Ask almost anyone after their first colonoscopy, and they’ll tell you, “The procedure was nothing, but the prep was awful.”

Now patients are reporting that combining MiraLAX®, an over-the-counter laxative, with 2 quarts of Gatorade tastes better and is easier to take than the standard 4-quart Golytely colonoscopy preparation. In a randomized clinical trial , almost 100 percent said they would repeat it again, compared to 1 out of 4 who wouldn’t take GoLYTELY® in the future.

In addition, doctors found no differences in how thoroughly the two preps clean the colon.

Splitting the dose between the night before the colonoscopy and the morning of the procedure did improve colon cleansing. But there was no difference in cleansing between split-dose GoLYTELY and split-dose MiraLAX with Gatorade.

Although the combination of MiraLAX and Gatorade is being used to clean the colon before colonoscopy by community gastroenterologists, there hasn’t been evidence that it was safe and effective. Gastroenterologists at the VA Healthcare System in Long Beach, California and at the University of California Irvine developed a randomized clinical trial to compare the MiraLAX prep with traditional  GoLYTELY.

They also compared bowel cleansing quality between giving all of the dose the night before colonoscopy to splitting the dose between the evening before and the morning of the exam.

Results:

• There was no difference in bowel cleansing between the GoLYTELY and the MiraLAX/Gatorade preps.
• There was a significant difference in bowel cleansing when either prep was given in a split dose. Split doses were better.
• On a questionnaire, patients reported better taste and tolerability for the MiraLAX prep.
• 96.8 percent of patients said they would be willing to repeat the MiraLAX prep compared to 75 percent of the GoLYTELY patients.
• There were no significant changes in electrolytes before and after the prep between MiraLAX and GoLYTELY or in single-dose or split doses.

GoLYTELY is a powdered form of polyethylene glycol (PEG-ES) and electrolytes. It is combined with about a gallon of water to draw fluid into the colon to flush out feces.

MiraLAX is also powdered PEG, but doesn’t contain electrolytes. It needs to be combined with two quarts of Gatorade to replace the electrolytes lost in watery diarrhea during the prep process.

Jason B Samarasena MD and his colleagues concluded,

Split-dosed MiraLAX/Gatorade was an effective, safe, and tolerable option for bowel preparation before colonoscopy in the low-risk patients in this study. MiraLAX/Gatorade appears to be more tolerable than Golytely as a bowel cleansing regimen and was the preferred agent by the patients in this study.

What This Means for Patients

Ask your gastroenterologist about combining MiraLAX with Gatorade as a preparation for colonoscopy.

Splitting the prep in two doses: one the evening before your test and the other half the morning before the exam will improve colon cleansing. A clean colon is critical to an accurate exam.

Source: Samarasena et al, The American Journal of Gastroenterology, advance online publication May 8, 2012.

Click Here to Get updates from Fight Colorectal Cancer

The first four sites where colorectal cancer patients can get regorafenib are now open.  Bayer Healthcare expects to open additional sites in the next two or three weeks.

Colorectal cancer patients whose cancer has gotten worse on all standard treatments can now be considered for the Regorafenib Extended Access program.

Bayer Healthcare has applied for FDA approval of regorafenib to treat colorectal cancer, but until it is actually approved and on the market, the expanded access program is the only way patients who might benefit can receive it.

Last fall, early results from the randomized Phase 3 CORRECT clinical trial showed colorectal cancer patients who received regorafenib lived longer than a similar group who got a placebo.

Results of the CORRECT trial were discussed at the 2012 GI Cancers Symposium in January.  Axel Grothey, MD and his team concluded,

Statistically significant benefit in overall survival and progression-free survival was observed for regorafenib over placebo in patients with metastatic colorectal cancer who have failed all approved standard therapies. No new or unexpected safety signal was found.

Patients in the expanded access program will get regorafenib pills every day for three weeks, followed by a week’s rest before repeating the treatment cycle.

The first sites are now open in:

• Sumter, SC
• Charleston, SC
• Jefferson City, MO
• Aventura, FL

For additional information email clinical-trials-contact@bayerhealthcare.com

The FDA reminds patients who use fentanyl patches for pain to take special care storing, using, and discarding them.

Recently the FDA evaluated 26 cases of children’s accidents that involved the patches including 10 deaths and 12 hospitalizations. Sixteen children were under two years of age.

Problems included curious children finding patches in the trash or stored within their reach. In addition, loose patches transferred the potent narcotic medicine to children who were being held or carried. Even used patches can still contain significant amounts of fentanyl, enough to seriously hurt a child.

Before using either the brand name Duragesic® or generic fentanyl transdermal system patches, read the FDA approved Medication Guide.

Safety includes

• Storing fentanyl patches where children cannot reach them, including in locked cabinets or behind child-safe latches.
• Making sure patches are firmly attached. Patches can be covered with special Bioclusive™ or Tegaderm™ see-through adhesive dressings for extra security, but don’t use any other bandage or tape. Check the patch often to make sure it is still securely in place.
• Disposing of fentanyl patches properly. Fold the sticky sides together and flush down the toilet. Do not put in the trash.

