Liver Cancer:仑伐替尼联合或不联合药物洗脱微球经动脉化疗栓塞治疗不可切除晚期肝细胞癌的疗效

2022-03-11 yd2015 MedSci原创

研究表明,仑伐替尼联合药物洗脱微球经动脉化疗栓塞治疗不可切除晚期肝细胞癌疗效显著,安全性好。

近期,国内多中心团队在Liver Cancer 杂志上发表了一项真实世界研究成果,主要是探索仑伐替尼联合或不联合药物洗脱微球经动脉化疗栓塞(DEB-TACE) 治疗不可切除晚期肝细胞癌的疗效。

本回顾性分析2018年11月至2019年11月在我国15个中心接受仑伐替尼(LEN)联合DEB-TACE治疗的142例患者和69例仅接受仑伐替尼一线治疗的患者。评估两组患者的总生存期(OS)、无进展生存期(PFS)、客观缓解率(ORR)和安全性。

LEN + DEB-TACE组中位随访时间为13.5(7.4-18)个月,LEN组中位随访时间为8.2(5.8-13.9)个月。LEN + DEB-TACE组中位OS为15.9 (95%CI, 12.3 19.5)个月,显著长于LEN组(8.6 [95%CI, 6.3 10.9]个月(p=0.002);同样联合组也较单药组明显延长中位PFS(8.6 [95%CI, 7.2 10.0] vs 4.4[4.0-4.7]月,p<0.001)。

经过倾向匹配分析后,联合组均较单药组明显延长患者的中位OS(13.8 [95% CI: 9.2 18.4]个月vs 7.8 [95% CI: 6.5 8.8]个月,p=0.03)和PFS(7.8 [95% CI: 6.2 9.52]个月vs 4.5 [95% CI: 4.1 4.9]个月,p=0.009)。

LEN + DEB-TACE联合组CR、PR、SD和PD的发生率分别为4.23%、42.25%、30.28%和23.24%,而LEN组CR、PR、SD和PD的发生率分别为4.35%、8.7%、43.48%和43.48%。并且,LEN + TACE组的ORR和DCR分别为46.48%和76.76%,显著高于单药组的13.05%和56.52%(P均<0.001)。

经多变量Cox回归分析,肿瘤数量(HR=1.23 [95%CI, 1.03-1.46], p=0.024)、MVI (HR,1.56 [95%CI, 1.13-2.15], p=0.012)、AFP水平(HR=1.56 [95%CI, 1.13-2.15], p=0.007)、治疗方式(HR=0.42 [95%CI, 0.30-0.60], p<0.001)是PFS的独立预测因素。

在两组患者中,主要的AEs是天冬氨酸转氨酶(AST)升高(54.9%)和疲劳(46.4%)。LEN + DEBTACE组中最常见的3/4级AEs为蛋白尿(10.6%)和高血压(8.5%)。相比之下,在LEN单药治疗组中,蛋白尿和高血压发生率分别为8.6%和10.1%。在LEN + TACE组中,有35例(24.6%)患者因AE而中断或减少药物剂量,与单药治疗组(23.1%)的患者比例相当。此外,两组均未发生治疗相关死亡。

综上,研究表明,仑伐替尼联合药物洗脱微球经动脉化疗栓塞治疗不可切除晚期肝细胞癌疗效显著,安全性好。

原始出处:

Xia D, Bai W, Wang E, et al. Lenvatinib with or without concurrent drug-eluting beads transarterial chemoembolization in patients with unresectable, advanced hepatocellular carcinoma: A real-world, multicenter, retrospective study. Liver Cancer , DOI: 10.1159/000523849. Published online: March 9, 2022

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