Navigation Links
DNA Test Predicts Harmful Effects of Cancer Drug
Date:8/28/2007

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 hmcleod@unc.edu.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... or "Company") (NASDAQ: UNIS ; ASX: UNS), a developer ... results for the second quarter of fiscal 2016 (three months ended ... Financial Results for the Second Quarter of Fiscal 2016 ... for the second quarter of fiscal 2016 was $4.5 million, compared ... from customers for the second quarter of fiscal 2016 were $17.8 ...
(Date:2/9/2016)... 9, 2016  Axovant Sciences Ltd. (NYSE:  AXON), ... treatment of dementia, today announced further details of ... and functional aspects of Lewy body dementia, a ... U.S. Two out of the three studies were ... start later this quarter. In addition, the Company ...
(Date:2/9/2016)... LONDON , Feb. 9, 2016 Hearing ... amount of sound energy transmitted to the inner ear. ... and hearing bands. These devices are recommended for users ... eight hours. Earplugs refer to HPD that are inserted ... attenuation earplugs are designed to provide more natural sound ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... ... Jacksonville, FL 32224, February 26th: Amateur & Professional Divisions - Time: 7:00pm ... 7:00pm – 10:00pm | Ticket Prices $30, Social Media: http://www.USPoleSportsFed.org , ...
(Date:2/10/2016)... DC (PRWEB) , ... February 10, 2016 , ... Anxiety ... level since the start of Medicare Part D a decade ago, according to ... comments from older adults on how they are coping with rapidly rising costs. ...
(Date:2/10/2016)... ... February 09, 2016 , ... According to a recent article ... in the number of patients under the age of 30. According to Southern California ... their offices, and may indicate an overall shift in the rapidly growing social acceptance ...
(Date:2/9/2016)... ... February 09, 2016 , ... Center for ... are diagnosed with autism spectrum disorder (ASD). Beginning Jan. 1, 2016, Medicaid is ... behavior analysis (ABA) is key to providing effective treatment for individuals with ASD. ...
(Date:2/9/2016)... ... 2016 , ... A new study from the Workers Compensation ... for a variety of medical services in Illinois as of 2015. , ... Schedule Rates in Illinois, are professional medical services, hospital outpatient and ambulatory ...
Breaking Medicine News(10 mins):