Du Wei, Gadgeel Shirish M, Simon Michael S
Department of Pediatrics, Wayne State University, Detroit, Michigan 48201, USA.
Cancer. 2006 Jan 15;106(2):420-5. doi: 10.1002/cncr.21638.
Clinical trials may offer patients innovative therapeutic options with potentially better outcomes, which are particularly relevant for patients afflicted with lung carcinoma, because current therapies provide only modest survival benefits. Only approximately 5% of patients with newly diagnosed cancer participate in clinical trials nationwide, and African-American (AA) patients are particularly under-represented.
To determine predictors of clinical trials enrollment, the authors reviewed the medical records of 427 patients with lung carcinoma (175 AA patients and 252 non-AA patients) who were eligible for clinical trials between 1994 and 1998 at the Karmanos Cancer Institute in Detroit, Michigan. Logistic regression analysis was used to assess the association of patient demographic characteristics and clinical trial enrollment.
Ninety-one patients (21%) were enrolled onto a lung cancer clinical trial during the period of the current study. Enrollment was associated significantly with race (P < 0.001), gender (P = 0.048), age (P = 0.005), and insurance type (P = 0.024). After multivariable adjustment, only race and gender remained significant predictors of enrollment. AA patients were less likely to enroll than non-AA patients (odds ratio [OR], 0.485; 95% confidence interval [95% CI], 0.243-0.966), and men were more likely than women to enroll (OR, 1.812; 95% CI, 1.033-3.178).
The current results suggest disparities by race and gender in the enrollment of patients onto lung cancer clinical trials and support the need to improve educational and outreach endeavors that would make clinical trials available to a wider range of eligible patients.
临床试验可为患者提供具有潜在更好疗效的创新治疗选择，这对于肺癌患者尤为重要，因为目前的治疗方法仅能带来有限的生存获益。在全国范围内，新诊断癌症患者中只有约5%参与临床试验，而非洲裔美国（AA）患者的代表性尤其不足。
为确定临床试验入组的预测因素，作者回顾了1994年至1998年期间在密歇根州底特律的卡曼诺斯癌症研究所符合临床试验条件的427例肺癌患者（175例AA患者和252例非AA患者）的病历。采用逻辑回归分析评估患者人口统计学特征与临床试验入组之间的关联。
在本研究期间，91例患者（21%）入组了肺癌临床试验。入组与种族（P < 0.001）、性别（P = 0.048）、年龄（P = 0.005）和保险类型（P = 0.024）显著相关。经过多变量调整后，只有种族和性别仍然是入组的显著预测因素。AA患者入组的可能性低于非AA患者（比值比[OR]，0.485；95%置信区间[95%CI]，0.243 - 0.966），男性入组的可能性高于女性（OR，1.812；95%CI，1.033 - 3.178）。
目前的结果表明，在肺癌临床试验患者入组方面存在种族和性别差异，并支持需要改进教育和推广工作，以使更多符合条件的患者能够参与临床试验。
