The Journey to Improve the College of American Pathologists Cancer Biomarker Reporting Protocols.

Brett Baskovich, Alexander Baras, Raja R Seethala, Patrick L Fitzgibbons, Frank Schneider, Brent T Harris, Joseph Khoury
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Abstract

Context.—: Biomarker reporting has increasingly become a key component of pathology reporting, providing diagnostic, prognostic, and actionable therapeutic data for patient care.

Objective.—: To expand and improve the College of American Pathologists (CAP) biomarker protocols.

Design.—: We surveyed CAP members to better understand the limitations they experienced when reporting cancer biomarker results. A Biomarker Workgroup reviewed the survey results and developed a strategy to improve and standardize biomarker reporting. Drafts of new and revised biomarker protocols were reviewed in both print and electronic template formats during interactive webinars presented to the CAP House of Delegates. Feedback was collected, and appropriate revisions were made to finalize the protocols.

Results.—: The first phase of the CAP Biomarker Workgroup saw the development of (1) a new stand-alone general Immunohistochemistry Biomarker Protocol that includes reporting for ER (estrogen receptor), PR (progesterone receptor), Ki-67, HER2 (human epidermal growth factor receptor 2), PD-L1 (programmed death ligand-1), and mismatch repair; (2) a new Head and Neck Biomarker Protocol that updates the prior 2017 paper-only version into an electronic template, adding new diagnostic and theranostic markers; (3) a major revision to the Lung Biomarker Protocol to streamline it and add in pan-cancer markers; and (4) a revision to the Colon and Rectum Biomarker Protocol to add HER2 reporting.

Conclusions.—: We have taken a multipronged approach to improving biomarker reporting in the CAP cancer protocols. We continue to review current biomarker reporting protocols to reduce and eliminate unnecessary methodologic details and update with new markers as needed. The biomarker templates will serve as standardized modular units that can be inserted into cancer-reporting protocols.

美国病理学家学会癌症生物标记物报告规程的改进之旅。
背景生物标记物报告已日益成为病理报告的关键组成部分,为患者护理提供诊断、预后和可操作的治疗数据:扩展并改进美国病理学家学会(CAP)生物标记物协议:我们对 CAP 成员进行了调查,以更好地了解他们在报告癌症生物标记物结果时遇到的限制。一个生物标记物工作组对调查结果进行了审查,并制定了改进和规范生物标记物报告的策略。在提交给 CAP 代表大会的互动式网络研讨会上,以印刷和电子模板的形式对新的和修订的生物标记物协议草案进行了审查。收集了反馈意见,并进行了适当的修订,最终确定了协议:CAP 生物标志物工作组第一阶段的工作包括:(1)制定新的独立的普通免疫组化生物标志物方案,其中包括报告 ER(雌激素受体)、PR(孕酮受体)、Ki-67、HER2(人表皮生长因子受体 2)、PD-L1(程序性死亡配体-1)和错配修复;(2) 新的《头颈部生物标记物协议》将 2017 年之前的纸质版更新为电子模板,增加了新的诊断和治疗标记物;(3) 对《肺部生物标记物协议》进行了重大修订,以简化该协议并增加泛癌症标记物;(4) 修订了《结肠和直肠生物标记物协议》,增加了 HER2 报告。结论我们采取了多管齐下的方法来改进 CAP 癌症方案中的生物标记物报告。我们将继续审查当前的生物标记物报告规程,以减少和消除不必要的方法细节,并根据需要更新新的标记物。生物标记物模板将作为标准化模块单元,可插入癌症报告规程中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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