Evaluating the feasibility of performing window of opportunity trials in breast cancer.

IF 1.6 Q4 ONCOLOGY
International Journal of Surgical Oncology Pub Date : 2015-01-01 Epub Date: 2015-01-20 DOI:10.1155/2015/785793
Angel Arnaout, Susan Robertson, Iryna Kuchuk, Demetrios Simos, Gregory R Pond, Christina L Addison, Mehrzad Namazi, Mark Clemons
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引用次数: 17

Abstract

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.

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评估在乳腺癌中进行机会之窗试验的可行性。
背景:手术前的等待期是评估新治疗策略的宝贵“机会之窗”。在此期间进行的介入性研究需要重要的多学科合作来克服后勤障碍。我们进行了为期一年的前瞻性机会窗研究,以评估可行性。方法:符合条件的新诊断绝经后,雌激素受体阳性的乳腺癌患者等待初次手术,每天服用阿那曲唑直到手术。可行性通过(a)同意和(b)完成研究的患者比例进行评估。比较研究前后Ki67标记指数和cleaved caspase 3评分(CC3)。结果:22/131(16.8%)例患者确认符合条件,20/22(91%)例患者完成研究。19/20(95%)患者同意接受选择性的额外组织活检。阿那曲唑的平均使用时间为24.7(15-44)天。与治疗前后比较,Ki67指数平均下降48.8% (p < 0.001), CC3下降趋势有统计学意义(p = 0.17)。结论:乳腺癌机会之窗试验是评估手术前不同治疗方法生物学疗效的可行方法。大多数符合条件的妇女愿意参与,包括接受额外的组织活检。
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来源期刊
CiteScore
3.70
自引率
0.00%
发文量
5
审稿时长
20 weeks
期刊介绍: International Journal of Surgical Oncology is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies in all areas of surgical oncology.
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