Screening for Colorectal Cancer

Colorectal cancer is one of the most commonly diagnosed diseases, but also one of the easiest to prevent.

Editor’s note: This is a reprint of an article Repertoire published in March 2014, updated with the most current statistics.

Colorectal cancer is the second leading cause of cancer-related deaths in the United States and the third most common cancer in men and in women, according to the Centers for Disease Control and Prevention.

In 2013 (the most recent year numbers are available):

136,119 people in the United States were diagnosed with colorectal cancer, including 71,099 men and 65,020 women.
51,813 people in the United States died from colorectal cancer, including 27,230 men and 24,583 women

One of the early warning signs of the disease is hidden (or occult) blood in the stool, which can be detected by a fecal occult blood test. For over 40 years, guaiac fecal occult blood tests (gFOBTs) have been available, which are based on the oxidation of guaiac by hydrogen peroxide to a blue-colored compound. A positive gFOBT may be due to bleeding in the upper and/or lower gastrointestinal tract and does not necessarily indicate colon cancer. In addition, gFOBT is not specific for human hemoglobin. Certain foods and medications can interfere with the accuracy of the test results.

Immunochemical fecal occult tests (IFOBT) – also called fecal immunochemical tests (FIT) – have been available for the last 14 years. They are said to be more sensitive and specific to human hemoglobin and do not involve the dietary or medicine restrictions indicated by guaiac tests. Although FITs do not detect upper gastrointestinal bleeding, they can be used to determine lower gastrointestinal bleeding indicative of colorectal cancer. FITs can also be used to screen for polyps, diverticulitis and colitis.

In spite of the benefits of FITs, some physicians continue to rely on digital rectal exams (DRE) to screen for colorectal cancer. However, medical guidelines warn against using DREs, as they tend to generate negative results, and some studies suggest these patients have nearly the same likelihood of having advanced neoplasia as patients who do not undergo any stool testing.

How the test works
Fecal immunochemical tests are antibody-based tests designed to screen for blood in the stool. They may be used to determine gastrointestinal bleeding found in several gastrointestinal disorders, including colorectal cancer, polyps, diverticulitis and colitis. Primary care physicians (e.g., internists, general practitioners and family physicians), gastroenterologists and ob/gyns usually perform FITs as an annual screening in their offices, however the test also is used in laboratories and hospitals. Most medical societies recommend that patients be screened beginning at age 50, unless they are at high risk for colorectal cancer. (See related article.) The American Cancer Society Guidelines for the Early Detection of Colorectal Cancer recommends that patients also use the multiple-day stool take-home test, as one test performed in the physician’s office is not adequate.

The fecal immunochemical test is a one-step lateral flow chromatographic immunoassay test. Depending on the test, the patient generally takes a collection device home to collect his or her stool, and then returns the device to the physician’s office. The fecal sample is applied to a dry sample collection card, or it is suspended in a liquid and placed into a cassette for testing and results.

How to sell
A good number of physicians today continue to rely on traditional guaiac tests, and convincing them to switch to fecal immunochemical tests can sometimes present a challenge. True, FITs cost the physician more money upfront, but they offer greater clinical sensitivity and specificity and, as such, a valuable service to patients. In order for physicians to be reimbursed for either test, the patient must return the collection device with his or her stool sample. However, guaiac tests are associated with low reimbursement rates, and some doctors do not bother to file.

To successfully convert accounts from guaiac to FITs, sales reps should be prepared to discuss technology and performance, as well as reimbursement and costs. They should separate the patient take-home collection cost from the total cost of the test. In spite of the higher cost of FITs, reimbursement is significantly higher, making this option economically feasible. (Again, physicians are reimbursed only when the patient returns his or her sample and the development portion of the test is completed.)

Sales reps should approach their physician customers with the following questions:

“How many patients at risk for colorectal cancer do you see each year?”
“How do you currently address colorectal cancer with these patients?”
“Are you interested in expanding your use of rapid tests?”
“Do you currently use guaiac tests or fecal immunochemical tests for colorectal cancer screening?”
“Are you aware of the benefits of fecal immunochemical tests?”

