Vanderbilt University School of Medicine, Nashville, Tennessee.
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
J Vasc Interv Radiol. 2023 Dec;34(12):2147-2154.e2. doi: 10.1016/j.jvir.2023.08.039. Epub 2023 Aug 30.
To determine overall survival (OS), best response, and toxicities in patients with hepatocellular carcinoma (HCC) previously treated with chemoembolization (TACE+) or yttrium-90 resin transarterial radioembolization (TARE) compared with those of TACE-naïve (T-N) participants.
In this prospective, observational study, 262 adult participants with HCC were divided into TACE+ (n = 93, 35%) or T-N (n = 169, 65%) groups, included from 36 centers in the United States. Overall survival (OS) was assessed using Kaplan-Meier analysis from the date of TARE. Best response at 6 months was evaluated using modified Response Evaluation Criteria in Solid Tumors. Six-month toxicities were reported using Common Terminology Criteria for Adverse Events, version 5.
Median OS for patients in the TACE+ and T-N groups was 22.3 months (95% CI: 17.2 to not reachable) and 21.5 months (95% confidence interval [CI]: 14.9-29.9), respectively (P = .6). Imaging at 6 months ± 2 weeks was available in 156 of 262 (60%) participants. Partial or complete response was seen in 27 of 55 patients (49%) in the TACE+ group and 65 of 101 patients (64%) in the T-N group (P = .2). Six-month toxicities were available in 69 of 93 patients (74%) in the TACE+ group and 135 of 167 patients (81%) in the T-N group. Attributable Grade 3 or greater liver function toxicities were similar between the study groups (all P > .05).
OS and imaging response at 6 months in the TACE+ group was similar to that in the T-N group with similar toxicities. Radioembolization is an acceptable treatment option for patients with HCC previously treated with TACE.
比较先前接受过化疗栓塞(TACE+)或钇-90 树脂经动脉放射栓塞(TARE)治疗的肝细胞癌(HCC)患者与 TACE 初治(T-N)患者的总生存期(OS)、最佳反应和毒性。
在这项前瞻性、观察性研究中,将 262 名成年 HCC 患者分为 TACE+(n=93,35%)或 T-N(n=169,65%)组,纳入了美国 36 个中心的患者。TARE 日期的 Kaplan-Meier 分析评估总生存期(OS)。采用改良实体瘤反应评价标准(mRECIST)评估 6 个月时的最佳反应。采用不良事件通用术语标准(CTCAE)第 5 版报告 6 个月的毒性。
TACE+组和 T-N 组患者的中位 OS 分别为 22.3 个月(95%置信区间:17.2 至不可评估)和 21.5 个月(95%置信区间:14.9-29.9)(P=0.6)。在 262 名患者中,有 156 名(60%)患者在 262 名患者中可以进行 6 个月±2 周的影像学评估。TACE+组 55 例患者中有 27 例(49%)和 T-N 组 101 例患者中有 65 例(64%)出现部分或完全缓解(P=0.2)。在 TACE+组的 93 名患者中有 69 名(74%)和 T-N 组的 167 名患者中有 135 名(81%)患者可以获得 6 个月的毒性(所有 P>0.05)。两组患者的肝功能 3 级或更高级别的毒性发生率相似(所有 P>0.05)。
TACE+组的 OS 和 6 个月时的影像学反应与 T-N 组相似,毒性也相似。放射栓塞是 TACE 治疗后 HCC 患者的一种可接受的治疗选择。