Time to catch up on some colorectal cancer news that we might have missed.

In Nutshell News: Virtual colonoscopy works just as well for over 65′s, over-the-counter and prescription stomach acid is connected to c. difficile diarrhea, and the recession cut into colorectal cancer screening among people with health insurance.

Older adults benefit from CT Colonography

CT colonography, so-called virtual colonoscopy, uses x-ray images to look into the colon. In the National CT Colonoscopy trial it was was as good at finding large polyps and cancers as optical colonoscopy.  However, the Centers for Medicare and Medicaid Services (CMS) doesn’t cover the test, citing lack of evidence that it works for older adults.

Analyzing people 65 and older enrolled in the National Trial, researchers at the Mayo Clinic in Arizona found no significant differences between Medicare-aged people and younger participants.  CT colonoscopy was able to find large adenomas and cancers at nearly the same rate in  older and younger trial enrollees. There was also a very small difference between intermediate size polyps over 6 mm.

As might be expected, older adults had more polyps. About 7 out of 100 (6.9%) had large polyps or cancer compared to 4  out of 100 (3.7%) younger people.

C. Daniel Johnson and his team concluded,

For most measures of diagnostic performance and in most subsets, the difference between senior-aged participants and those younger than 65 years was not statistically significant.

FDA Warning: Stomach Acid Drugs Linked to C. Diff Infections

The FDA has warned proton pump inhibitors (PPIs) are associated with Clostridium difficile (C. difficile) diarrhea (CDAD). The warning includes both prescription and over-the-counter medicines to treat frequent heartburn and medical conditions including as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

The FDA recommends that patients who are taking a PPI and develop diarrhea that doesn’t improve contact their healthcare professional.

Healthcare professionals are told:

• A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.
• Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
• Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Over-the-counter PPIs include Prevacid (lansoprazole), Prevacid 24hr, Prilosec (omeprazole), and Zegerid.

Additional prescription medicines are AcipHex (rabeprazole), Dexilant (dexlansoprazole), Nexium (esomeprazole), and Vimovo (esomeprazole and naproxen).

Recession Reduced Screening Colonoscopies for Insured

During the recent economic recession in the US, there were half a million fewer screening colonoscopies for patients with health insurance aged 50 to 64.  The need to share costs through deductibles and copays appears to be part of the reason.

From December 2007 through November 2009, 500,000 fewer screening colonoscopies were done for patients with commercial insurance compared to the previous two years. Health plans with out-of-pocket costs over $300 had lower screening rates both before and during the recession. The recession had a smaller impact on plans with the lowest out-of-pocket requirements.

Reporting their analysis of reports from 106 health plans, Spencer Dorn, MD, MPH, and his team at the University of North Carolina wrote,

Policies to reduce cost sharing could increase adherence to recommended preventive services such as colonoscopy examinations.

Fight Colorectal Cancer is supporting the Removing Barriers to Colorectal Cancer Screening Act of 2012 (H.R. 4120) which would change Medicare law so that seniors wouldn’t face additional copayments when polyps were removed during a screening colonoscopy.

The November issue of American Journal of Roentgenology described a program in which specially trained technicians performed computed tomography (virtual) CT colonoscopies in two Navajo Nation health centers and transmitted the tests for interpretation by radiologists hundreds of miles away at the University of Arizona Health Sciences Centers.

A retrospective review of 320 patients found that more than 90% of the tests showed adequate patient preparation and technical performance of the procedure.  Researchers did report a relatively high (54%) rate of false-positives, but “If there was any doubt, I called it positive and recommended a colonoscopy,” said Dr. Arthur Friedman, the lead radiologist for the study.

The study authors acknowledged that a better study would be a randomized trial comparing annual FOBT screening, optical and CT colonoscopy but, they noted, many residents in these and other rural areas live far from post offices or in homes lacking adequate plumbing, so compliance with fecal screening tests is poor, and there are not medical personnel to perform optical colonoscopies or sigmoidoscopies.

Source: Medscape, Oct. 29, 2010

Looking at more than 10,000 screening CT colonography or virtual colonoscopy exams, doctors found cancers in 1 in every 200 patients, but more often those cancers were not colorectal cancer, but unsuspected cancer found outside the colon.

