Underrepresentation of patients 65 years of age or older in cancer-treatment trials.
Underrepresentation of patients 65 years of age or older in cancer-treatment trials.
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DOI：
10.1056/nejm199912303412706
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发表时间：
1999-12-30
影响因子：
158.5
通讯作者：
Albain, KS
中科院分区：
文献类型：
--
作者：
Hutchins, LF;Unger, JM;Albain, KS
背景：研究已经证明，在临床试验中，女性和黑人的代表性不足，他们的招募现在是联邦政府授权的。然而，人们对老年患者的参与程度知之甚少。我们确定了65岁或65岁以上患者参加癌症治疗试验的比例。方法：我们分析了1993至1996年间连续参加164项西南肿瘤小组治疗试验的16,396名患者的数据，按性别、种族(黑人或白人)以及年龄在65岁或65岁或以上的患者进行分析。这些比率与1990年美国人口普查和美国国家癌症研究所1992年至1994年期间的监测、流行病学和最终结果计划得出的普通癌症患者的相应比率进行了比较。结果：参加西南肿瘤小组试验的女性和黑人的总体比例与美国癌症患者的估计比例相似或相同(女性分别为41%和43%；黑人分别为10%和10%)。相比之下，65岁或65岁以上的患者总体比例偏低(25%对63%，P<；0.001)，试验涉及除淋巴瘤以外的所有15种癌症。在乳腺癌治疗试验中，代表性不足尤其明显(9%vs.49%，P<；0.001)。当分析70岁或70岁以上患者的数据时，当15项排除老年患者的试验从分析中剔除时，以及当基于社区的登记与学术中心的登记分开分析时，结果是相似的。结论：在癌症治疗研究中，65岁或65岁以上的患者的代表性严重不足。应该澄清原因，并采取政策纠正这种代表性不足的情况。(N Engl J Med 1999；341：2061-7)(C)1999年，马萨诸塞州医学会。
Background: Studies have documented the underrepresentation of women and blacks in clinical trials, and their recruitment is now federally mandated. However, little is known about the level of participation of elderly patients. We determined the rates of enrollment of patients 65 years of age or older in trials of treatment for cancer.Methods: We analyzed data on 16,396 patients consecutively enrolled in 164 Southwest Oncology Group treatment trials between 1993 and 1996 according to sex, race (black or white), and age under 65 years or 65 or older. These rates were compared with the corresponding rates in the general population of patients with cancer, derived from the 1990 U.S. Census and from the National Cancer Institute's Surveillance, Epidemiology, and End Results Program for the period from 1992 through 1994. Fifteen types of cancer were included in the analysis.Results: The overall proportions of women and blacks enrolled in Southwest Oncology Group trials were similar to or the same as the estimated proportions in the U.S. population of patients with cancer (women, 41 percent and 43 percent; blacks, 10 percent and 10 percent, respectively). In contrast, patients 65 years of age or older were underrepresented overall (25 percent vs. 63 percent, P < 0.001) and in trials involving all 15 types of cancer except lymphoma. The underrepresentation was particularly notable in trials of treatment for breast cancer (9 percent vs. 49 percent, P < 0.001). The findings were similar when data on patients who were 70 years of age or older were analyzed, when 15 trials that excluded older patients were eliminated from the analysis, and when community-based enrollment was analyzed separately from enrollment at academic centers.Conclusions: There is substantial underrepresentation of patients 65 years of age or older in studies of treatment for cancer. The reasons should be clarified, and policies adopted to correct this underrepresentation. (N Engl J Med 1999;341:2061-7.) (C)1999, Massachusetts Medical Society.