In addition, they should educate their customers on variations in manufacturer recommendations, as well as recommendations from key medical societies and the U.S. Preventive Services Task Force.

In some cases physicians are under contract to refer their patients to a lab for fecal immunochemical testing. In general, however, many doctors can test in-house.

FITs have been reimbursable by Medicare since 2003. Reimbursement rates may vary by region or insurer.

Selling iFOBT

Susan Ward, global product manager, point of care, Sekisui Diagnostics – maker of OSOM® iFOBT – offers this advice on selling iFOBT.

Repertoire: Name three ways in which iFOBT tests represent advancement over guaiac-based fecal-occult-blood testing?

Susan Ward:

The gFOBT often returns false positives based on the presence of non-specific hemoglobin in a patient’s stool. FIT/iFOB is both sensitive and specific in that it only returns a positive for the presence of human hemoglobin.
The gFOBT tests require a patient to follow a seven-day dietary and drug-restriction regimen. Patients who are non-compliant with this pre-test regimen are at risk for returning an erroneous result, which could lead to further and more expensive diagnostic procedures.
The gFOBT tests required multiple stool samples following the above seven-day drug and dietary restriction due to chemicals or diet affecting the gFOBT test. Patient compliance with an FIT/iFOB will be much higher due to collection of one stool sample and no dietary or drug restrictions prior to collection for the test.

Repertoire: Which physician specialty(ies) are most likely to have an interest in iFOBT?

Ward: Family practice, internal medicine, OB/GYN, urgent care, multispecialty clinics.

Repertoire: What probing questions should sales reps ask to initiate a discussion about iFOBT?

Ward: Here are some simple questions to ask your customers to get a conversation started:

Do you currently screen for colorectal cancer?
Do you send the collection kit home with the patient, or do you do a digital exam in the office? What type of patient compliance are you getting?
Are you currently using an iFOB test? If so, which one?

Repertoire: What objections might sales reps encounter, and how should they respond?

Ward: The main objection is that still physicians are utilizing gFOBT during patient visits, which can increase the risk of returning an erroneous result – which could lead to further and more expensive diagnostic procedures.

Sales reps can provide physicians with the correct information and the benefits of utilizing a highly accurate iFOB test, which will reduce the unnecessary need for more invasive patient procedures, such as a colonoscopies, reducing cancer treatment expenses, hospital stays, and long-term-care costs that are critical to improving our healthcare system.

What the experts say

Colorectal cancer is among the leading causes of cancer-related deaths for men and women in the United States. Early detection – better yet, prevention – is critical. But what’s the best way to screen for colorectal cancer? A number of medical societies have weighed in with their own recommendations. Which to follow?

The American College of Physicians has an answer. In 2012, ACP published a guidance statement on screening for colorectal cancer after assessing current guidelines developed by other organizations. “When multiple guidelines are available on a topic or when existing guidelines conflict, ACP believes that it is more valuable to provide clinicians with a rigorous review of the available guidelines rather than develop a new guideline on the same topic.”

American Cancer Society
The American Cancer Society believes that preventing colorectal cancer — and not just finding it early — should be a major reason for getting tested. Having polyps found and removed keeps some people from getting colorectal cancer, according to the Society. Tests that have the best chance of finding both polyps and cancer are preferred.

Starting at age 50, men and women at average risk for developing colorectal cancer should use one of the screening tests below:

Tests that find polyps and cancer

Flexible sigmoidoscopy every five years. (Colonoscopy should be done if test results are positive.)
Colonoscopy every 10 years.
Double-contrast barium enema every five years. (Colonoscopy should be done if test results are positive.)
CT colonography (virtual colonoscopy) every five years. (Colonoscopy should be done if test results are positive.)

Tests that mainly find cancer

Guaiac-based fecal occult blood test (gFOBT) every year. (Colonoscopy should be done if test results are positive. Highly sensitive versions of these tests should be used with the take-home multiple sample method.)
Fecal immunochemical test (FIT) every year. (Colonoscopy should be done if test results are positive. Highly sensitive versions of these tests should be used with the take-home multiple sample method.)
Stool DNA test every three years. (Colonoscopy should be done if test results are positive.)

