Predictors of enrollment in lung cancer clinical trials
Predictors of enrollment in lung cancer clinical trials
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DOI：
10.1002/cncr.21638
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发表时间：
2006-01-15
期刊：
影响因子：
6.2
通讯作者：
Simon, MS
中科院分区：
文献类型：
--
作者：
Du, W;Gadgeel, SM;Simon, MS
背景。临床试验可能为患者提供创新的治疗选择，并可能带来更好的结果，这对于肺癌患者尤其重要，因为目前的疗法只能提供有限的生存获益。只有大约 5% 的新诊断癌症患者参加全国范围内的临床试验，非裔美国人 (AA) 患者的代表性尤其不足。方法。为了确定临床试验入组的预测因素，作者回顾了 1994 年至 1998 年间在密歇根州底特律 Karmanos 癌症研究所有资格参加临床试验的 427 名肺癌患者（175 名 AA 患者和 252 名非 AA 患者）的医疗记录。使用逻辑回归分析来评估患者人口统计特征与临床试验入组之间的关联。 结果。在本研究期间，91 名患者 (21%) 参加了一项肺癌临床试验。入学率与种族（P < 0.001）、性别（P = 0.048）、年龄（P = 0.005）和保险类型（P = 0.024）显着相关。经过多变量调整后，只有种族和性别仍然是入学的重要预测因素。 AA 患者比非 AA 患者入组的可能性较小（比值比 [OR]，0.485；95% 置信区间 [95% CI]，0.243-0.966），男性比女性更有可能入组（OR，1.812；95% CI，1.033-3.178）。结论。目前的结果表明，肺癌临床试验患者的登记存在种族和性别差异，并支持需要改进教育和推广工作，以使更广泛的合格患者能够参与临床试验。
BACKGROUND. 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.METHODS. 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.RESULTS. 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).CONCLUSIONS. 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.