Departments of Surgical Oncology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.
Br J Surg. 2014 Dec;101(13):1657-65. doi: 10.1002/bjs.9644. Epub 2014 Oct 13.
Results in breast cancer research are reported using study endpoints. Most are composite endpoints (such as locoregional recurrence), consisting of several components (for example local recurrence) that are in turn composed of specific events (such as skin recurrence). Inconsistent endpoint selection and definition might lead to unjustified conclusions when comparing study outcomes. This study aimed to determine which locoregional endpoints are used in breast cancer studies, and how these endpoints and their components are defined.
PubMed was searched for breast cancer studies published in nine leading journals in 2011. Articles using endpoints with a local or regional component were included and definitions were compared.
Twenty-three different endpoints with a local or regional component were extracted from 44 articles. Most frequently used were disease-free survival (25 articles), recurrence-free survival (7), local control (4), locoregional recurrence-free survival (3) and event-free survival (3). Different endpoints were used for similar outcomes. Of 23 endpoints, five were not defined and 18 were defined only partially. Of these, 16 contained a local and 13 a regional component. Included events were not specified in 33 of 57 (local) and 27 of 50 (regional) cases. Definitions of local components inconsistently included carcinoma in situ and skin and chest wall recurrences. Regional components inconsistently included specific nodal sites and skin and chest wall recurrences.
Breast cancer studies use many different endpoints with a locoregional component. Definitions of endpoints and events are either not provided or vary between trials. To improve transparency, facilitate trial comparison and avoid unjustified conclusions, authors should report detailed definitions of all endpoints.
乳腺癌研究的结果是通过研究终点来报告的。大多数是复合终点（如局部区域复发），由几个组成部分（如局部复发）组成，而这些组成部分又由特定的事件（如皮肤复发）组成。当比较研究结果时，不一致的终点选择和定义可能导致不合理的结论。本研究旨在确定乳腺癌研究中使用的局部区域终点，以及这些终点及其组成部分是如何定义的。
在 2011 年，在九种主要期刊上搜索了使用局部或区域成分的乳腺癌研究文章。包括使用具有局部或区域成分的终点的文章，并比较了定义。
从 44 篇文章中提取了 23 个具有局部或区域成分的不同终点。最常使用的是无病生存（25 篇文章）、无复发生存（7 篇）、局部控制（4 篇）、局部区域无复发生存（3 篇）和无事件生存（3 篇）。类似的结果使用了不同的终点。在 23 个终点中，有 5 个未定义，18 个仅部分定义。其中，16 个包含局部成分，13 个包含区域成分。在 57 个（局部）和 50 个（区域）病例中，未指定包含的事件。局部成分的定义不一致，包括原位癌和皮肤及胸壁复发。区域成分不一致，包括特定的淋巴结部位和皮肤及胸壁复发。
乳腺癌研究使用了许多具有局部区域成分的不同终点。终点和事件的定义要么没有提供，要么在试验之间存在差异。为了提高透明度，便于试验比较并避免不合理的结论，作者应报告所有终点的详细定义。
