NEW YORK (Reuters Health) - New research indicates that cancer patients over 65 years of age are underrepresented in registration trials of new cancer agents.

"If elderly patients do not participate in clinical trials, the treatments resulting from those trials may not be appropriate for them," lead author Dr. Lilia Talarico, from the US Food and Drug Administration in Rockville, Maryland, said in a statement. "This is a significant concern given that elderly patients represent the majority of cancer patients in the US."

The findings, which appear in the November 15th issue of the Journal of Clinical Oncology, are based on an analysis of demographic data for 28,766 cancer patients enrolled in a total of 55 registration trials. The ages of these patients were compared with the ages of patients in the overall US cancer population.

In the US cancer population, 60% of patients are at least 65 years of age. Yet, in the registration trials, just 36% of subjects were in this age group, the researchers report.

Similar differences were noted among subjects who were at least 70 and 75 years of age. The percentage of subjects in the cancer population and in trials was 46% and 20%, respectively, for the former group and 31% and 9%, respectively, for the latter group.

With the exception of trials looking at breast cancer hormonal therapies, all of the studies showed significant under-representation of the elderly (p < 0.001). Most of this under-representation involved subjects who were at least 70 years of age.

To improve representation of elderly cancer patients in new drug trials, the authors recommend using study protocols specifically designed for this age group, treatment modifications appropriate for older subjects, and using less stringent eligibility criteria.

J Clin Oncol 2004;22:4626-4631

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