HepaSphere药物洗脱微球经动脉化疗栓塞联合肝动脉灌注化疗作为晚期肝细胞癌二线治疗的疗效和安全性
Efficacy and Safety of HepaSphere Drug-Eluting Bead Transarterial Chemoembolization Combined with Hepatic Arterial Infusion Chemotherapy as the Second-Line Treatment in Advanced Hepatocellular Carcinoma.
作者信息
Liu Baojiang, Gao Song, Guo Jianhai, Kou Fuxin, Liu Shaoxing, Zhang Xin, Feng Aiwei, Wang Xiaodong, Cao Guang, Chen Hui, Liu Peng, Xu Haifeng, Gao Qinzong, Yang Renjie, Xu Liang, Zhu Xu
机构信息
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Interventional Therapy, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
出版信息
J Hepatocell Carcinoma. 2024 Mar 4;11:477-488. doi: 10.2147/JHC.S452120. eCollection 2024.
PURPOSE
Recently, hepatic arterial infusion chemotherapy (HAIC) has also gained popularity for hepatocellular carcinoma (HCC). Several studies have compared HAIC and Transarterial chemoembolization (TACE). However, comparisons between TACE plus HAIC and HAIC are rarely reported. Here, we evaluated the performance of HepaSphere DEB-TACE combined with HAIC (Hepa-HAIC) compared to HAIC in patients with advanced HCC.
PATIENTS AND METHODS
In this retrospective study, we enrolled 167 patients diagnosed with advanced HCC and treated at Peking University Cancer Hospital from May 2018 to May 2022. The cohort comprised 74 patients who received HepaSphere DEB-TACE combined with HAIC-FOLFOX (Hepa-HAIC) and 93 patients who received HAIC-FOLFOX. Over 60% of patients received prior treatments. To avoid selection bias, propensity score matching was applied to the efficacy and safety analyses. The primary endpoints are progression-free survival (PFS) and overall survival (OS); the secondary endpoints include objective response rate (ORR), disease control rate (DCR), and safety.
RESULTS
Propensity-matching yielded 48 pairs, and group baselines were almost equal after matching. Median PFS and median OS were both higher in the matched Hepa-HAIC cohort (median PFS: 8.9 vs 5.8 months, p = 0.035; median OS: 22.4 vs 9.5 months, p = 0.027), which was consistent with pre-matching analysis. The ORR in the Hepa-HAIC and HAIC cohorts was 75.0% and 37.5%, respectively; the DCR was 93.8% after Hepa-HAIC and 81.3% after HAIC. There was no treatment-related death. Grade 3-4 ALT elevation was more frequent in the Hepa-HAIC group (33.3% vs 8.3%, p = 0.003), while vomiting was more frequent in the HAIC group (29.2% vs 12.5%, p = 0.084).
CONCLUSION
The Hepa-HAIC group is superior to the HAIC group in metrics of PFS, OS, ORR, and DCR, which indicates the combination of HepaSphere DEB-TACE and HAIC may lead to improved outcomes with a comparable safety profile in advanced HCC.
目的
近年来，肝动脉灌注化疗（HAIC）在肝细胞癌（HCC）治疗中也越来越受欢迎。多项研究对HAIC与经动脉化疗栓塞术（TACE）进行了比较。然而，TACE联合HAIC与HAIC之间的比较报道较少。在此，我们评估了与单纯HAIC相比，载药微球（HepaSphere）载药微球栓塞化疗（DEB-TACE）联合HAIC（Hepa-HAIC）在晚期HCC患者中的疗效。
患者与方法
在这项回顾性研究中，我们纳入了2018年5月至2022年5月期间在北京大学肿瘤医院确诊并接受治疗的167例晚期HCC患者。该队列包括74例接受载药微球DEB-TACE联合HAIC-FOLFOX方案（Hepa-HAIC）的患者和93例接受HAIC-FOLFOX方案的患者。超过60%的患者接受过先前治疗。为避免选择偏倚，在疗效和安全性分析中应用了倾向评分匹配。主要终点为无进展生存期（PFS）和总生存期（OS）；次要终点包括客观缓解率（ORR）、疾病控制率（DCR）和安全性。
结果
倾向评分匹配产生了48对，匹配后两组基线基本相等。匹配后的Hepa-HAIC队列的中位PFS和中位OS均更高（中位PFS：8.9个月对5.8个月，p = 0.035；中位OS：22.4个月对9.5个月，p = 0.027），这与匹配前分析一致。Hepa-HAIC组和HAIC组的ORR分别为75.0%和37.5%；Hepa-HAIC组后的DCR为93.8%，HAIC组后为81.3%。无治疗相关死亡。Hepa-HAIC组3-4级谷丙转氨酶升高更常见（33.3%对8.3%，p = 0.003），而HAIC组呕吐更常见（29.2%对12.5%，p = 0.084）。
结论
在PFS、OS、ORR和DCR指标方面，Hepa-HAIC组优于HAIC组，这表明载药微球DEB-TACE与HAIC联合应用可能在晚期HCC中带来更好的疗效，且安全性相当。
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