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Health Sentinel: Cologuard colorectal cancer test gaining popularity, but not yet the 'gold standard'

The Cologuard test analyzes both DNA alterations and blood in the stool to detect the presence of colon cancer and pre-cancers. Patients can provide a sample in the privacy of their own home. Cologuard is available by prescription only. (Courtesy of Exact Sciences Corp.)
The Cologuard test analyzes both DNA alterations and blood in the stool to detect the presence of colon cancer and pre-cancers. Patients can provide a sample in the privacy of their own home. Cologuard is available by prescription only. (Courtesy of Exact Sciences Corp.)
Cost is not the primary reason people who should be screened for colorectal cancer fail to do so. As shown in this graphic, based on 2012 data from the U.S. Centers for Disease Control and Prevention, 76 percent of individuals who had never been screened were insured. Medicare and most insurers cover costs of various colorectal cancer screening tests, including colonoscopy. (Courtesy of the U.S. Centers for Disease Control and Prevention)
Cost is not the primary reason people who should be screened for colorectal cancer fail to do so. As shown in this graphic, based on 2012 data from the U.S. Centers for Disease Control and Prevention, 76 percent of individuals who had never been screened were insured. Medicare and most insurers cover costs of various colorectal cancer screening tests, including colonoscopy. (Courtesy of the U.S. Centers for Disease Control and Prevention)
Dr. Paul Conarty, a colorectal surgeon with Parkview Medical Group and associate chief medical officer for Parkview Regional Medical Center. (Courtesy photo)
Dr. Paul Conarty, a colorectal surgeon with Parkview Medical Group and associate chief medical officer for Parkview Regional Medical Center. (Courtesy photo)
<p>Carol Rulka</p>
<p>(Courtesy photo)</p>

Carol Rulka

(Courtesy photo)

More Information

Your medical history matters

Current recommendations for colorectal cancer screening for adults ages 50-75 include a colonoscopy every 10 years for those of average risk, meaning they have no personal history of polyps or colon cancer and no first-degree relative with such a history.

National data show one in three adults is not doing that, which is largely to blame for an estimated 46,000 U.S. deaths from colorectal cancer in 2016.

Carol Rulka is not one of the avoiders, but her recent experience with a later-than-recommended second colonoscopy, in which multiple pre-cancerous polyps were found, is compelling her to tell people to make certain their physicians know their personal and family medical history. Don’t just assume it’s in the medical chart.

In 2007, just a year after turning 50, the Fort Wayne hair stylist had her first colonoscopy. No polyps or other issues were found, so she was told she could wait 10 years for the next one.

The news brought great relief, especially since just the year before, she had been diagnosed with non-Hodgkin’s lymphoma. Six months of chemotherapy successfully eradicated the cancer. Rulka was again going about her busy life, exercising daily, helping care for her ailing mother at the time and operating the busy hair salon she owns.

Then in late 2016, she saw her gynecologist, who reviewed in detail Rulka’s medical records.

“My gynecologist said I was overdue for a colonoscopy and that I needed to get it done right away,” Rulka recalled. “I said I was told I didn’t need another one for 10 years.”

The gynecologist explained screening for Rulka should be at least every five years because of her personal history of cancer. Certain other types of cancer may also increase colorectal cancer risk. Additionally, Rulka’s mother had benign colon polyps removed. Somehow this information had been overlooked when Rulka had her first colonoscopy, though Rulka had written it down on forms.

Granted, back in 2007, electronic medical records (EMRs) were in their infancy, and many physicians were still keeping paper records. A study published in 2010 in the American Journal of Managed Care found EMRs can lead to a higher quality of care if they include interactive features, such as software that searches for gaps in care.

“Fortunately, my gynecologist caught it,” Rulka said of the oversight. It was a very close call. In December, in her second colonoscopy, a new colorectal surgeon found multiple polyps, including one very large one. “The doctor said if I’d waited another month, it would have been cancer.

“People say they don’t want to have a colonoscopy because of all the prep work,” Rulka said, adding, “but I can tell you firsthand that going through the prep is a lot easier than six months of chemo. Having a colonoscopy is one day out of your life versus six months — or longer — of chemotherapy.”

— By Jennifer L. Boen
Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.The Associated Press

The noninvasive test is touted as an alternative to colonoscopy for average-risk people.

Monday, January 30, 2017 02:01 am
The death rate from colorectal cancer has been declining, but it’s still the second leading cause of cancer deaths in this country, according to the National Institutes of Health. Yet deaths from this cancer are highly preventable if people would only get screened. Only two out of three Hoosiers over age 50 have ever had a colonoscopy. The national rate is slightly higher, Centers for Disease Control data show.

In several surveys of at-risk individuals who said they’d never had a screening colonoscopy, people gave these key reasons for not having the test: They believed it was not necessary because they had no symptoms; they disliked the idea of the procedure and/or the prep for it; and they thought it was too expensive.

Now a relatively new test, touted in TV ads as an alternative for colonoscopy for average-risk individuals, is available. Cologuard, approved by the Food and Drug Administration in late 2014, is a non-invasive test that looks at cellular DNA changes in the stool that could indicate cancer and some pre-cancerous polyps. With Cologuard, a person’s entire bowel movement is collected at home in a simple-to-use kit, then shipped by UPS for testing.

Is it as good as a colonoscopy? Not quite, said Dr. Paul Conarty, a colorectal surgeon with Parkview Medical Group.

