This past March, colorectal cancer advocates:

• Urged Congress to support colorectal cancer research and prevention at Fight Colorectal Cancer’s Call-on Congress
• Made calls to their legislators in support of H.R. 4120
• Got Colorectal Cancer Awareness proclamations in 19 states and cities
• Rang the NASDAQ Closing Bell

This is only a part of the fight though. We must use the momentum of the past month to further our efforts throughout the rest of the year. We must now work even harder and raise our voices even louder to continue to demand a cure for colon and rectal cancer.

Please help us keep our efforts going throughout the year with a donation today, even a $10 or $15 donation will make a major difference. Help make every month a colorectal cancer awareness month!

The time has come in America when the same kind of concentrated effort that split the atom and took man to the moon should be turned toward conquering this dread disease. Let us make a total national commitment to achieve this goal.

Among other things, the legislation

• Strengthened the National Cancer Institute.
• Made the NCI Director a Presidential appointee.
• Provided $400 million to the NCI for 1972.
• Put funding for NCI into a direct bypass budget.
• Gave NCI the power to establish cancer centers and fund research grants.

In 1975 half adults and children with cancer died. Today nearly 7 out of 10 adults and 8 out of 10 children will be alive five years after they are diagnosed.

So are we winning?

Yes

• Between 1990 and 2007, cancer death rates went down 22% for men and 14% for women.
• Over a similar time, death rates from colorectal cancer went down 33.4% for men and 28.4% for women.
• From a single, fifties-era chemo drug for colorectal cancer, we now have 7 approved drugs and targeted agents.
• Colorectal cancer screening, brand-new in 1970, now is a major force in preventing colorectal cancer.
• Chemotherapy after surgery for local and regional colon cancer has pushed the cure rate up to 75%.
• Better imaging and better surgery is now curing more metastatic colorectal cancer.

No

• In 2010, 571,950 people in the United States died from cancer.  That’s more than one person every minute of every day.
• This year 49,380 men and women will die from colorectal cancer, nearly 6 people every hour.
• While fewer people are smoking, obesity is increasing and people are sitting more and exercising less.
• Essentially flat budgets for the NCI since 2003 have meant a loss in research purchasing power of over $1 billion.

“In order to win the war against cancer, we must fund the war against cancer.”  President George W. Bush, September 18, 2002.

Maybe

Have we been asking the wrong questions?

In a recent interview with Medscape Today, Harold Varmus, MD, Director of the National Cancer Institute said that the war on cancer metaphor is no longer valid,

First of all, I think we’ve changed the metaphor. It’s inaccurate, in my view, to think of a war on cancer as though cancer were a single, individual enemy, nor is the metaphor of war exactly right. We now understand that cancer is actually a constellation of diseases, many different diseases arising in different tissues. Indeed the number of diseases that cancer represents has only multiplied over the last 40 years as we understand more and more about how cancers arise.

Second, we understand that cancer is an outgrowth of some fundamental principles of biology, how genes control our development, how development goes awry, how different genes can influence the initiation and progression of cancer.

For more information on progress toward ending suffering and death from cancer:

• American Society of Clinical Oncology CancerProgress.Net Timeline
• American Association for Cancer Research Cancer Progress Report 2011: Transforming Patient Care Through Innovation
• American Cancer Society Cancer Facts and Figures 2011
• NCI Video: President Nixon signing the National Cancer Act of 1971

In the AACR Cancer Progress Report 2011, AACR leaders write,

We live in an unprecedented time of scientific opportunities, and our commitment to prevent and cure cancer has never been stronger.

Fight Colorectal Cancer agrees.

However, it’s important to note that the virtual colonoscopies were done without laxative preparation.

In addition, optical colonoscopies found more advanced lesions (large polyps and cancers) than CT colonography.

However, as an overall strategy, the yield of advanced lesions per 100 people invited to participate in screening was the same because more people agreed to have a CT colonography.

Dutch researchers randomly invited nearly 9,000 people, aged 50 to 74, living in areas around Amsterdam and Rotterdam to participate in colorectal cancer screening either by traditional colonoscopy or CT colonography.  Twice as many were invited for colonoscopy as CT colonography.

CT colonography was done without the usual harsh laxative preparation, but patients were given medicine to “tag” feces.

If CT colonography exams found cancer or polyps bigger than 9 millimeters, doctors referred patients on for a colonoscopy. For smaller polyps 6 to 9 millimeters, surveillance with further CT colonography was recommended.

The research team found:

• For colonoscopy, 5,924 people were asked and 1,276 agreed — 22 percent.
• For CT colonography, 2,920 were asked and 982 agreed — 34%.
• 9 percent (111) of those having colonoscopy had an advanced adenoma or cancer.
• 6 percent (60) of those having CT colonography had an advanced lesion.
• 8.7 advanced lesions were found for every 100 invited people with colonoscopy compared to 6.1 advanced adenomas or cancer for those who had CT colonography — a similar “yield” per invitee.