The tests found 22 colorectal cancers (1 in every 500 patients examined) and 36 other cancers (1 in every 300 patients.)  More than half were found at an early stage I.  After an average follow-up time of 30 months, only 3 patients had died of cancer.

Renal cell cancer was the most frequent extracolonic cancer, discovered in 11 patients who didn’t have symptoms.  Eight lung cancers were also found along with six cases of non-Hodgkins lymphoma and eleven cancers in other sites.  More specific information about patients, their cancers, and their survival is part of the report in Radiology.

CT colonography allows radiologists limited views of the body outside of the colon, particularly in the pelvis, abdomen, and part of the lungs.  About 6 percent of the time, the exam leads to additional testing for other diseases, although more than half of that testing will eventually prove benign.

If polyps or suspected colorectal cancer is found during CTC screening, referrals are necessary for a traditional optical colonoscopy where polyps can be removed and biopsied.

During an exam patients are exposed to about 10 millisieverts (mSv) of radiation, about the same amount they receive from normal background radiation in three years.

In a news release from the Radiological Society of North America (RSNA), lead author Perry J. Pickhardt, M.D., professor of radiology and chief of GI Imaging, at the University of Wisconsin School of Medicine & Public Health, noted,

We are finding that virtual colonoscopy screening actually identifies more unsuspected cancers outside of the colon than within it. As with asymptomatic colorectal cancers identified by virtual colonoscopy screening, these cancers are often detected at an early, curable stage.

However, he points out that CT colonography does find benign conditions that nevertheless need follow-up.

Although extracolonic evaluation at screening CT colonography does carry some disadvantages, such as patient anxiety, inconvenience, or the potential for benign biopsy, our results suggest that early detection of asymptomatic extracolonic cancer represents an additional benefit of screening CT colonography that is not available with optical colonoscopy

Reporting their results in the April issue of Radiology, Pickhardt and his colleagues concluded,

The overall detection rate of unsuspected cancer is approximately one per 200 asymptomatic adults undergoing routine screening CT colonography, including about one invasive CRC per 500 cases and one extracolonic cancer per 300 cases. Detection and treatment at an early presymptomatic stage may have contributed to the favorable outcome.

SOURCES:  Pickhard et al., Radiology, Volume 255, Issue 1, pages 83-88, April 2010.

RSNA News Release: Virtual Colonoscopy Allows Detection of Unsuspected Cancers Beyond Colon, March 23, 2010.

This morning, President Barack Obama completed his first routine periodic physical examination as President at the National Naval Medical Center in Bethesda, Maryland.  The President’s exam included a colorectal cancer screening test.  Dr. Jeff Kuhlman, a Navy captain and Physician to the President, Chief White House Physician and Director of the White House Medical Unit examined the President.  Dr. Kuhlman, issued the following report following the exam:

“The President completed all age-appropriate screening tests, to include colorectal cancer screening.  A CT-colonography was performed with normal results.  Follow-up colorectal cancer screening is recommended in 5 years for routine colon cancer screening.”

Screening is just one important way to prevent colorectal cancer.  Take a few minutes to read more about preventing colorectal cancer.

CT colonography (virtual colonoscopy) found more than twice the rate of large polyps or cancer in patients 65 and older compared to everyone being screened for colorectal cancer using the radiology-based test.

About one in six older patients was referred for an optical colonoscopy based on findings from the scans.

There were no major complications including colon perforations or bleeding, from either the CT procedure or the follow-up colonoscopy.

Researchers at the University of Wisconsin reviewed results of 577 people from 65 to 79 tested in the university’s CT colonography screening program and found either an advanced adenoma or cancer in 44 (7.6 percent).  There were 5 cancers detected.

The rate of advanced neoplasia (advanced adenoma or cancer) for all the patients screened in the program, young and old, was 3.2 percent.

The percentage of older patients who were referred for an optical colonoscopy was about twice that of those under 65 — 15.3 percent of patients 65 and older, 7.6 percent of younger people.  Optical colonoscopy confirmed the positive CT findings in all but 4 percent of cases, not verifying 3.6 percent of smaller polyps measuring 6 to 10 mm and 2.1 percent of those larger than 10 mm.

