Removing the entire colon (subtotal colectomy) is sometimes recommended for patients with Lynch syndrome when colon cancer is diagnosed.  In addition, some people who have an inherited Lynch mutation have their colons removed to prevent colon cancer.

While subtotal colectomy didn’t reduce deaths from Lynch-related colon cancer, it did cut down on additional colorectal cancer diagnoses and the need for other abdominal surgery.

Five years after surgery, 93 percent of patients who had subtotal colectomy were alive compared to 88 percent of those who had more limited operations or no surgery.  This wasn’t a significant difference.  However, 84 percent survived the five years without needing additional abdominal surgery compared to 63 percent of the group who had limited or no surgery.

Researchers analyzed people with Lynch syndrome in the Creighton University database.  Cases included those who had subtotal colectomy, either at the time of colon cancer diagnosis or as preventive surgery. They were compared to controls who had limited operations to remove only part of the colon (segmental colectomy).

In subtotal colectomy the colon is removed and the small intestine is attached to the rectum, which remains in place.

Five years after surgery, comparing those who had subtotal colectomy to those with limited resection:

• 94 percent were alive without another colorectal cancer compared to 74 percent of the controls alive and without subsequent colorectal cancer.
• 84 percent survived without needing abdominal surgery compared to 63 percent of controls.
• 93 percent lived five years compared to 88 percent of controls.
• Time to another colorectal cancer or the need for abdominal surgery was shorter for those who had a limited resection.

Their conclusion:

Even though no survival benefit was identified between the cases and controls the increased incidence of metachronous colorectal cancer and increased abdominal surgeries among controls warrant the recommendation of subtotal colectomy in patients with Lynch syndrome.

Lynch syndrome is a highly increased risk for colorectal and other related cancers caused by an inherited mutation in one of the mismatch repair genes.  People with a Lynch syndrome genetic mutation have a lifetime risk for colorectal cancer as high as 80 percent.

SOURCE: Natarajan et al., Diseases of the Colon and Rectum, Volume 53, Issue 1, pages 72-82, January 2010.

The first of this year’s Get Your Rear in Gear walks and runs to raise awareness of colorectal cancer is scheduled for February 28 in Lafayette, LA.

The day begins with a Kids Fun Run at 8:00 am, followed by a 5K timed run/walk at 8:30

You can pre-register by mail through February 15 or online through February 23.  After that registration is available the day of the run.

Currently there are 22 Get Your Rear in Gear events planned for 2010 across the country in cities from New York to San Francisco.  The next walk/run is scheduled for Raleigh, NC on March 6.

The sponsors of the Get Your Rear in Gear events, the Colon Cancer Coalition, describe them:

Get Your Rear in Gear races are a series of nationwide events to raise awareness and funds for colorectal cancer. Funds raised will be invested in local programs to raise awareness of colon and rectal cancer, invest in innovative projects to help increase screening for colorectal cancer, especially for the under- or non-insured, and provide support to those touched by colorectal cancer. By working together, we can have a positive impact on colon and rectal cancer in our community and beyond.

The Colon Cancer Coalition is headquartered in Bloomington, MN.

The fiscal year 2011 budget process got underway today when President Obama sent Congress his budget proposal.  The President’s $3.8 trillion budget includes a three-year freeze on non-security discretionary spending in order to save about $250 billion over 10 years and start narrowing the $1.6 trillion gap between proposed budget outlays and tax receipts.  The freeze caps the overall level of spending so that some programs get increases (for example, cancer research at NIH and NCI receives a funding increase), while other programs (including some of the cancer control programs at the CDC) are cut.  The freeze comes on top of a proposal to eliminate, or scale back, 120 programs in order to save more than $20 billion.

U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius issued the following statement of support,

“[u]nder this budget, we will provide the health and human services that Americans depend on more effectively, slashing waste and focusing programs on results.  And we’ll make many of the necessary investments our country has been putting off for years, including investments in fighting health care fraud, strengthening our public health infrastructure, and getting serious about health and wellness,” said Sebelius. “This budget is a big step toward a healthier, stronger America.”

