Patients Unaware of Clinical Trials
A survey of nearly 6,000 cancer patients just released by Harris Interactive found that an alarming 85 percent were either unaware or unsure that they could participate in a clinical trial. Importantly, three out of four of these patients "would have been willing to enroll had they known it was possible."
The implications of such findings are huge. Nearly all of the advances in current breast cancer clinical treatment now available to women have come from major randomized clinical trials. These include the use of mammography for screening, the use of adjuvant chemotherapy and hormonal therapy, and the use of lumpectomy and radiation. In addition, these trials provide for long-term follow-up of complications in large numbers of women.
And yet, participation rates by eligible cancer patients-especially older and minority patients-is woefully inadequate.
A panel discussion sponsored by the Susan G. Komen Breast Cancer Foundation reported that only 3 percent of eligible breast cancer patients participate in clinical trials in the United States, while enrollment rates are as high as 70 percent for breast cancer trials in Scandinavia and 50 percent for U.S. pediatric cancer trials.
Reasons cited for this low enrollment rate were: failure by the physician to mention that trials existed; time requirements on physicians, and basic misperceptions about the nature of trials. Furthermore, both patients and physicians may be uncomfortable with randomization, said the panelists, even though cancer patients are randomized either to the best standard therapy or to promising new therapies.
In the Harris Interactive survey, close to a third of those patients who knew about clinical trials but declined to participate made their decision because they believed the new therapy would be less effective than "the standard treatment."
Similarly, another third feared that they might receive an inactive placebo rather than the treatment under study. Twenty-two percent feared being treated "like a guinea pig," and 20 percent feared the cost would not be covered by their insurance.
Yet, 93 percent of the patients who had actually participated in clinical trials said their overall experience was "positive" and three-fourths said they "would recommend participation to someone else with cancer."
A study published in the New England Journal of Medicine looked at how many patients 65 years of age and older were involved in 164 Southwest Oncology Group (SWOG) cancer treatment trials between 1993 and 1996. Dr. Laura Hutchins of the University of Arkansas for Medical Sciences in Little Rock and colleagues analyzed treatment trials for 15 types of cancer and found that older patients are "substantially underrepresented."
Patients who were 65 years of age or older accounted for only 25 percent of patients in SWOG trials, but they comprised 63 percent of the cancer patients in the U.S. population, they wrote.
They added that the underenrollment of older patients was "particularly striking" for breast cancer trials. In those studies, only 9 percent of participants were 65 years of age or older, versus 49 percent of patients in the general population with breast cancer.
Hutchins echoed what many other researchers have also concluded: Far too many doctors-and even patients themselves-assume that older patients would not be able to tolerate or benefit from many of the most promising treatments under study. However, given that the number of people over the age of 65 is expected to double in the coming decades, such assumptions could be disastrous.
It is not just seniors who are underrepresented; virtually every minority group has traditionally lagged in clinical trial enrollment.
For example, a recent trial that investigated the preventive use of tamoxifen for breast cancer had so few African-American participants that there was insufficient data to show whether tamoxifen could benefit these women. African-American women are known to have estrogen-receptor-negative tumors more often than white women and to develop the disease at a younger age.
In a symposium last year sponsored by the Magic Johnson Foundation, a dais of speakers noted that minorities in general-and African Americans in particular-face unique barriers that limit their participation in clinical trials. Factors cited by the panel included lack of information from physicians, cultural biases, less access to quality medical care, and even patients' lingering mistrust because of the infamous Tuskegee Experiment (in which black patients were unwittingly exposed to syphilis as part of a government research program).
However, the panel emphasized that another barrier to involvement is a basic lack of awareness that clinical trials were available. Until recently, only oncologists who were members of NCI-sponsored cooperative research groups could refer patients to clinical trials. Many outside physicians were simply not aware of pertinent trials for their patients.
In response to a growing number of such findings-and an alarming lack of clinical trial participants-the National Cancer Institute launched the Expanded Participation Project in March. The objective is to extend clinical trial privileges to qualified oncologists beyond those who are members of the major research cooperatives. Any qualified oncologist can now participate in an NCI-sponsored trial.
Before you decide to take part in a clinical trial, you should know as much as possible. Ask your medical doctor for more details on the trial, such as:
If you want additional information regarding breast cancer clinical trials, the following organizations may be helpful:
CancerNet - National Cancer Institute
900 Rockville Pike
Building #31, HSV2580, Room 10A046
Bethesda, MD 20892
1-800-422-6237
http://www.cancernet.nci.nih.gov
National Alliance of Breast Cancer Organizations
9 East 37th Street, 10th floor
New York, NY 10016
212-719-0154
http://www.nabco.org/trials
Susan G. Komen Breast Cancer Foundation
5005 LBJ Freeway #370
Dallas, TX 75244
1-800-463-9273
http://www.breastcancerinfo.com
CenterWatch Clinical Trials Listing Service
581 Boylston Street, Suite 200
Boston, MA 02116
617-247-2327
http://www.centerwatch.com
National Institutes of Health
http://www.clinicaltrials.gov
SOURCES:
Journal of Clinical Oncology, August 2000; 18: 2805-2810
New England Journal of Medicine, December 30, 1999; 341:2061-2067
"African Americans and Breast Cancer," a symposium sponsored by the Magic Johnson Foundation, Sept. 14, 2000, New York, NY
The National Cancer Institute (http://www.nci.nih.gov)
Susan G. Komen Breast Cancer Foundation (http://www.komen.org)
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