Shorter Duration Adjuvant Therapy for Stage III Colon Cancer

Three months of capecitabine and oxaliplatin therapy was noninferior to 6 months of therapy in patients with lower-risk disease.

A standard 6-month course of adjuvant chemotherapy after curative surgery has been shown to provide a survival benefit for patients with stage III colon cancer. However, the risk for toxicity — in particular, sensory neuropathy from oxaliplatin, contained in standard adjuvant regimens — has highlighted the need for a shorter-duration treatment.

Investigators now report the results of a prospective, pooled analysis of 6 international trials comparing 3 versus 6 months of adjuvant chemotherapy for stage III colon cancer. Nearly 13,000 patients received chemotherapy with either CAPOX (capecitabine and oxaliplatin) or FOLFOX (fluorouracil, leucovorin, and oxaliplatin). Most patients (59%) had lower-risk disease (T1, T2, or T3 N1); 41% had higher-risk disease (T4 or N2).

At a median follow-up of 41.8 months, results were as follows:

  • Noninferiority for 3-year disease-free survival (the primary endpoint) was not demonstrated for 3 versus 6 months of therapy in the modified intention-to-treat analysis.
  • Noninferiority for 3 versus 6 months of therapy was demonstrated in patients with lower-risk disease (83.1% and 83.3%, respectively); in patients with higher-risk disease, 6 months of therapy was superior (64.4% vs. 62.7%).
  • Noninferiority for 3 versus 6 months of therapy was demonstrated in patients with lower-risk disease treated with CAPOX (85.0% and 83.1%, respectively), but not with FOLFOX; among patients with higher-risk disease, 3 months of CAPOX compared favorably with 6 months of CAPOX (64.1% vs 64.0%) but failed to demonstrate noninferiority.
  • Toxicity was significantly less with 3 months of therapy; grade 2 or higher neurotoxicity was lower with 3 versus 6 months of CAPOX (14.2% vs. 44.9%) and with 3 versus 6 months of FOLFOX (16.6% vs. 47.7%).


These results establish 3 months of CAPOX as acceptable adjuvant therapy for lower-risk colon cancer. Patients can be counseled about the marginal difference for 3 versus 6 months of CAPOX in higher-risk disease. Use of FOLFOX should be limited to patients treated for 6 months.

Link between high-cholesterol diet and colon cancer: UCLA Study

Adjuvant Chemotherapy in Colon Cancer With Microsatellite Instability



Another Perk for Drinking Coffee

Nearly 60 percent of Americans drink coffee, and for many the habit is a daily one.1 Coffee drinking has long been viewed as more of a vice or a crutch to get a quick energy boost to power through the day, but this view is now changing as the health benefits of coffee continue to be revealed.

This is good news for those of you who sip on a cup of joe in the morning, as it turns out this may be a quite healthy way to start your day.

However, please remember that coffee is one of the most heavily pesticide sprayed crops in the world. If you drink it please be sure to get organic and ideally fair traded, This is less than 3% of all coffee.

Daily Coffee Boosts Colon Cancer Survival

Among people with advanced (stage III) colon cancer, drinking four or more cups of caffeinated coffee daily lowered the risk of cancer recurrence or death during the study by 52 percent compared to those who drank no coffee.

Drinking two or three cups per day was also beneficial, lowering the risk of recurrence or death by 31 percent.

The researchers stressed that other caffeinated beverages, such as soda, did not have the same effect. No link was found between decaffeinated coffee and risk of colon cancer recurrence either.

Further, a causal link was not found. This means it could simply be that coffee drinkers tend to follow a healthier overall lifestyle that’s contributing to the lower risk. However, the antioxidants and other beneficial plant compounds in coffee have been linked to a lower chronic disease risk before.

In fact, coffee has been linked to a lower risk type 2 diabetes as well, a condition known to increase the risk of colon cancer. It’s likely that compounds in coffee may lower the risk of multiple chronic diseases via similar pathways.

