■药物洗脱珠经动脉化疗栓塞(DEB-TACE)中最常见的可加载化疗药物包括阿霉素,表柔比星,等。CalliSpheres®珠已经表现出雷替曲塞以及体外和动物实验的有效负载能力和洗脱特性。然而,雷替曲塞负荷DEB-TACE治疗中期肝细胞癌(HCC)患者的疗效和安全性尚不清楚.
■评估雷替曲塞负荷DEB-TACE对中晚期HCC患者的疗效和安全性。
■该研究是作为单臂前瞻性研究进行的。
■这项研究是一项前瞻性研究,2019年6月至2022年6月进行的单臂试验。在DEB-TACE程序中使用装载有雷替曲塞的CalliSpheres®珠子。随访持续至少1年或直至死亡。主要终点是总生存期(OS),次要终点是进展时间(TTP),无进展生存期(PFS),客观反应率(ORR),和不良事件(AE)。
■6个月ORR和疾病控制率分别为90.1%和93.8%,分别。中位OS为33.0个月。1-,2-,3年生存率为95.1%,82.1%,和43.6%,分别。Child-Pugh类和双叶疾病的发生被确定为独立的OS预测因子。中位TTP和PFS分别为22.7和19.8个月,分别。11例(11.5%)患者至少经历过一次3级不良事件,5名参与者报告严重不良事件(5.2%).没有患者经历4级或5级AE。
■拉替曲塞加载DEB-TACE是可行的,安全,对中期肝癌患者有效。
■该试验已在www注册。chictr.org.cn下的标识符:1900024097于2019年6月25日。
装载雷替曲塞的DEB-TACE在中期肝细胞癌患者中的功效和安全性在体外和动物实验中已经证明了装载雷替曲塞的CalliSphere®珠子在药物洗脱珠子经动脉化疗栓塞(DEB-TACE)中的实用性。然而,其在中期肝细胞癌(HCC)患者中的疗效和安全性尚不清楚.因此,本研究旨在评估DEB-TACE对此类患者的疗效和安全性.我们发现加载雷替曲塞的DEB-TACE导致6个月的ORR为90.1%,中位OS为33.0个月,中位TTP为22.7个月,中位PFS为19.8个月。1-,2-,3年生存率为95.1%,82.1%,和43.6%,分别。Child-Pugh等级和双叶疾病发生等因素被确定为OS的独立预测因子。该研究还显示了可接受的安全性,3级不良事件发生率低,无4级或5级不良事件。结果表明,用于TACE的雷替曲塞洗脱CalliSpheres®珠子可以是治疗中期HCC患者的可行选择。
UNASSIGNED: The most common loadable chemotherapeutic drugs in drug-eluting bead
transarterial chemoembolization (DEB-TACE) include doxorubicin, epirubicin, etc. CalliSpheres® beads have exhibited efficient loadability and eluting characteristics for raltitrexed as well as in vitro and animal experiments. However, the efficacy and safety of raltitrexed-loaded DEB-TACE in patients with intermediate-stage hepatocellular carcinoma (HCC) remain unclear.
UNASSIGNED: To assess the efficacy and safety of raltitrexed-loaded DEB-TACE in patients with intermediate-stage HCC.
UNASSIGNED: The study was conducted as a single-arm prospective study.
UNASSIGNED: This study was a prospective, single-arm trial conducted between June 2019 and June 2022. CalliSpheres® beads loaded with raltitrexed were used in the DEB-TACE procedure. The follow-up lasted for at least 1 year or until death. The primary endpoint was overall survival (OS), and the secondary endpoints were time to progression (TTP), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs).
UNASSIGNED: The 6-month ORR and disease control rates were 90.1% and 93.8%, respectively. The median OS was 33.0 months. The 1-, 2-, and 3-year survival rates were 95.1%, 82.1%, and 43.6%, respectively. Child-Pugh class and bilobar disease occurrence were identified as independent OS predictors. The median TTP and PFS were 22.7 and 19.8 months, respectively. Eleven (11.5%) patients experienced at least one grade 3 AE, and serious AEs were reported in five participants (5.2%). No patient experienced grade 4 or 5 AEs.
UNASSIGNED: Raltitrexed-loaded DEB-TACE is feasible, safe, and effective in patients with intermediate-stage HCC.
UNASSIGNED: This trial was registered at www.chictr.org.cn under the identifier: 1900024097 on 25 June 2019.
Efficacy and safety of raltitrexed-loaded DEB-TACE in patients with intermediate-stage hepatocellular carcinoma The utility of raltitrexed-loaded CalliSphere® beads in drug-eluting bead
transarterial chemoembolization (DEB-TACE) has been demonstrated in in vitro and animal experiments. However, its efficacy and safety in patients with intermediate-stage hepatocellular carcinoma (HCC) remain unclear. Hence, this study aimed to assess the efficacy and safety profiles of DEB-TACE for such patients. We discovered that raltitrexed-loaded DEB-TACE led to a 6-month ORR of 90.1%, a median OS of 33.0 months, a median TTP of 22.7 months, and a median PFS of 19.8 months. The 1-, 2-, and 3-year survival rates were 95.1%, 82.1%, and 43.6%, respectively. Factors such as Child-Pugh class and bilobar disease occurrence were identified as independent predictors of OS. The study also showed acceptable safety profiles, with a low incidence of grade 3 adverse events and no grade 4 or 5 adverse events. The results indicated that raltitrexed-eluting CalliSpheres® beads for TACE can be a viable option for treating patients with intermediate-stage HCC.