Abstract：
BACKGROUND: Although systemic therapies are recommended for hepatocellular carcinoma (HCC) patients with main portal vein (MPV) invasion and preserved liver function, the outcome is limited. In the real-world, chemoembolization is a commonly used local treatment for advanced HCC.
OBJECTIVE: To evaluate whether the additional chemoembolization treatment yields survival benefits compared to systemic therapy for HCC patients with MPV invasion and preserved liver function (Child-Pugh score ≤ B7) in a real-world study from multiple centers.
METHODS: Between January 2020 and December 2022, 91 consecutive HCC patients with MPV invasion who received either systemic medical therapy (i.e., tyrosine kinase inhibitors (TKIs) plus anti-PD-1 immunotherapy, S group, n = 43) or in combination with chemoembolization treatment (S-T group, n = 48) from five centers were enrolled in the study. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS) and treatment response. Adverse events (AEs) related to treatment were also recorded. Survival curves were constructed with the Kaplan-Meier method and compared using the log-rank test.
RESULTS: The baseline characteristics were comparable between the two groups. The mean number of chemoembolization sessions per patient was 2.1 (range 1-3). The median OS was 10.0 months and 8.0 months in the S-T group and S group, respectively (P = 0.254). The median PFS between the two groups was similar (4.0 months vs. 4.0 months, P = 0.404). The disease control rate between the S-T and S groups were comparable (60.4% vs. 62.8%, P = 0.816). Although no chemoembolization-related deaths occurred, 13 grade 3-4 AEs occurred in the S-T group.
CONCLUSIONS: The results of the real-world study demonstrated that additional chemoembolization treatment did not yield survival benefits compared to TKIs plus anti-PD-1 immunotherapy for the overall patients with advanced HCC and MPV invasion.
OBJECTIVE: To evaluate whether the additional chemoembolization treatment yields survival benefits compared to systemic therapy for HCC patients with MPV invasion and preserved liver function (Child-Pugh score ≤ B7) in a real-world study from multiple centers.
METHODS: Between January 2020 and December 2022, 91 consecutive HCC patients with MPV invasion who received either systemic medical therapy (i.e., tyrosine kinase inhibitors (TKIs) plus anti-PD-1 immunotherapy, S group, n = 43) or in combination with chemoembolization treatment (S-T group, n = 48) from five centers were enrolled in the study. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS) and treatment response. Adverse events (AEs) related to treatment were also recorded. Survival curves were constructed with the Kaplan-Meier method and compared using the log-rank test.
RESULTS: The baseline characteristics were comparable between the two groups. The mean number of chemoembolization sessions per patient was 2.1 (range 1-3). The median OS was 10.0 months and 8.0 months in the S-T group and S group, respectively (P = 0.254). The median PFS between the two groups was similar (4.0 months vs. 4.0 months, P = 0.404). The disease control rate between the S-T and S groups were comparable (60.4% vs. 62.8%, P = 0.816). Although no chemoembolization-related deaths occurred, 13 grade 3-4 AEs occurred in the S-T group.
CONCLUSIONS: The results of the real-world study demonstrated that additional chemoembolization treatment did not yield survival benefits compared to TKIs plus anti-PD-1 immunotherapy for the overall patients with advanced HCC and MPV invasion.
摘要：
背景：尽管对于有主门静脉（MPV）侵袭和肝功能保留的肝细胞癌（HCC）患者，建议进行全身治疗，结果是有限的。在现实世界中,化疗栓塞是晚期肝癌常用的局部治疗方法。
目的：评估在多个中心的真实世界研究中，对于MPV侵袭和肝功能保留（Child-Pugh评分≤B7）的HCC患者，与全身治疗相比，额外的化学栓塞治疗是否会产生生存益处。
方法：在2020年1月至2022年12月之间，连续91例MPV侵袭的HCC患者接受了全身药物治疗（即酪氨酸激酶抑制剂（TKIs）加抗PD-1免疫疗法，S组,n=43）或联合化疗栓塞治疗（S-T组，来自五个中心的n=48)被纳入研究。主要结果是总生存期（OS），次要结局是无进展生存期(PFS)和治疗反应.记录与治疗相关的不良事件（AE）。用Kaplan-Meier方法构建存活曲线，并使用对数秩检验进行比较。
结果：两组的基线特征相当。每位患者的平均化疗栓塞次数为2.1（范围1-3）。S-T组和S组的中位OS分别为10.0个月和8.0个月。分别为(P=0.254)。两组之间的中位PFS相似（4.0个月vs.4.0个月,P=0.404）。S-T组和S组之间的疾病控制率相当(60.4%vs.62.8%,P=0.816)。虽然没有化疗栓塞相关的死亡发生，S-T组发生13例3-4级不良事件。
结论：现实世界研究的结果表明，对于晚期HCC和MPV侵袭的总体患者，与TKIs联合抗PD-1免疫疗法相比，额外的化学栓塞治疗没有产生生存益处。
目的：评估在多个中心的真实世界研究中，对于MPV侵袭和肝功能保留（Child-Pugh评分≤B7）的HCC患者，与全身治疗相比，额外的化学栓塞治疗是否会产生生存益处。
方法：在2020年1月至2022年12月之间，连续91例MPV侵袭的HCC患者接受了全身药物治疗（即酪氨酸激酶抑制剂（TKIs）加抗PD-1免疫疗法，S组,n=43）或联合化疗栓塞治疗（S-T组，来自五个中心的n=48)被纳入研究。主要结果是总生存期（OS），次要结局是无进展生存期(PFS)和治疗反应.记录与治疗相关的不良事件（AE）。用Kaplan-Meier方法构建存活曲线，并使用对数秩检验进行比较。
结果：两组的基线特征相当。每位患者的平均化疗栓塞次数为2.1（范围1-3）。S-T组和S组的中位OS分别为10.0个月和8.0个月。分别为(P=0.254)。两组之间的中位PFS相似（4.0个月vs.4.0个月,P=0.404）。S-T组和S组之间的疾病控制率相当(60.4%vs.62.8%,P=0.816)。虽然没有化疗栓塞相关的死亡发生，S-T组发生13例3-4级不良事件。
结论：现实世界研究的结果表明，对于晚期HCC和MPV侵袭的总体患者，与TKIs联合抗PD-1免疫疗法相比，额外的化学栓塞治疗没有产生生存益处。