As reported by the New York Times:2

The researchers’ hypothesis is that the factors that increase risk for Type 2 diabetes, such as obesity, a sedentary lifestyle, and high insulin levels, also drive colon cancer, Dr. [Charles S.] Fuchs [director of the Gastrointestinal Cancer Center at Dana-Farber Cancer Institute in Boston] said.

And many studies have shown that coffee consumption is associated with a lower risk for Type 2 diabetes, a chronic illness that may increase the risk of colon cancer.

‘We believe that activating the energy pathways that contribute to heart disease and diabetes is also relevant for the proliferation of cancer cells,’ Dr. Fuchs said, while also stressing that more research was needed.

The analysis determined the lowered risk associated with coffee was… because of the caffeine. One hypothesis is that caffeine increases the body’s sensitivity to insulin, so it requires less of the hormone. That, in turn, may reduce inflammation, which is a risk factor for diabetes and cancer.”

What Else Does the Research Say About Coffee and Cancer?

While a number of individual studies have suggested coffee consumption might increase your cancer risk, when multiple studies are analyzed, such as is the case with meta-analyses, the association disappears, and, in fact, becomes protective.

For instance, one 2007 meta-analysis found an increase in consumption of two cups of coffee per day was associated with a 43 percent reduced risk of liver cancer3 – a finding that has been confirmed by more recent research.

Not to mention, coffee appears to have additional benefits for liver health, slowing down the progression of liver disease to cirrhosis, improving responses in people with hepatitis C, and lowering the risk of death in people with cirrhosis.4

The potential benefit of coffee for liver health appears so strong that researchers have stated daily coffee consumption should be encouraged in people with chronic liver disease.5

Another meta-analysis involving 59 studies revealed an increase in consumption of one cup of coffee per day was associated with a 3 percent reduced risk of cancers.6 According to the researchers:

“[C]offee drinking was associated with a reduced risk of bladder, breast, buccal and pharyngeal, colorectal, endometrial, esophageal, hepatocellular, leukemic, pancreatic, and prostate cancers.”7

There’s even research showing coffee consumption could lower your risk of skin cancer. Drinking four cups of caffeinated coffee daily might reduce your risk of melanoma, the most dangerous form of skin cancer.8

According to researchers:

“[C]offee constituents suppress UVB-induced skin carcinogenesis, induce cell apoptosis, protect against oxidative stress and DNA damage, reduce inflammation in epidermal cells, and inhibit changes in DNA methylation.”9

Women who consumed more than three cups of coffee a day had a significantly lower risk of basal cell carcinoma (non-melanoma skin cancer) than those who consumed less than one cup per month.10

Roasted Coffee Contains More Than 1,000 Compounds, Many of Which May Help Fight Cancer

Coffee has multiple potential anti-cancer pathways. As mentioned, caffeine is one of them, as its been shown to both stimulate and suppress tumors depending on the cancer and when it’s administered.11

Polyphenols in coffee, such as lignan phytoestrogens, flavonoids, and polyphenols are also known to have anti-cancer properties, as does caffeic acid, which inactivates several pathways involved in the development of tumors – including cell cycle regulation, inflammatory and stress response, and apoptosis.

Researchers noted in the journal BMC Cancer:12

“There are two specific diterpenes in coffee, cafestol and kahweal, which produce biological effects compatible with anti-carcinogenic properties, including the induction of phase II enzymes involved in carcinogen detoxification, specific inhibition of the activity of phase I enzyme responsible for carcinogen activation, and stimulation of intracellular antioxidant defense mechanisms.

Coffee is also a major source of the chlorogenic acid that contributes to its antioxidant effect. Intake of chlorogenic acid has been shown to reduce glucose concentrations in rats and intake of quinides, degradation products of chlorogenic acid, increases insulin sensitivity.

Chronic hyperinsulinemia and insulin resistance are confirmed markers of high risk for some cancer sites.”

