Navigation Links
DNA Test Predicts Harmful Effects of Cancer Drug

Study Questions FDA Guidelines for Colon Cancer Drug

CHAPEL HILL, N.C., Aug. 28 /PRNewswire/ -- Not everyone needs a genetic test before taking the cancer drug irinotecan, and the U.S. Food and Drug Administration should modify its prescription guidelines to say so, according to researchers at the University of North Carolina at Chapel Hill.

Irinotecan, also known by its brand name Camptosar, is used mainly as a second-line treatment for colorectal cancer, the third most common form of cancer in the United States. The FDA currently recommends screening patients for a gene that could make them more susceptible to the harmful side effects of the drug, the most worrisome of which is neutropenia, a blood disorder characterized by an abnormally low number of white blood cells, which decreases the body's ability to fight off infections.

In a paper published in the August 28 Journal of the National Cancer Institute, UNC's Dr. (PhD) and colleagues analyzed data from nine previous studies of irinotecan. They found that only patients who received a medium or high dose of the drug had greater risk of neutropenia if they had two copies of a variation of the gene UGT1A1, known as UGT1A1*28. At lower doses, however, the risk was the same regardless of what UGT1A1 gene the patients had.

"Many institutions saw the FDA's recommendation as authorization to test all patients before treating them with irinotecan, even though many clinicians didn't think it was always necessary since low doses of the drug weren't causing problems," said Prof. Howard McLeod, senior author of the study and director of the UNC Institute for Pharmacogenomics and Individualized Therapy.

"Our review showed that at low doses, the drug is well tolerated and can be taken by most people," McLeod said. "Testing only becomes essential when the dosage increases and genetics become a larger factor in determining what side effects patients experience".

Having a genetic test available for a medicine is valuable, but so is knowing when to use that test, said Dr. Richard Goldberg, a co-author of the study and physician in chief of the Carolina Cancer Hospital.

"There are so many treatment options for cancer patients that the more information we have about matching the right therapy to the patient, the better off we all are," Goldberg said. "Studies like this one give oncologists the tools needed to take better care of patients while avoiding unnecessary tests and expenses."

The authors recommended that the FDA amend the product information for irinotecan to describe the association between irinotecan dose and risk of hematologic toxicity among patients with two UGT1A1*28 genes.

About the authors: McLeod is the Fred Eshelman Distinguished Professor at the UNC School of Pharmacy. Goldberg is the associate director of UNC's Lineberger Comprehensive Cancer Center and chief of the UNC Division of Hematology/Oncology. Hoskins is of the UNC School of Pharmacy. Qu and Ibrahim are of the UNC School of Public Health.

For more information about this study, please contact Professor Howard McLeod, Director, UNC Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina at Chapel Hill by phone at 919-966-0512 or 314-420-8182, or by email at

SOURCE University of North Carolina at Chapel Hill
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Presented at the ACC Shows Inflammatory Enzyme Lp-PLA2 Predicts Heart Disease Risk in Metabolic Syndrome Patients
2. Inimex Product Candidate is First Immune Defense Regulator to Cure Infections Without Causing Harmful Inflammation
3. Common Preterm Labor Drug Has More Side Effects Than Alternative, Finds Study from Packard Childrens Hospital and Stanford
4. Promising Data on Cognitive Effects of Safinamide in Early Parkinsons Disease
5. XYOTAX More Cost Effective With Fewer Side Effects Than Gemcitabine or Vinorelbine in Treating Non-Small Cell Lung Cancer
6. Repros Androxal Shows Highly Statistically Significant Positive Effects in Men with Secondary Hypogonadism
7. New Data Suggests Less Abuse-Related Effects For OROS Methylphenidate
8. New Long-Term Data Analyses for Bifeprunox Show Favorable Effects Versus Placebo in Stabilized Patients with Schizophrenia
9. The International Myeloma Foundation Says New Clinical Trial Results Could Improve Survival While Reducing Side Effects For Many Patients
10. Studies Show Mild Hyperthermia Enhances Antitumor Effects of Alfacells Onconase
11. Breast Cancer and HER-2/neu: Diagnostic Tools for Targeted Therapy
Post Your Comments:
(Date:11/26/2015)... North Carolina , 26 november 2015 ... Inc. (AAIPharma/CML) kondigt de geplande investering aan ... uitbreiding van de laboratoria en het mondiale ... . De uitbreiding zal resulteren in extra ... wordt voldaan aan de groeiende behoeften van ...
(Date:11/26/2015)... , Nederland, November 26, 2015 ... Een nieuwe aanpak combineert immunotherapie met ... kanker. ) ...      (Photo: ) ... Leids Universitair Medisch Centrum (LUMC) ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( ) ... Pacemaker Market Outlook to 2019 - Rise in Cardiac Disorders ... report to their offering. Boston ... Boston scientific and others. --> ... Biotronik, Boston scientific and others. ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... ... According to an article published November 15th by ABC News, while ... light of the recent terrorist attacks in Paris, other cities are taking extra precautions ... reaching U.S. soil. Especially around special events that may be high-profile in nature, the ...
(Date:11/27/2015)... ... November 27, 2015 , ... A team of Swiss ... to treat it. Surviving Mesothelioma has just posted the findings on the website. ... Zurich analyzed the cases of 136 mesothelioma patients who were treated with chemotherapy followed ...
(Date:11/27/2015)... ... November 27, 2015 , ... "When I ... an inventor from Hillside, N.J. "Many people catch diseases simply from sitting on ... will always be protected from germs." , He developed the patent-pending QUDRATECS to ...
(Date:11/27/2015)... ... November 27, 2015 , ... The print component of ... in Atlanta, Dallas, New York, Minneapolis, South Florida, with a circulation of approximately ... nationally, through a vast social media strategy and across a network of top ...
(Date:11/27/2015)... , ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating community in the ... Table 1-1 ). More than 3.7 billion people under the age of 50 ... (HSV-1), according to WHO's first global estimates of HSV-1 infection . , "The data ...
Breaking Medicine News(10 mins):