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Back To Vidyya Lack Of Older Patients In Cancer Studies A Problem, Report Warns

Elderly Severely Underrepresented

Elderly cancer patients are severely underrepresented in cancer clinical studies, according to a study published in The New England Journal of Medicine.* Sixty-three percent of people with cancer in the United States are age 65 or older, yet this group comprises just 25 percent of patients enrolled in cancer studies.

The low number of older study patients could affect research results of new treatments, warn the study authors, leading to uncertainty about whether new drugs can be tolerated by the elderly at the same dosage levels given to younger patients.

"The clinical applicability of the results of a treatment trial depends in large part on whether the sample of patients represents the entire spectrum of patients" who have the cancer under study, write Laura Hutchins, M.D., and colleagues from the Southwest Oncology Group (SWOG), which conducts a large number of cancer clinical trials.

The researchers evaluated enrollment on SWOG studies conducted from 1993 through 1996, which enrolled 16,396 patients. They compared the proportion of elderly patients in the SWOG studies to the proportion found in the population of all cancer patients, as reported by the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program.

The most striking disparities were found in breast cancer studies, where the elderly make up 49 percent of patients but only 9 percent of study enrollees; and in patients over age 70, who comprise 47 percent of all cancer patients but only 13 percent of study enrollees.

This lack of older patients in studies contrasts sharply to the recruitment of women and African-Americans. These two groups are represented proportionately in cancer studies, mainly because researchers have made concerted efforts to include them in response to federal guidelines established in the early 1990s.

But no such effort has been made with the elderly, and doctors may be excluding these patients from studies out-of-hand. A 1994 survey published in the Journal of Clinical Oncology reported that up to 50 percent of physicians do not offer clinical trials to patients based on age alone.

Other barriers to elderly participation include misconceptions -- by either patient or physician -- about the benefits and risks of being involved in a study; co-existing medical conditions that preclude study enrollment; and patient fears that doctor's visits and other routine expenses will not be reimbursed by Medicare. (Until very recently, the healthcare agency did not pay for any treatment deemed experimental, which includes most cancer clinical trials. In addition, Medicare generally did not pay for drugs needed to control the side effects of chemotherapy. President Clinton recently directed the Department of Health and Human Services, the cabinet-level agency in charge of Medicare, to immediately begin reimbursing claims for routine patient care costs of clinical trials.)

The importance of including the elderly in clinical studies is borne out by a few targeted investigations, including a SWOG leukemia study reported in 1995. That study found that the elderly with leukemia tend to fare poorly when they undergo intensive treatment -- treatment that often works with younger patients. Additional studies show that differences in biology explain the poor outcomes, and these findings have led to research exploring ways to increase treatment tolerance in older patients.

Despite these few studies, however, there is a distinct lack of data on the dosages of chemotherapy that the elderly can tolerate. This void "can be answered definitively only by prospective enrollment of large numbers of elderly patients in clinical trials," write the authors.

*The article "Underrepresentation of Patients 65 Years of Age or Older in Cancer Treatment Trials," appears in The New England Journal of Medicine, vol. 341, no. 27, pp. 2061-67.


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Editor: Susan K. Boyer, RN
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