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本文引用的文献

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Response-adaptive decision-theoretic trial design: operating characteristics and ethics.响应自适应决策理论试验设计:操作特征和伦理学。
Stat Med. 2013 Sep 20;32(21):3752-65. doi: 10.1002/sim.5807. Epub 2013 Apr 4.
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Personalizing lung cancer prevention through a reverse migration strategy.通过逆向迁移策略实现肺癌预防的个性化。
Top Curr Chem. 2013;329:221-40. doi: 10.1007/128_2012_338.
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Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657.肿瘤完全缓解通过亚组更有效地预测无复发生存:来自 I-SPY 1 试验——CALGB 150007/150012、ACRIN 6657 的结果。
J Clin Oncol. 2012 Sep 10;30(26):3242-9. doi: 10.1200/JCO.2011.39.2779. Epub 2012 May 29.
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Locally advanced breast cancer: MR imaging for prediction of response to neoadjuvant chemotherapy--results from ACRIN 6657/I-SPY TRIAL.局部晚期乳腺癌:MR 成像预测新辅助化疗反应——来自 ACRIN 6657/I-SPY 试验的结果。
Radiology. 2012 Jun;263(3):663-72. doi: 10.1148/radiol.12110748.
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The BATTLE trial: personalizing therapy for lung cancer.BATTLE 试验:为肺癌患者实施个体化治疗。
Cancer Discov. 2011 Jun;1(1):44-53. doi: 10.1158/2159-8274.CD-10-0010. Epub 2011 Jun 1.
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Toward precision medicine: a new social contract?迈向精准医学:一份新的社会契约?
Sci Transl Med. 2012 Apr 11;4(129):129ed3. doi: 10.1126/scitranslmed.3003473.
7
Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: design strategies for personalized therapy trials.2010 年临床与转化癌症研究智库会议报告:个性化治疗试验的设计策略。
Clin Cancer Res. 2012 Feb 1;18(3):638-44. doi: 10.1158/1078-0432.CCR-11-2018.
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Adaptive clinical trials in oncology.肿瘤学中的适应性临床试验。
Nat Rev Clin Oncol. 2011 Nov 8;9(4):199-207. doi: 10.1038/nrclinonc.2011.165.
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The BATTLE to personalize lung cancer prevention through reverse migration.通过反向迁移实现肺癌个体化预防的斗争。
Cancer Prev Res (Phila). 2011 Jul;4(7):962-72. doi: 10.1158/1940-6207.CAPR-11-0232.
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Adaptive clinical trials: the promise and the caution.适应性临床试验:前景与警示。
J Clin Oncol. 2011 Feb 20;29(6):606-9. doi: 10.1200/JCO.2010.32.2685. Epub 2010 Dec 20.

精准医学临床试验:定义新的治疗策略。

Precision medicine clinical trials: defining new treatment strategies.

作者信息

Heckman-Stoddard Brandy M, Smith Judith J

出版信息

Semin Oncol Nurs. 2014 May;30(2):109-16. doi: 10.1016/j.soncn.2014.03.004.

DOI:10.1016/j.soncn.2014.03.004
PMID:24794084
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4280791/
Abstract

OBJECTIVES

To discuss the role of clinical trials in the changing landscape of cancer care resulting in individualized cancer treatment plans including a discussion of several innovative randomized studies designed to evaluate multiple targeted therapies in molecularly defined subsets of individuals.

DATA SOURCES

Medical and nursing literature, research articles, and clinicaltrials.gov.

CONCLUSION

Recent advancements in cancer biomarkers and biomedical technology have begun to transform fundamentals of cancer therapeutics and clinical trials through innovative adaptive trial designs. The goal of these studies is to learn not only if a drug is safe and effective but also how it is best delivered and who will derive the most benefit.

IMPLICATIONS FOR NURSING PRACTICE

Implementation of clinical trials in the cancer biomarker era requires knowledge, skills, and expertise related to the use of biomarkers and molecularly defined processes underlying a malignancy, as well as an understanding of associated ethical, legal, and social issues to provide competent, safe, and effective health care and patient communication.

摘要

目标

探讨临床试验在癌症治疗格局变化中所起的作用,这种变化促成了个性化癌症治疗方案的制定,包括讨论多项旨在评估针对分子定义的个体亚组的多种靶向治疗的创新性随机研究。

数据来源

医学与护理文献、研究文章以及临床试验.gov。

结论

癌症生物标志物和生物医学技术的最新进展已开始通过创新性适应性试验设计改变癌症治疗学和临床试验的基础。这些研究的目标不仅是了解一种药物是否安全有效,还包括了解其最佳给药方式以及谁将从中获益最多。

对护理实践的启示

在癌症生物标志物时代实施临床试验需要具备与生物标志物的使用以及恶性肿瘤潜在的分子定义过程相关的知识、技能和专业知识,同时需要理解相关的伦理、法律和社会问题,以提供称职、安全且有效的医疗保健服务以及与患者的沟通。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/693f/4280791/f545912d7f67/nihms585299f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/693f/4280791/c08f364d88ef/nihms585299f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/693f/4280791/f545912d7f67/nihms585299f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/693f/4280791/c08f364d88ef/nihms585299f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/693f/4280791/f545912d7f67/nihms585299f2.jpg