文章：

快速、实时病理审查用于ECOG/ACRIN 1412研究：精准医学时代未来淋巴瘤临床试验的一种新颖且成功的范式

Rapid, real time pathology review for ECOG/ACRIN 1412: a novel and successful paradigm for future lymphoma clinical trials in the precision medicine era

原文发布日期：2018-02-28

DOI: 10.1038/s41408-018-0064-9

类型: Article

开放获取: 是

英文摘要：

ECOG/ACRIN 1412 (E1412) is a randomized, phase II open-label study of lenalidomide/RCHOP vs. RCHOP alone in adults with newly diagnosed de novo diffuse large B-cell lymphoma (DLBCL) and requires NanoString gene expression profiling (GEP) for cell-of-origin testing. Because of high ineligibility rate on retrospective expert central pathology review (ECPR), real-time (RT) ECPR was instituted to confirm diagnosis and ensure adequate tissue for GEP prior to study enrollment. Goal was notification of eligibility within 2 working days (WD). Initially, 208 patients were enrolled, 74 (35.6%) of whom were deemed ineligible by retrospective ECPR. After initiation of RT-ECPR, 219 patients were registered. Of these, 73 (33.3%) were ineligible and were declined enrollment; 47 (21.5% of total) had an ineligible diagnosis on RT-ECPR, and 26 (11.9% of total) had inadequate tissue. Because the 73 ineligible patients were never enrolled, no study slots were “lost” during this phase. Notification of eligibility occurred in an average of 1 WD (Range 0–4) with 97.3% within 2 WD. This novel RT-ECPR serves as a model for future lymphoma trials. Real-time ECPR can help to reduce costs and ensure that study slots accurately reflect the targeted population. In the precision-medicine era, rapid collection of relevant pathology/biomarker data is essential to trial success.

摘要翻译： 

ECOG/ACRIN 1412 (E1412) 是一项随机、二期开放标签研究，针对新诊断的原发性弥漫性大B细胞淋巴瘤（DLBCL）成人患者，比较来那度胺/RCHOP方案与单独RCHOP方案的疗效，并需通过NanoString基因表达谱（GEP）进行细胞起源分型检测。由于回顾性专家中心病理复核（ECPR）的不合格率较高，研究引入了实时（RT）ECPR机制，以在患者入组前确认诊断并确保组织样本足够进行GEP分析。目标是在2个工作日内通知入组资格。初步阶段共入组208例患者，其中74例经回顾性ECPR判定为不合格。启动实时ECPR后，共有219例患者完成注册，其中73例不符合入组标准并被拒绝入组；47例经实时ECPR诊断为不符合条件，26例存在组织样本量不足的问题。由于这73例不合格患者从未正式入组，该阶段未浪费任何研究名额。资格通知平均耗时1个工作日，97.3%的病例在2个工作日内完成。这种创新的实时ECPR模式为未来淋巴瘤临床试验提供了范本。实时ECPR有助于降低成本，并确保研究名额精准覆盖目标人群。在精准医疗时代，快速收集相关病理学/生物标志物数据对临床试验的成功至关重要。

原文链接：

Rapid, real time pathology review for ECOG/ACRIN 1412: a novel and successful paradigm for future lymphoma clinical trials in the precision medicine era