钇 90 微球放射栓塞与载药微球化疗栓塞治疗不可切除肝细胞肝癌：TRACE Ⅱ 期随机对照试验结果。
Y Radioembolization versus Drug-eluting Bead Chemoembolization for Unresectable Hepatocellular Carcinoma: Results from the TRACE Phase II Randomized Controlled Trial.
机构信息
From the Departments of Vascular and Interventional Radiology (E.D., L. Hermie, L. Huyck, P.V., L.D.), Gastroenterology and Hepatology (A.G., X.V., M.A., H.V.V.), and General and HPB Surgery and Liver Transplantation (A.V., F.B.), Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium; and the Departments of Diagnostic Sciences (B.L.) and Human Structure and Repair (R.I.T.), Ghent University, Ghent, Belgium.
出版信息
Radiology. 2022 Jun;303(3):699-710. doi: 10.1148/radiol.211806. Epub 2022 Mar 8.
Background Transarterial chemoembolization (TACE) is the recommended treatment for intermediate hepatocellular carcinoma (HCC) according to the Barcelona Clinic Liver Cancer guidelines. Prospective uncontrolled studies suggest that yttrium 90 (Y) transarterial radioembolization (TARE) is a safe and effective alternative. Purpose To compare the efficacy and safety of TARE with TACE for unresectable HCC. Materials and Methods In this single-center prospective randomized controlled trial (TRACE), Y glass TARE was compared with doxorubicin drug-eluting bead (DEB) TACE in participants with intermediate-stage HCC, extended to Eastern Cooperative Oncology Group performance status 1 and those with early-stage HCC not eligible for surgery or thermoablation. Participants were recruited between September 2011 and March 2018. The primary end point was time to overall tumor progression (TTP) (Kaplan-Meier analysis) in the intention-to-treat (ITT) and per-protocol (PP) groups. Results At interim analysis, 38 participants (median age, 67 years; IQR, 63-72 years; 33 men) were randomized to the TARE arm and 34 (median age, 68 years; IQR, 61-71 years; 30 men) to the DEB-TACE arm (ITT group). Median TTP was 17.1 months in the TARE arm versus 9.5 months in the DEB-TACE arm (ITT group hazard ratio [HR], 0.36; 95% CI: 0.18, 0.70; = .002) (PP group, 32 and 34 participants, respectively, in each arm; HR, 0.29; 95% CI: 0.14, 0.60; < .001). Median overall survival was 30.2 months after TARE and 15.6 months after DEB-TACE (ITT group HR, 0.48; 95% CI: 0.28, 0.82; = .006). Serious adverse events grade 3 or higher (13 of 33 participants [39%] vs 19 of 36 [53%] after TARE and DEB-TACE, respectively; = .47) and 30-day mortality (0 of 33 participants [0%] vs three of 36 [8.3%]; = .24) were similar in the safety groups. At the interim, the HR for the primary end point, TTP, was less than 0.39, meeting the criteria to halt the study. Conclusion With similar safety profile, yttrium 90 radioembolization conferred superior tumor control and survival compared with chemoembolization using drug-eluting beads in selected participants with early or intermediate hepatocellular carcinoma. Clinical trial registration no. NCT01381211 © RSNA, 2022
背景 经巴塞罗那临床肝癌指南推荐，对中期肝细胞癌（HCC）患者采用经动脉化疗栓塞术（TACE）治疗。前瞻性非对照研究表明，钇 90（Y）经动脉放射栓塞术（TARE）是一种安全有效的替代疗法。目的 比较不可切除 HCC 患者采用 TARE 与 TACE 的疗效和安全性。材料与方法 在这项单中心前瞻性随机对照试验（TRACE）中，将 Y 玻璃 TARE 与多柔比星载药微球（DEB）TACE 进行比较，研究对象为中晚期 HCC 患者，ECOG 体能状态扩展至 1 级，以及不适合手术或热消融治疗的早期 HCC 患者。参与者于 2011 年 9 月至 2018 年 3 月期间招募。主要终点是意向治疗（ITT）和方案（PP）组的总肿瘤进展时间（TTP）（Kaplan-Meier 分析）。结果 在中期分析时，38 名参与者（中位年龄 67 岁；IQR，63-72 岁；33 名男性）被随机分配至 TARE 组，34 名参与者（中位年龄 68 岁；IQR，61-71 岁；30 名男性）被分配至 DEB-TACE 组（ITT 组）。TARE 组的中位 TTP 为 17.1 个月，DEB-TACE 组为 9.5 个月（ITT 组 HR，0.36；95%CI：0.18，0.70； =.002）（PP 组，分别有 32 和 34 名参与者入组，每组；HR，0.29；95%CI：0.14，0.60； <.001）。TARE 组的中位总生存期为 30.2 个月，DEB-TACE 组为 15.6 个月（ITT 组 HR，0.48；95%CI：0.28，0.82； =.006）。3 级或更高级别的严重不良事件（TARE 和 DEB-TACE 组分别为 13 名参与者[39%]和 19 名参与者[53%]； =.47）和 30 天死亡率（TARE 组 0 名参与者[0%]，DEB-TACE 组 3 名参与者[8.3%]； =.24）在安全性组中相似。在中期，主要终点 TTP 的 HR 小于 0.39，达到停止研究的标准。结论 在选择的早期或中期 HCC 患者中，与 DEB-TACE 相比，钇 90 放射栓塞术具有相似的安全性，可提供更好的肿瘤控制和生存。临床试验注册号 NCT01381211 © RSNA，2022
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