[ Back to EurekAlert! ] Public release date: 6-Jul-2011
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Contact: Renee McGaw
renee.mcgaw@ucdenver.edu
31-205-493-413
International Association for the Study of Lung Cancer

Women, elderly, minorities poorly represented in lung cancer drug trial data submitted to US FDA

Women, older people and minorities are enrolled less frequently in lung cancer drug trials and the numbers do not reflect the prevalence of lung cancer in these populations, according to research presented at the 14th World Conference on Lung Cancer in Amsterdam, hosted by the International Association for the Study of Lung Cancer (IASLC).

"Our results suggest that the trial population used for approval of drugs do not represent well the U.S. population who may receive the marketed agent," said principal investigator Dr. Shakun Malik, a medical officer at the U.S. Food and Drug Administration (FDA) in Silver Spring, Maryland.

Researchers reviewed trial data submitted for FDA drug approvals for the treatment of non-small cell lung cancer (NSCLC) over the last decade.

Of U.S. patients diagnosed with lung cancer according to the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) data released on April 15, 2011, and collected between years 1975-2008, 58% were men and 42% women. But in 10 national and international trials for agents approved to treat NSCLC between January 2000 and December 2010, 68% of enrollees were men and 32% were women.

In addition, 73% of U.S. lung cancer patients are older than 65 but only 36% of the drug trial population was older than 65, researchers found.

Meanwhile, African-Americans develop lung cancer at higher rates (72.7 per 100,000) than Caucasians (68 per 100,000), but only 2% of trial participants were black. Caucasians made up 78% of the trial population, Asians 15%, Hispanics 2% and "other" 2%.

"Disparity was especially pronounced in the age and ethnicity," Dr. Malik wrote. "This fact is concerning particularly for older patients who may experience greater toxicity when given the same dose and combination of drugs based on testing in a younger population."

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Dr. Shakun Malik will discuss the research with journalists during a WCLC press conference at 10 a.m. CET on Wednesday, July 6. For individual interview requests, please call Renée McGaw at +31 20 549 3413 between July 3-7 in the press office at Amsterdam RAI, Amsterdam, the Netherlands. You may also email her at renee.mcgaw@ucdenver.edu

About the IASLC:

The International Association for the Study of Lung Cancer (IASLC), based in Denver, Colorado, U.S.A., is the only global organization dedicated to the study of lung cancer. Founded in 1972, the association's membership includes more than 3,000 lung cancer specialists in 80 countries.

IASLC members promote the study of etiology, epidemiology, prevention, diagnosis, treatment and all other aspects of lung cancer and thoracic malignancies. IASLC disseminates information about lung cancer to scientists, members of the medical community and the public, and uses all available means to eliminate lung cancer as a health threat for the individual patients and throughout the world. Membership is open to any physician, health professional or scientist interested in lung cancer.

IASLC publishes the Journal of Thoracic Oncology, a valuable resource for medical specialists and scientists who focus on the detection, prevention, diagnosis and treatment of lung cancer. To learn more about IASLC please visit http://iaslc.org/



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