Esther M. Stoop, MD and her colleagues concluded,

Participation in colorectal cancer screening with CT colonography was significantly better than with colonoscopy, but colonoscopy identified significantly more advanced neoplasia per 100 participants than did CT colonography. The diagnostic yield for advanced neoplasia per 100 invitees was similar for both strategies, indicating that both techniques can be used for population-based screening for colorectal cancer. Other factors such as cost-effectiveness and perceived burden should be taken into account when deciding which technique is preferable.

In an editorial accompanying the article in The Lancet Oncology, radiologist Dr. Perry Pickardt said,

The bottom line is quite simple—too many people are dying of a readily preventable disease. The issue with screening for colorectal cancer is not related to test efficacy per se, but rather to the willingness of patient participation (and study availability). By offering the additional option of CT colonography for screening, overall patient outcomes will be positively affected by the equivalent (or greater) yield for advanced neoplasia coupled with a decrease in complications and costs.

Of note, both colonoscopy and CT colonography confer the crucial advantage of cancer prevention through detection (and removal) of advanced adenomas over the cancer detection aspect alone that is provided by current stool-based testing. The additive yields of having both colonoscopy and CT colonography available as primary screening options could have a profound effect on the incidence and mortality of colorectal cancer in the future.

Dr. Pickardt also pointed out that the CT colonography in the study was done without laxative preparation and using an older two-dimensional CT reading. Other studies with bowel prep and three-dimensional readings have found both methods equivalent in finding advanced polyps and cancer.

SOURCES

Stoop et al., The Lancet Oncology, Early Online Publication, 15 November 2011

Pickhardt Editorial, The Lancet Oncology, Early Online Publication, 15 November 2011

Taped before a live audience in Charlotte, NC comprised of cancer survivors and those touched by cancer, Kaleidoscope on Ice will air nationally on FOX on Thanksgiving Day at 4:00pm EST, immediately following the FOX Thanksgiving Day football telecast.

Olympic champions Scott Hamilton & Dorothy Hamill will co-host this year’s event which combines the beauty of Skating, the excitement of Song and the brave message of Survivorship to raise awareness of the key issues surrounding cancer.

Kaleidoscope on Ice will feature an unprecedented line up of Olympic and World champion figure skaters and award winning musical talent including Olympic silver medalist Nancy Kerrigan, 3-time U.S. national champion Johnny Weir, and Olympic silver medalist Sasha Cohen. The unforgettable, star-studded roster also includes 4-time world champion Kurt Browning, Olympic silver medalist Paul Wylie, Olympic bronze medalist Joannie Rochette, and more.

Complimenting amazing skating, the legendary, Grammy Award winner Patti LaBelle and American Idol winner Jordin Sparks will be performing, along with rising country musician Hunter Hayes, and Billboard’s 2011 Artist to Watch, Andy Grammer.  

Now in its 3^rd year, the Kaleidoscope mission is to provide America’s 12 million+ cancer survivors and their caregivers with inspiration, information and resources to help them thrive, live life to its fullest and feel empowered as they navigate their journey of survivorship.

They were almost three times as likely to have been screened and more likely to be diagnosed early.

Researchers analyzed information in the Surveillance, Epidemiology, and End Results Medicare–linked database for people diagnosed with colorectal cancer between 1994 and 2005 to look for links between primary care and outcomes after diagnosis.

They found that compared to colorectal cancer patients who never saw a primary care doctor or saw one only once, Medicare patients who visited their doctor 5 to 10 times in the 3 to 27 months before diagnosis were

• 16% less likely to die of colorectal cancer
• 35% more likely to be diagnosed early
• 6% less likely to die from any cause
• 2.6 times more likely to have been screened for colorectal cancer

Family physician Jeanne M. Ferrante, MD, MPH and her colleagues concluded,

Medicare beneficiaries with colorectal cancer have better outcomes if they have greater utilization of primary care before diagnosis. Revitalization of primary care in the United States may help strengthen the national efforts to reduce the burden of CRC.

SOURCE: Ferrante et al,  Archives of Internal Medicine, Vol. 171 No. 19, October 24, 2011

Surveillance, Epidemiology, and End Results–Medicare–linked database

On Saturday, November 5, 2011, Get Your Rear in Gear will hold its annual 5k Run/Walk for colon cancer awareness and the Tony Snow Mile for a Miracle at Fort Hunt Park in Alexandria, Virginia. The event will begin with the Mile for a Miracle at 8:30 a.m. followed by the 5K Run at 8:45 a.m. and the 5K Walk at 8:50 a.m. Funds raised from the event will benefit Fight Colorectal Cancer.

