本研究旨在确定治疗开始前可用的风险标准，可用于对接受高危结肠癌新辅助化疗 (NAC) 的患者的梗阻风险进行分层。结肠癌新辅助化疗 (NAC) 的全球实施根据 FOxTROT 试验的信息，可能会增加肠梗阻的风险。一项病例对照研究，嵌套在一项国际随机对照试验中 (FOxTROT.ClinicalTrials.gov: NCT00647530)。确定了患有高风险可手术结肠癌（放射学分期 T3-4 N0-2 M0）的患者，这些患者被随机分配至 NAC 组并出现大肠梗阻。首先，比较在 FOxTROT 中接受 NAC 并发生和未发生梗阻的患者的临床结果。其次，使用随机抽样将梗阻患者（病例）与未发生梗阻的患者（对照）按 1:3 的比例进行年龄和性别匹配。使用贝叶斯条件混合效应逻辑回归模型来探索与阻塞相关的临床、放射学和病理特征。根据是否存在风险标准，对所有接受 NAC 的患者估计阻塞的绝对风险。在 FOxTROT 中随机分配的 1053 名患者中，699 例接受了 NAC，其中 30 例 (4.3%) 出现阻塞。患者在欧洲医院接受治疗，其中包括 88 家英国医院、7 家丹麦医院和 3 家瑞典医院。梗阻患者的开放手术较多（65.4% vs. 38.0%，P = 0.01），pR1 率较高（12.0% vs. 3.8%，P = 0.004），但术后结果相当。在病例对照匹配贝叶斯模型中，确定了两个独立的风险标准：（1）内窥镜检查中存在阻塞性疾病和/或无法穿过肿瘤（调整后的比值比：9.09，95％可信区间：2.34-39.66）和放射学或内窥镜检查显示狭窄性疾病（OR：7.18，95% C.I.：1.84-32.34）。根据是否存在这些标准定义了三个风险组：63.4% (443/698) 的患者处于极低风险 (<1%)，30.7% (214/698) 处于低风险 (<10%) ，5.9% (41/698) 处于高风险 (>10%)。可以通过使用治疗开始前可用的两个特征来安全选择结肠癌 NAC，并识别少数术前高风险患者阻塞。版权所有 © 2023 作者。由 Wolters Kluwer Health, Inc. 出版

This study aimed to identify risk-criteria available before the point of treatment initiation that can be used to stratify risk of obstruction in patients undergoing neoadjuvant chemotherapy (NAC) for high-risk colon cancer.Global implementation of neoadjuvant chemotherapy (NAC) for colon cancer, informed by the FOxTROT trial, may increase risk of bowel obstruction.A case-control study, nested within an international randomised controlled trial (FOxTROT. ClinicalTrials.gov: NCT00647530). Patients with high-risk operable colon cancer (radiologically-staged T3-4 N0-2 M0) that were randomised to NAC and developed large bowel obstruction were identified. Firstly, clinical outcomes were compared between patients receiving NAC in FOxTROT that did and did not develop obstruction. Secondly, obstructed patients (cases) were age- and sex-matched with patients that did not develop obstruction (controls) in a 1:3 ratio using random sampling. Bayesian conditional mixed-effects logistic regression modelling was used to explore clinical, radiological, and pathological features associated with obstruction. Absolute risk of obstruction based on the presence or absence of risk criteria was estimated for all patients receiving NAC.Of 1053 patients randomised in FOxTROT, 699 received NAC, of whom 30 (4.3%) developed obstruction. Patients underwent care in European hospitals including 88 UK, 7 Danish and 3 Swedish centres. There was more open surgery (65.4% vs. 38.0%, P =0.01) and a higher pR1 rate in obstructed patients (12.0% vs. 3.8%, P =0.004), but otherwise comparable postoperative outcomes. In the case-control matched Bayesian model, two independent risk criteria were identified: (1) obstructing disease on endoscopy and/or being unable to pass through the tumour (adjusted odds ratio: 9.09, 95% credible interval: 2.34-39.66) and stricturing disease on radiology or endoscopy (OR: 7.18, 95% C.I.: 1.84-32.34). Three risk groups were defined according to the presence or absence of these criteria: 63.4% (443/698) of patients were at very low risk (<1%), 30.7% (214/698) at low risk (<10%), and 5.9% (41/698) at high risk (>10%).Safe selection for NAC for colon cancer can be informed by using two features that are available before treatment initiation and identify a small number of patients with high risk of preoperative obstruction.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.