The Benefits of Coffee: From Your Heart to Your Brain

The benefits of coffee are becoming so well established that, for the first time, a government advisory committee included a mention of caffeine in its recommendations for the 2015 edition of Dietary Guidelines for Americans. The report said Americans could safely consume up to five cups of coffee a day, or approximately 400 milligrams (mg) of caffeine, with no detrimental effects.13

The recommendation was based on an evaluation of multiple meta-analyses and other studies evaluating the link between coffee and chronic diseases, including cancer, type 2 diabetes, heart disease, Parkinson’s, and Alzheimer’s. Here’s a sampling of what the research shows:

Heart Health

In a study of more than 25,000 people, those who drank a moderate amount of coffee – defined as three to five cups daily – were less likely to have calcium deposits in their coronary arteries than those who drank no coffee or more coffee daily.14

A large part of arterial plaque consists of calcium deposits (atherosclerosis), hence the term “hardening of the arteries.” Coronary artery calcium can be a significant predictor of future heart disease risk.

In addition, one study showed moderate coffee drinking reduces your chances of being hospitalized for heart rhythm problems. 15 Another study found it may trigger a 30 percent increase in blood flow in your small blood vessels, which might take some strain off your heart.16

Another study, a meta-analysis that included data from 11 studies and nearly 480,000 people found drinking two to six cups of coffee a day was associated with a lower risk of stroke.17

Multiple Sclerosis and Parkinson’s Disease

Drinking four to six cups of coffee a day is associated with a lower risk of multiple sclerosis, as is drinking a high amount of coffee over five to 10 years. According to researchers, Caffeine has neuroprotective properties and seems to suppress the production of pro-inflammatory cytokines.”18 Higher coffee and caffeine intake are also associated with a lower risk of Parkinson’s disease.19


Caffeine promotes production of the neurotransmitters serotonin, dopamine, and noradrenaline, and triggers the release of brain-derived neurotrophic factor (BDNF), which activates brain stem cells to convert into new neurons, thereby improving your brain health.

Among people with mild cognitive impairment (MCI), those with higher blood levels of caffeine (due to coffee consumption) were less likely to progress to full-blown dementia.20 Caffeine/coffee intake is associated with a reduced risk of dementia or delayed onset, particularly for those who already have MCI,” the researchers said.

Premature Death

Research published in the New England Journal of Medicine has even shown that coffee consumption is inversely associated with premature death. The more coffee drank, the lower the risk of death became, including deaths from heart disease, respiratory disease, stroke, injuries and accidents, diabetes, and infections.21

Coffee Is the Number One Source of Antioxidants in the US

Another reason why coffee may have such dramatic effects on Americans’ health is because it is the number one source ofantioxidants in the US diet. The research, which was presented at the 230th national meeting of the American Chemical Society, showed that Americans get more antioxidants from drinking coffee than from any other dietary source, with researchers noting “nothing else even comes close.”22

Examples of the antioxidants in coffee include significant amounts of hydrocinnamic acid and polyphenols. Antioxidants are nature’s way of providing your cells with adequate defense against attack by reactive oxygen species (ROS) or free radicals.

Free radicals are a type of a highly reactive metabolite that is naturally produced by your body as a result of normal metabolism and energy production. They are your natural biological response to environmental toxins like cigarette smoke, sunlight, chemicals, cosmic, and manmade radiation, and are even a key feature of pharmaceutical drugs. Your body also produces free radicals when you exercise and when you have inflammation anywhere in your body.

As long as you have these important micronutrients, your body will be able to resist aging caused by your everyday exposure to pollutants. If you don’t have an adequate supply of antioxidants to help squelch free radicals, then you can be at risk of oxidative stress, which leads to accelerated tissue and organ damage.

While fruits, such as berries, and vegetables are ideal sources of antioxidants, many Americans don’t eat the recommended amounts each day. This is why coffee, which is consumed widely on a daily basis, represents such a large dietary share of antioxidants. If you’re not a coffee drinker, you can easily boost your antioxidant intake by eating fresh produce – and even if you do drink coffee, getting your antioxidants from a wide variety of sources is still important.

