Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Utrecht, The Netherlands; and
Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Utrecht, The Netherlands; and.
J Nucl Med. 2018 Apr;59(4):582-588. doi: 10.2967/jnumed.117.197194. Epub 2017 Sep 15.
Radioembolization of liver malignancies with Ho-microspheres has been shown to be safe in a phase 1 dose-escalation study. The purpose of this study was to investigate the efficacy of Ho radioembolization. In this prospective single-arm study, 56 patients were enrolled, all with liver metastases refractory to systemic therapy and ineligible for surgical resection. The primary outcome was a response by 2 target lesions on triphasic liver CT scans 3 mo after therapy, as assessed using RECIST, version 1.1. Secondary outcomes included overall tumor response, time to imaging progression, overall survival, toxicity, quality of life, and quantification of the microspheres on SPECT and MRI. Between May 2012 and March 2015, 38 eligible patients were treated, one of whom was not evaluable. In 27 (73%) of 37 patients, the target lesions showed complete response, partial response, or stable disease (disease control) at 3 mo (95% confidence interval [CI], 57%-85%). The median overall survival was 14.5 mo (95% CI, 8.6-22.8 mo). For colorectal cancer patients ( = 23), the median overall survival was 13.4 mo (95% CI, 8.2-15.7 mo). Grade 3 or 4 toxic events after treatment (according to the Common Terminology Criteria for Adverse Events, version 4.03) included abdominal pain (in 18% of patients), nausea (8%), ascites (3%), fatigue (3%), gastric stenosis (3%), hepatic failure (3%), liver abscesses (3%), paroxysmal atrial tachycardia (3%), thoracic pain (3%), upper gastrointestinal hemorrhage (3%), and vomiting (3%). On SPECT, Ho could be quantified with high accuracy and precision, with a mean overestimation of 9.3% ± 7.1% in the liver. Radioembolization with Ho-microspheres induced a tumor response with an acceptable toxicity profile in salvage patients with liver metastases.
钬[Ho]微球放射性栓塞治疗肝脏恶性肿瘤的安全性已在 1 期剂量递增研究中得到证实。本研究旨在探讨 Ho 放射性栓塞的疗效。 在这项前瞻性单臂研究中，共纳入 56 例患者，所有患者均为系统治疗耐药且不符合手术切除条件的肝转移瘤。主要结局为治疗后 3 个月时通过三时相肝脏 CT 扫描评估的 2 个靶病变的反应，采用 RECIST 1.1 版评估。次要结局包括总体肿瘤反应、影像学进展时间、总生存期、毒性、生活质量和 SPECT 和 MRI 上的微球定量。 2012 年 5 月至 2015 年 3 月，38 例符合条件的患者接受了治疗，其中 1 例无法评估。在 37 例患者中的 27 例（73%）中，3 个月时靶病变完全缓解、部分缓解或稳定（疾病控制）（95%置信区间[CI]，57%-85%）。中位总生存期为 14.5 个月（95%CI，8.6-22.8 个月）。对于结直肠癌患者（n=23），中位总生存期为 13.4 个月（95%CI，8.2-15.7 个月）。根据通用不良事件术语标准 4.03 版，治疗后发生 3 级或 4 级毒性事件包括腹痛（18%的患者）、恶心（8%）、腹水（3%）、乏力（3%）、胃狭窄（3%）、肝衰竭（3%）、肝脓肿（3%）、阵发性房性心动过速（3%）、胸痛（3%）、上消化道出血（3%）和呕吐（3%）。在 SPECT 上，Ho 可以高度准确和精确地定量，肝脏平均高估 9.3%±7.1%。 在挽救性治疗的肝转移患者中，钬[Ho]微球放射性栓塞治疗诱导了肿瘤反应，且具有可接受的毒性特征。
