|
Scientists puzzled by severe allergic reaction to cancer drug in the middle Southern US
August 21, 2007CHAPEL HILL - A patient's expectations about the side effects of chemotherapy usually focus on nausea, hair loss, fatigue and other side effects. Worries about severe allergic reactions to their therapy is usually not a concern.
A recent study from the Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill, the Vanderbilt-Ingram Comprehensive Cancer Center and the Sarah Canon Cancer Center in Nashville have identified an unusually high rate of allergic reaction in cancer patients living in the middle South who received a common drug used for treating their cancer.
This study was presented at the 43rd annual meeting of the American Society of Clinical Oncology in Chicago in June, 2007 and appears online Aug. 17th in the Journal of Clinical Oncology.
The drug, cetuximab, marketed by Bristol-Meyers Squibb as Erbitux, is a widely used chemotherapeutic agent for treating colon cancer, head and neck tumors, and is being studied in the treatment of ovarian, lung, breast and gastrointestinal tumors.
When cetuximab was first approved, the first three patients treated at UNC had severe reactions to the drug. Doctors at both Sarah Canon and Vanderbilt also had more patients than expected react with a drop in blood pressure and shortness of breath or other hypersensitivity reactions within minutes of infusion of cetuximab.
"After speaking with others, we realized that patients who lived on a line across North Carolina, Tennessee, northern Arkansas and southern Missouri had these adverse reactions to the drug," said study leader Dr. Bert O'Neil, assistant professor of medicine, division of hematology and oncology at UNC. "So, we thought it appropriate to see what common bonds were there."
Cancer researchers from UNC and Vanderbilt pooled their patients dating back to when the drug received approval from the Food and Drug Administration, in 2004. More than 140 patients from ongoing clinical trials (at Vanderbilt) and current clinical records (at UNC) were reviewed for the presence of immediate, severe hypersensitivity reactions as well as pertinent demographics to determine this region's rate of allergic reactions and to see if a profile of the potentially allergic patient was evident.
The nationwide rate of severe allergic reactions to cetuximab is only about 2 percent. However, 22 percent of patients in this study showed severe allergic reactions to the drug. Cetuximab normally is infused over a two-hour period, but allergic patients had a reaction within minutes of starting the infusion, a classic anaphylactic reaction. The strongest predictor of a reaction to cetuximab was a history of other hypersensitivities, such as allergic asthma, food allergies, bee stings or allergies to other drugs, such as penicillin.
What is it about this strip across the middle South" "A good question," said O'Neil. "The most likely places to look would be food- or plant-based allergens. If it is of plant origin, finding the source could be a needle-in-a-haystack search. And it's a narrow geographic band; colleagues in Atlanta or the University of Virginia haven't seen this type of reaction."
The research team felt that clinicians in this middle South region must obtain a thorough history of allergic reaction and be prepared to use an alternative drug, such as panitumimab, for patients with a history of hypersensitivity reactions, O'Neil said.
"Bristol-Myers Squibb is studying a screening test for the specific factor that leads to the reaction. In the meantime, doctors in the middle South need to be aware of, and be prepared to treat, sudden, severe allergic reactions when using cetuximab," O'Neil said.
Based on the results of this study, UNC has a physician, physician assistant or nurse practitioner present for the first 30 minutes of all infusions of cetuximab. The Sarah Cannon Cancer Center halted all studies the drug.
"This is a curious problem, but not a problem we can't deal with," said O'Neil. "As long as we know the patient's allergy history, we know what to do."
University of North Carolina at Chapel Hill
The drug, cetuximab, marketed by Bristol-Meyers Squibb as Erbitux, is a widely used chemotherapeutic agent for treating colon cancer, head and neck tumors, and is being studied in the treatment of ovarian, lung, breast and gastrointestinal tumors.
When cetuximab was first approved, the first three patients treated at UNC had severe reactions to the drug. Doctors at both Sarah Canon and Vanderbilt also had more patients than expected react with a drop in blood pressure and shortness of breath or other hypersensitivity reactions within minutes of infusion of cetuximab.
"After speaking with others, we realized that patients who lived on a line across North Carolina, Tennessee, northern Arkansas and southern Missouri had these adverse reactions to the drug," said study leader Dr. Bert O'Neil, assistant professor of medicine, division of hematology and oncology at UNC. "So, we thought it appropriate to see what common bonds were there."
