Department of Internal Medicine, Japanese Red Cross Himeji Hospital, Himeji, Japan.
Faculty of Nursing, Gifu Kyoritsu University, Ogaki, Japan.
Oncology. 2021;99(8):518-527. doi: 10.1159/000515896. Epub 2021 Apr 27.
AIM/BACKGROUND: Transarterial chemoembolization (TACE) is recommended for patients with intermediate-stage hepatocellular carcinoma (HCC). In this study, we investigated the impact of early lenvatinib administration in patients with intermediate-stage HCC, especially those with tumors beyond the up-to-7 criteria.
MATERIALS/METHODS: A total of 208 patients with intermediate-stage HCC whose initial treatment was early lenvatinib administration or TACE were enrolled. Multivariate overall survival analysis was performed in this cohort. In addition, the impact of early lenvatinib administration on survival in patients with HCC beyond the up-to-7 criteria was clarified using inverse probability weighting (IPW) analysis.
The overall cumulative survival rates at 6, 12, 18, and 24 months were 94.4, 79.9, 65.8, and 50.1%, respectively. Multivariate analysis with Cox proportional hazards modeling showed that HCC treatment with lenvatinib (hazard ratio [HR], 0.199; 95% confidence interval [CI], 0.077-0.517; p < 0.001), α-fetoprotein ≥100 ng/mL (HR, 1.687), Child-Pugh class B disease (HR, 1.825), and beyond the up-to-7 criteria (HR, 2.016) were independently associated with overall survival. The 6-, 12-, 18-, and 24-month cumulative survival rates were 96.0, 90.4, 65.7, and 65.7%, respectively, in patients treated with lenvatinib, and 94.1, 78.5, 65.3, and 48.4%, respectively, in patients who received TACE (p < 0.001). In addition, univariate analysis with Cox proportional hazards modeling adjusted by IPW showed that lenvatinib therapy was significantly associated with overall survival in patients with HCC beyond the up-to-7 criteria (HR, 0.230; 95% CI, 0.059-0.904; p = 0.035).
Lenvatinib may be a suitable first-line treatment for patients with intermediate-stage HCC beyond the up-to-7 criteria.
目的/背景：经动脉化疗栓塞（TACE）被推荐用于治疗中期肝细胞癌（HCC）患者。在本研究中，我们研究了早期仑伐替尼治疗在中期 HCC 患者中的作用，尤其是那些肿瘤超出 7 分标准的患者。
材料/方法：共纳入 208 例接受早期仑伐替尼治疗或 TACE 作为初始治疗的中期 HCC 患者，对该队列进行多变量总生存分析。此外，通过逆概率加权（IPW）分析明确早期仑伐替尼治疗对超出 7 分标准的 HCC 患者生存的影响。
6、12、18 和 24 个月的总累积生存率分别为 94.4%、79.9%、65.8%和 50.1%。Cox 比例风险模型多变量分析显示，仑伐替尼治疗 HCC（风险比 [HR]，0.199；95%置信区间 [CI]，0.077-0.517；p<0.001）、α-胎蛋白≥100ng/ml（HR，1.687）、Child-Pugh 分级 B 级（HR，1.825）和超出 7 分标准（HR，2.016）与总生存独立相关。接受仑伐替尼治疗的患者 6、12、18 和 24 个月的累积生存率分别为 96.0%、90.4%、65.7%和 65.7%，而接受 TACE 治疗的患者分别为 94.1%、78.5%、65.3%和 48.4%（p<0.001）。此外，通过 IPW 调整的 Cox 比例风险模型的单变量分析显示，仑伐替尼治疗与超出 7 分标准的 HCC 患者的总生存显著相关（HR，0.230；95%CI，0.059-0.904；p=0.035）。
仑伐替尼可能是超出 7 分标准的中期 HCC 患者的一种合适的一线治疗选择。
