Evaluating the Feasibility of Performing Window of Opportunity Trials in Breast Cancer
Evaluating the Feasibility of Performing Window of Opportunity Trials in Breast Cancer
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DOI：
10.1155/2015/785793
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发表时间：
2015-01-01
影响因子：
1.5
通讯作者：
Clemons, Mark
中科院分区：
文献类型：
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作者：
Arnaout, Angel;Robertson, Susan;Clemons, Mark
背景手术等待期是评估新治疗策略的宝贵“机会之窗”。在此期间进行的干预性研究需要大量的多学科合作，以克服后勤障碍。我们进行了为期一年的前瞻性机会之窗研究，以评估可行性。方法.符合条件的新诊断的绝经后、雌激素受体阳性乳腺癌患者等待初次手术，每天接受阿那曲唑直至手术。通过（a）同意和（B）完成研究的患者比例评估可行性。比较研究前和研究后Ki 67标记指数和裂解半胱天冬酶3评分（CC 3）。结果确认22/131例（16.8%）患者合格，20/22例（91%）患者完成研究。19/20例（95%）患者同意接受可选的额外组织活检。阿那曲唑的平均使用时间为24.7（15-44）天。当比较治疗前和治疗后值时，平均Ki 67指数统计学显著下降48.8%（p < 0.001），CC 3下降趋势显著（p = 0.17）。结论在乳腺癌中进行机会窗口试验是评估术前不同治疗的生物学疗效的可行方法。大多数符合条件的女性愿意参与，包括接受额外的组织活检。
Background. The waiting period to surgery represents a valuable "window of opportunity" to evaluate novel therapeutic strategies. Interventional studies performed during this period require significant multidisciplinary collaboration to overcome logistical hurdles. We undertook a one-year prospective window of opportunity study to assess feasibility. Methods. Eligible newly diagnosed postmenopausal, estrogen receptor positive breast cancer patients awaiting primary surgery received anastrozole daily until surgery. Feasibility was assessed by (a) the proportion of patients who consented and (b) completed the study. Comparison of pre- and poststudy Ki67 labelling index and cleaved caspase 3 scores (CC3) was performed. Results. 22/131 (16.8%) patients were confirmed eligible and 20/22 (91%) patients completed the study. 19/20 (95%) patients agreed to undergo optional additional tissue biopsies. The mean duration of anastrozole use was 24.7 (15-44) days. There were a statistically significant decline in mean Ki67 indices of 48.8% (p < 0.001) and a trend towards significance in the decline of CC3 (p = 0.17) when comparing pre- with posttreatment values. Conclusion. window of opportunity trials in breast cancer are a feasible way of assessing the biologic efficacy of different therapies in the presurgical setting. The majority of eligible women were willing to participate including undergoing additional tissue biopsies.