Probiotic lactobacillus supplements reduced diarrhea during 5FU chemotherapy

Diarrhea can be a serious complication when 5FU (fluorouracil) is used to treat colon cancer.  It can lead to dehydration, hospitalization, and the need to reduce or discontinue chemo treatment.

Colon cancer patients in Helsinki were randomly assigned to receive daily supplements of Lactobacillus rhamnosus GG during 5FU chemotherapy.  They were also randomly treated with 5FU either as part of the monthly bolus Mayo Clinic regimen or the twice monthly  infusional deGramont program.

Those who received the probiotic lactobacillus supplements had significantly less severe diarrhea (grades 3 and 4) than those who did not — 22 percent versus 37 percent. 

They had less abdominal discomfort, were hospitalized less often, and needed fewer chemo dose reductions due to bowel problems.

No toxicity due to lactobacillus was detected.

Overall there were significantly more severe side effects of all kinds with the bolus Mayo Clinic regimen than with the infusional deGramont treatment — 89 percent versus 45 percent, including serious diarrhea.

Pia Osterlund and colleagues wrote,

We conclude that Lactobacillus GG supplementation is well tolerated and may reduce the frequency of severe diarrhea and abdominal discomfort related to 5-FU-based chemotherapy.

SOURCE: Osterlund et al, British Journal of Cancer, early online publication, September 25, 2007.

Posted by Kate Murphy on September 30th, 2007
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Young age affects treatment and better survival after colon cancer

Is being diagnosed with colon cancer under forty a bad sign? Not according to recently published research that found younger patients were no more likely to die of their cancer than older patients.

Surgeons at Memorial Sloan Kettering Cancer Center in New York reviewed a database of more than 1,300 patients with stage I-III colon cancer who had surgery between 1990 and 2001.

Five percent (68 patients) were forty years old or younger when they were diagnosed. They were more likely to have left-sided cancers, but were no more likely than older patients to have symptoms, be diagnosed at an advanced stage, or have worse pathology.

They did have more lymph nodes removed and tested — a median of 18 nodes for younger patients versus 14 for those over age 40.

They were also more likely to have chemotherapy, especially for stage II cancer.  Thirty-nine percent (39%) of the forty and under group with stage II cancers had chemotherapy after surgery compared to 14 percent of older patients.

After five years there was no difference in cancer-specific survival between the younger and older patients — 86 percent vs 87 percent.  However, overall survival (death from any cause) was significantly higher in younger patients where 84% were alive compared to 73% of those diagnosed over the age of 40.

The team concluded,

Younger patients undergoing complete resection of stage I–III colon cancer had disease-specific survival similar to older patients. However, younger patients had more nodes retrieved from their specimens and were more likely to receive adjuvant therapy, especially for node-negative disease. These factors may have contributed to their overall favorable outcome.

SOURCE:  Quah et al, Annals of Surgical Oncology, Volume 14, Number 10, October 2007.

Posted by Kate Murphy on September 30th, 2007
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FDA issues public health advisory on safe use of Fentora

The Food and Drug Administration issued a public health advisory on September 26, 2007 regarding the safe use of Fentora®, an oral medicine used to treat breakthrough cancer pain.

Fentora is a strong  fentanyl-based drug that is dissolved along the gum for increased cancer pain that “breaks through” pain control provided by another long-acting opioid pain drug.

The FDA has received reports of deaths and life-threatening side effects when Fentora was prescribed or used incorrectly.  Issues that have led to problems include:

• patients who did not have cancer pain and should not have been prescribed Fentora
• patients who were not already receiving a round-the-clock opioid drug and were not tolerant to strong narcotic drugs.
• patients who were prescribed the wrong Fentora dose
• patients who took too many Fentora tablets
• doctors who substituted Fentora for other fentanyl drugs such as Actiq® without adjusting the dose to reflect the difference in strength.

In its advisory the FDA emphasizes:

• Fentora should only be used for breakthrough pain in cancer patients who are already opioid-tolerant.  It should not be used to treat other short term pain such as headache, injury, or pain after surgery.
• Fentora should not be used by patients who only take a narcotic pain medicine occasionally.  It is designed to be used together with a regular, round-the-clock opiate drug.
• The dosage strength of Fentora is not equal to strength of other fentanyl drugs.  Fentora dosage should not be substituted directly for other fentanyl medicines including Actiq.
• Doctors need to select the dose of Fentora carefully for each patient.
• Patients and their caregivers need to understand the directions for using Fentora safely and not exceed the dose or number of pills recommended by their doctors.
• Health care professionals, patients, and caregivers need to be aware of the signs of fentanyl overdose and get medical help right away if they occur.

Signs of fentanyl overdose include trouble breathing, shallow breathing, unusual tiredness, sleepiness,inability to think, talk, or walk normally,or  feeling dizzy or confused.

Cephalon, the manufacturer of Fentora, issued a letter to doctors and health professionals early in September emphasizing  how to use Fentora safely. They stressed careful selection of patients and dose, patient and caregiver education, and not substituting Fentora for other fentanyl medications without adjusting the dose.

In their letter to health professionals Cephalon describes what opioid tolerance means:

FENTORA is indicated only for the management of breakthrough pain (BTP) in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphinelday, at least 25 rncg transdermal fentanylhour, at least 30 mg of oral oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

 They stress that patients

• Should not take more than two tablets for any one episode of breakthrough pain.
• Should wait at least four hours between episodes of breakthrough pain before taking another Fentora tablet.
• Should only have one strength of tablet available to avoid dose confusion.
• Should keep the tablets out of the reach of children.