The scans also found potential problems outside the colon in 89 patients, 45 of whom needed additional medical studies.  Workups discovered 21 previously undetected abnormalities including a lung cancer and 18 aneurysms.

The authors point out the the study was retrospective, looking back at experience in their program, and that negative findings were not verified by an optical colonoscopy.

Last year, the Centers for Medicare and Medicaid Services (CMS) declined coverage of screening colonoscopy for Medicare beneficiaries, stating lack of evidence for its effectiveness in people 65 and older.  CMS was also concerned that CT colonography identifies issues outside the colon which require additional medical follow-up and may not be serious medical problems.

David H. Kim, MD and his colleagues at the University of Wisconsin concluded,

CT colonography is a safe and effective screening modality for the older population.

SOURCE:  Kim et al., Radiology, Volume 254, pp 493-500, February 2010.

Research this week finds that people with severe cancer weight loss get less benefit from fentanyl pain patches and explores why people with Down Syndrome have less cancer.

In other headlines, shut-down of a Canadian nuclear reactor threatens the supply of medical isotopes used in many cancer tests.  Free drug samples may do more harm than good, and CT colonography finds cancers and other serious conditions outside the colon in about 2 or 3 out of 100 tests.  Finally, we provide a link to a Cancer.Net podcast with information about what to expect from your colonoscopy.

Research Reports

• Patients with cancer cachexia or loss of weight, muscle mass, and fat due to cancer had lower blood levels of fentanyl two and three days into using a fentanyl patch for pain management than did normal weight patients.  Cachectic patients had significantly thinner upper arm folds with less fat but there was no difference in local blood flow, sweating, or skin temperature.  Pain clinic researchers in Helsinki concluded that, “Absorption of transdermal fentanyl is impaired in cachectic patients compared with that of normal weight cancer pain patients.” Tarji Heiskan and team reported their research in Pain online May 13, 2009.
• People with Down Syndrome are rarely diagnosed with solid tumor cancers, and researchers at Children’s Hospital in Boston have found a reason.  Children with Down Syndrome are born with an extra copy of chromosome 21, and additional protein controlled by an extra DSCR1 gene acts within cells themselves to suppress VEGF (vascular endothelial growth factor) preventing potential cancers from developing the blood supply they need to grow and spread.  Both cell and mouse studies confirm the activity of DSCR1 proteins to block angiogenesis.  The discovery is reported in a letter from lead author to the journal Nature published online May 20, 2009.  More detailed information about the study is available from Science Daily, May 21, 2009.

Other Headlines

• The shut-down of a Canadian nuclear reactor in Chalk River, Ontario to repair  leaking heavy water has imperiled millions of medical imaging tests in the United States.  The reactor supplies the radioactive isotope molybdenum-99, injected into patients during nuclear medicine studies.  The Canadian reactor is one of only five worldwide that produce medical isotopes, and it provides them for half of hospitals and clinics in the United States.  Nuclear medicine experts predict that costs will rise, patients will have to be switched to less accurate testing, and some patients will not be able to have testing at all.  The reactor closure is expected to last at least a month and probably longer. Julie Steenhuysen has written about the reactor problems on Reuters Health.
• Health policy researchers Susan Chimonas and Jerome P. Kassirer discuss the negative impact of free drug samples in an essay on PLoS Medicine.  They review research that shows only a third of samples go to low-income patients and patients in the highest income categories were most likely to receive free samples.  Many samples are diverted for personal use by health professionals.  Low-income patients given starter packs of medicines frequently do not fill prescriptions to continue them and have no oversight by a pharmacist.  Samples raise the cost of health care with patients who receive them having higher out-of-pocket costs than those who don’t.  Estimates are that free samples are worth about $16 billion retail dollars annually in the US.  The complete essay by Chimonas and Kassirir is available on PLoS Medicine, published May 12, 2009.
• CT colonography can find cancers outside of the colon.  In fact, in a study of over 10,000 people who were screened with CTC, 38 non-colorectal cancers were discovered — more than the 21 colorectal cancers.  Most were in the kidney, but lung cancer and lymphomas were also found.  Such discoveries are rare.  Dr. Perry Pickhardt, discussing them at the  2009 International Symposium on Multidetector-Row CT, pointed out that they occur about once in every 300 CTC procedures.  In addition, other serious medical conditions can be seen including unsuspected abdominal aneuryms.  However, while a suspicious problem occurs in about 1 out of 10 CTC exams, only 2 or 3 of them will actually be something serious needing treatment.
• Wonder what happens during a colonoscopy?  Cancer.Net, the patient and consumer information web site of the American Society of Clinical Oncology, has a podcast that can help. Colonoscopy — What to Expect.