Early signs of fentanyl exposure may be hard to notice in children. If there is any reason to suspect an infant or child has come into contact with fentanyl, get emergency help right away.

Image courtesy of the FDA.

Dole Fresh Vegetables is voluntarily recalling over 750 cases of DOLE® Seven Lettuces salad with Use-by Date of April 11, 2012.

While no illness has yet been associated with eating the salads, a random sample collected by the State of New York found contamination with Salmonella.

The recalled packages have a UPC code of 71430 01057 and Product Codes 0577N089112A and 0577N089112B.

Consumers should check the codes and the use-by date and throw out any suspicious salads. Retailers are being told to check shelves for any remaining Dole Seven Lettuce salads and remove them.

If you have questions, you can call the Dole Food Company Consumer Response Center at (800) 356-3111, which is open 8:00 am to 3:00 pm (PDT) Monday – Friday.

People with cancer or who are on chemotherapy should be especially careful to avoid foods that may carry bacteria. They have less healthy immune systems and can become seriously ill from Salmonella infections.  Young children and the elderly are also at risk for severe, sometimes life-threatening infections.

More information about Salmonella from the Centers for Disease Control.

Symptoms of salmonella infection include diarrhea, vomiting, and abdominal cramps that develop 12 to 72 hours after eating something contaminated by the bacteria. Most healthy adults recover without treatment, but severe cases may require a trip to the hospital and antibiotics.

When patients  were offered a choice of colorectal cancer screening with either FOBT or colonoscopy, they were significantly more likely to complete that screening than when their doctors recommended only FOBT or only colonoscopy.

Nearly 1000 racially and ethnically diverse patients in urban primary care practices were randomly assigned to get colorectal cancer screening via:

• Fecal occult blood testing (FOBT)
• Colonoscopy, or
• Their choice of either FOBT or colonoscopy.

Overall, 58 percent were screened within the next year. 

• 67 percent of those offered an FOBT home test finished screening.
• 38 percent of those who got a colonoscopy recommendation actually had the exam.
• 69 percent of patients who had a choice were screened.

Non-whites were more likely to complete FOBT, while whites accepted colonoscopy more often. Latinos and Asians were more likely to complete screening than African Americans

John M. Inadomi, MD and his team concluded,

The common practice of universally recommending colonoscopy may reduce adherence to CRC screening, especially among racial/ethnic minorities. Significant variation in overall and strategy-specific adherence exists between racial/ethnic groups; however, this may be a proxy for health beliefs and/or language. These results suggest that patient preferences should be considered when making CRC screening recommendations.

SOURCE: Inadomi et al, Archives of Internal Medicine, Volume 172, Number 7, April 9, 2012.

How soon should average risk people get another colorectal cancer screening after they have a normal colonoscopy?

No sooner than 10 years, the American Gastroenterological Association recommends as part of the Choosing Wisely campaign.

The AGA’s list of Five Things Physicians and Patients Should Question includes:

1. Use the lowest possible effective dose of acid reducing medicines to treat gastroesophageal reflux disease (GERD).
2. After a negative, quality colonoscopy, don’t repeat colorectal cancer screening by any method for 10 years.
3. After removing 1 or 2 small (less than 1 centimeter) adenomatous polyps without signs of cellular change (dysplasia), don’t repeat the colonoscopy for at least 5 years.
4. After two endoscopies without dysplasia, people with Barrett’s esophagus shouldn’t have another upper endoscopy for at least 3 years.
5. Patients with abdominal pain shouldn’t have a repeat CT scan unless there are major changes in symptoms or clinical findings.

AGA’s list is based on current published recommendations for the time between colonoscopy and endoscopy in people with low risks for cancer.

The Choosing Wisely campaign wants doctors and patients to talk together about tests and treatments that are supported by evidence, don’t duplicate other tests or procedures, are free from harm, and are truly necessary.

Ask your doctor, “Do I really need this test?” and “Do I need it now?”

Oncologists have joined eight other physician specialty organizations in the Choosing Wisely® campaign with a list of the Top Five Cancer-Related Tests, Procedures, and Treatments That Many Patients Do Not Need.

Choosing Wisely asked each of the specialist groups to come up with a list of five things doctors and patients should question in order to improve evidence-based care, avoid tests or treatments that don’t help, and reduce the burden of health care costs. Here are the Top Five lists from the other groups.

The American Society of Clinical Oncology  built the Top Five List for Oncology, based on work that ASCO’s Cost of Care Task Force has been doing for several years to identify diagnostic tests or treatments that are commonly ordered, expensive, and of unproven value.

While the Top Five list is based on evidence for effective cancer care, its recommendations are not written in stone. They are guidelines for patients, families, and doctors to begin a conversation about tests and treatments and costs in order to make good decisions about the best care for each individual.

Briefly the Top Five list recommends

1. Stop active cancer treatment when patients are too ill to benefit, aren’t eligible for a clinical trial, previous treatments haven’t worked, and there are no more standard treatment options.
2. Don’t use advanced imaging tests (CT, PET, bone scans) for early prostate cancer which has a low risk of spreading.
3. Don’t use similar imaging tests for early breast cancer that has a low risk of spreading.
4. Don’t use PET, CT, bone scans or biomarkers to follow-up breast cancer patients without symptoms after treatment intended to cure them.
5. Don’t give medicines to stimulate white cells in patients with a low risk of developing low counts with fever.