Palmetto GBA, the designated national contractor for Oncotype DX Colon Cancer Assay, has determined that the test

Meets criteria for analytical and clinical validity and clinical utility as a reasonable and necessary Medicare benefit. Effective September 18, 2011, Palmetto GBA will reimburse Oncotype DX® Colon Cancer Assay services for patients diagnosed with Stage II colon cancer.

The Oncotype DX Colon Cancer Assay indicates how likely it is that stage II colon cancer will return (recur).  It tests tumor tissue for twelve genes to develop a recurrence score that patients and their doctors can use in combination with other clinical information to make decisions about having chemotherapy after surgery.

The test does not predict whether or not chemotherapy will reduce risk of recurrence, but it does indicate risk for recurrence.

The Oncotype DX test is done with tumor tissue removed during colon cancer surgery and preserved in paraffin blocks.  Your doctor can help you obtain that tissue from the pathology laboratory where it was analyzed after your operation and stored.

Genomic Health, which developed and markets the Oncotype DX Colon Cancer Assay, warns that while Palmetto GBA processes original Medicare claims nationwide, Medicare Advantage plans may not all cover the test.  If you have Medicare Advantage, check with your plan for coverage information.

For other insurance programs Genomic Health’s Genomic Access Program (GAP) will help determine coverage, obtain prior authorization if necessary, and help with appeals if the claim is denied.

Genomic Health also has a financial assistance program to help uninsured or underinsured patients with the cost of the test.

For help with coverage questions call Genomic Health Customer Service at 866-ONCOTYPE (866-662-6897).

Frequently asked questions about Oncotype DX Colon Cancer Assay.

More information about how the 12-gene genomic test was developed and validated from Fight Colorectal Cancer.

Disclosure: Fight Colorectal Cancer has accepted funding for projects and educational programs from Genomic Health in the form of unrestricted educational grants. Fight Colorectal Cancer has ultimate authority over website content.

They have a new website that can help you start the communication with your doctor, even before you get to your appointment.

AHRQ says,

Asking questions and providing information to your doctor and other care providers can improve your care. Talking with your doctor builds trust and leads to better results, quality, safety, and satisfaction.

They suggest beginning with these ten critical questions during your medical visit:

1. What is the test for?
2. How many times have you done this procedure?
3. When will I get the results?
4. Why do I need this treatment?
5. Are there any alternatives?
6. What are the possible complications?
7. What hospital is best for my needs?
8. How do you spell the name of that drug?
9. Are there any side effects?
10. Will this medicine interact with medicines I am already taking?

You can build your own set of questions using AHRQ’s online Question Builder.

Molly Glassman is her mother’s advocate.  Sometimes she worries that asking questions will “rub her Mom’s doctors or nurses the wrong way” and affect quality of care.  But her experience is very different and asking questions helped her mother. Watch her talk about getting a medicine that harmed her mom changed and making sure the change got communicated to the nursing staff and the computer.

It is important to write down the questions you want answered.  In busy medical practices, having three most important questions at the top of your list makes sure your most serious concerns get answered.

The interval for taking the medicine will also change from 2 pills every 4 to 6 hours to 2 pills every 6 hours.

McNeil Consumer Healthcare, the makers Tylenol of announced the change to help prevent overdoses of acetaminophen.

Although acetaminophen is safe when used as directed, it is part of over 600 over-the-counter and prescribed medicines.  Maximum doses can be exceeded when people take several different medications at the same time, and too much acetaminophen can cause liver damage.

In addition to labeling changes, McNeil has launched several websites to help consumers understand acetaminophen risks and discover what medicines they are taking that include acetaminophen.

• Get Relief Responsibly has facts about acetaminophen and risks to the liver.
• Find out which of your medicines include acetaminophen and print out a list for your doctor.
• Learn how to read a drug facts label.

Cancer patients need to know that pain medicines such as Percoset®, Vicodin®, and oxycodone/APAP all contain acetaminophen.  Check the labels carefully for the amount of acetaminophen and don’t exceed the recommended daily dosage for all sources of acetaminophen.  Ask your doctor or pharmacist for more help.

Now, a new study that looked at nearly 44,000  Medicare patients is challenging that assumption.

Medicare patients 66 and older with high risk stage II colon cancer didn’t do better when they received chemotherapy according to an analysis of information in the SEER-Medicare database.   Whether or not they had chemo, their chance of being alive five years after diagnosis was about 56%.

A research team at the University of Wisconsin analyzed Surveillance, Epidemiology, and End Results (SEER) cancer registries linked to Medicare claims data from 1992 though 2005 for patients with stage II and III colon cancer.  Their goal was to find out whether, using the large number of patients in that database who were being treated in the community, they could prove that adjuvant chemotherapy made a difference in the percentage of patients who lived at least five years after their cancer diagnosis.

