Drug Administration. Summary of safety and effectiveness data, Epi proColon®. PMA number P130001. Published April 12, 2016. Accessed November 30, 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf13/p130001b.pdf  

  1. FDA approves blood tests that can help guide cancer treatment. National Institutes of Health, National Cancer Institute. Published October 15, 2020. Accessed November 30, 2023. https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-guardant-360-foundation-one-cancer-liquid-biopsy  

  1. Foundation Medicine. US Food and Drug Administration (FDA) approves FoundationOne®LiquidCDx as a companion diagnostic for Pfizer’s BRAFTOVI® (encorafenib) in combination with cetuximab to identify patients with BRAF V600E alterations in metastatic colorectal cancer [press release]. Published June 10, 2023. Accessed November 30, 2023. https://www.foundationmedicine.com/press-releases/f9b285eb-db6d-4f61-856c-3f1edb803937 
     

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Colorectal cancer (CRC) is the third most common cancer in the United States, and early detection and monitoring are crucial for improving patient outcomes.1 Liquid biopsy (LB) is a revolutionary approach that may offer a non-invasive way to diagnose and manage CRC. The history of LB for CRC reflects a progression from early attempts to detect biomarkers in blood to the current era of precise genetic analysis using circulating tumor deoxyribonucleic acid (ctDNA) and analyzed with next-generation sequencing. The technology has significantly improved over time, leading to the potential for integration into clinical practice and to provide more personalized and effective CRC management.2

LB offers several potential advantages for CRC screening compared to traditional non-invasive screening with a stool sample, or invasive screening with colonoscopy. A blood test that could identify high-risk individuals who need colonoscopy is exciting, because it is possible that adherence to screening would be improved with LB. However, there are many challenges. Reduction of CRC mortality or incidence will depend on the ability of the test to accurately detect individuals with early-stage cancer or precancerous advanced polyps. It is not clear if the biology of such lesions would result in an adequate signal in blood if the lesion were not invasive. Test performance also depends on completion of colonoscopy if individuals have an abnormal LB. Testing methods, cost consideration, and clinical validation of performance will need to be addressed.3 As the technology advances, the role of LB in CRC screening will likely evolve and expand.

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Colorectal cancer: New observations, new implications

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The incidence and mortality of colorectal cancer (CRC) have declined by 3% per year over the past 10-15 years – a remarkable achievement. The decline in incidence has been dramatic for individuals over age 50 years, who are targeted by screening. However, the reduction in CRC risk does not apply to all populations in the United States. New epidemiologic trends and observations point to patient demographics and regional variation as potential risk factors. While such observations provide what I call “blurry snapshots,” they may well have important implications for our approach to screening and prevention.

Dr. David Lieberman, Oregon Health and Science University, Portland
Dr. David Lieberman
Recent evidence suggests that rates of CRC have been increasing, not decreasing, in individuals younger than age 50 years – a demographic we have traditionally regarded as low risk. This cohort accounts for more than 10% of CRC, and this trend is occurring in developed countries in Europe and Asia, as well as in the United States.

What are the reasons? There are several personal and environmental factors that could be contributing. Obesity and metabolic syndrome are risk factors for CRC and have been more commonly developing in childhood over the past 40 years. Alteration of the microbiome could also potentially predispose one to developing CRC. The use of antibiotics in childhood was more common for some of these younger generations than it was for the preceding generations, and antibiotics have been introduced into the food industry to fatten animals. The introduction of food chemicals could also either alter the microbiome and/or promote inflammation, which could lead to neoplasia. Exposure to more ambient radiation may be another risk factor.

These hypotheses are biologically plausible – but untested. Nevertheless, this observational trend does have implications for clinicians. First, studies have shown that up to 20% of CRCs before age 50 years are associated with germline mutations, while others are associated with a family history of CRC. Therefore, it is important to capture and update family history. In addition, there is evidence that individuals aged 40-49 years with rectal bleeding have a higher risk of advanced adenomas, so our threshold for performing diagnostic colonoscopy should be lowered. African Americans also have a higher risk of CRC at a younger age than do other racial groups and might benefit from early screening at age 45 years. Notably, recent recommendations from the American Cancer Society call for consideration of screening everyone at age 45 years.

There is substantial state-to-state and county-to-county variation in the incidence and mortality of CRC. While some of this variation can be explained by racial variation, smoking, obesity, and social determinants of health, there are “hot-spots” that may defy easy explanation. There has been very little research about environmental factors (air, water, and ambient radiation). Two regions at particularly high risk are the Mississippi Delta region and Appalachia – areas where water pollution could be a factor. The substantial county-to-county variation within these high-risk areas points to a potential environmental culprit, but further research is needed.

For the GI community, there are several implications to be found in these changing demographics and risks. For one, we may need to consider expanding our risk concepts to include not only genetic and personal risk factors but also environmental factors. To mitigate risk, providers and public health officials may need to then target these high-risk areas for more intensive screening efforts.
 

Dr. Lieberman is a professor of medicine and chief of gastroenterology and hepatology at Oregon Health and Science University in Portland. He has no conflicts of interest. Dr. Lieberman made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.

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The incidence and mortality of colorectal cancer (CRC) have declined by 3% per year over the past 10-15 years – a remarkable achievement. The decline in incidence has been dramatic for individuals over age 50 years, who are targeted by screening. However, the reduction in CRC risk does not apply to all populations in the United States. New epidemiologic trends and observations point to patient demographics and regional variation as potential risk factors. While such observations provide what I call “blurry snapshots,” they may well have important implications for our approach to screening and prevention.