WHAT THIS MEANS FOR PATIENTS

Fentora is a strong narcotic drug that can lead to serious, life-threatening problems if not used correctly.

Don’t use Fentora for pain other than cancer pain that already requires you to take another opiate-based drug such as oral morphine, fentanyl patches, oxycodone, or hydromorphone.  You should have been taking one of those drugs for at least a week before starting Fentora.

Fentora is for breakthrough pain or pain that gets worse despite being on a regular, round-the-clock dose of another opioid pain medicine.

Before you begin using Fentora, be sure that your doctor has given you the Medication Guide.  Read it and follow the directions carefully.  If you are caring for someone with cancer, read the Guide and follow it.  Ask your doctor if you don’t understand anything in it.

If you feel breakthrough pain, take only one Fentora tablet in the strength your doctor has prescribed.  If pain does not improve within 30 minutes, take a second tablet — but do not exceed this number.

Wait at least four hours before taking additional Fentora.

If you have  more than 4 episodes of breakthrough pain a day, talk to your doctor about managing your pain medicines differently.

Don’t share Fentora with anyone else, even if they seem to have the same pain you do.

Fentora comes in pills of different doses.  If your doctor changes the dose, discard old pill so you won’t be confused.

Watch for signs of overdose including difficulty breathing, shallow breathing, trouble talking, walking, or thinking normally, excessive sleepiness, or dizziness.  Call your doctor right away or get emergency help.  An overdose can be life-threatening within a short time.

KEEP FENTORA OUT OF THE REACH OF CHILREN.  If a child gets an accidental dose, get emergency help immediately.

Posted by Kate Murphy on September 27th, 2007
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C3 Helps Congressman Boren (D-OK) Announce Colorectal Cancer Legislation

from left: Joe Arite (C3: Colorectal Cancer Coalition), Fran Campion (Colon Cancer Alliance), Andrew Porter (Men’s Health Network), Dr. Ralph T. Guild, M.D. (American College of Gastroenterologists), Rep. Dan Boren (D-OK), and Peter Blanchard (Constituent and Colorectal Cancer Survivor) and son

C3: Colorectal Cancer Coalition was proud to help introduce The Colorectal Cancer Screening and Detection Act of 2007 (HR 3060) on Tuesday. A press conference was held on Capitol Hill.

HR 3060 will provide the same protections to non-Medicare beneficiaries that are already provided to Medicare beneficiaries.

Congressman Boren lost his mother to colon cancer nine years ago, and personally understands the need for early detection of the disease.

“Cancer unfortunately has affected millions of lives across the United States,” Boren said. “Coverage is required for many other equally important preventative cancer screenings across the nation. With early detection leading to a 90 percent survival rate, a simple and proven procedure could save the lives of so many (of our) loved ones,” Boren said.

Studies have shown that doctors many times do not refer their patients for tests if those tests are not covered by insurance.

“Americans deserve these life saving medical benefits and should be able to count on these protections,” Boren said.

Currently, 22 states, including Texas and the District of Columbia, require coverage. Oklahoma does not currently require coverage of these cancer screenings.

Congressman Ralph Hall (R-TX) has joined Congressman Boren in his fight.

Joe Arite, Policy and Grassroots Manager for C3

Posted by Joe Arite on September 26th, 2007
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Colorectal cancer more frequent in people with coronary artery disease

Some of the same risk factors for coronary artery disease also increase risk for colon polyps and colorectal cancer.  In an effort to find out if  there was an association between coronary artery disease and pre-malignant colorectal polyps and cancers, patients who had an angiography for suspected coronary artery disease also had a screening colonoscopy.

Three groups  in Hong Kong were identified for the study:  coronary artery disease (CAD) positive, CAD negative, and a sex and age matched control group recruited from the general population.  Patients were considered to be CAD positive if their angiography showed at least a 50 percent narrowing in any one of the major coronary arteries.

Patients who used aspirin or statins, had a personal history of colorectal disease, or who had a colonoscopy in the past ten years were not included in the analysis.

After adjusting for age and sex, CAD positive patients were almost twice as likely to have a polyp or cancer than those without coronary artery disease.  They were two and a half times as likely to have cancer.

Any colorectal neoplasm found::

• CAD positive:  34 percent
• CAD negative:  18.8 percent
• General population:  20.8 percent

Advanced colorectal adenoma (polyp) found:

• CAD  positive: 18.4 percent
• CAD negative   8.7 percent
• General population: 5.8 percent

Colorectal cancer:

• CAD positive:  4.4 percent
• CAD negative:  0.5 percent
• General population 1.1 percent

Patients who smoked had five times the risk of  having both coronary artery disease and an advanced colorectal polyp or cancer.   Those with metabolic syndrome had six times the associated risk.

Annie On On Chan, MD, PhD and her colleagues concluded,

In this study population undergoing coronary angiography, the prevalence of colorectal neoplasm was greater in patients with CAD. The association between the presence of advanced colonic lesions and CAD was stronger in persons with the metabolic syndrome and a history of smoking.

SOURCE:  Chan et al, Journal of the American Medical Association, Volume 298, Number 12, September 26, 2007.

Posted by Kate Murphy on September 25th, 2007
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