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Angela Nicholas, MD

Angela Nicholas, MD
Chief Medical Officer
Einstein Medical Center Montgomery
Philadelphia, Pennsylvania

Empowering Patients to Take Action When It Comes to Colorectal Cancer Screening

Sponsored by Exact Sciences


When I consider the many challenges I face as a primary care provider (PCP), colorectal cancer is one of the most concerning. The staggering incidence and mortality rates of colorectal cancer keep me up at night. Beyond the data, I’ve seen its impact firsthand. In April 2019, I lost my husband to colorectal cancer after he was diagnosed with Stage IV disease at age 45. My personal experience and fervent commitment to protect individuals and their families from a similar fate have brought me to the forefront of the colorectal cancer screening conversation. While my patients may be tired of hearing about it, I’ll never stop fighting and advocating for screening.

The numbers are alarming. According to the American Cancer Society (ACS), approximately 147,950 people will be diagnosed with colorectal cancer in 2020, and 53,200 will die from the disease.1 These numbers are expected to be exacerbated as a result of the COVID-19 screening crisis. Based on data from the peak of the pandemic, COVID-19 has resulted in an 85% to 90% decrease in screenings for colorectal cancer.2,3,4,5 Experts predict that this screening drop-off could result in more deaths due to colorectal cancer over the next decade.6 Despite all of this, colorectal cancer is still considered one of the most preventable cancers because of proven methods of early detection and intervention that are widely available.7 In fact, when detected in earlier stages, colorectal cancer is treatable in 90% of patients – all the more reason we must work urgently to make up for this drop off.8*

Empowering patients is essential – and that begins with providing them with information about who should be screened and when. It also means making them aware that they have a choice in screening options – a key step toward encouraging them to follow through on screening. Even during a pandemic, patients need to know that screening is not only possible, it’s critical.

Nearly two-thirds of colorectal cancers are found in average-risk individuals.9 Yet, an estimated 44 million average-risk Americans ages 45 to 7410** are eligible for screening but remain unscreened.10 Why is that? I think one reason is that people may not understand what it means to be “average risk” or realize that average risk is still at-risk for developing colorectal cancer. The ACS categorizes people at “high risk” as those with a personal or family history of colorectal cancer, a hereditary colorectal cancer syndrome, a personal history of inflammatory bowel disease or a personal history of receiving radiation to the abdomen or pelvic area to treat a prior cancer – everyone else is defined as being at “average risk”.11

Patients and providers may not be aware that more patients than ever need to be screened for colorectal cancer due to changing guidelines that recommend screening begin at age 45 for those at average risk.11 Colorectal cancer has been on the rise in Americans under age 50, with the incidence increasing dramatically – 51% between 1994 and 2014.11 Not only that, but patients younger than 50 are more likely to be diagnosed with an advanced stage of cancer, which is typically associated with a poor prognosis and outcome.12 In response to the growing body of evidence, the ACS revised their screening guidelines in 2018 to recommend that average-risk adults ages 45 years and older undergo regular screening (qualified recommendation). This October, the U.S. Preventive Services Task Force (USPSTF), a volunteer panel comprised of independent healthcare professionals from across the United States, published its updated draft colorectal cancer screening guidelines to also recommend that screening begin at age 45, outlining a diverse choice of proven screening methods.13 Because many clinicians and insurance companies refer to these guidelines as the gold standard for both practice and coverage – this is a major step in the right direction. The final USPSTF guidelines are expected in 2021. A recommendation to begin screening at age 45 would demonstrate commitment to closing the screening gap in a key population.

As a PCP and colorectal cancer advocate – I have found that conducting outreach and offering choice to patients makes a big difference in getting them to complete their screenings and may increase screening rates. By using this approach, we have seen my own practice’s rates increase 8% in a year, and in two years, all of our primary care practices were able to increase our screening rates by 11%.

When patients in my practice approach age 45, I have meaningful conversations with them about why early detection is so important and share the memory of my husband as an urgent and real reminder why action is vital. I explain how regular screening can detect precancerous polyps early before they can become cancer – or cancer in early stages before it metastasizes. I discuss various screening options so patients can choose the test that best suits their personal preferences when it comes to risk, comfort, privacy and lifestyle. I discuss colonoscopy, as well as noninvasive stool-based tests, such as FIT and Cologuard®, an at-home, reliable, DNA-based stool test that is FDA-approved for average-risk adults age 45 and older.14 This prescription at-home option has a unique, built-in feature to encourage patients to complete their screening test – a 24/7 patient compliance program that provides support in the form of reminders, hands-on instruction and insurance support in over 240 languages to ensure screening completion.

