PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
背景：经动脉化疗栓塞（TACE）是中期肝细胞癌（HCC）的标准治疗方法。由于缺乏对常规TACE（cTACE）和药物洗脱珠TACE（DEB-TACE）的患者有不可切除的HCC伴肿瘤浸润肝总导管或胆管一级分支（B1型胆管侵犯；B1-BDI）胆道引流后，我们回顾性比较了DEB-TACE和cTACE在该患者人群中的安全性和有效性.
方法：使用来自五个三级医疗中心（2017年1月至2021年12月）的数据，我们比较了并发症,总生存期（OS），进展时间（TTP），在成功进行胆道引流后接受DEB-TACE或cTACE的B1-BDI不可切除HCC患者之间的肿瘤反应率。X-tile软件计算TACE前总胆红素（TBil）截止值，指示引流后连续TACE的最佳时间。进行倾向评分匹配(PSM)。
结果：该研究包括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。PSM后（每组n=53），DEB-TACE组的TTP较长（8.9vs.6.7个月,p=0.038)和更高的客观反应率(64.2%vs.39.6%,p=0.011）比cTACE组，尽管操作系统具有可比性(16.7与15.3个月，p=0.115）。DEB-TACE组术后平均白蛋白-胆红素评分增量较少，TBil,和丙氨酸氨基转移酶（ALT），30天内严重不良事件的发生率显着降低（肝功能衰竭，ALT增加,和TBil增加）比cTACE组（均p<0.05）。TACE前TBil截断值为99μmol/L；两组患者的OS值均较高（>99μmol/L），差异有统计学意义（p<0.05）。
结论：DEB-TACE在合并B1-BDI的不可切除HCC成功胆道引流后是安全有效的，在肝毒性方面可能优于cTACE，TTP,ORR。通过成功的引流将TBil降低到99μmol/L以下可能为连续TACE创造理想条件。
方法：使用来自五个三级医疗中心（2017年1月至2021年12月）的数据，我们比较了并发症,总生存期（OS），进展时间（TTP），在成功进行胆道引流后接受DEB-TACE或cTACE的B1-BDI不可切除HCC患者之间的肿瘤反应率。X-tile软件计算TACE前总胆红素（TBil）截止值，指示引流后连续TACE的最佳时间。进行倾向评分匹配(PSM)。
结果：该研究包括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。PSM后（每组n=53），DEB-TACE组的TTP较长（8.9vs.6.7个月,p=0.038)和更高的客观反应率(64.2%vs.39.6%,p=0.011）比cTACE组，尽管操作系统具有可比性(16.7与15.3个月，p=0.115）。DEB-TACE组术后平均白蛋白-胆红素评分增量较少，TBil,和丙氨酸氨基转移酶（ALT），30天内严重不良事件的发生率显着降低（肝功能衰竭，ALT增加,和TBil增加）比cTACE组（均p<0.05）。TACE前TBil截断值为99μmol/L；两组患者的OS值均较高（>99μmol/L），差异有统计学意义（p<0.05）。
结论：DEB-TACE在合并B1-BDI的不可切除HCC成功胆道引流后是安全有效的，在肝毒性方面可能优于cTACE，TTP,ORR。通过成功的引流将TBil降低到99μmol/L以下可能为连续TACE创造理想条件。