Is Decaf Coffee a Healthy Choice?

The coffee beans used to make decaffeinated, or decaf, coffee undergo a process to remove most of the caffeine. In order to be labeled decaffeinated, the coffee must have 97 percent of the original caffeine content removed.23 This may be preferable for those who are highly sensitive to caffeine (for instance experiencing jitters after one regular cup), but there are some considerations. For starters, some of the research on coffee’s health benefits have shown caffeinated coffee to be more effective than decaf (the featured colon cancer study is one such example).

In particular, caffeinated coffee has also been linked to a lower risk of liver damage, increased metabolic rate, reduced risk of depression and suicidal thoughts, and enhanced athletic performance while decaf coffee has not.24 The process used to decaffeinate the coffee is also important to be aware of.

One of the most commonly used methods is Direct Process, which uses the chemical methyl chloride to remove the caffeine from coffee beans. Starbucks, for instance, uses this process on most of its decaf brews (although it also offers a “naturally processed” decaf Sumatra blend).25

The National Cancer Institute lists methyl chloride as a possible carcinogen, so it’s something you’re better off avoiding (trace amounts are sometimes detected in decaf coffee, although typically at levels below 1 part per million). Natural Process decaffeination uses either ethyl acetate (a plant hormone) or carbon dioxide to remove caffeine, while the Swiss Water process uses only water. Only the carbon dioxide or Swiss water methods are allowed in coffee that’s certified organic. If you choose to drink decaffeinated coffee, be sure to choose one that is decaffeinated using one of these latter two methods.

Another option, if you’re simply looking for a lower-caffeine blend, is to choose Arabica beans, which naturally have about half the caffeine content of Robusta beans. 26 Also, keep in mind that even decaffeinated coffee is not caffeine free (a typical cup of decaf may contain 3 to 18 milligrams (mg) of caffeine, compared to between 140 to 300 mg in a regular cup.

This is an important distinction for pregnant women to be aware of. Public health agencies suggest pregnant women limit daily caffeine to 200 mg (or about two cups of coffee a day). However, caffeine can significantly impact the growing fetus. It is able to freely pass through the placenta, and since caffeine does not provide any benefits to your baby, only potential hazards, I strongly recommend pregnant women avoid ALL forms of caffeine.

How to Ruin a Good Cup of Coffee…

If you want to drink coffee for its health benefits, drink your coffee black, without sugar, non-dairy creamer or cream, or flavorings. If you are dousing your cup of coffee in creamer, non-dairy creamer, sugar, and other sweeteners and flavorings, you are missing out on the therapeutic benefits and potentially harming your health.

The natural blend of polyphenol antioxidants are part of what makes coffee so healthy. However, some research suggests that adding dairy to your coffee may interfere with your body’s absorption of beneficial chlorogenic acids.27 Meanwhile, if you add sugar to your coffee you’ll spike your insulin levels, which contributes to insulin resistance.

Also, coffee beans are one of the most heavily pesticides-sprayed crops. So, you should select only coffee beans that are certified organic. Remember, you will obliterate any positive effects if you consume coffee that’s been doused in pesticides or other chemicals. Whenever possible, purchase sustainable “shade-grown” coffee to help prevent the continued destruction of our tropical rain forests and the birds that inhabit them.

There are many who say shade-grown coffee tastes better as well. In addition, you’ll want to purchase whole bean coffee that smells and tastes fresh, not stale; if your coffee does not have a pleasant aroma, it is likely rancid. Grind it yourself to prevent rancidity, as pre-ground coffee may be rancid by the time you get it home. If you use a “drip” coffee maker, be sure to use non-bleached filters. The bright white ones are chlorine-bleached, and some of this chlorine will leach from the filter during the brewing process. Bleached filters are also notoriously full of dangerous disinfection byproducts, such as dioxin.

