背景:癌症临床试验的累积性差可能导致青少年和年轻人(AYAs)(15-39岁)癌症患者的生存率改善较低。如果没有可靠的机制将事件案例与研究登记联系起来,这很难量化。利用国家癌症研究所指定的综合癌症中心的独特资源,作者比较了AYAs的百分比,孩子们,和老年人参加癌症临床试验,并确定纳入的预测因素。
方法:从2008年1月至2012年12月在南加州大学的1家儿科医院和2家成人医院诊断为癌症的患者通过加州癌症登记处进行鉴定,并分别与机构试验登记数据库相关联。评估了临床试验的可用性。
结果:整个中心,AYA的入学率(6%)等于老年人的入学率(6%),但低于儿童(22%)(P<0.01)。在儿童医院内,AYA的入学率也低于儿童(15%对23%,分别为;P<0.01)。在多变量分析中,发现诊断和治疗部位可预测AYA纳入治疗性和非治疗性研究.与非西班牙裔白人相比,西班牙裔和亚洲/太平洋岛民更有可能参加非治疗性研究。但治疗性研究未观察到种族/民族差异.
结论:在当前的研究中,接受治疗试验的AYAs和老年人的比例较低,但相似.诊断,护理场所,种族/民族似乎是入学的预测因素。必须建立前瞻性机制,以捕获未加入AYA的原因并制定纠正措施。
BACKGROUND: Poor accrual to cancer clinical trials may contribute to the lower improvement in survival observed for adolescents and young adults (AYAs) (those aged 15-39 years) with cancer. This has been difficult to quantify without reliable mechanisms to link incident cases with study enrollments. Using unique resources available at their National Cancer Institute-designated comprehensive cancer center, the authors compared the percentage of AYAs, children, and older adults enrolled onto cancer clinical trials and determined predictors of enrollment.
METHODS: Patients diagnosed with cancer from January 2008 through December 2012 at 1 pediatric and 2 adult University of Southern California hospitals were identified through the California Cancer Registry and individually linked to institutional trial enrollment databases. The availability of clinical trials was assessed.
RESULTS: Across the center, the enrollment percentage for AYAs (6%) was equal to that of older adults (6%), but was less than that for children (22%) (P < .01). Within the children\'s hospital, the AYA enrollment percentage was also less than that for children (15% vs 23%, respectively; P<.01). On multivariate analysis, diagnosis and site of care were found to be predictive of AYA enrollment onto therapeutic and nontherapeutic studies. Hispanic and Asian/Pacific Islander individuals were more likely to enroll onto nontherapeutic studies compared with non-Hispanic whites, but no racial/ethnic difference was observed for therapeutic studies.
CONCLUSIONS: In the current study, the percentages of AYAs and older adults enrolled onto therapeutic trials were low but similar. Diagnosis, site of care, and race/ethnicity appear to be predictive of enrollment. Prospective mechanisms must be instituted to capture reasons for nonenrollment of AYAs and develop corrective interventions.