Variations in diagnostic and therapeutic procedures in a multicentre, randomized clinical trial (EORTC 10853) investigating breast-conserving treatment for DCIS
Variations in diagnostic and therapeutic procedures in a multicentre, randomized clinical trial (EORTC 10853) investigating breast-conserving treatment for DCIS
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DOI：
10.1053/ejso.2000.1062
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发表时间：
2001-03-01
期刊：
影响因子：
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通讯作者：
van Dongen, JA
中科院分区：
文献类型：
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作者：
Bijker, N;Rutgers, EJT;van Dongen, JA
目的：评价欧洲癌症研究和治疗组织（EORTC）的一项随机临床试验中遵循的诊断和治疗程序，该试验旨在研究放射治疗在乳腺导管原位癌（DCIS）保乳治疗（BCT）中的作用。方法：在对30个参与研究的机构进行现场访问期间，对1010名随机患者中的824名（82%）的医疗档案进行了审查。发生了很大的变化，特别是在进行的外科手术和组织病理学检查中。重要的风险因素，如肿瘤大小和边缘状态，在医疗瓷砖中的量化较差。这些发现强调需要建立DCIS诊断和治疗程序的统一指南，以及明确定义DCIS BCT后复发的风险因素。由于其随机性，试验的主要问题，即放疗对局部复发风险的影响，不会受到变化的影响。然而，局部复发的风险本身，以及BCT治疗DCIS的成功率，可能会受到初始手术质量的影响。(C)2001年哈考特出版社有限公司
Aims: To evaluate the diagnostic and therapeutic procedures which were followed in a European Organization for Research and Treatment of Cancer (EORTC) randomized clinical trial investigating the role of radiotherapy in breast-conserving treatment (BCT) for ductal carcinoma in situ (DCIS) of the breast.Methods: The medical files of 824 of the 1010 randomized patients (82%) were reviewed during site visits to 30 participating institutes.Results: Large variations occurred, particularly in the surgical procedures and histopathological work-up which were performed. Important risk factors like tumour size and margin status were poorly quantified in the medical tiles.Conclusions: These findings emphasize the need for establishing uniform guidelines for diagnostic and therapeutic procedures for DCIS, and for clearly defined risk factors for recurrence after BCT for DCIS, Because of its randomized nature, the main question of the trial, i.e. the effect of radiotherapy on the risk of local recurrence, will not be influenced by variation. The risk of local recurrence in itself, and hence the success of BCT for DCIS, may however be influenced by the quality of the initial procedures that were conducted. (C) 2001 Harcourt Publishers Ltd.