“It’s about 92 percent as accurate in detecting colon cancer as endoscopy (colonoscopy),” said Conarty, who is also associate chief medical officer for Parkview Regional Medical Center. “Colonoscopy is still the gold standard.”

Finding cancer is certainly important but, ideally, “We want to find precancerous polyps before they turn into cancer,” Conarty said. While most polyps remain benign, 95 percent of colorectal cancers develop from a type of polyp called an adenoma. If a polyp is found during a colonoscopy, it is removed and biopsied. The earlier this is done in the growth of the polyp, the greater the likelihood, in most cases, cancer is prevented.

Colonoscopy has a 90 percent sensitivity likelihood of detecting a 1 centimeter or larger polyp that shows cellular precancerous changes, Conarty said, noting, “Cologuard has a 40 (percent) to 45 percent ability to pick up advanced pre-cancerous lesions” of that size.

Conarty emphasizes Cologuard, which requires a prescription, is for average-risk individuals, meaning they have no personal history of polyps, colon cancer or certain other cancers or gastrointestinal diseases. Cologuard is also not for people with a first-degree relative, such as a parent or sibling, who has had a history of polyps or colon cancer.

Still, he concurs that because the test is done at home, is non-invasive and requires no prep, Cologuard may well increase colorectal screening rates.

“I’d rather see someone screened with Cologuard than not screened at all,” Conarty said.

In clinical trials, he added, Cologuard was more sensitive in detecting both colorectal cancer and advanced precancerous lesions compared to all other stool tests, which only look for hidden blood in the stool. Cologuard also looks for blood.

Cologuard’s cost also gives it an advantage. It is about one-fourth to one-third the cost of a colonoscopy, which may give insurers incentive to cover it for the average-risk, age 50-and-older population. Medicare now covers Cologuard as well as a growing number of private companies such as Blue Cross Blue Shield and Humana. Unlike colonoscopy, which is recommended every 10 years for average-risk people, Cologuard is recommended every three years.

Under Affordable Care Act provisions for preventive screenings, colonoscopy is a covered test starting at age 50 for those who are enrolled in insurance plans. For people over age 75, the U.S. Preventive Services Task Force recommends screening be done on a case-by-case basis.

Colonoscopy is not a perfect test. Some very small types of lesions can be missed. It also carries some risks, such as anesthesia reaction or bowel perforation, though those risks are low.

Cologuard’s efficacy will continue to be studied, but the test is already gaining acceptance. In 2016, Exact Sciences Corp., developer of Cologuard, reported 244,000 Cologuard tests were completed. The Madison, Wis.-based company recently reported 2016 revenues of $99 million, up 150 percent from 2015.

It remains to be seen whether Cologuard one day will be the gold standard in screening for average-risk individuals.

Jennifer L. Boen is a freelance writer in Fort Wayne who writes frequently about health and medicine. This column is the personal opinion of the writer and does not necessarily reflect the views or opinion of The News-Sentinel.   

More Information

Your medical history matters

Current recommendations for colorectal cancer screening for adults ages 50-75 include a colonoscopy every 10 years for those of average risk, meaning they have no personal history of polyps or colon cancer and no first-degree relative with such a history.

National data show one in three adults is not doing that, which is largely to blame for an estimated 46,000 U.S. deaths from colorectal cancer in 2016.

Carol Rulka is not one of the avoiders, but her recent experience with a later-than-recommended second colonoscopy, in which multiple pre-cancerous polyps were found, is compelling her to tell people to make certain their physicians know their personal and family medical history. Don’t just assume it’s in the medical chart.

In 2007, just a year after turning 50, the Fort Wayne hair stylist had her first colonoscopy. No polyps or other issues were found, so she was told she could wait 10 years for the next one.

The news brought great relief, especially since just the year before, she had been diagnosed with non-Hodgkin’s lymphoma. Six months of chemotherapy successfully eradicated the cancer. Rulka was again going about her busy life, exercising daily, helping care for her ailing mother at the time and operating the busy hair salon she owns.

Then in late 2016, she saw her gynecologist, who reviewed in detail Rulka’s medical records.

“My gynecologist said I was overdue for a colonoscopy and that I needed to get it done right away,” Rulka recalled. “I said I was told I didn’t need another one for 10 years.”

The gynecologist explained screening for Rulka should be at least every five years because of her personal history of cancer. Certain other types of cancer may also increase colorectal cancer risk. Additionally, Rulka’s mother had benign colon polyps removed. Somehow this information had been overlooked when Rulka had her first colonoscopy, though Rulka had written it down on forms.

Granted, back in 2007, electronic medical records (EMRs) were in their infancy, and many physicians were still keeping paper records. A study published in 2010 in the American Journal of Managed Care found EMRs can lead to a higher quality of care if they include interactive features, such as software that searches for gaps in care.

“Fortunately, my gynecologist caught it,” Rulka said of the oversight. It was a very close call. In December, in her second colonoscopy, a new colorectal surgeon found multiple polyps, including one very large one. “The doctor said if I’d waited another month, it would have been cancer.

“People say they don’t want to have a colonoscopy because of all the prep work,” Rulka said, adding, “but I can tell you firsthand that going through the prep is a lot easier than six months of chemo. Having a colonoscopy is one day out of your life versus six months — or longer — of chemotherapy.”

— By Jennifer L. Boen

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