Sainamthip Panot, Kongphanich Chutcharn, Prasongsook Naiyarat, Chirapongsathorn Sakkarin
Department of Pharmacology, Chulalongkorn University, Bangkok 10330, Thailand.
Department of Radiology, Phramongkutklao College of Medicine, Bangkok 10400, Thailand.
World J Clin Cases. 2021 Oct 26;9(30):9059-9069. doi: 10.12998/wjcc.v9.i30.9059.
Even in the immuno-oncology era, transcatheter arterial chemoembolisation (TACE) is the most effective way to treat intermediate stage hepatocellular carcinoma (HCC). Postembolisation syndrome (PES) is the most common side effect from TACE and there is still no standard prevention guideline.
To evaluate the efficacy of single dose intravenous dexamethasone regimen to prevent PES after TACE among patients with HCC.
This study enrolled patients with HCC who had eligible indication for TACE without macrovascular invasion/extrahepatic metastasis. Patients were randomly assigned to either an intravenous single dose of dexamethasone 8 mg or placebo one hour before TACE. The primary outcome was a negative result of PES at 48 h after TACE, which was defined as score < 2 of Southwest Oncology Group toxicity coding criteria using fever, nausea, vomiting and pain to calculated. And the secondary end point was duration of admission between two groups.
One hundred patients were randomly assigned 1:1. Under intention-to-treat analysis, 49 patients were randomly assigned to the dexamethasone and 51 to the placebo groups. Both groups were similar for baseline characteristics. The negative PES rate was significantly higher in the dexamethasone group than in the placebo group (63.3% 29.4%; = 0.005). Mean Southwest Oncology Group toxicity coding PES was 2.14 (95%CI: 1.41-2.8) 3.71 (95%CI: 2.97-4.45) between the dexamethasone and placebo groups, respectively. Cumulative incidence of fever was significantly lower in dexamethasone group with < 0.001, pain, nausea and vomiting were also lower in the dexamethasone group compared with the placebo group ( = 0.16, = 0.11, and = 0.49). The dexamethasone regimen was generally well tolerated by patients with HCC patients including those with hepatitis B virus infection and well-controlled diabetes mellitus.
Single dose dexamethasone was effective at preventing PES among patients with HCC treated with TACE. The study showed no adverse events of special interest related to dexamethasone.
即使在免疫肿瘤学时代，经动脉化疗栓塞术（TACE）仍是治疗中期肝细胞癌（HCC）最有效的方法。栓塞后综合征（PES）是TACE最常见的副作用，目前仍没有标准的预防指南。
评估单剂量静脉注射地塞米松方案预防HCC患者TACE术后PES的疗效。
本研究纳入了有TACE适应证且无大血管侵犯/肝外转移的HCC患者。患者在TACE前1小时被随机分为静脉注射单剂量8mg地塞米松组或安慰剂组。主要结局是TACE术后48小时PES为阴性结果，定义为根据发热、恶心、呕吐和疼痛按照西南肿瘤协作组毒性编码标准计算得分<2分。次要终点是两组的住院时间。
100例患者按1:1随机分组。在意向性分析中，49例患者被随机分配到地塞米松组，51例被分配到安慰剂组。两组基线特征相似。地塞米松组的PES阴性率显著高于安慰剂组（63.3%对29.4%；P = 0.005）。地塞米松组和安慰剂组的西南肿瘤协作组毒性编码PES平均分分别为2.14（95%CI：1.41 - 2.8）和3.71（95%CI：2.97 - 4.45）。地塞米松组发热的累积发生率显著更低（P < 0.001），与安慰剂组相比，地塞米松组的疼痛、恶心和呕吐发生率也更低（P分别为0.16、0.11和0.49）。地塞米松方案在HCC患者中总体耐受性良好，包括乙型肝炎病毒感染患者和血糖控制良好的糖尿病患者。
单剂量地塞米松可有效预防接受TACE治疗的HCC患者发生PES。该研究未显示与地塞米松相关的特别关注的不良事件。