Cancer researchers from UNC and Vanderbilt pooled their patients dating back to when the drug received approval from the Food and Drug Administration, in 2004. More than 140 patients from ongoing clinical trials (at Vanderbilt) and current clinical records (at UNC) were reviewed for the presence of immediate, severe hypersensitivity reactions as well as pertinent demographics to determine this region's rate of allergic reactions and to see if a profile of the potentially allergic patient was evident.
The nationwide rate of severe allergic reactions to cetuximab is only about 2 percent. However, 22 percent of patients in this study showed severe allergic reactions to the drug. Cetuximab normally is infused over a two-hour period, but allergic patients had a reaction within minutes of starting the infusion, a classic anaphylactic reaction. The strongest predictor of a reaction to cetuximab was a history of other hypersensitivities, such as allergic asthma, food allergies, bee stings or allergies to other drugs, such as penicillin.
What is it about this strip across the middle South" "A good question," said O'Neil. "The most likely places to look would be food- or plant-based allergens. If it is of plant origin, finding the source could be a needle-in-a-haystack search. And it's a narrow geographic band; colleagues in Atlanta or the University of Virginia haven't seen this type of reaction."
The research team felt that clinicians in this middle South region must obtain a thorough history of allergic reaction and be prepared to use an alternative drug, such as panitumimab, for patients with a history of hypersensitivity reactions, O'Neil said.
"Bristol-Myers Squibb is studying a screening test for the specific factor that leads to the reaction. In the meantime, doctors in the middle South need to be aware of, and be prepared to treat, sudden, severe allergic reactions when using cetuximab," O'Neil said.
Based on the results of this study, UNC has a physician, physician assistant or nurse practitioner present for the first 30 minutes of all infusions of cetuximab. The Sarah Cannon Cancer Center halted all studies the drug.
"This is a curious problem, but not a problem we can't deal with," said O'Neil. "As long as we know the patient's allergy history, we know what to do."
University of North Carolina at Chapel Hill
Allergic Reaction News and Current Allergic Reaction Events RSSAsthma and other allergies tied to absence of specialized cells
When it comes to allergies, both the problem and the solution are found within us. Our immune systems respond to foreign substances with an arsenal of cells.
Hayfever hope
With the peak grass pollen season approaching, scientists can reveal that a daily dose of probiotic can change the immune status of people with hay fever.
Deadly dose: Rensselaer heparin expert helps uncover source of lethal contamination
The mysterious death of patients around the world following a routine dosage of the common blood thinner, heparin, sent researchers on a frantic search to uncover what could make the standard drug so toxic.
MIT-led teams unravel heparin death mystery
An international team of researchers led by MIT has explained how contaminated batches of the blood-thinner heparin were able to slip past traditional safety screens and kill dozens of patients recently in the United States and Germany.
National Jewish Medical and Research Center Evaluating Treatment To Prevent Allergic Reactions to Food
Researchers at National Jewish Medical and Research Center are conducting trials to evaluate a method to prevent allergic reactions to food. They are feeding peanut- and egg-allergic people increasing doses of an investigational protein extract from the foods to see if they can induce the participants' immune systems to tolerate the food.
A new more effective tuberculosis screening test for HIV victims
World Health Organization (WHO) figures show that each year an estimated 9 million new cases of tuberculosis (TB) arise in the world.
Scientists move closer to developing a new class of asthma and allergy drugs
A team of Biotechnology and Biological Sciences Research Council (BBSRC) funded scientists has moved a step closer to developing a new class of effective asthma and allergy drugs.
Doctors may be giving the wrong dosage of adrenaline in an emergency because of labelling
A new study by Cambridge University reveals that doctors treating life-threatening emergencies such as allergy attacks may give the wrong dosage of adrenaline (epinephrine) because of confusing labelling.
Fight against hay fever and other allergies helped by new immune system discovery
A mechanism which can lead to hay fever and other allergic reactions, by preventing the immune system from regulating itself properly, has been discovered by scientists.
NIH selects LIAI for major study on allergy molecular causes and possible treatments
A major study that will provide a new window into understanding and potentially treating allergies will be conducted by the La Jolla Institute for Allergy & Immunology (LIAI) under a $5 million federal contract.
More Allergic Reaction News Articles
| © 2008 BrightSurf.com |