Finally, while it appears coffee in moderation is beneficial, be careful not to overdo it, as some studies have found adverse effects when about 10 cups a day or more are consumed. When referring to a “cup” of coffee, most research considers it to be five to eight ounces with about 100 mg of caffeine. In contrast, a small cup at many coffee houses starts at 12 ounces while a large cup may hold 20 to 24 ounces. Simply be aware of how much you’re actually consuming.

Forget X-Rays, Soon We’ll Be Popping Pills to Scan for Certain Cancers

Getting a colonoscopy is no fun. As a procedure that focuses on one of the body’s least-pleasant organs, it’s invasive, uncomfortable, and for many of us, an unavoidable medical necessity. But it might not be that way for long.

According to Quartz, a medical company called Cap Check is in the process of testing a high-tech colonoscopy alternative that could drastically change the way doctors test for colon cancer. Unlike the standard procedure, which involves a visual survey of the interior of the colon by way of a camera inserted rectally, Cap Check’s method claims to be less invasive and more effective at the same time. All a patient does is swallow a pill.

image via (cc) flickr user thenationalguard

…Okay, so it’s no ordinary pill. In fact, Cap Check’s capsule is much more akin to a tiny x-ray machine than your average aspirin. Once it’s swallowed, the high-tech pill travels into the patient’s colon (as most things that are swallowed eventually do), where it is able to scan the interior of the organ, and transmit that data to a dermal patch the patient wears on their torso. Once the pill has (ahem) completed its journey, a patient just lets nature take its course. The patch, meanwhile, has all the data from the pill’s scan, which can then be handed over to a doctor, who can now examine a 3-D rendered model of the colon’s interior.

As creator Yoav Kimchy explained to Quartz, the edible x-ray machine is advantageous not only for being a significantly less intense experience for the patient (radiation-wise, it’s around the same level as a standard chest x-ray), but also because it affords physicians an inside-out, unobstructed view of what’s happening on the interior of the colon, without any “murky water” to contend with. What’s more, Kimchy estimates the procedure will be less expensive than a traditional colonoscopy, as well.

The pill-and-patch combo is currently in the midst of European clinical trials and, barring any unexpected problems, should begin testing with the U.S. Food and Drug Administration in around a year and a half from now. In the meantime, the technology behind the micro-scanners continues to progress. So while Cap Check’s pill is designed specifically to detect signs of colon cancer, perhaps some day we’ll be popping pills for *all* our x-ray needs.

Watch the video. URL:

Scientific Review Suggests Aspirin Significantly Cuts Cancer Rates

A recent review of several studies confirms that taking a small daily dose of aspirin significantly reduces the risk of developing – or dying from several kinds of cancer.

Several clinical studies have suggested that aspirin can reduce the risk of colon, and other cancer’s of the gastrointestinal tract. (2,3,4) In order to study this further, researchers analyzed all the available evidence from studies and clinical trials evaluating taking aspirin daily for 10 years and confirmed that daily aspirin could reduce bowel cancer cases by around 35 percent and deaths from the disease by 40 percent.  These results were published in the Annals of Oncology journal.(1)

Aspirin, originally developed by the German drug maker Bayer, is a cheap, over-the-counter drug generally used to combat pain or reduce fever.  The drug when taking in smaller doses of 75-100 milligrams per day reduces the risk of clots forming in blood vessels and can therefore protect against heart attacks and strokes, so it is often prescribed for people who already suffer with heart disease and have already had one or several attacks.
The authors found that in addition to reducing the risk of developing colon cancer, the risk of esophageal and stomach cancer were cut by 30 percent and deaths from these cancers reduced by 35 to 50 percent.

The authors of the current study observed that if everyone between 50 and 65 years of age started taking aspirin daily for at least 10 years, there would be a 9 percent reduction in the number of cancers, strokes and heart attacks overall in men, and around 7 percent in women.

