1 Oncology Radiodiagnostics, Oncology Institute of Veneto, Institute for the Research and Treatment of Cancer, Padova, Italy.
2 Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, San Salvatore Hospital, Via Lombroso 1, Pesaro 61122, Italy.
AJR Am J Roentgenol. 2017 Aug;209(2):430-434. doi: 10.2214/AJR.16.17477. Epub 2017 May 24.
The purpose of this study is to determine the efficacy and tolerability of transarterial chemoembolization (TACE) using polyethylene glycol (PEG) drug-elutable microspheres loaded with doxorubicin for treatment of hepatocellular carcinoma (HCC).
Forty-two patients with unresectable HCC, as determined by a tumor board, were assigned to undergo TACE and were treated with PEG drug-elutable embolics loaded with doxorubicin. Patients were prospectively enrolled and included 32 (76%) men and 10 (24%) women. Their median age was 65 years (range, 42-83 years). Patients were treated with 50 mg of doxorubicin loaded in 2 mL of PEG embolics (mean [± SD] diameter, 100 ± 25 µm) that were infused via a chemoembolization method. Data collected included previous cancer therapy, tumor size, number of lesions, history of TACE, tumor response (at 1, 3, and 6 months), type and intensity of adverse events, and quality of life (QOL) analysis.
One month after TACE, the overall tumor response rate was 79% (50% complete response, 29% partial response, 17% stable disease, and 5% progressive disease). At 3 months, the rates were 48% for complete response, 24% for partial response, 24% for stable disease, and 3% for progressive disease. At 6 months, the rates were 43% for complete response, 19% for partial response, 29% for stable disease, and 10% for progressive disease. TACE was well tolerated by all patients, with no evidence of procedure-related complications or systemic drug-related adverse events. Fever (33%), increase in transaminase level (17%), and pain (33%) were the most frequent adverse events, and their intensity was mostly mild (grades 1 and 2). The QOL scores were 80 at 1 month, 81 at 3 months, and 82 at 6 months after TACE.
These data suggest that PEG embolics are efficacious and safe for the treatment of HCC, as indicated by their good tolerability, QOL scores, and high tumor response.
本研究旨在确定聚乙二醇（PEG）载多柔比星药栓行经动脉化疗栓塞（TACE）治疗肝细胞癌（HCC）的疗效和耐受性。
肿瘤委员会确定的 42 例不可切除 HCC 患者被分配行 TACE 治疗，并接受 PEG 载多柔比星药栓栓塞治疗。患者前瞻性入组，包括 32 例（76%）男性和 10 例（24%）女性。中位年龄为 65 岁（范围：42-83 岁）。患者接受 50mg 多柔比星负载于 2ml PEG 栓塞剂（平均[±SD]直径为 100±25μm），通过化疗栓塞法注入。收集的数据包括既往癌症治疗、肿瘤大小、病灶数量、TACE 史、肿瘤反应（1、3 和 6 个月）、不良事件类型和强度以及生活质量（QOL）分析。
TACE 后 1 个月，总体肿瘤反应率为 79%（完全缓解 50%，部分缓解 29%，稳定疾病 17%，进展疾病 5%）。3 个月时，完全缓解率为 48%，部分缓解率为 24%，稳定疾病率为 24%，进展疾病率为 3%。6 个月时，完全缓解率为 43%，部分缓解率为 19%，稳定疾病率为 29%，进展疾病率为 10%。所有患者均能耐受 TACE，无与治疗相关的并发症或全身药物相关不良事件的证据。最常见的不良反应为发热（33%）、转氨酶水平升高（17%）和疼痛（33%），其强度大多为轻度（1 级和 2 级）。TACE 后 1 个月、3 个月和 6 个月的 QOL 评分分别为 80、81 和 82。
这些数据表明，PEG 栓塞剂治疗 HCC 是有效且安全的，其良好的耐受性、QOL 评分和高肿瘤反应均表明这一点。