The President’s budget includes $32.09 billion for the National Institutes of Health (NIH).  The proposed funding level for NIH would be an increase of $1 billion (3.2 percent) over last year to support innovative projects from basic to clinical research.  The increase in funding for the NIH will allow the agency to initiate 30 new drug trials in 2011, and double the number of novel compounds in Phase 1 – 3 clinical trials by 2016.  In addition, FY 2011 funding will support the completion of a comprehensive catalog of cancer mutations for the 20 most common malignancies, setting the stage for complete genomic characterization of every cancer as part of medical care within 10 years.

The NIH budget includes:

• $5.26 billion for the National Cancer Institute – an increase of $161 million (3.16 percent); and
• $219 million for the National Center on Minority Health and Health Disparities – a $7 million increase (3.5 percent).

The President’s FY 2011 budget proposal also provides $2.5 billion for the Food and Drug Administration (FDA) – an increase of $148 million (6.26 percent) over last year.  The funding increases for the FDA include increases to bring more lower cost generic drugs and generic biologics to market as well as funding to expand post-market safety surveillance of medical products, and to support FDA’s efforts to make safety data more comprehensive and accessible to patients, providers, and scientists.

That is the good news.

The bad news is the Centers for Disease Control and Prevention (CDC) budget.  The President’s FY 2011 budget proposal reduces funding for CDC cancer prevention and control programs, including the Office of Smoking and Health, by $19 million (3.9 percent) below last year’s funded level.  Specifically, the National Breast and Cervical Early Detection Program is cut by $4 million (2 percent) and the Office of Smoking and Health is cut by more than $3 million (3.2 percent).

The CDC’s Colorectal Cancer Screening, Education & Outreach program is funded at $45 million.  This is the same level the program was funded at for fiscal year 2010.

Two CDC cancer control programs are eliminated under the President’s budget.  The Geraldine Ferraro Blood Cancer Program, which received $4.7 million in FY 2010, and the Gynecologic Cancer and Education and Awareness (Johanna’s Law) Program, which received $6.8 million in FY 2010, are zeroed out under the President’s FY 2011 budget proposal.

The Centers for Disease Control and Prevention have identified more than 200 people who got sick with the Montevideo strain of salmonella from salami.

On January 23, 2010 the US Department of Agriculture Food Safety and Inspection Service announced that the Rhode Island company, Daniele International, was recalling over a million pounds of ready-to-eat Italian sausages, including salami.  The USDA FSIS lists the products being recalled.

The Rhode Island Department of Health found the salmonella Montevideo strain in an open container of black pepper at Daniele, Inc.  That particular brand of pepper is only distributed to Daniele, limiting risk of contamination of foods from other manufacturers.  Daniele is recalling all its products that contain black pepper.

The CDC provides the following information about salmonella infections, which may be of particular worry to people with cancer where chemotherapy has compromised their immune systems and to the elderly.

Most persons infected with Salmonella develop diarrhea, fever, and abdominal cramps 12–72 hours after infection. Infection is usually diagnosed by culture of a stool sample. The illness usually lasts from 4 to 7 days. Although most people recover without treatment, severe infections may occur. Infants, elderly persons, and those with weakened immune systems are more likely than others to develop severe illness. When severe infection occurs, Salmonella may spread from the intestines to the bloodstream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.

If you have questions about the recall you can contact the Daniele hotline at (888) 345-4160.

The CDC warns that potentially contaminated products may still be in stores or in home freezers.  Check the list of recalled meats on the USDA FSIS list and either return the package to the store or seal it securely so it cannot be eaten by people or animals and throw it in the trash.

Although Medicare pays for colorectal cancer screening, not all older people enrolled in Medicare are screened.

Reviewing published medical literature, a task group from the National Colorectal Cancer Roundtable found research identifying both barriers to screening and factors that made it easier.

The most frequently mentioned barrier related to healthcare providers was lack of a doctor’s recommendation.  Having a usual source of health care facilitated getting screened.

Other barriers included:

• Low level of education
• African American race
• Hispanic ethnicity
• female gender

Being married or living with a partner was the most frequent personal faciliator.

Lack of health insurance or dual coverage with Medicare and Medicaid were most frequently reported insurance barriers to getting screened, while Medicare coverage was consistently reported as facilitating it.

