BIOEMBRACE-I 旨在研究 EMBRACE 研究中除临床病理因素外的生物标志物对接受放化疗和 MRI 引导近距离放射治疗 (BT) 治疗局部晚期宫颈癌的患者疾病结果的影响。2018 年至 2021 年期间，有 8 项 EMBRACE -I 位点为 p16、PD-L1 和 L1CAM 的免疫组织化学提供了肿瘤组织。对这些生物标志物和临床病理因素（FIGO 2009 分期、淋巴结状态、组织学、MRI 坏死）进行分析，以预测近距离放射治疗 (BT) 的不良反应（BT 时的高风险临床靶体积 [HR-CTV] ≥40cc），以及5 年局部控制、盆腔控制和无病生存 (DFS)。研究了 p16、PD-L1、放疗剂量 (HR-CTV D90) 和疾病结果之间的相互作用。进行单变量和多变量分析。纳入 264 名患者。 HR-CTV D90 中位数为 89 (86-95) Gy。 p16 阳性 (pos)、PD-L1>1% 和 L1CAM ≥ 10% 的比例分别为 86.6%、20.1% 和 17.8%。 P16 阴性 (neg) 状态 (OR 2.0 (1.0-5.7), p=0.04)、MRI 坏死 (OR 2.1 (1.1-4.3), p<0.02) 独立预测 HR-CTV≥40cc，FIGO 分期和肿瘤宽度>5cm。 PDL1>1% 与局部（82% vs. 94%，p=0.02）和骨盆控制（79% vs. 89%，p=0.02）降低相关。 HR-CTV D90 <85Gy 与 p16 患者的 5 年局部控制较差相关，尤其是在 PD-L1 共表达的情况下。在多变量分析中，PD-L1>1%是5年局部控制的唯一独立因素（HR 3.3，p=0.04），L1CAM≥50%是骨盆控制的唯一独立因素（HR 5.5（1.3-23.3），p=0.02） MRI 上的 P16 阴性状态和肿瘤坏死与放化疗反应不良独立相关，而 PD-L1>1% 和 L1CAM≥50% 对局部和盆腔控制具有独立影响，表明生物标志物表达对结果的影响。需要进一步验证。版权所有 © 2024。由 Elsevier Inc. 出版。

BIOEMBRACE-I was designed to study the impact of biomarkers in addition to clinic-pathological factors on disease outcomes in patients treated with chemoradiation and MRI-guided brachytherapy (BT) for locally advanced cervical cancer in EMBRACE study.Between 2018-2021, eight EMBRACE-I sites contributed tumour tissue for immunohistochemistry of p16, PD-L1 and L1CAM. These biomarkers and clinicopathological factors (FIGO 2009 stage, nodal status, histology, necrosis on MRI) were analysed to predict poor response at brachytherapy (BT) (high-risk clinical target volume [HR-CTV] ≥40cc) at BT), and 5-year local control, pelvic control and disease-free survival (DFS). Interaction between p16, PD-L1, radiotherapy dose (HR-CTV D90) and disease outcomes was investigated. Univariable and multivariable analysis were performed.Two-hundred sixty-four patients were included. The median HR-CTV D90 was 89 (86-95) Gy. p16 positive (pos), PD-L1>1% and L1CAM ≥ 10% was noted in 86.6%, 20.1% and 17.8% respectively. P16 negative (neg) status (OR 2.0 (1.0-5.7), p=0.04), necrosis on MRI (OR 2.1 (1.1-4.3), p<0.02) independently predicted for HR-CTV≥40cc, as did FIGO stage and tumour width >5cm. PDL1>1% was associated with reduced local (82% vs. 94%, p=0.02) and pelvic control (79% vs. 89%, p=0.02). HR-CTV D90 <85Gy was associated with inferior 5-year local control in p16+ patients especially if PD-L1 was co-expressed. On multivariable analysis, PD-L1>1% was the only independent factor for 5-year local control (HR 3.3, p=0.04) and L1CAM ≥50% for pelvic control (HR 5.5 (1.3-23.3), p =0.02).P16 neg status and tumor necrosis on MRI are independently associated with poor response to chemoradiation, whereas PD-L1>1% and L1CAM≥50% have an independent impact on local and pelvic control suggesting impact of biomarker expression on outcomes. Further validation is needed.Copyright © 2024. Published by Elsevier Inc.