Department of Interventional Oncology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Cancer Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Cancer Med. 2024 Jul;13(13):e7419. doi: 10.1002/cam4.7419.
Transarterial chemoembolization (TACE) is the standard treatment for intermediate-stage hepatocellular carcinoma (HCC). Given the lack of specific recommendations for conventional TACE (cTACE) and drug-eluting bead TACE (DEB-TACE) in patients having unresectable HCC with tumor infiltrating the common hepatic duct or the first-order branch of the bile ducts (B1-type bile duct invasion; B1-BDI) after biliary drainage, we retrospectively compared the safety and efficacy of DEB-TACE with cTACE in this patient population.
Using data from five tertiary medical centers (January 2017-December 2021), we compared complications, overall survival (OS), time to progression (TTP), and tumor response rate between patients having unresectable HCC with B1-BDI who underwent DEB-TACE or cTACE after successful biliary drainage. X-tile software calculated the pre-TACE total bilirubin (TBil) cutoff value, indicating optimal timing for sequential TACE after drainage. Propensity score matching (PSM) was performed.
The study included 108 patients with unresectable HCC (B1-BDI) who underwent DEB-TACE and 114 who received cTACE as initial treatment. After PSM (n = 53 for each group), the DEB-TACE group had a longer TTP (8.9 vs. 6.7 months, p = 0.038) and higher objective response rate (64.2% vs. 39.6%, p = 0.011) than did the cTACE group, although OS was comparable (16.7 vs. 15.3 months, p = 0.115). The DEB-TACE group exhibited fewer post-procedural increments in the mean albumin-bilirubin score, TBil, and alanine aminotransferase (ALT), along with a significantly lower incidence of serious adverse events within 30 days (hepatic failure, ALT increase, and TBil increase) than the cTACE group (all p < 0.05). The pre-TACE TBil cutoff value was 99 μmol/L; patients with higher values (>99 μmol/L) had poorer OS in both groups (p < 0.05).
DEB-TACE is safe and effective after successful biliary drainage in unresectable HCC with B1-BDI, potentially better than cTACE in terms of liver toxicity, TTP, and ORR. Lowering TBil below 99 μmol/L through successful drainage may create ideal conditions for sequential TACE.
经动脉化疗栓塞术（TACE）是治疗中期肝细胞癌（HCC）的标准治疗方法。鉴于对于接受胆道引流后存在不可切除 HCC 且肿瘤浸润肝总胆管或胆管一级分支（B1 型胆管侵犯；B1-BDI）的患者，常规 TACE（cTACE）和载药微球 TACE（DEB-TACE）缺乏具体推荐，我们回顾性比较了 DEB-TACE 和 cTACE 在这一患者人群中的安全性和疗效。
使用来自五个三级医疗中心的数据（2017 年 1 月至 2021 年 12 月），我们比较了胆道引流后接受 DEB-TACE 或 cTACE 治疗的不可切除 HCC 且存在 B1-BDI 患者的并发症、总生存期（OS）、无进展生存期（TTP）和肿瘤缓解率。X-tile 软件计算了胆道引流前总胆红素（TBil）的截断值，提示胆道引流后序贯 TACE 的最佳时机。进行了倾向评分匹配（PSM）。
研究纳入了 108 例接受 DEB-TACE 治疗的不可切除 HCC（B1-BDI）患者和 114 例接受 cTACE 作为初始治疗的患者。经过 PSM（每组 n=53）后，DEB-TACE 组的 TTP 更长（8.9 个月 vs. 6.7 个月，p=0.038），客观缓解率更高（64.2% vs. 39.6%，p=0.011），尽管 OS 无差异（16.7 个月 vs. 15.3 个月，p=0.115）。DEB-TACE 组术后白蛋白-胆红素评分、TBil 和丙氨酸氨基转移酶（ALT）的平均增量较少，30 天内严重不良事件的发生率显著较低（肝衰竭、ALT 升高和 TBil 升高）（均 p<0.05）。胆道引流前 TBil 的截断值为 99μmol/L；两组中 TBil 值较高（>99μmol/L）的患者 OS 更差（p<0.05）。
对于存在 B1-BDI 的不可切除 HCC 患者，胆道引流后 DEB-TACE 是安全有效的，在肝毒性、TTP 和 ORR 方面可能优于 cTACE。通过成功引流将 TBil 降低至 99μmol/L 以下可能为序贯 TACE 创造理想条件。