Idris Guessous led the study team from the National Colorectal Cancer Roundtable Screening Among the 65 Plus Task Group.

SOURCE: Guessous et al., Preventive Medicine, Volume 50, Issues 1-2, pages 3-10, January-February 2010.

Briefly

• The Colorectal Cancer Association of Canada is sponsoring a contest for print and video ads that raise awareness of colorectal cancer.
• Clinical trials at the NIH Clinical Center in Bethesda, MD are an option for cutting-edge treatment at no cost.
• When co-pays are raised for Medicare, the elderly make fewer outpatient visits but are hospitalized more often and stay in the hospital longer.

Raise CRC awareness with an ad or video and win!

Your print or video public service announcement to raise awareness of colorectal cancer and its prevention could be a winner.

The Colorectal Cancer Association of Canada will award $2,500 for the best video and $1,000 for the best print ad that reduces colorectal cancer by encouraging:

• Prevention= health lifestyles, diet and exercise, screening
• Awareness= signs, symptoms, stats
• Education= knowledge about treatments
• Support= cancer coaching and psychosocial aspects
• Advocacy = access to diagnostics and medicine

Entries must be submitted online and be received by March 31, 2010.

Cancer clinical trials at the National Institutes of Health in Bethesda

The National Cancer Institute Center for Cancer Research in Bethesda, MD, just outside of Washington D.C., conducts cancer clinical trials, including trials for colon and rectal cancer.

There is no cost to participate in a clinical trial at the NIH Clinical Center.  In addition, transportation expenses are paid and there is a per diem to cover meals and lodging for outpatients.

Higher co-pays for Medicare end up costing more

When Medicare co-pays are raised for ambulatory visits, plan members make fewer out-patient visits, but are hospitalized more often and for more days.

In plans that raised co-pays, there were 20 fewer out-patient visits per 100 enrollees each year, but 2 more hospitalizations and 13 more days in the hospital compared to plans that kept co-pays stable.

For every 100 patients in plans that raised co-pays, the plan got $5,950 in extra money from co-pays and saved $1,200 from fewer outpatient visits for a net savings to the insurance plan of $7,150.  However, with an average cost of $11,o65 for each hospitalization of a patient 65 to 84, the increase in hospitalization cost $24,000 for each 100 plan enrollees.

Increased co-pays hit low-income, black, and less-educated patients particularly hard, decreasing numbers of visits and increasing hospitalizations.

Writing in the January 28, 2010 issue of the New England Journal of Medicine, lead author Amal N. Trivedi, MD, MPH and team concluded,

Increasing copayments for ambulatory care reduced the use of outpatient care among elderly enrollees in managed-care plans, but this decline was offset by an increase in hospitalizations, particularly among enrollees with low socioeconomic status and those with chronic disease. Increasing copayments for ambulatory care among elderly patients may have adverse health consequences and may increase spending for health care

Patients with stage IV colorectal cancer live longer when tumors in their liver can be removed surgically, but not all patients have cancer that can be operated on.

Separating patients with liver tumors from colorectal cancer into three groups according to possible liver resectability, British doctors found a wide variation in both overall survival and progression-free survival three years later.

A team of surgeons, medical oncologists, and radiologists at the Royal Marsden Hospital in London divided patients in a clinical trial studying CAPOX chemotherapy into three groups:

• A — those whose treatment was considered to be palliative and not treatable with surgery.
• B — those where chemotherapy might convert initially unresectable metastases and make surgery possible.
• C — patients with resectable liver mets receiving neoadjuvant chemotherapy before surgery.

Among 128 patients who were part of the study, 74 were in the palliative group, 22 in the conversion, and 32 in the neoadjuvant groups.

Patients had scans every four  chemotherapy cycles, and when it was possible liver surgery was attempted after four or eight cycles.

• Ten patients (45 percent) of the conversion group and 19 (59 percent) of the neoadjuvant group eventually had surgery.
• Three years later, 10 percent of the conversion and 37 percent of the neoadjuvant group were alive and their cancer had not gotten worse (progression-free survival).

