1 Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
2 The Danish Cancer Society Research Center, Copenhagen, Denmark.
J Clin Oncol. 2019 May 1;37(13):1111-1119. doi: 10.1200/JCO.18.01983. Epub 2019 Mar 12.
In this nationwide registry study, we investigated socioeconomic and structural patterns in referral to phase I cancer trials in a case-control study design.
Personal identification numbers on all Danish patients referred to the Danish Phase I Unit at Rigshospitalet from 2005 to 2016, and a control group matched on age, sex, type of cancer, year of diagnosis, and time from diagnosis to referral ensured individual-level linkage between several registries. We examined the association between nonclinical factors-indicators of socioeconomic position and distance to the Phase I Unit-and referral using a conditional logistic regression analysis adjusted for several clinical factors. Association between nonclinical factors and enrollment once referred was examined with a Cox proportional hazards regression analysis in an historical cohort study design.
Complete data were available for 1,026 (84%) of 1,220 referred patients. Significantly decreased odds for referral were identified for patients with long distance to the Phase I Unit compared with short distance (adjusted odds ratio [OR], 0.35; 95% CI, 0.30 to 0.41), for less education (less than 9 years) compared with more (more than 12 years; OR, 0.69; 95% CI, 0.56 to 0.91), and for belonging to the lowest income quintile compared with the highest (OR, 0.78; 95% CI, 0.62 to 0.97). Medium education (9 to 12 years) compared with more, being outside the workforce compared with being within, and living alone compared with living with a partner were also negatively associated with referral. Among patients referred, 252 enrolled in a trial. Nonclinical factors were not associated with enrollment.
On the basis of individual long-term registry data from an unselected cohort, novel anticancer therapies seem to be tested on a socially selected group of patients with cancer.
在这项全国性的登记研究中,我们以病例对照研究设计,调查了社会经济和结构模式在 I 期癌症试验转介中的作用。
从 2005 年至 2016 年,所有被转介到丹麦里格医院 I 期病房的丹麦患者都使用个人身份号码,并且根据年龄、性别、癌症类型、诊断年份和诊断到转介的时间,为对照组匹配了一组患者,以确保在多个登记处之间进行个体层面的链接。我们使用条件逻辑回归分析,调整了几个临床因素,研究了非临床因素(社会经济地位的指标和距离 I 期病房的距离)与转介之间的关联。在历史队列研究设计中,使用 Cox 比例风险回归分析研究了非临床因素与一旦转介后的入组之间的关联。
1220 名被转介的患者中,有 1026 名(84%)患者的完整数据可用。与距离 I 期病房较近的患者相比,距离较远的患者转介的可能性显著降低(调整后的优势比 [OR],0.35;95%CI,0.30 至 0.41);与接受教育年限较多(超过 12 年)的患者相比,接受教育年限较少(少于 9 年)的患者(OR,0.69;95%CI,0.56 至 0.91);与收入最低五分位数的患者相比,收入最高五分位数的患者(OR,0.78;95%CI,0.62 至 0.97)。中等教育(9 至 12 年)与更多教育、不在劳动力中与在劳动力中、独居与与伴侣居住相比,也与转介呈负相关。在被转介的患者中,有 252 名患者参加了一项试验。非临床因素与入组无关。
根据一项未选择队列的个体长期登记数据,新的抗癌疗法似乎是在一个具有社会选择性的癌症患者群体中进行测试的。