More specifically the Top Five for Oncology published ahead of print in the Journal of Clinical Oncology April 3  are:

1. Do not use cancer-directed therapy for patients with solid tumors who have the following characteristics: low performance status (3 or 4), no benefit from prior evidence-based interventions, not eligible for a clinical trial, and with no strong evidence supporting the clinical value of further anticancer treatment.
2. Don’t perform PET, CT and radionuclide bone scans in the staging of early prostate cancer at low risk for metastasis.
3. Don’t perform PET, CT and radionuclide bone scans in the staging of early breast cancer at low risk for metastasis
4. Don’t perform surveillance testing (biomarkers) or imaging (PET, CT and radionuclide bone scans) for asymptomatic individuals who have been treated for breast cancer with curative intent.
5. Don’t use white cell stimulating factors for primary prevention of febrile neutropenia for patients with less than 20% risk for this complication.

Patients with advanced colorectal cancer and their families may be alarmed at the recommendation to stop chemotherapy when performance status is poor and there are no standard, evidence-based treatments.

Patients with a performance status of 3 spend at least half their day in bed or in a chair and have difficulty taking care of themselves. Poor performance status is often a sign of increasing toxicity from chemo, reduced response to the chemo drugs, and poor survival time. Treatment may do more harm than good.

A rule of thumb for performance status is whether a patient can walk without help into the chemotherapy suite.

At this point supportive care may benefit patients more than additional chemotherapy. It’s time for a frank discussion with the doctor about the benefit and harm of more treatment.

Lowell E. Schnipper and the team who developed the Top Five write,

The available guidelines established by expert panels have all concluded that if a patient’s cancer has grown during three different regimens, the likelihood of treatment success is so poor and toxicity so high that further anticancer treatment is not recommended.

While patients and families may urge doing everything possible, this is not always the best course.

Schipper and his colleagues conclude,

The Top 5 list represents a series of practices in frequent use in common clinical scenarios that are not supported by strong evidence. Reconsidering their use, one patient at a time, is likely to improve the value of care that is provided, which in this case means the desired clinical outcome at the lowest cost to the patient and society. Nonetheless, ASCO recognizes that the care of every person with a life threatening disease is challenging and must be responsive to unique features of that particular individual’s circumstances. For that there will never be a substitute.

Perifosine was no better than a placebo in improving survival time for people with late-stage colorectal cancer according to a news release from Keryx Biopharmaceuticals.

Despite success in a smaller Phase II clinical trial, the X-PECT Phase III trial failed to meet its primary objective — longer survival time.

X-PECT randomized 468 patients to receive either:

• Xeloda® (capecitabine) plus perifosine, or
• Xeloda plus a placebo

Although final details were not provided, the perifosine group did not live longer than the patients who got a dummy pill.

Patients in the trial had refractory colorectal cancer, tumors that had already gotten worse on at least two standard chemotherapy regimens. Had perifosine helped increase survival time, it would have been a significant new treatment for patients who have exhausted all their standard treatment options.

Based on these results, Keryx will not be pursuing FDA approval for perifosine for refractory colorectal cancer.

The American Association for Cancer Research (AACR) says that declining budgets at the National Institutes of Health a crisis standing in the way of bringing cancer research to patient’s lives.

For the past ten years, NIH budgets have been essentially flat.  Factoring in rising research costs, flat funding means a loss of nearly $6 billion dollars in purchasing power.

AACR is calling on its members and the advocacy community to work even harder with Congress to invest in medical research.  The AACR board of directors said,

Therefore, the AACR announced this morning that it plans to redouble its efforts to engage with Congress to make research funding a higher national priority, raise public awareness of the importance of continued investment in cancer research, and call on its 34,000 members and broader advocacy community constituencies to join together to help better explain and illustrate the value of cancer research and biomedical science to the economic health and well-being of this nation.

AACR President Judy E. Garber, MD, MPH said,

We already see the effects on our most precious resource, young investigators. This is potentially disastrous, as we are relying on them to ensure the continuing pipeline of new discoveries that will have ever greater impact on the welfare of patients and the public health.

AACR is holding its 2012 annual meeting in Chicago this week – Accelerating Science: Concept to Clinic.

Fight Colorectal Cancer President Carlea Bauman was joined by staff, survivors, advocates and fighters to “get behind a cure” and ring the NASDAQ closing bell.

We ring the bell to bring attention that colorectal cancer is the number two cancer killer in America. We need awareness that colorectal cancer can be prevented, treated, and beaten. We are issuing a call to action to increase funding for research, better access to colorectal screening, and the very best treatment for every American who is diagnosed with colon or rectal cancer.

On stage with Carlea was: Ben Basloe, Todd Jones, Josh Young, Rose Hausmann, Joanne Kimmel, Dana Rye, Katelyn Sherry and David Dubin.