Median overall survival for all three groups:

• Palliative treatment — 14.6 months
• Conversion chemotherapy — 24.5 months
• Neoadjuvant chemo — 52.9 months

Patients in the study received CAPOX chemotherapy in three week cycles.  The CAPOX regimen was oral Xeloda® (capecitabine) daily for 14 days after an initial infusion of oxaliplatin on day one.

The team concluded,

This prospective study shows the wide variation in outcome according to baseline resectability status and highlights the potential clinical value of a modified staging system to distinguish between these patient subgroups.

SOURCE: Watkins et al., British Journal of Cancer, Volume 102, pp. 255-261, published online January 19, 2010.

In good news for cancer patients at the end of life,  the Food and Drug Administration has approved a concentrated liquid morphine to relieve acute and chronic pain in patients where other opiates are no longer working.

Although concentrated doses of liquid morphine have used to manage pain for opiate-tolerant patients for some time, the oral concentrated dose was not FDA approved.

The FDA has worked with Roxane Laboratories, the only manufacturer of the 20mg/mL formulation, to be sure that adequate supplies are available to patients in need. 

The action is part of the FDA unapproved drugs initiative.

As part of the unapproved drugs initiative, the FDA had previously sent warning letters to companies that manufactured and distributed  concentrated liquid morphine. After hospice programs and others who help patients at the end of life expressed serious concerns about not having the liquid morphine for cancer patients who could no longer swallow pills, FDA put the ban on hold until the medicines could get approval.

In announcing the approval, Douglas Throckmorton, M.D., deputy director for the FDA’s Center for Drug Evaluation and Research said,

An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards. Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.

C3 President Carlea Bauman at the National Press Club

Today, C3 hosted a forum with Olympus in Washington DC to discuss current trends in colorectal cancer screening and prevention.

C3 President, Carlea Bauman, gave keynote remarks at the forum.  Carlea spoke about the frustration that we face at C3 when we receive calls to our Answer Line from individuals looking for assistance finding affordable screening services and we only have a patch-work network of assistance available to them.  Carlea explained that the way to change this is with enactment of a national screening and treatment program, “I look forward to the day where a national program exists so that when these calls come in, we can say, ‘Yes, you can get screened and yes, you can afford it.’”

I spoke on one of the panels about the impact the pending health care reform legislation will have on colorectal screening and why even if health care reform passes we will still need to enact legislation creating a national screening and treatment program for colorectal cancer.  To read the text of my remarks, click here.

Other speakers at today’s forum included:

• Dr. David Johnson, MD, Professor of Medicine and Chief of Gastroenterology, Eastern Virginia Medical School
• Dr. Douglas Rex, MD, Director of Endoscopy at Indiana University Hospital and Professor of Medicine at Indiana University School of Medicine
• Mr. David Woodmansee, Senior Specialist for State and Local Campaigns, Colorectal Cancer Screening Programs, American Cancer Society Cancer Action Network
• Dr. Gregory Ginsberg, MD, Professor of Medicine and Director of Endoscopy, University of Pennsylvania Health System
• Dr. Laura Seeff, MD, Associate Director of Colorectal Cancer Programs, Centers for Disease Control and Prevention
• Dr. Ronald Myers, PhD, Director of the Kimmel Cancer Center and Professor of Medicine, Thomas Jefferson University
• Dr. Patrick Okolo, MD, Chief of Endoscopy, Johns Hopkins Hospital

The panelists provided an overview of where the nation is regarding colorectal cancer screening.  They discussed the role of insurance in screening rates and the difference between states with and without mandates.  They provided an overview of current guidelines and the strong evidence for screening as well as discussing the importance of quality in screening services.

Dr. Seeff with the CDC gave an overview of the CDC’s Screen for Life and Colorectal Cancer Control Programs.  She and the other panelists also discussed the lack of screening access for underserved populations and potential solutions.

Speakers also discussed the current and projected colorectal cancer screening capacity.  In addition, panelists discussed how adherence to guidelines and improving patient follow through are critical for doctors.

As soon as it is available, we will be posting video of today’s forum so that you can listen to the discussion from all of the panelists about the current state of colorectal cancer screening and prevention.

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.