There are however some serious side effects of aspirin including a risk of bleeding in the stomach.  Among 60-year-olds who take daily aspirin for 10 years, the risk of digestive tract bleeding increases from 2.2 percent to 3.6 percent, and this could be life-threatening in a small proportion of people. The risk of bleeding has prevented some doctors from advising patients to take aspirin as regularly as every day. This risk of bleeding is well known and should not be ignored especially in individuals at high risk.  In this era of wellness however where many individuals look to alternative medicines, nutritional supplements and foods rich in anti-oxidants, and other nutrients to reduce their caner risk an aspirin a day may be the simplest and most cost effective way to reduce the risk of gastrointestinal cancers.

1.    Cuzick J, Thorat MA, Bosetti C. et al. Estimates of benefits and harms of prophylactic use of aspirin in the general population. Annals of Oncology. 10,2014 doi:10.1093/annonc/md
2.    Burn J, Bishop T, Mecklin JP, et al. Effect of aspirin or resistant starch on colorectal neoplasia in the lynch syndrome. New England Journal of Medicine. 2008; 359: 2567-2578.
3.    Burn J, Gerdes A-M, Macrae F et al. Long-term effect of aspirin on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial. Lancet. Early online publication October 28, 2011.
4.    Tan X-L, Reid Lombardo KM, Bamlet WR, Robinson DP, Anderson K, Petersen GM. Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen and risk of pancreatic cancer. Presented at the 102nd Annual Meeting of the American Association for Cancer Research (AACR), April 2-6, 2011, Orlando, FL. Abstract 1902.

Lung Cancer Is Invisible, And Other Reasons The Deadliest Cancers Are So Dangerous

A graph outlining which cancers kill the most people. Photo courtesy of the National Health Service

Cancer is the Boogeyman of the adult world. But unlike its fictional counterpart, cancer doesn’t linger in the shadows of children’s bedrooms, but rather the dark corners of our minds. In modern times, we’ve become better at diagnosing and thus treating cancer, but its death tolls are still in the thousands — some forms of cancer taking a considerably larger amount of lives than others. Here is a list of the deadliest cancers and why.

Little Or No Early Symptoms

Lung cancer is cancer’s heavyweight champion. According to the American Lung Association, lung cancer takes more lives than pancreas, breast, and coloncombined. The reason that lung cancer claims so many lives is that most patients don’t even realize there’s anything wrong until it’s much too late.

The same goes for colon cancer, which is the number two deadliest cancer. According to USC, only about a third of cases are diagnosed in the earliest, most survivable stages.

Breast cancer is the fourth most deadly cancer, according to the UK’s National Health Service. An estimated 10,100 individuals die from this disease each year, even though the cancer is relatively treatable. However, like lung and bowel cancer, the American Cancer Society reports that most breast cancer patients have no early symptoms.

This is why screening tests are so important. The ACA recommends that women aged 40 and older should have a screening mammogram every year. Women in their 20s and 30s should have a clinical breast exam as part of their regular health exam every three years. However, women of all ages are advised to regularly check their own breast for abnormalities.

Other highly deadly cancers showing little to no early symptoms include:pancreatic cancer, prostate cancer, liver cancer, and kidney cancer.

Spread Very Far, Very Fast

While early diagnosis is important for treating all cancers, for some, it’s their rapid spread that makes them truly threatening.

Skin cancer is one of the most treatable of all cancer types, but that doesn’t stop if from taking around 4,820 lives each year. Melanoma is described as the most aggressive form of skin cancer by the ACA. When melanoma spreads to the nearest lymph node to the original tumor, it is able to quickly reach other more distant areas of the body. Once this spread occurs, the cancer is labeled as stage IV, and treatments such as chemotherapy and radiation will most likely be needed.

Leukemia is another one of these quick spreading cancers. Although it starts in the bone marrow, the cancer can quickly spread into the blood. From here, it’s truly limitless and can continue to spread to vital organs, such as the spleen, liver, and lymph nodes. Leukemia is listed as the 11th deadliest cancer and kills an estimated 3,670 individuals each year.

