Background: The presence of macrovascular invasion (MVI) is associated with poor prognosis in advanced hepatocellular carcinoma (HCC). This study aims to evaluate the efficacy and safety of Cinobufacini therapy via hepatic arterial infusion (HAI) in advanced HCC patients with MVI.
Methods: The clinical records of 130 consecutive patients with unresectable advanced HCC and MVI who had received Cinobufacini or cisplatin plus 5-fluorouracil (CF) treatment via HAI were retrospectively analyzed. The therapeutic efficacy, overall survival (OS), progression-free survival (PFS), and adverse events were compared between the two treatment groups.
Results: The Cinobufacini group demonstrated significant curative effects on treatment via HAI compared with the CF group, including the objective response rate (44.9% vs 27.9%, P=0.048), the median OS (14.8 months vs 11.1 months, P=0.010), and the median PFS (10.3 months vs 6.0 months, P=0.006). Result in subgroup analysis of portal vein invasion grade supported the efficacy in Cinobufacini treatment, especially in the median OS of Vp1-2 (18.3 months vs 14.3 months, P=0.043) and Vp3 (15.0 months vs 11.4 months, P=0.046), as well as the median PFS of Vp1-2 (14.8 months vs 10.2 months, P=0.028) and Vp3 (10.8 months vs 6.6 months, P=0.033) compared with CF treatment. Cox proportional hazards model and forest plot analysis of factors confirmed the survival benefit from HAI with Cinobufacini over CF (hazard ratio [HR], 0.61; 95% CI: 0.40– 0.91; P=0.010). Multivariable analysis identified portal vein invasion grade (Vp4; HR, 1.78; 95% CI: 1.03– 2.16; P=0.032) and AFP (> 1000; HR, 1.61; 95% CI: 1.08– 1.91; P=0.039) as the independent factors for prognosis. Moreover, the total incidence of adverse events in the Cinobufacini group was significantly lower than in the CF group (60.9% vs 82.0%, P=0.009).
Conclusion: Cinobufacini therapy via HAI is a viable strategy for curing advanced HCC with MVI, due to prolonged survival and a superior safety profile.



中文翻译：

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华蟾素肝动脉灌注治疗伴有大血管侵犯的晚期肝细胞癌的疗效和安全性：一项回顾性队列研究

背景：大血管侵犯（MVI）的存在与晚期肝细胞癌（HCC）的不良预后相关。本研究旨在评估华蟾素通过肝动脉灌注（HAI）治疗患有 MVI 的晚期 HCC 患者的疗效和安全性。
方法：回顾性分析连续 130 例通过 HAI 接受华蟾素或顺铂加 5-氟尿嘧啶（CF）治疗的不可切除的晚期 HCC 和 MVI 患者的临床资料。比较两个治疗组的治疗效果、总生存期（OS）、无进展生存期（PFS）和不良事件。
结果：与CF组相比，华蟾素组通过HAI治疗的疗效显着，包括客观有效率（44.9% vs 27.9%，P = 0.048）、中位OS（14.8个月vs 11.1个月，P = 0.010） ，以及中位 PFS（10.3 个月 vs 6.0 个月，P = 0.006）。门静脉侵犯分级亚组分析结果支持华蟾素治疗的疗效，尤其是 Vp1-2 的中位 OS（18.3 个月 vs 14.3 个月，P = 0.043）和 Vp3（15.0 个月 vs 11.4 个月，P = 0.046），以及与 CF 治疗相比的 Vp1-2（14.8 个月 vs 10.2 个月， P = 0.028）和 Vp3（10.8 个月 vs 6.6 个月，P = 0.033）的中位 PFS。Cox比例风险模型和因素森林图分析证实了华蟾素HAI相对CF的生存获益（风险比[HR]，0.61；95% CI：0.40-0.91；P = 0.010）。多变量分析确定门静脉侵犯分级（Vp4；HR，1.78；95% CI：1.03-2.16；P = 0.032）和 AFP（> 1000；HR，1.61；95% CI：1.08-1.91；P = 0.039）作为预后的独立因素。此外，华蟾素组的不良事件总发生率显着低于CF组（60.9% vs 82.0%，P =0.009）。
结论：华蟾素通过 HAI 治疗是治疗伴有 MVI 的晚期 HCC 的可行策略，因为它具有延长的生存期和卓越的安全性。