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三十年的I期放化疗试验:最新进展。

Thirty years of phase I radiochemotherapy trials: Latest development.

作者信息

Rivoirard Romain, Vallard Alexis, Langrand-Escure Julien, Ben Mrad Majed, Wang Guoping, Guy Jean-Baptiste, Diao Peng, Dubanchet Alexandre, Deutsch Eric, Rancoule Chloe, Magne Nicolas

机构信息

Department of Medical Oncology, Lucien Neuwirth Cancer Institute, Saint Priest-en-Jarez, France.

Department of Radiotherapy, Lucien Neuwirth Cancer Institute, Saint Priest-en-Jarez, France.

出版信息

Eur J Cancer. 2016 May;58:1-7. doi: 10.1016/j.ejca.2016.01.012. Epub 2016 Feb 23.

DOI:10.1016/j.ejca.2016.01.012
PMID:26922167
Abstract

Radiochemotherapy is undergoing a complete expansion. Currently, possibilities of treatment combination are skyrocketting, with different anticancer and targeted molecules, different radiotherapy techniques, and dose escalation with each therapy. The development of a modern phase I radiochemotherapy trial becomes more and more complex and should be fully investigated. In the literature, there are no exhaustive reviews describing the necessity of their characteristics. The present article explores historical and current phase I clinical trials involving a combination of radiation therapy and anticancer therapies. Selected trials were identified by searching in PubMed databases. A total of 228 studies were identified in the last three decades, and a portrait of their characteristics is presented. As expected, most frequently studied malignancies were head and neck cancers, followed by non-small cell lung cancer and brain cancer. Toxicity is reported in more than 90% of the studies. Most studies were published since 2010, at the area of targeted therapies, but mainly concerned classical chemotherapies (cisplatin and 5-fluorouracil). The present review highlights some limits. Indeed, methodology seems not optimised and could be based on more accurate methods of dose-escalation. The present portrait of phase I radiochemotherapy trials suggests that radiochemotherapy notion must be reinvented and trials should be adapted to its complexity. Step by step method does not sound like an option anymore. Let us build the future of radiochemotherapy on past evidences.

摘要

放化疗正在经历全面扩张。目前,治疗组合的可能性正在迅速增加,涉及不同的抗癌和靶向分子、不同的放疗技术以及每种疗法的剂量递增。现代I期放化疗试验的开展变得越来越复杂,需要进行充分研究。在文献中,没有详尽的综述描述其特点的必要性。本文探讨了涉及放疗与抗癌疗法联合的历史和当前I期临床试验。通过在PubMed数据库中检索确定了所选试验。在过去三十年中总共确定了228项研究,并呈现了它们的特点概述。正如预期的那样,研究最频繁的恶性肿瘤是头颈癌,其次是非小细胞肺癌和脑癌。超过90%的研究报告了毒性。大多数研究自2010年以来发表于靶向治疗领域,但主要涉及传统化疗(顺铂和5-氟尿嘧啶)。本综述强调了一些局限性。确实,方法似乎未得到优化,可基于更精确的剂量递增方法。目前I期放化疗试验的概述表明,放化疗概念必须重新塑造,试验应适应其复杂性。逐步方法似乎不再是一种选择。让我们依据过去的证据构建放化疗的未来。

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Focus on the expected quality of reporting in SBRT/radiosurgery prospective studies: how far have we come in 30 years?聚焦 SBRT/放射外科前瞻性研究中的报告预期质量:30 年来我们已经走了多远?
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Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs.为临床试验设计增添灵活性:基于实例的适应性设计实际应用指南。
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Characteristics of Radiotherapy Trials Compared With Other Oncological Clinical Trials in the Past 10 Years.过去 10 年放疗试验与其他肿瘤临床试验的特点比较。
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