Welcome back from the quick break and now we're coming to the final stretch of this two day course. Nowhere better way to begin this than with a with a final lecture here from Dr. Joe Bakari MD MBA who's practicing GI at the Rockford gastroenterology group in Rockford, Illinois, and is also clinical assistant professor of medicine at the University of Illinois College of Medicine. Dr. Bakari is also a counselor with the ASCE and co chair of the value of colonoscopy campaign. And welcome Joe and look forward to your lecture. And after this talk, there will be a roundtable with all the faculty, and we'll finish off with any remaining questions. Let's finish with a topic that should be near and dear to all of our hearts. It has some personal meaning to me, a childhood friend of mine at the age of 49 was diagnosed with a sigmoid cancer and at the time his diagnosis had a single hepatic met. He received outstanding colorectal surgery care as well as hepatic care at Mount Sinai in New York City, and I am very happy to say that nine years later, he is alive well and cancer free. With that, let's talk about some colorectal cancer screening and alternative screening modalities. We'll start with polling questions. The first question, which of the following is the correct indication for MT stool DNA or multi targeted stool DNA testing, otherwise known as Cologuard family history of colon cancer screening for colon cancer and average risk patients screen for dysplasia in patients with ulcerative colitis or a personal history of colon adenoma. Again, there's only one correct answer. Excellent. There is only one correct answer that this test should only be used to screen for colon cancer in an average risk patient, and more to come on this topic. Our next question, colon cancer rates are rising in which of the following groups or group age greater than 75 age 65 to 75 age 50 to 65 age group less than 50 and again there's only one correct choice. Excellent. There is only one correct choice age group less than 50. This is an alarming trend as the numbers involved are not small, and this patient group tends to present with advanced disease. So the big picture. We're going to review essentially a primer on colorectal cancer screening. We'll take a look at colorectal cancer screening by the numbers. Take a look at science. Look at some of the screening methods and prevention approaches, always using guideline based approaches and evidence based data. Look at the pros and cons of each test, and then review some take home points. First the numbers. So, this is 2019 where we look at new cases of colorectal cancer United States. Although the total numbers are down to about 145,000, they peaked at about 155 to 160,000. It still involves a large number of people every year with an estimated death group of about 51,000 patients caught early. This is not quite survivable, but if you look at the overall five year survival rates, it's only about 64%. So we certainly can do better. This is an infamous cancer, unfortunately, in many people including many famous people. This has definitely helped our cause as we try to promote screening for colon cancer. President Reagan had colon cancer, Pope John Paul II, Vince Lombardi, Justice Ginsburg, Sharon Osborne, Daryl Strawberry, and unfortunately, the most recent sad case of Chadwick Boseman. Some of these people succumb to their disease. So, how is it to screen or it is easier to screen and prevent colon cancer or because of the adenoma to carcinoma sequence? And I really like this slide. It gives us a quick overview of the adenoma carcinoma sequence and it shows you why an intervention can prevent colon cancer. So we start off on the left with some hyperproliferation of tissue, ultimately end up with a small adenomatous polyp, then a larger adenomatous polyp. If the polyp is not removed, it continues to progress potentially to severe dysplasia, and ultimately adenocarcinoma in a polyp. And finally, what we're trying to avoid, colon cancer. So there is a sequence of development from adenoma to carcinoma that allows for intervention and removal of the polyp to prevent colon cancer. I do want to remind you that not all polyps are cancerous. So if we start at the top left, that's a good example of a small hyperplastic polyp typically seen in the rectum or rectal sigmoid. This is not a precancerous polyp and it's not one that we are concerned with. As we start to go clockwise around the pictures, we see a small pedunculated tubular adenoma. Remember, there are three types of adenomatous polyps, tubular adenomas, tubulovilous adenomas, and ultimately villous adenomas. And I like to simply think of villous adenomas as the villain. Any villous component does portend a more aggressive potential future and is at the highest risk of the precancerous polyps to progress to cancer if not removed. The next polyp we see in the right lower screen is a tubular adenoma with high grade dysplasia, another high risk factor that portends a potentially more aggressive future for a