People who are at an increased or high risk of colorectal cancer might need to start colorectal cancer screening before age 50 and/or be screened more often, according to the Society. The following conditions make one’s risk higher than average:

A personal history of colorectal cancer or adenomatous polyps.
A personal history of inflammatory bowel disease (ulcerative colitis or Crohn’s disease).
A strong family history of colorectal cancer or polyps.
A known family history of a hereditary colorectal cancer syndrome such as familial adenomatous polyposis (FAP) or Lynch syndrome (hereditary non-polyposis colon cancer or HNPCC).

Source: American Cancer Society, http://www.cancer.org/cancer/colonandrectumcancer/moreinformation/colonandrectumcancerearlydetection/colorectal-cancer-early-detection-acs-recommendations

American Gastroenterological Association
As part of Choosing Wisely® (http://www.choosingwisely.org) – a seven-year-old campaign in which more than 70 medical specialty societies have identified wasteful or unnecessary medical tests, treatments and procedures – the American Gastroenterological Association made this recommendation:

Do not repeat colorectal cancer screening (by any method) for 10 years after a high-quality colonoscopy that does not detect neoplasia.

A screening colonoscopy every 10 years is the recommended interval for adults without increased risk for colorectal cancer, beginning at age 50 years, according to AGA. Published studies indicate the risk of cancer is low for 10 years after a high-quality colonoscopy fails to detect neoplasia in this population. Therefore, following a high-quality colonoscopy that does not detect neoplasia, the next interval for any colorectal screening should be 10 years following that normal colonoscopy.

Source: Choosing Wisely®, http://www.choosingwisely.org/societies/american-gastroenterological-association/

U.S. Preventive Services Task Force

In June 2016, the U.S. Preventive Services Task Force posted these recommendations on colorectal cancer screening on its website:

For adults aged 50 to 75 years: Screen for colorectal cancer starting at age 50 years and continuing until age 75 years.

Adults aged 76 to 85 years: The decision to screen for colorectal cancer in adults aged 76 to 85 years should be an individual one, taking into account the patient’s overall health and prior screening history. Adults in this age group who have never been screened for colorectal cancer are more likely to benefit.

Screening would be most appropriate among adults who 1) are healthy enough to undergo treatment if colorectal cancer is detected and 2) do not have comorbid conditions that would significantly limit their life expectancy.

Source: U.S. Preventive Services Task Force, https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/colorectal-cancer-screening2?ds=1&s=colorectal

American College of Physicians
To develop its 2012 Guidance Statement, the American College of Physicians searched the National Guideline Clearinghouse to identify guidelines developed in the United States. Four guidelines met the inclusion criteria: a joint guideline developed by the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology and individual guidelines developed by the Institute for Clinical Systems Improvement, the U.S. Preventive Services Task Force, and the American College of Radiology.

Guidance Statement 1: ACP recommends that clinicians perform individualized assessment of risk for colorectal cancer in all adults.

Guidance Statement 2: ACP recommends that clinicians screen for colorectal cancer in average-risk adults starting at the age of 50 years and in high-risk adults starting at the age of 40 years or 10 years younger than the age at which the youngest affected relative was diagnosed with colorectal cancer.

Guidance Statement 3: ACP recommends using a stool-based test, flexible sigmoidoscopy, or optical colonoscopy as a screening test in patients who are at average risk. ACP recommends using optical colonoscopy as a screening test in patients who are at high risk. Clinicians should select the test based on the benefits and harms of the screening test, availability of the screening test, and patient preferences.

Guidance Statement 4: ACP recommends that clinicians stop screening for colorectal cancer in adults over the age of 75 years or in adults with a life expectancy of less than 10 years.

Source: “Screening for Colorectal Cancer: A Guidance Statement From the American College of Physicians,” March 6, 2012 Annals of Internal Medicine, http://annals.org/aim/article/1090701/screening-colorectal-cancer-guidance-statement-from-american-college-physicians