Other cancers known for their rapid spread include, (but of course are not limited to); bladder cancer, lymphoma, and oral cancer.

Difficult to Treat

Other cancers, although detectable and not as quick to spread, are highly dangerous because of how difficult they are to treat. One such cancer is that of the brain. Brain cancer tumors, called glioblastoma, are extremely hard to destroy. Dr. Inder Verma told LiveScience that the cancer often comes back after treatment because “every cell that is left behind has the ability to start all over again.” Although the cancer is relatively rare in the scope of cancers, it does kill around 1,270 people each year.

Stomach cancer is also rather difficult to treat, not because its tumors are incredibly durable, but because there is no specific test for diagnosing the disease. Stomach cancer symptoms include loss of appetite, weight loss, and nausea, all of which can easily be misdiagnosed as another illness. In order todiagnose stomach cancer, a doctor may perform an upper endoscopy, ultrasound, CT scan, MRI, PET scan, and other tests to find abnormalities in the stomach cavity. A biopsy of the cancerous cells will also be done to confirm suspected stomach cancer.

Help Is On The Way

As the case with all cancers, earlier and more accurate diagnosis is intrinsically tied to higher survival rates. A number of companies are working to improve cancer detection technologies. One such company is Vantage Health, whichMedical Daily had the opportunity to speak with. The company is working on commercializing a breath sensor that can detect chemical residue associated with certain cancers, allowing health care providers, and eventually even members of the public, to diagnose cancer with a single exhalation.

Allison Swan, currently the corporate development officer at Vantage Health, explained that while the technology is geared toward early lung cancer detection, it’s possible to reach far beyond this scope. Eventually a simple switch of the technology’s application would allow physicians to detect a variety of cancers, including breast and colon.

“Earliest detection is really what we’re working for — not just about cancer, different types of disease, and narcotics on their breath, what prevalence, and all different types (of uses)” Swan said.

DNA Test Wins FDA, CMS Approval at Same Time.

The first-ever DNA-based screening test for colorectal cancer has received FDA approval and preliminary approval for Medicare coverage of the test.

The Cologuard test detects hemoglobin and mutant DNA in cells sloughed into stool by cancers and adenomatous polyps. A positive test indicates a need for colonoscopy to identify or rule out colon cancer.

At the same time, the Centers for Medicare and Medicaid Services (CMS) issued a proposal to cover the DNA test, a first for the two regulatory agencies.

“This approval offers patients and physicians another option to screen for colorectal cancer,”Alberto Gutierrez, PhD, director of FDA’s office of in vitro diagnostics and radiological health, said in a statement. “Fecal blood testing is a well-established screening tool, and the clinical data showed that the test detected more cancers than a commonly used fecal occult test.”

The clinical data cited by Gutierrez came from a 10,000-patient comparison of the DNA test and the fecal immunochemical test (FIT). Stool specimens from the patients were evaluated by FIT and the DNA test, and all patients underwent colonoscopy to determine the presence or absence of cancer or polyps.

The results showed that the DNA test detected 92% of colon cancers and 42% of advanced adenomas, as compared with 74% and 24% for FIT. The fecal occult blood test did have a higher specificity, correctly ruling out colon lesions 95% of the time versus 87% for the DNA test.

The CMS proposal calls for coverage of the DNA test once every 3 years for beneficiaries who meet specific criteria: ages 50 to 85, asymptomatic (including negative FIT or guaiac fecal occult blood test), and average risk of colorectal cancer.

The parallel review occurred as part of a pilot program to expedite FDA and CMS action on selected devices submitted for premarket approval.

“This is the first time in history that FDA has approved a technology and CMS has proposed national coverage in the same day,” Patrick Conway, MD, CMS chief medical officer, said in a statement. “This parallel review represents unprecedented collaboration between the two agencies and industry and, most importantly, will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer.”

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