Background Studies have documented the underrepresentation ofwomen and blacks in clinical trials, and their recruitment isnow federally mandated. However, little is known about the levelof participation of elderly patients. We determined the ratesof enrollment of patients 65 years of age or older in trialsof treatment for cancer.
Methods We analyzed data on 16,396 patients consecutively enrolledin 164 Southwest Oncology Group treatment trials between 1993and 1996 according to sex, race (black or white), and age under65 years or 65 or older. These rates were compared with thecorresponding rates in the general population of patients withcancer, derived from the 1990 U.S. Census and from the NationalCancer Institute's Surveillance, Epidemiology, and End ResultsProgram for the period from 1992 through 1994. Fifteen typesof cancer were included in the analysis.
Results The overall proportions of women and blacks enrolledin Southwest Oncology Group trials were similar to or the sameas the estimated proportions in the U.S. population of patientswith cancer (women, 41 percent and 43 percent; blacks, 10 percentand 10 percent, respectively). In contrast, patients 65 yearsof age or older were underrepresented overall (25 percent vs.63 percent, P<0.001) and in trials involving all 15 typesof cancer except lymphoma. The underrepresentation was particularlynotable in trials of treatment for breast cancer (9 percentvs. 49 percent, P<0.001). The findings were similar whendata on patients who were 70 years of age or older were analyzed,when 15 trials that excluded older patients were eliminatedfrom the analysis, and when community-based enrollment was analyzedseparately from enrollment at academic centers.
Conclusions There is substantial underrepresentation of patients65 years of age or older in studies of treatment for cancer.The reasons should be clarified, and policies adopted to correctthis underrepresentation.
Source Information
From the Department of Medicine, Division of Hematology and Oncology, University of Arkansas for Medical Sciences, Little Rock (L.F.H.); the Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle (J.M.U., J.J.C.); the Department of Medical Oncology, University of Texas Health Science Center at San Antonio, San Antonio (C.A.C.); and the Department of Medicine, Division of Hematology and Oncology, Loyola University Medical Center, Maywood, Ill. (K.S.A.).
Address reprint requests to the Southwest Oncology Group, Operations Office, 4980 Omicron Dr., San Antonio, TX 78245-3217, or to bgranados{at}swog.org.
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