polyp if not removed. And on the left, we see a larger tubular adenoma. So different types of polyps with different histology and different sizes. This polyp is a very large polyp. You can see it's flat. Some different color imaging is used on this particular image. And you can see the pattern that we can see, which I like to simply think of, we almost see a brain-like pattern. Some of the pattern on this looks like the sulci in the brain. So this is a villous adenoma with a much more aggressive future if not removed. Our ultimate goal is to prevent this, and that is to prevent colon cancer. So how can we do that? Some good news. The rates of new colon cancers have dropped significantly, down about 30%, between 2000 and 2010. And these rates continue to decline in the 50- to 80-year-old age group. The reason for this decline is it parallels the initiation of widespread use of colonoscopy, which began in about 2000, 2001, once Medicare approved it as a covered benefit, soon to be followed by all other insurance plans. So we have great success between 50- and 80-year-old in reducing colon cancer. Before we get too excited, we have to step back. We still have a large pool of eligible Americans who have not undergone any form of colorectal cancer screening. That represents approximately 40% of patients who should be screened. If we compare colorectal cancer screening to screening for cervical cancer and screening for breast cancer, we still have a lot of work to do. There are potentially a number of reasons why we've not done so well, including access, cost, and reluctance, and we will definitely cover some of the other obstacles that patients see to undergoing colorectal cancer screening. One big one that we certainly have control over is you will hear from patients, my doctor didn't mention that I needed this test. If you look at surveys, it's the number two reason given by patients why they don't proceed with colorectal cancer screening. Less than 10% of eligible patients were told about screening tests in one study. And so that's kind of an abysmal and disappointing number. A second number that's concerning is more than half of Medicare patients surveyed had almost five visits per year. So there were five opportunities for primary care physicians and possibly specialists, such as GI physicians, and even OBGYN specialists who patients view as their primary to speak about colorectal cancer screening. If you look at surveys, patients will state that recommendations given by their primary care physicians are followed to a high degree, followed by recommendations by specialists, such as gastroenterologists. So, in our practice, we view every visit as an opportunity to speak to patients about colorectal cancer, and I think all of us should do that if we want to improve our colorectal cancer screening rates. Another place that's humbling, as I mentioned, is colorectal cancer in younger patients. The incidence of colorectal cancer in patients less than 50 is rising and rising at an alarming rate. In one study that looked at colorectal cancer cases in patients less than 50 from 2008 to 2011, one in seven colon cancers occurred in this age group. And as I said earlier, unfortunately, these patients present with advanced disease. I've seen two patients in the last three months that came in for rectal bleeding, they were less than 40, that have presented with advanced colorectal cancer. And that's a very sad story, and it's a very difficult, potentially difficult management scheme. Another study from 2004 to 2015 showed that 12% of all colorectal cancers occurred in patients less than 50 years old. So, humbling and concerning. Reason for increased rates, we don't have any specific answers at this time, but much discussion revolves around our obesity epidemic and the impact that may have on not only colon cancer, but other cancers. A California database has some nice data, and it showed that there were some ethnic differences. The highest risk in younger people was amongst African Americans, the lowest overall risk in Hispanics. However, this group has the greatest acceleration in incidence of colorectal cancer. So, helpful to understand what is happening and allow potentially for us to intervene and prevent colorectal cancer. There is certainly a group of undiagnosed hereditary colorectal cancer syndromes. There could be some environmental exposures, and there is even some weak literature on the widespread use of antibiotics, many times, perhaps inappropriately. So, a number of areas are being looked at from an epidemiologic standpoint, answers still to come. So, what can't we change about patients' risk factors for colorectal cancer? And many times, I like to think about what we can change about diseases, as well as what we can change about diseases. So, what we can change is age as a risk factor. As we age, the risks of colorectal cancer can increase. As we just looked at, racial and ethnic backgrounds cannot be changed. We cannot change our genetics. We can't change a personal history of