American Cancer Society Chief Medical Officer Otis W. Brawley, M.D., says that he is disappointed in the decision by the Centers of Medicare and Medicaid Services not to cover CT colonography screening for elderly Americans on Medicare.

Dr. Brawley points out that randomized clinical trials have shown the CTC option as effective as traditional optical colonoscopy in finding early cancers and precancerous polyps.  He also concerned that there is not a sufficient supply of trained specialists providing colonoscopy to meet the need for screening and that new options are needed.

The American Cancer Society believes, Brawley says, that a full battery of testing for colorectal cancer screening should be available, particularly to the Medicare population who are at higher risk of developing and dying from colorectal cancer.

Dr. Brawley’s statement:

I am disappointed in this decision, as randomized clinical trials clearly show CT colonography (CTC) is as effective as optical colonoscopy for the early detection of early cancers and pre-malignant lesions. Medicare coverage for CTC, also known as virtual colonoscopy, would have provided an additional option for colorectal cancer screening. Additional options are absolutely necessary as the supply of gastroenterologists and other trained specialists is currently inadequate to supply optical colonoscopy to all of those who need it, and many people are unwilling to undergo colonoscopy or other currently reimbursed tests. It is our belief that by increasing the proportion of Americans 50 and over who get colorectal cancer screening, we could increase the number of lives saved from this devastating disease and decrease long term medical costs. Providing access to all proven screening options is even more important for those in the Medicare population, most of whom are at even greater risk of developing and dying from colorectal cancer due to their advanced age. The American Cancer Society still believes that a battery of different tests for colorectal cancer screening should be available to the American people. This includes optical colonoscopy, virtual colonoscopy, stool blood testing, as well as sigmoidoscopy.

The Centers for Medicare and Medicaid issued a final National Coverage Decision on May 12, 2009 denying Medicare payments for CT colonography (virtual colonoscopy) to screen for colorectal cancer.

Despite an overwhelming number of comments urging that CMS overturn their provisional determination not to cover the test, the agency remained unconvinced that there was sufficient evidence to conclude that CT colonography was appropriate to screen for colorectal cancer.

Almost 95 percent of 357 comments supported CT colonography screening, including comments from the American Cancer Society and C3:Colorectal Cancer Coalition.

Briefly,

The Centers for Medicare and Medicaid Services (CMS) concludes the following:

The evidence is inadequate to conclude that CT colonography is an appropriate colorectal cancer screening test under § 1861(pp)(1) of the Social Security Act.  CT colonography for colorectal cancer screening remains noncovered.

A new type of drug was successful in helping patients with cancer cachexia regain muscle and strength, and counting circulating tumor cells helped predict survival for people with advanced colorectal cancer.

Free colonoscopies are available through a Connecticut program, the FDA and FTC warn the public to be wary of websites or ads promising treatments for 2009 H1N1 influenza, and people in remote areas of Arizona were able to have CT colonoscopy screening with teleradiology.

