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头颈部鳞状细胞癌临床试验中治疗与结果的统计学评估

The Statistical Evaluation of Treatment and Outcomes in Head and Neck Squamous Cell Carcinoma Clinical Trials.

作者信息

Fortpied Catherine, Vinches Marie

机构信息

EORTC Headquarters, Brussels, Belgium.

出版信息

Front Oncol. 2019 Jul 12;9:634. doi: 10.3389/fonc.2019.00634. eCollection 2019.

DOI:10.3389/fonc.2019.00634
PMID:31355146
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6640189/
Abstract

The purpose of this article is two-fold: to help statisticians confronted with the design, implementation and analysis of clinical trials and new to the field of head and neck cancer; but also to sensitize research physicians with the role, the tasks and the challenges faced by the medical statisticians. These two purposes altogether will hopefully encourage and enable fluid communication between the research physician and the medical statistician and the understanding of each other's field and concerns. In particular, the methodological challenges resulting from the heterogeneity of the head and neck cancer, the complexity of the treatments and the associated comorbidities are presented with examples borrowed from medical literature and from the practical experience of the authors in this field.

摘要

本文的目的有两个

帮助初涉头颈癌领域、面临临床试验设计、实施和分析的统计学家;同时让研究医师了解医学统计学家的角色、任务以及所面临的挑战。希望这两个目的能共同促进研究医师和医学统计学家之间的顺畅沟通,增进对彼此领域和关注点的理解。特别是,本文通过借鉴医学文献以及作者在该领域的实践经验中的实例,阐述了由于头颈癌的异质性、治疗的复杂性以及相关合并症所带来的方法学挑战。

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本文引用的文献

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Head Neck. 2019 Jun;41(6):1725-1737. doi: 10.1002/hed.25609. Epub 2019 Jan 12.
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Predictive Value of Cetuximab-Induced Skin Toxicity in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NECK.西妥昔单抗诱导的皮肤毒性对头颈部复发或转移性鳞状细胞癌的预测价值
Front Oncol. 2018 Dec 13;8:616. doi: 10.3389/fonc.2018.00616. eCollection 2018.
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Surrogate study endpoints in the era of cancer immunotherapy.癌症免疫治疗时代的替代研究终点
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4
Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial.放疗联合西妥昔单抗或顺铂治疗人乳头瘤病毒阳性口咽癌(NRG 肿瘤学 RTOG 1016):一项随机、多中心、非劣效性试验。
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5
Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial.放疗联合顺铂或西妥昔单抗治疗低危型人乳头瘤病毒阳性口咽癌(De-ESCALaTE HPV):一项开放标签随机对照 3 期临床试验。
Lancet. 2019 Jan 5;393(10166):51-60. doi: 10.1016/S0140-6736(18)32752-1. Epub 2018 Nov 15.
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