Children and teens who have a confirmed mutation for familial adenomatous polyposis (FAP) are being recruited for a randomized clinical trial of Celebrex® (celecoxib).  The study wants to know if Celebrex can increase the time before polyps begin to develop or reduce the number of polyps.

Familial adenomatous polyposis or FAP is an inherited condition, passed directly from parent to child.  People with FAP develop hundreds, sometimes thousands, of polyps that literally carpet their large intestine due to a mutation in the APC gene which regulates cell growth.

Without intervention, polyps eventually progress to colorectal cancer. Polyps usually begin to appear in early teens with an average age for developing cancer of 39.

In order to be eligible, children must

• Be between the ages of 10 and 17.
• Have a confirmed genetic mutation for FAP.
• Have no more than 20 polyps, which must be removed before the study medicine is given.

Young people with attenuated familial adenomatous polyposis,  a different form of FAP with fewer polyps, are not eligible for the trial.

The study is being conducted in Spain and in Tennessee and Texas in the United States.  In the double-blinded study, half of the children in the trial will receive Celebrex, half a placebo.

Request information about a study center or call Pfizer CT.gov Call Center    
1-800-718-1021.

Senator John McCain (R-AZ) had a “Super” win on “Super Tuesday” last evening. The Southwest Senator emerged as the top dog in the GOP fight for delegates.

Big wins in California and New York widened the lead for McCain and left Governors Romney and Huckabee trying to regain any momentum they had.

The race on the Democratic side is not so cut and dry. Senators Hilary Clinton and Barack Obama split states and delegates throughout the night. With primaries in Ohio and Texas along with the Potomac States still to come, this fight is far from over.

For Super Tuesday results click here

Although there are no clear guideposts to predict how long patients with cancer and chronic illness will live, all patients approaching the end of life should be assessed regularly for pain, breathlessness, and depression.  End of life or palliative care should not wait until patients are very close to death.

New clinical guidelines for palliative care at the end of life have been developed by the American College of Physicians based on known evidence for meeting the physical, psychological, social, and practical needs of patients and their caregivers. 

End of life is defined as that time when a person is living with an illness that will worsen and eventually cause death.  Good care can prevent or reduce suffering and provide support for patients and their families during a difficult time.

Strong recommendations from the ACP for patients with serious illness at the end of life include:

• Health professionals should regularly assess patients for pain, breathlessness, and depression.
• Therapies with proven effectiveness should be used to manage pain.  For cancer patients this includes nonsteroidal anti-inflammatory drugs (NSAIDS), opioids, and biophosphonates.
• Therapies with proven effectiveness should be used to manage breathlessness (dyspnea) which includes oxygen for short-term relief and opioids when dyspnea is unrelieved.
• Therapies with proven effectiveness should be used to manage depression.  For patients with cancer this includes, tricyclic antidepressants, selective serotonin reuptate inhibitors (SSRIs), or psychosocial therapy.
• Health professionals should ensure that advance care planning happens and advance directives are in place.

Studies have found that there is better use of palliative care and better outcomes for patients when

• Multidisciplinary teams involve nurses and social workers.
• Collaboration leads to continuity of care and service coordination.
• Communication is facilitated.

In addition, health teams should routinely screen family caregivers for emotional and practical needs as they care for patients at the end of life.

Planning for an individual’s end of life care should begin as early as possible in the course of a serious illness and be reassessed when medical situations change.

Headed by Dr. Amir Qaseem, the clinical guidelines team summarized:

Symptom control, continuity in care, and reducing caregiver burdens are critical elements of care for managing patients nearing the end of life. In addition, following appropriate treatment strategies for pain, dyspnea, and depression substantially affect patients’ end-of-life experiences.

Interventions where advance care planning includes trained facilitators (including palliative care providers), involves key decision makers, and addresses care across settings are beneficial for improving care.

Further research on potentially beneficial but understudied interventions, and conditions other than cancer, should be a high priority.

SOURCE: Qaseem et al. Annals of Internal Medicine, Volume 148, Number 2, January 15, 2008.

President Bush released his Fiscal Year 2009 budget on Monday. This will be the last budget for the 43rd President of the United States. The $3.1 trillion budget includes sizable increases in military spending and protects the President’s well-known tax cuts.

Though the FY 09 budget is the highest in history, the Health and Human Services Department was cut by $2 billion, amounting to a 3 percent reduction

The National Institutes of Health (NIH) was not even given a cost of living increase, and this once again will hurt advancements in Medical Research.

The cure for cancer may be just across the bridge…too bad we don’t have enough to pay the toll.

If you would like to review the Health and Human Services (HHS) budget click here

FROM 2008 ORLANDO GI SYMPOSIUM

An independent panel of radiologists has not been able to verify an earlier concern that the use of calcium and magnesium infusions to reduce chemotherapy-caused neuropathy increased cancer progression.  Their reviews of scans from patients who received calcium and magnesium during chemotherapy and those who got a placebo found no significant relationship between the infusions and how quickly the cancer got worse.

Each scan was independently reviewed by two radiologists, who did not know the patient’s outcome.  When there was disagreement, a third radiologist also reviewed the scan.

Last June, a clinical trial looking at whether or not infusions of calcium and magnesium could reduce neuropathy from colorectal cancer chemotherapy was stopped when early information showed that those infusions might reduce chemotherapy effectiveness. At that time, the data monitoring committee recommended closing the trial because there was some evidence that the calcium/magnesium infusions led to a lowered response rate and more rapid time to treatment failure.

At that time plans were made for an independent review of cancer progression in the trial by a panel of radiologists. 

In July, the researchers leading the trial published a letter in the Journal of Clinical Oncology warning about the information and urging doctors to take care in using Ca/Mg infusions.

The clinical trial called CONcePT (Combined Oxaliplatin Neurotoxicity Prevention Trial) was testing two strategies for preventing peripheral neuropathy that is associated with oxaliplatin chemotherapy.  Since 60 percent of patients with metastatic colorectal cancer who are being treated with FOLFOX (oxaliplatin, 5FU, and leucovorin) will stop treatment before their cancer actually gets worse, often because of neuropathy, the researchers wanted to know if an intermittent use of oxaliplatin or using calcium and magnesium infusions before and after oxaliplatin would decrease neuropathy and increase time before treatment failed.

More information about the trial results will be available later this year at ASCO and the full report will be published.

Howard S. Hochster, MD presented the results of the independent radiology review at the GI Symposium.

Details about the GI Symposium presentation are on MedPage Today.

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