Research Reports

• Ostarine or GTx-024, the first of a new drug class called selective androgen receptor modulators (SARMS) increased lean muscle mass in patients with cancer cachexia. Patients were also stronger, as shown by improved performance on a stair climbing task.  They didn’t gain weight because fat tissue was replaced with muscle.   Cancer cachexia or wasting causes significant weight loss and reduced lean muscle leaving patients tired, weak, and with little appetite.  Merely eating more — or trying to eat more — doesn’t help patients gain weight or strength.  In the study, nearly 160 patients were randomized to a placebo or two different strengths of ostarine.  Before beginning the trial, patients with a number of different cancers had lost an average of almost ten percent of their body weight.  There was no difference in serious side effects among the three groups.  Read more about the study in a news release from GTx, the company developing the drug.
• The number of circulating tumor cells (CTCs) can predict both how long it will take for colorectal cancer to get worse (progression-free interval) and overall survival time.  Both progression-free interval (PFS) and overall survival (OS) were shorter when three or more CTCs were found in the blood.  Those with fewer than three CTC  had median PFS of 7.8 months compared to 4.4 months for those with three or more. Overall survival was 20.6 months with fewer than three CTCs compared to 9.4 months for three or more.  The study, led by Dr. S.J. Cohen, was published in Annals of Oncology in advance online March 26,2009.

Other Headlines

• Connecticut has a free screening colonoscopy program for the uninsured and people whose insurance doesn’t cover screening colonoscopy. Working with the Community Health Center Association of Connecticut, the University of Connecticut, and gastroenterologists statewide, the program refers Connecticut residents, ages 50 through 64, for colonoscopy screening and follow-up.  Find telephone numbers of participating community health centers.
• Teleradiology is helping bring virtual colonoscopy to remote areas of Arizona.  While physicians and equipment for optical colonoscopy screening often is not available in rural areas, CT colonography can be performed by technologists and information be uploaded to a workstation and interpreted by an off-site radiologist.  During a study at the University of Arizona, 86 patients were screened with CT colonography in two rural health centers. Radiologist Arnold Friedman, MD, FACR, who led the study, reported its results at the American Roentgen Ray Society meeting in Boston
• The FDA and the Federal Trade Commission warn consumers against websites or products that offer to prevent, treat, or cure the 2009 H1N1 influenza virus.   FTC Chairman Jon Leibowitz said, “The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies. The FTC will act swiftly against companies that resort to deceptive advertising.” The FDA provides information about buying medicine online and has a web page dedicated to influenza information, including H1N1 updates.

In response to a proposed national coverage decision by the Centers for Medicare and Medicaid Services not to pay for screening CT colonography (CTC) for Medicare enrollees, C3 has submitted comments asking that CMS cover screening CT colonography (virtual colonoscopy) as part of a Coverage with Evidence Development (CED) process.

A CED would enable CMS to determine if CT colonography is safe and effective in the older Medicare population and which patients might benefit from screening using CTC rather than optical colonoscopy.

We believe that older patients should have a choice for colorectal cancer screening methods after a discussion of the risks and benefits of each method with their doctors.  And we want good information available for those patient decisions. 

Recognizing the difference in screening guidelines from the American Cancer Society developed in consensus with the Multi-Society Task Force on Colorectal Cancer and the American College of Radiology which include CTC as a test that can prevent colorectal cancer and those of the United States Preventive Services Task Force (USPSTF) which found “insufficient evidence to assess the balance of risks and benefits of CTC“, C3 urges coverage that could provide more information to clear up this confusion.

C3 comments included:

Therefore, C3 strongly urges CMS to gather the evidence by approving coverage of CTC, and implement the new coverage through a Coverage with Evidence Development (CED) process. A CED will generate additional safety and efficacy data in people over the age of 65, a population that is typically under-represented in clinical research. CED can also generate information that will help to identify patients who can benefit from CTC as opposed to optical colonoscopy.

A complete denial of coverage is akin to “throwing the baby out with the bathwater.” Thus, we urge CMS to use its unique ability to generate data from its consumer base, and determine whether CTC is appropriate for people over age 65.

Background information supporting our comments included:

• Studies that showed CTC equivalent to optical colonoscopy in finding large polyps and colorectal cancers with fewer colon perforations and other complications.
• The need to reach additional people who are not now being screened and who might agree to be tested if CTC were covered by Medicare.
• Confusing and conflicting guidelines that don’t provide clear guidance to balance  risks and benefits for Medicare patients who are deciding on a screening method.

In conclusion,

C3 urges reconsideration of the non-coverage decision by CMS, and strongly urges CMS to gather the evidence by approving coverage of CTC, and implementing the new coverage through a Coverage with Evidence Development (CED) process.

Click here to read the entire comment.