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Enrollment onto breast cancer therapeutic clinical trials: A tertiary cancer center experience

机译:参加乳腺癌治疗性临床试验:三级癌症中心的经验

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Background: Advances in breast cancer prevention, diagnosis, and treatment are in part the result of patient involvement in clinical trials. Despite increases in new clinical research initiatives and trials open to accrual, only 2-3% of women with breast cancer enroll. There is a need to identify the barriers interfering patient accrual. Methods: Data were extracted from patients with breast cancer seen for treatment in 2009 retrospectively. Descriptive analysis of patient demographic on enrollment were performed using logistic regression analyses. Results: Of 418 patients evaluated for treatment, 163 had a trial available; 138 of these were eligible. Eighty (58%) participated in a clinical trial; the remainder declined (24%) or were not presented for a trial by their treating physicians (76%). Age, preferred language, marital status, family history, or race/ethnicity did not predict for enrollment on a therapeutic clinical trial. Patients with stage II or III breast cancer were more likely to be enrolled on a trial compared to patients with stage 0 or I (odds ratio 2.89, 9.17; p= .02, .0005 respectively). Conclusions: Enrollment of breast cancer patients on therapeutic clinical trials was relatively high (58% eligible, 19% overall). Prospective studies observing breast cancer stage, clinical trial design, and inclusion of community based physician practices would add breadth to the understanding of poor accrual to breast cancer clinical trials.
机译:背景:乳腺癌预防,诊断和治疗方面的进展部分是患者参与临床试验的结果。尽管新的临床研究计划和试验有待增加,但只有2-3%的乳腺癌女性入选。需要确定妨碍患者应计的障碍。方法:回顾性分析2009年接受治疗的乳腺癌患者的数据。使用logistic回归分析对入选患者进行人口统计学描述性分析。结果:在418位接受治疗评估的患者中,有163位接受了试验。其中138个符合条件。八十(58%)人参加了临床试验;其余的则下降了(24%)或未由主治医师进行试验(76%)。年龄,偏爱的语言,婚姻状况,家族史或种族/族裔无法预测是否参加治疗性临床试验。与0期或I期患者相比,II期或III期乳腺癌患者更有可能参加试验(比值分别为2.89、9.17; p = .02,.0005)。结论:乳腺癌患者接受治疗性临床试验的人数相对较高(58%合格,整体19%)。观察乳腺癌阶段,临床试验设计以及纳入社区医师做法的前瞻性研究将使人们对乳腺癌临床试验的应计性差的理解更加广泛。

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