Mishkin Grace, Minasian Lori M, Kohn Elise C, Noone Anne-Michelle, Temkin Sarah M
Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.
Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.
Gynecol Oncol. 2016 Dec;143(3):611-616. doi: 10.1016/j.ygyno.2016.09.026. Epub 2016 Sep 30.
Enrollment of a representative population to cancer clinical trials ensures scientific reliability and generalizability of results. This study evaluated the similarity of patients enrolled in NCI-supported group gynecologic cancer trials to the incident US population.
Accrual to NCI-sponsored ovarian, uterine, and cervical cancer treatment trials between 2003 and 2012 were examined. Race, ethnicity, age, and insurance status were compared to the analogous US patient population estimated using adjusted SEER incidence data.
There were 18,913 accruals to 156 NCI-sponsored gynecologic cancer treatment trials, ovarian (56%), uterine (32%), and cervical cancers (12%). Ovarian cancer trials included the least racial, ethnic and age diversity. Black women were notably underrepresented in ovarian trials (4% versus 11%). Hispanic patients were underrepresented in ovarian and uterine trials (4% and 5% versus 18% and 19%, respectively), but not in cervical cancer trials (14 versus 11%). Elderly patients were underrepresented in each disease area, with the greatest underrepresentation seen in ovarian cancer patients over the age of 75 (7% versus 29%). Privately insured women were overrepresented among accrued ovarian cancer patients (87% versus 76%), and the uninsured were overrepresented among women with uterine or cervical cancers. These patterns did not change over time.
Several notable differences were observed between the patients accrued to NCI funded trials and the incident population. Improving representation of racial and ethnic minorities and elderly patients on cancer clinical trials continues to be a challenge and priority.
招募具有代表性的人群参与癌症临床试验可确保结果的科学可靠性和普遍性。本研究评估了参与美国国立癌症研究所（NCI）支持的妇科癌症试验的患者与美国新发病例人群的相似性。
研究了2003年至2012年期间参与NCI赞助的卵巢癌、子宫癌和宫颈癌治疗试验的情况。将种族、民族、年龄和保险状况与使用调整后的监测、流行病学与最终结果（SEER）发病率数据估算的类似美国患者人群进行比较。
156项NCI赞助的妇科癌症治疗试验共招募了18913名患者，其中卵巢癌试验占56%，子宫癌试验占32%，宫颈癌试验占12%。卵巢癌试验纳入的种族、民族和年龄多样性最少。黑人女性在卵巢癌试验中的代表性明显不足（4%对11%）。西班牙裔患者在卵巢癌和子宫癌试验中的代表性不足（分别为4%和5%对18%和19%），但在宫颈癌试验中并非如此（14%对11%）。老年患者在每个疾病领域的代表性都不足，75岁以上的卵巢癌患者代表性不足最为明显（7%对29%）。在参与的卵巢癌患者中，有私人保险的女性比例过高（87%对76%），而未参保女性在子宫癌或宫颈癌患者中比例过高。这些模式并未随时间变化。
在参与NCI资助试验的患者与新发病例人群之间观察到了一些显著差异。提高种族和少数民族以及老年患者在癌症临床试验中的代表性仍然是一项挑战和优先事项。