colon cancer or a personal history of advanced colorectal polyps, such as villus adenomas or polyps with high-grade dysplasia. We cannot change our personal history of ulcerative colitis or Crohn's disease, which can be risk factors for colorectal cancer. We can't, again, change our genetics, a family history of colorectal cancer, or family history of advanced polyps. And again, I'll be repetitive to make sure we understand advanced polyps. Advanced polyps are any polyp with villus component, any polyp with high-grade dysplasia, and any adenomatous polyp greater than 10 millimeters in size, and inherited syndromes, such as familial adenomatous polyposis and Lynch syndrome. What can be changed? Diet. There are multiple studies that show limiting or avoiding red meat, and especially processed meats, can help reduce the risk of colorectal cancer. Increasing daily vegetables and fiber in our diet can certainly help reduce the risk. Increased physical activity is important, probably through its reduction or decreased chance of obesity and the impact obesity may have on colorectal cancer. And that ties into our next point, which is weight loss, and always weight loss through proper diet and exercise. I look at weight loss and any exercise program as truly being a marathon. We need to make small changes over time so that any changes we can do to improve our overall body mass index and maintain an exercise program are sustainable. If we have type 2 diabetes, try to maximize control of type 2 diabetes, avoid or quit smoking, limit alcohol use, and most importantly, and that's where we'll spend the rest of our time, most importantly, get screened for colorectal cancer. This is an important advance that's been implemented over the last year. Multiple publications and guidelines have come out to say that we should start colorectal cancer screening at age 45. So no longer do we start age 50, we start at age 45. And thankfully, we've seen insurance companies follow suit with coverage for all types of screening of tests for colorectal cancer screening. One of the take-home points, an important one, is we now start at age 45, and this is a great opportunity to talk about colorectal cancer screening with your patients. Let's look at the available tests and current recommended tests. And there's a very nice tier system, one in which is based on evidence and one I think we should follow. So the Tier 1 recommended test to screen for colorectal cancer, a colonoscopy every 10 years, a fecal immunochemical test annually. So those are the only recommended Tier 1 tests. They have the most evidence to support their use. Tier 2 test is a fit fecal DNA test every three years, that is ColoGuard. The data support it as slightly inferior to the Tier 1 testing. However, the company that makes ColoGuard has done an outstanding job at marketing, and I'm sure you've seen widespread use of this test. But based on evidence, it is a Tier 2 test. And I've crossed out other tests such as CT colography, flexible sigmoidoscopy, as well as capsule endoscopy. I've crossed these off as other options. They are no longer recommended. So the gold standard is colonoscopy. It's the gold standard based on evidence-based medicine. And it is the only test that can be used for diagnostic and therapeutic purposes. So we can diagnose and remove a polyp in one setting. It detects three times more advanced lesions than the fecal immunochemical test and two times more advanced lesions than the combined fit fecal DNA test, which is ColoGuard. Advanced lesions are the most important lesions that we could find and remove as they potentially pose the greatest risk to developing colon cancer. Reasons patient delay colonoscopy. You've heard all of the excuses, and these are all understandable. It's an invasive test, and I would like to avoid an invasive test. I'm really worried about the PrEP. My friends have told me the PrEP is terrible. I'm going to vomit. I'm going to get diarrhea. I know that sounds silly, but they're worried about the amount of diarrhea they'll have. They're concerned for the safety of an invasive procedure, whether that be the risk of perforation or even an infection risk, as they perhaps read something in the lay press that colonoscopy has been associated with infections, which we all know is at a very, very low risk. They're self-conscious about their body image and someone perhaps looking at their backside during colonoscopy or judging their body image. Logistics. They have to take a day off from work. They need a driver. And unfortunately, some insurance plans still have a high deductible or high co-pays for colonoscopy. Colonoscopy risk, as we talked about in my previous talk, they are small. I won't go over the details to save some time, but major complications are very, very low for average risk screening colonoscopy patients. Preventing post-polymectomy, as we discussed, is also low, and death is incredibly small for colonoscopy. So these are items we can easily discuss and reassure our patients that there is