The team’s primary outcome was 5-year overall mortality, meaning death from any cause during the five years following a diagnosis of colon cancer.

Overall, they had information on 43,032 people, including 24,847 with stage II colon cancer and 18,135 with stage III.

Poor prognostic clinical features available in the SEER-Medicare data included:

• colon obstruction at the time of diagnosis
• colon perforation
• T4 tumor — tumor that penetrates the outermost layer of the intestines or invades nearby organs
• poorly differentiated pathology — cells that look very different from normal colon cells under the microscope.
• fewer than 12 lymph nodes examined

Information about two other factors that have a poor prognosis in colon cancer were not available to study:

• CEA level before surgery
• peritumoral lymphatic/venous invasion

Results

While five-year survival was higher for all stage II patients with no poor prognostic features than for those whose tumor had at least one high risk issue, getting chemotherapy didn’t make a difference in the percentage of patients — high risk or not — who were alive five years after their diagnosis.

In considering these numbers remember that they apply to people who did not die from any cause five years after diagnosis, not only from colon cancer, and they are based on people 66 and older who are more likely to die than younger individuals.  They cannot tell any individual their risk of dying from colon cancer.

Poor prognostic features didn’t play a large role in choosing patients for chemotherapy.  About 20% of patients in both the stage II risk groups received chemo. Instead, people who were younger, male, married, and not have other health problems were more likely to be treated with chemotherapy after surgery.

The team, led by Erin S. O’Connor, M.D., concluded,

In conclusion, we find that patients with stage II colon cancer,even those with any of six identified poor prognostic features, do not have a significant survival benefit from chemotherapy. Given the frequent use ofchemotherapy in this generalizable population of older adults, this suggests that, in practice, many patients may be receiving chemotherapy with a disadvantageous risk-benefit ratio. Given the statistical power of this study, clinicians may wish to counsel high-risk older adults with colon cancer that any possible survival benefit is likely less than 2% at 5 years.

In an editorial accompanying the study, Neal Merapol, M.D., reminds us that, “We we must not divert attention from discovery of more effective treatments.”  Dr. Merapol writes,

 The study by O’Connor et al suggests that in a real-world setting,adjuvant treatment of older patients with stage II colon cancer and high-risk clinical features does not improve survival. Is this example of comparative effectiveness research sufficient to guide clinical practice?

Given consistency with clinical trial data and the lack of compelling data to the contrary, this report must be viewed as more than merely hypothesis-generating, and should discourage routine use of adjuvant treatment in this patient population

During a JCO Podcast, Leonard B. Saltz, M.D., head of the Colorectal Oncology Section at Memorial Sloan Kettering Cancer Center, discusses the O’Connor study and stage II challenges faced by doctors and patients.

SOURCE

O’Connor et al, Journal of Clinical Oncology, published online before print July 25, 2011.

Meropol, Ongoing Challenge of Stage II Colon Cancer, Journal of Clinical Oncology, published online before print July 25, 2011.

What This Means for Patients

This study adds additional information to that available for colon cancer patients who are trying to make a good decision about whether or not to have chemotherapy after surgery for stage II colon cancer.

While based on a large number of patients treated in real-world settings, it cannot provide a definitive answer for every patient:

• Patients in the study were all older than 65.
• Since the information only went through 2005, few patients treated with oxaliplatin are likely included.
• Risk factors are clinical ones.  The study doesn’t include molecular markers, such as microsatellite instability, that are know to improve survival in stage II.

ASCO Recommendations on the Use of Adjuvant Chemotherapy for Stage II Colon Cancer published in 2004 say,

Recommendations: The routine use of adjuvant chemotherapy for medically fit patients with stage II colon cancer is not recommended. However, there are populations of patients with stage II disease that could be considered for adjuvant therapy, including patients with inadequately sampled nodes, T4 lesions, perforation, or poorly differentiated histology.

Conclusion: Direct evidence from randomized controlled trials does not support the routine use of adjuvant chemotherapy for patients with stage II colon cancer. Patients and oncologists who accept the relative benefit in stage III disease as adequate indirect evidence of benefit for stage II disease are justified in considering the use of adjuvant chemotherapy, particularly for those patients with high-risk stage II disease. The ultimate clinical decision should be based on discussions with the patient about the nature of the evidence supporting treatment, the anticipated morbidity of treatment, the presence of high-risk prognostic features on individual prognosis, and patient preferences. Patients with stage II disease should be encouraged to participate in randomized trials.

 Bottom Line

Discuss risks and benefits of chemotherapy for stage II colon cancer with your doctor.