Department of Radiology, Northwestern Feinberg School of Medicine, Chicago, IL.
Department of Radiology, University of Washington, Seattle, WA.
Hepatology. 2021 Nov;74(5):2342-2352. doi: 10.1002/hep.31819. Epub 2021 Jun 11.
Locoregional therapies, including yttrium-90 radioembolization, play an important role in the treatment of unresectable HCC. The aim of the LEGACY (Local radioEmbolization using Glass Microspheres for the Assessment of Tumor Control with Y-90) study was to evaluate objective response rate (ORR) and duration of response (DoR) in patients with solitary unresectable HCC treated with yttrium-90 glass microspheres.
LEGACY is a multicenter, single-arm, retrospective study conducted at three sites that included all eligible, consecutive patients with HCC treated with radioembolization between 2014 and 2017. Eligibility criteria included solitary HCC ≤ 8 cm, Child-Pugh A cirrhosis, and Eastern Cooperative Oncology Group performance status 0-1. Primary endpoints were ORR and DoR based on modified Response Evaluation Criteria in Solid Tumors in the treated area (localized), as evaluated by blinded, independent, central review. Radioembolization was performed with intent of ablative-level dosimetry in a selective fashion when possible. Overall survival was evaluated using Kaplan-Meier and multivariate Cox proportional hazards. Among the 162 patients included, 60.5% were Eastern Cooperative Oncology Group 0, and the median tumor size was 2.7 cm (range: 1-8) according to blinded, independent, central review. Radioembolization served as neoadjuvant therapy for transplantation or resection in 21.0% (34 of 162) and 6.8% (11 of 162) of patients, respectively, and as primary treatment for all others. Median follow-up time was 29.9 months by reverse Kaplan-Meier. ORR (best response) was 88.3% (CI: 82.4-92.4), with 62.2% (CI: 54.1-69.8) exhibiting a DoR ≥ 6 months. Three-year overall survival was 86.6% for all patients and 92.8% for those neoadjuvant patients with resected or transplanted liver.
In this multicenter study of radioembolization, clinical meaningful response rates and prolonged DoR were observed in the treatment of unresectable, solitary HCC ≤ 8 cm.
局部区域治疗，包括钇-90 放射性栓塞术，在不可切除的 HCC 治疗中发挥着重要作用。LEGACY（使用玻璃微球进行 Y-90 放射性栓塞以评估肿瘤控制的局部放射性治疗）研究的目的是评估接受钇-90 玻璃微球治疗的不可切除的单发 HCC 患者的客观缓解率（ORR）和缓解持续时间（DoR）。
LEGACY 是一项多中心、单臂、回顾性研究，在三个地点进行，纳入了 2014 年至 2017 年期间接受放射性栓塞治疗的所有符合条件的连续 HCC 患者。入选标准包括单发 HCC ≤ 8cm、Child-Pugh A 级肝硬化和东部肿瘤协作组体能状态 0-1。主要终点是根据改良的实体瘤反应评估标准（RECIST）在治疗区域（局部）评估的 ORR 和 DoR，评估由盲法、独立、中心审查进行。放射性栓塞尽可能采用选择性的消融水平进行。使用 Kaplan-Meier 和多变量 Cox 比例风险进行总体生存评估。在纳入的 162 例患者中，60.5%为东部肿瘤协作组 0，根据盲法、独立、中心审查，中位肿瘤大小为 2.7cm（范围：1-8）。21.0%（34/162）和 6.8%（11/162）的患者分别将放射性栓塞作为移植或切除的新辅助治疗，其余所有患者均将其作为一线治疗。通过反向 Kaplan-Meier 中位随访时间为 29.9 个月。ORR（最佳反应）为 88.3%（CI：82.4-92.4），62.2%（CI：54.1-69.8）的患者 DoR≥6 个月。所有患者的 3 年总生存率为 86.6%，新辅助治疗后接受肝切除或移植的患者为 92.8%。
在这项关于放射性栓塞的多中心研究中，观察到了不可切除的单发 HCC（≤8cm）治疗中具有临床意义的缓解率和延长的 DoR。
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