Colorectal cancer can be prevented if detected early, and regular screening for those at average risk has been shown to reduce mortality.15 At the end of the day, the best screening test is the one that gets done – advances in screening and technology mean nothing if people don’t get screened in the first place. That’s why it’s so important to ensure that eligible patients are screened. We must make a point of impressing upon our patients that early detection can save lives. We must inform them about the availability of various screening options, including tests that are effective, convenient and easy to use at home. We must empower them to choose the screening test that best fits their needs to increase the chance of early diagnosis and treatment. Fortunately, we have the tools to reduce the impact that this preventable disease has on families – and catch cancer before it’s too late.

*Based on a five-year survival rate
**Estimate based on the U.S. population ages 45-74 as of 2018, adjusted for the reported rates of high-risk condition and prior screening history for colorectal cancer.

Indications and Important Risk Information

Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 45 years or older, who are at typical average risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Cologuard is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; have had a positive result from another colorectal cancer screening method within the last 6 months; have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease; or have a family history of colorectal cancer, or certain hereditary syndromes.

Positive Cologuard results should be referred to diagnostic colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient.

False positives and false negatives do occur. In a clinical study, 13% of patients without cancer received a positive result (false positive) and 8% of patients with cancer received a negative result (false negative). The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.

Cologuard performance when used for repeat testing has not been evaluated or established. Rx only.

Cologuard is a registered trademark of Exact Sciences Corporation.

 

References

  1. ACS. Colorectal cancer facts and figures 2020-2022. Atlanta: American Cancer Society; 2020.
  2. IQVIA Institute for Human Data Science. Shifts in healthcare demand, delivery and care during the COVID-19 era. April 2020. Accessed August 12, 2020. https://www.iqvia.com/insights/the-iqvia-institute/covid-19/shifts-in-healthcare-demand-delivery-and-care-during-the-covid-19-era.
  3. Epic Health Research Network. Preventive cancer screenings during COVID-19 pandemic. Updated May 1, 2020. Accessed August 6, 2020. https://www.ehrn.org/articles/delays-in-preventive-cancer-screenings-during-covid-19-pandemic. Updated May 1, 2020.
  4. London JW, Fazio-Eynullayeve E, Palchuk MB, et al. Effects of the COVID-19 pandemic on cancer-related patient encounters. JCO Clin Cancer Inform. Published online July 27, 2020. doi: 10.1200.CCI.20.00068.
  5. Komodohealth x Fight Colorectal Cancer. Research brief: New colorectal cancer diagnoses fall by one-third as colonoscopy screenings and biopsies grind to a halt during height of COVID-19. May 2020. Accessed August 6, 2020. https://fightcolorectalcancer.org/wp-content/uploads/2020/05/COVID19-Impact-on-CRC-Patients_Research-Brief_Komodo-Health-Fight-CRC.pdf.
  6. Sharpless NE. COVID-19 and cancer. Science. 2020;368:1290.
  7. Itzkowitz SH. Incremental advances in excremental cancer detection tests. J Natl Cancer Inst. 2009;101:1225-1227.
  8. NCI. SEER cancer stat facts: colorectal cancer. 2020. Accessed November 19, 2020. https://seer.cancer.gov/statfacts/html/colorect.html.
  9. ACS. Colorectal cancer risk factors.  Updated June 29, 2020. Accessed November 19, 2020. https://www.cancer.org/cancer/colon-rectal-cancer/causes-risks-prevention/risk-factors.html.
  10. Piscitello A, Edwards D. Estimating the screening-eligible population size, aged 45 to 74, at average risk to develop colorectal cancer in the United States. Cancer Prev Res. 2020;13(5):443-448.
  11. Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68(4):250-281.
  12. Virostko J, Capasso A, Yankeelov TE, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer.125(21):3828-3835.
  13. US Preventive Services Task Force. Draft Recommendation Statement Colorectal Cancer: Screening. October 27, 2020. Accessed November 19, 2020. https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/colorectal-cancer-screening3. 
  14. Cologuard Physician Brochure. Exact Sciences Corporation. Madison, WI.
  15. Brenner AT, Dougherty M, Reuland DS. Colorectal cancer screening in average risk patients. Med Clin North Am. 2017;101(4): 755-767.

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