Dr. David Lieberman, Oregon Health and Science University, Portland
Dr. David Lieberman
Recent evidence suggests that rates of CRC have been increasing, not decreasing, in individuals younger than age 50 years – a demographic we have traditionally regarded as low risk. This cohort accounts for more than 10% of CRC, and this trend is occurring in developed countries in Europe and Asia, as well as in the United States.

What are the reasons? There are several personal and environmental factors that could be contributing. Obesity and metabolic syndrome are risk factors for CRC and have been more commonly developing in childhood over the past 40 years. Alteration of the microbiome could also potentially predispose one to developing CRC. The use of antibiotics in childhood was more common for some of these younger generations than it was for the preceding generations, and antibiotics have been introduced into the food industry to fatten animals. The introduction of food chemicals could also either alter the microbiome and/or promote inflammation, which could lead to neoplasia. Exposure to more ambient radiation may be another risk factor.

These hypotheses are biologically plausible – but untested. Nevertheless, this observational trend does have implications for clinicians. First, studies have shown that up to 20% of CRCs before age 50 years are associated with germline mutations, while others are associated with a family history of CRC. Therefore, it is important to capture and update family history. In addition, there is evidence that individuals aged 40-49 years with rectal bleeding have a higher risk of advanced adenomas, so our threshold for performing diagnostic colonoscopy should be lowered. African Americans also have a higher risk of CRC at a younger age than do other racial groups and might benefit from early screening at age 45 years. Notably, recent recommendations from the American Cancer Society call for consideration of screening everyone at age 45 years.

There is substantial state-to-state and county-to-county variation in the incidence and mortality of CRC. While some of this variation can be explained by racial variation, smoking, obesity, and social determinants of health, there are “hot-spots” that may defy easy explanation. There has been very little research about environmental factors (air, water, and ambient radiation). Two regions at particularly high risk are the Mississippi Delta region and Appalachia – areas where water pollution could be a factor. The substantial county-to-county variation within these high-risk areas points to a potential environmental culprit, but further research is needed.

For the GI community, there are several implications to be found in these changing demographics and risks. For one, we may need to consider expanding our risk concepts to include not only genetic and personal risk factors but also environmental factors. To mitigate risk, providers and public health officials may need to then target these high-risk areas for more intensive screening efforts.
 

Dr. Lieberman is a professor of medicine and chief of gastroenterology and hepatology at Oregon Health and Science University in Portland. He has no conflicts of interest. Dr. Lieberman made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.

 

The incidence and mortality of colorectal cancer (CRC) have declined by 3% per year over the past 10-15 years – a remarkable achievement. The decline in incidence has been dramatic for individuals over age 50 years, who are targeted by screening. However, the reduction in CRC risk does not apply to all populations in the United States. New epidemiologic trends and observations point to patient demographics and regional variation as potential risk factors. While such observations provide what I call “blurry snapshots,” they may well have important implications for our approach to screening and prevention.

Dr. David Lieberman, Oregon Health and Science University, Portland
Dr. David Lieberman
Recent evidence suggests that rates of CRC have been increasing, not decreasing, in individuals younger than age 50 years – a demographic we have traditionally regarded as low risk. This cohort accounts for more than 10% of CRC, and this trend is occurring in developed countries in Europe and Asia, as well as in the United States.

What are the reasons? There are several personal and environmental factors that could be contributing. Obesity and metabolic syndrome are risk factors for CRC and have been more commonly developing in childhood over the past 40 years. Alteration of the microbiome could also potentially predispose one to developing CRC. The use of antibiotics in childhood was more common for some of these younger generations than it was for the preceding generations, and antibiotics have been introduced into the food industry to fatten animals. The introduction of food chemicals could also either alter the microbiome and/or promote inflammation, which could lead to neoplasia. Exposure to more ambient radiation may be another risk factor.

These hypotheses are biologically plausible – but untested. Nevertheless, this observational trend does have implications for clinicians. First, studies have shown that up to 20% of CRCs before age 50 years are associated with germline mutations, while others are associated with a family history of CRC. Therefore, it is important to capture and update family history. In addition, there is evidence that individuals aged 40-49 years with rectal bleeding have a higher risk of advanced adenomas, so our threshold for performing diagnostic colonoscopy should be lowered. African Americans also have a higher risk of CRC at a younger age than do other racial groups and might benefit from early screening at age 45 years. Notably, recent recommendations from the American Cancer Society call for consideration of screening everyone at age 45 years.

There is substantial state-to-state and county-to-county variation in the incidence and mortality of CRC. While some of this variation can be explained by racial variation, smoking, obesity, and social determinants of health, there are “hot-spots” that may defy easy explanation. There has been very little research about environmental factors (air, water, and ambient radiation). Two regions at particularly high risk are the Mississippi Delta region and Appalachia – areas where water pollution could be a factor. The substantial county-to-county variation within these high-risk areas points to a potential environmental culprit, but further research is needed.

For the GI community, there are several implications to be found in these changing demographics and risks. For one, we may need to consider expanding our risk concepts to include not only genetic and personal risk factors but also environmental factors. To mitigate risk, providers and public health officials may need to then target these high-risk areas for more intensive screening efforts.
 

Dr. Lieberman is a professor of medicine and chief of gastroenterology and hepatology at Oregon Health and Science University in Portland. He has no conflicts of interest. Dr. Lieberman made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.

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