minimal chance of a significant adverse event. In a colonoscopy summary, we need to stress to our patients that it is safe and well-tolerated, stressing that the prep is well-tolerated and someone is available every night to call if they have problems for us to help them get through their prep. It is by far the most sensitive test. It is the only test proven to prevent colorectal cancer. It should be the first test offered to average risk patients. It is the only test that can diagnose and remove polyps in the same setting. And it's the only test recommended for high-risk patients. And I have a slide at the end to summarize. This is a very important point. It's the only test recommended for high-risk patients, such as those with a family history of colon cancer, those in a surveillance program, those with a history of colorectal cancer, as examples. And it should be done by high-performing gastroenterologists or high-performing endoscopists, those with high sequel intubation rates and, more importantly, high adenoma detection rates. Fecal immunochemical test. This stool test is a stool-based test that checks for hemoglobin. It assumes cancers will bleed, and it's looking to find blood in the stool. This is a test that can be performed once a year, and it does, again, require a stool sample that can be easily obtained and mailed in by the patient. The threshold for most tests in the United States for the detection of hemoglobin is about 20 micrograms of feces. It makes this test have a decent sensitivity and specificity. Unfortunately, at this level, the specificity is low enough where we run the risk of detecting blood from other sources, such as those who are on NSAIDs and have micro occult bleeding, perhaps those who have other bleeding sources in the GI tract, or even those who perhaps have COPD and are coughing up blood and swallow blood. It's sensitivity and specificity for colorectal cancer at this level is okay but not great. Some advantages, it's done at home, it's low cost, and in many settings, including a large closed setting at Kaiser Permanente Healthcare, has a very good adherence when an organized program is set up. Again, it's a tier one test and a good test. Take-home points for FIT testing. One, it's low cost, it's easy to use, good but not great sensitivity for colorectal cancer, as I said. It's much improved if we decrease the hemoglobin threshold, but that brings on a host of other potential problems. Colonoscopy is needed if the test is positive, so an important part of discussion when you talk about FIT testing with your patients is to emphasize that if the FIT test is positive, the patient needs to undergo colonoscopy. FIT test only prevents colonoscopy when the end result is a colonoscopy if the test is positive. Finally, FIT fecal DNA testing or ColoGuard. Patients will describe this as the stool test in a box that they mail in. It's a combination of a FIT test and fecal DNA. The fecal DNA portion is looking for methylation markers, which can be seen in polyps, adenomatous polyps, and cancers. This is the most important point. It is intended for and only for average risk colon cancer screening patients between the ages of 40 and 85, although most screening programs typically run between 45 and 75. Between 75 and 85, colorectal cancer screening with any test is still a benefit under Medicare. ColoGuard is not, I repeat, is not recommended for adenomas on prior colonoscopies, family history of colon cancer advanced, polyps, colon cancer, and unfortunately all of us have seen the misuse of this test in our practices. I see many patients in our practice that come in for ColoGuard positive test and they've had polyps, so they have a family history of colon cancer. We presented an abstract at DDW a few years ago, and our false positive rate was about 13 to 15%, and our misuse rate was a bit higher. I don't remember that exact number, but that combined rate is not a small number. So we really need to work on making sure we select the proper patients and educate our primary care referring base how to use this test and how to use the FIT test. FIT fecal DNA, if FIT fecal DNA is negative or normal, then we repeat that every three years. Advantages over colonoscopy, as with the FIT test, it's done at home. No preparation is needed, so that's attractive to patients. No days off are needed, and that's again attractive to patients, and they don't need to have a driver because this test is done at home. As with the FIT test, colonoscopy is needed if the test is positive, and this test is only effective if the patient follows up with a colonoscopy. So very important, again, to stress that if you, the patient, have a positive test, you need to follow up with colonoscopy. Let's look at some screening comparisons. FIT fecal DNA finds colon cancer about 92% of the time. It finds high-risk polyps greater than 10 millimeter adenomas. Other features, villus adenomas, high-grade dysplasia about 42% of the time, and in general has a false positive rate of about 12%. It misses