Weiss L, Dorman K, Boukovala M, Schwinghammer F, Jordan P, Fey T, Hasselmann K, Subklewe M, Bücklein V, Bargou R, Goebeler M, Sayehli C, Spoerl S, Lüke F, Heudobler D, Claus R, von Luettichau I, Lorenzen S, Lange S, Westphalen C B, von Bergwelt-Baildon M, Heinemann V, Gießen-Jung C
Department Medicine III (Hematology and Oncology), LMU University Hospital Munich, Munich, Germany.
Bavarian Cancer Research Center (BZKF), Munich, Germany.
J Cancer Res Clin Oncol. 2023 Nov;149(14):13383-13390. doi: 10.1007/s00432-023-05196-x. Epub 2023 Jul 25.
Early clinical trials are the first step into clinical therapies for new drugs. Within the six Bavarian university-based hospitals (Augsburg, Erlangen, Regensburg, Munich (LMU and TU), Würzburg) we have enrolled a virtual network platform for patient discussion.
The virtual Early Clinical Trial Unit Tumor Board (ECTU Tumor Board) is a secured web-based meeting to evaluate early clinical trial options for patients, where representatives from local ECTUs participate. We retrospectively analyzed patient cases discussed between November 2021 and November 2022.
From November 2021 to November 2022, a total of 43 patients were discussed in the ECTU Tumor Board. Median age at diagnosis was 44.6 years (range 10-76 years). The median number of previous lines of therapies was 3.7 (range 1-9 therapies) including systemic treatment, surgery, and radiation therapy. A total of 27 different tumor entities were presented and 83.7% (36/43) patients received at least one trial recommendation. In total, 21 different active or shortly recruiting clinical trials were recommended: ten antibody trials, four BiTE (bispecific T cell engager) trials, six CAR (chimeric antigen receptor) T-cell trials, and one chemotherapy trial. Only six trials (28.6%) were recommended on the basis of the previously performed comprehensive genetic profiling (CGP).
The ECTU Tumor Board is a feasible and successful network, highlighting the force of virtual patient discussions for improving patient care as well as trial recruitment in advanced diseases. It can provide further treatment options after local MTB presentation, aiming to close the gap to access clinical trials.
早期临床试验是新药进入临床治疗的第一步。在巴伐利亚州的六所大学附属医院（奥格斯堡、埃尔朗根、雷根斯堡、慕尼黑（路德维希 - 马克西米利安大学和慕尼黑工业大学）、维尔茨堡）中，我们设立了一个用于患者讨论的虚拟网络平台。
虚拟早期临床试验单元肿瘤委员会（ECTU肿瘤委员会）是一个基于网络的安全会议，用于评估患者的早期临床试验方案，当地ECTU的代表会参与其中。我们回顾性分析了2021年11月至2022年11月期间讨论的患者病例。
2021年11月至2022年11月期间，ECTU肿瘤委员会共讨论了43例患者。诊断时的中位年龄为44.6岁（范围10 - 76岁）。先前治疗线数的中位数为3.7（范围1 - 9种治疗方法），包括全身治疗、手术和放射治疗。共展示了27种不同的肿瘤实体，83.7%（36/43）的患者至少获得了一项试验推荐。总共推荐了21项不同的正在进行或即将招募患者的临床试验：10项抗体试验、4项双特异性T细胞衔接器（BiTE）试验、6项嵌合抗原受体（CAR）T细胞试验和1项化疗试验。只有6项试验（28.6%）是基于先前进行的全面基因谱分析（CGP）推荐的。
ECTU肿瘤委员会是一个可行且成功的网络，突出了虚拟患者讨论在改善患者护理以及晚期疾病试验招募方面的作用。它可以在当地多学科治疗团队（MTB）讨论后提供更多治疗选择，旨在缩小进入临床试验的差距。
