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21世纪的放射肿瘤学:改变实践的前瞻性随机试验……还是并未改变!

Radiation Oncology in the 21st Century: Prospective Randomized Trials That Changed Practice… or Didn't!

作者信息

Zakeri Kaveh, Coleman C Norman, Vikram Bhadrasain

机构信息

Radiation Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD, United States.

Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA, United States.

出版信息

Front Oncol. 2018 Apr 30;8:130. doi: 10.3389/fonc.2018.00130. eCollection 2018.

DOI:10.3389/fonc.2018.00130
PMID:29761073
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5937169/
Abstract

In a two-part article published in 2009, we discussed the limitations of conventional radiation therapy, the challenges of studying new technologies in radiation oncology, and summarized the state-of-the science for various malignancies (1, 2). Here, we summarize some of the most important prospective, randomized trials that during the intervening years have attempted to improve the tumor control and/or decrease the adverse effects of radiation therapy. For consistency, we have focused here on the null and alternate hypotheses as articulated by the investigators at the onset of each trial, since the outcome of the investigational treatment should be considered clinically significant only if the null hypothesis was rejected. The readers (and patients) are of course free to make their own judgments about the clinical significance of the results when the null hypothesis was not rejected.

摘要

在2009年发表的一篇分两部分的文章中,我们讨论了传统放射治疗的局限性、放射肿瘤学新技术研究面临的挑战,并总结了各种恶性肿瘤的科学现状(1, 2)。在此,我们总结了一些最重要的前瞻性随机试验,这些试验在其间的几年里试图改善肿瘤控制和/或减少放射治疗的不良反应。为保持一致性,我们在此重点关注每个试验开始时研究者阐述的原假设和备择假设,因为只有在原假设被拒绝时,研究性治疗的结果才应被视为具有临床意义。当然,当原假设未被拒绝时,读者(和患者)可以自由对结果的临床意义做出自己的判断。

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Radiation Oncology in the 21st Century: Prospective Randomized Trials That Changed Practice… or Didn't!21世纪的放射肿瘤学:改变实践的前瞻性随机试验……还是并未改变!
Front Oncol. 2018 Apr 30;8:130. doi: 10.3389/fonc.2018.00130. eCollection 2018.
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Regarding: Rosenthal DI, Glatstein E. "We've Got a Treatment, but What's the Disease?" The Oncologist 1996;1.关于:罗森塔尔·迪、格拉茨坦·埃。《我们有了一种治疗方法,但疾病是什么?》,《肿瘤学家》1996年;第1期。
Oncologist. 1997;2(1):59-61.
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本文引用的文献

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Effect of Standard vs Dose-Escalated Radiation Therapy for Patients With Intermediate-Risk Prostate Cancer: The NRG Oncology RTOG 0126 Randomized Clinical Trial.标准剂量与剂量递增放疗治疗中危前列腺癌患者的效果:NRG 肿瘤学 RTOG 0126 随机临床试验。
JAMA Oncol. 2018 Jun 14;4(6):e180039. doi: 10.1001/jamaoncol.2018.0039.
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Bayesian Adaptive Randomization Trial of Passive Scattering Proton Therapy and Intensity-Modulated Photon Radiotherapy for Locally Advanced Non-Small-Cell Lung Cancer.局部晚期非小细胞肺癌被动散射质子治疗与强度调制光子放疗的贝叶斯自适应随机试验。
J Clin Oncol. 2018 Jun 20;36(18):1813-1822. doi: 10.1200/JCO.2017.74.0720. Epub 2018 Jan 2.
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Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.Durvalumab 用于 III 期非小细胞肺癌放化疗后的治疗。
N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
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Interim results from the CATNON trial (EORTC study 26053-22054) of treatment with concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma: a phase 3, randomised, open-label intergroup study.CATNON 试验(EORTC 研究 26053-22054)的中期结果,该试验采用同步和辅助替莫唑胺治疗 1p/19q 非共缺失间变性神经胶质瘤:一项 3 期、随机、开放标签的分组间研究。
Lancet. 2017 Oct 7;390(10103):1645-1653. doi: 10.1016/S0140-6736(17)31442-3. Epub 2017 Aug 8.
5
Postoperative stereotactic radiosurgery compared with whole brain radiotherapy for resected metastatic brain disease (NCCTG N107C/CEC·3): a multicentre, randomised, controlled, phase 3 trial.术后立体定向放射外科与全脑放疗治疗脑转移瘤切除术(NCCTG N107C/CEC·3):一项多中心、随机、对照、3期试验
Lancet Oncol. 2017 Aug;18(8):1049-1060. doi: 10.1016/S1470-2045(17)30441-2. Epub 2017 Jul 4.
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J Thorac Oncol. 2017 Oct;12(10):1561-1570. doi: 10.1016/j.jtho.2017.06.015. Epub 2017 Jun 23.
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