cancers with a false negative rate is about 1 in 13. FIT DNA or fecal immunochemical testing finds cancer about 75% to 80% of the time, finds high-risk polyps about 30% to 40% of the time, has a lower false positive rate than FIT fecal DNA, and misses about 1 in 5 cancers. Colonoscopy, although not perfect, and remember, no test, no operator is perfect. I in no way want to say that this is a perfect test, but evidence-based data shows performed by high-quality performers, this is our best test. It finds colon cancer 95% of the time. It finds and removes high-risk polyps greater than 95% of the time. No false positives and false negatives. False negatives, the cancer miss rate, it's real, it's between 0 and 6% as defined by interval cancers based on studies. So again, no operator, no test is perfect, but to this point, this is our best option. So some take-home points. For FIT fecal DNA, it's easier than colonoscopy. It misses about 1 in 13 colon cancers. It misses greater than 30% of polyps that will become cancer, and it can miss almost 60% of polyps that could turn into cancer. Overall, only prevents colon cancer if it results in colonoscopy and polyp removal. Most important take-home point. FIT fecal DNA, easier than colonoscopy, as with FIT, misses 1 in 13 cancers. Overall, miss rate of about 60% of polyps that could turn into cancer. Only prevents colon cancer if it results in colonoscopy and polyp removal. So once again, stress to our patients. If you prefer this test, great, we approve. But make sure you follow up for colonoscopy if it's positive. Overall take-home points, colon cancer is common and deadly. However, if we can intervene in an early stage, survival is much greater. Colon cancer rates are rising in younger patients. This is a concerning area because they tend to present with advanced disease. The decrease to start at age 45 for colorectal cancer screening should help this growing problem. Colon cancer and death is entirely preventable if we can increase the pool of screened patients. Unfortunately, to date, 40% of eligible patients have been screened. And we need to start to get that 60% people that have been screened up to 80% or more that we see with cervical cancer screening and breast cancer screening. Remember, any screening test is better than no screening test. And although colonoscopy is the best, I like to think of it this way. The best colorectal cancer screening test is the one that gets done. That's the bottom line when it comes to colorectal cancer screening. Colonoscopy remains the only test that prevents colon cancer of the entire colon. We start at age 45. Family history of colon cancer at advanced palps, we're going to start earlier. Perhaps colonoscopy age 40 or 10 years before diagnosis in those who have a family history of colon cancer or advanced palps, whichever is younger. For patients who refuse colonoscopy for whatever reason, then the next test we should offer is FIT testing every year based on tier one test recommendations and based on evidence-based studies. If the patient wants ColoGuard by all means proceed, then proceed with FIT fecal DNA. It's an important test. It does have important limitations. But again, the best screening test is the one that gets performed. And I'd like to leave you with this box, this final table. And I think it's important to kind of etch this in our memory so that when we communicate with patients and we communicate with referring physicians, we do our best to clear up any confusion and to make sure our patients and referring physicians understand the role of each test. So in average risk patients, all of these tests can be used. Stool DNA, stool FIT, and colonoscopy. Of course, pointing to tier one test recommendations, FIT and colonoscopy. And I know I sound like a broken record. One of my former partners would say he heard me twice the first time. But the best test to screen for colon cancer is the one that gets done. So that for average risk screening, all tests are on the table. For surveillance, stool DNA does not apply. Stool FIT testing does not apply, only colonoscopy. For high risk patients, family history of colon cancer, family history of advanced lesions, stool DNA test only does not apply. Stool FIT does not apply. Only colonoscopy applies. And just so we throw in there to properly educate our patients and referring physicians, although it does not apply to this discussion, diagnostic purposes. Patients with symptoms. Stool DNA does not apply. It should not be used in patients with symptoms. Stool FIT should not be used in symptomatic patients. Only colonoscopy should be offered. And if FIT or Cologuard is positive, then we have to impress upon our patients they must follow up with colonoscopy to prevent colon cancer by removal of polyps if they are present. Thank you for listening. And I'll turn it back to Vivek to move on to our Q&A session.

colorectal cancer screening

alternative screening modalities

early detection

colonoscopy

sensitivity and specificity

educating patients