Lenvatinib, toripalimab, plus hepatic arterial infusion chemotherapy versus lenvatinib alone for advanced hepatocellular carcinoma.
Lenvatinib, toripalimab, plus hepatic arterial infusion chemotherapy versus lenvatinib alone for advanced hepatocellular carcinoma.
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DOI：
10.1177/17588359211002720
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发表时间：
2021
影响因子：
4.9
通讯作者：
Shi M
中科院分区：
文献类型：
--
作者：
He MK;Liang RB;Zhao Y;Xu YJ;Chen HW;Zhou YM;Lai ZC;Xu L;Wei W;Zhang YJ;Chen MS;Guo RP;Li QJ;Shi M
乐伐替尼是晚期肝癌的一线治疗药物，但预后仍不理想。最近，肝动脉灌注化疗（HAIC）和免疫检查点抑制剂对晚期肝细胞癌显示出有希望的结果。考虑到不同的抗恶性肿瘤机制，结合这三种治疗可能会改善结果。本研究旨在比较乐伐替尼、toripalimab联合HAIC与乐伐替尼治疗晚期肝细胞癌的疗效和安全性。这是一项回顾性研究，包括接受乐伐替尼[8 mg（> 60 kg）或12 mg（>60 kg）每日一次]或乐伐替尼、托普利单抗联合HAIC治疗的患者[LeToHAIC组，初始HAIC前0-1周接受乐伐替尼，每个HAIC周期前0-1天接受240 mg托普利单抗，HAIC联合FOLFOX方案]（奥沙利铂85 mg/m2，甲酰四氢叶酸400 mg/m2，第1天5-氟尿嘧啶推注400 mg/m2，5-氟尿嘧啶输注2400 mg/m2，持续46 h，每3周一次）]。比较无进展生存期、总生存期、客观缓解率和治疗相关不良事件。从2019年2月至2019年8月，157例患者入组本研究：71例在LeToHAIC组，86例在乐伐替尼组。LeToHAIC组的无进展生存期较长，（11.1 vs 5.1个月，p < 0.001），总生存期更长（未达到与11个月，p < 0.001），以及更高的客观反应率（RECIST：59.2% vs 9.3%，p < 0.001;改良RECIST：67.6% vs 16.3%，p < 0.001）。此外，根据改良的RECIST标准，LeToHAIC组中分别有14.1%和21.1%的患者实现了所有病灶的完全缓解和肝内靶病灶的完全缓解。LeToHAIC组比乐伐替尼组更常见的3/4级治疗相关不良事件包括中性粒细胞减少（8.5% vs 1.2%）、血小板减少（5.6% vs 0）和恶心（5.6% vs 0）。在晚期肝细胞癌中，与乐伐替尼单药治疗相比，乐伐替尼、toripalimab联合HAIC具有可接受的毒性作用，并可能改善生存率。
Lenvatinib is the first-line treatment for advanced hepatocellular carcinoma, but prognosis is still unsatisfactory. Recently, hepatic arterial infusion chemotherapy (HAIC), and immune checkpoint inhibitors showed promising results for advanced hepatocellular carcinoma. Considering different anti-malignancy mechanisms, combining these three treatments may improve outcomes. This study aimed to compare the efficacy and safety of lenvatinib, toripalimab, plus HAIC versus lenvatinib for advanced hepatocellular carcinoma. This was a retrospective study including patients treated with lenvatinib [8 mg (⩽60 kg) or 12 mg (>60 kg) once daily] or lenvatinib, toripalimab plus HAIC [LeToHAIC group, lenvatinib 0–1 week prior to initial HAIC, 240 mg toripalimab 0–1 day prior to every HAIC cycle, and HAIC with FOLFOX regimen (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil bolus 400 mg/m2 on day 1, and 5-fluorouracil infusion 2400 mg/m2 for 46 h, every 3 weeks)]. Progression-free survival, overall survival, objective response rate, and treatment-related adverse events were compared. From February 2019 to August 2019, 157 patients were included in this study: 71 in the LeToHAIC group and 86 in the lenvatinib group. The LeToHAIC group showed longer progression-free survival (11.1 versus 5.1 months, p < 0.001), longer overall survival (not reached versus 11 months, p < 0.001), and a higher objective response rate (RECIST: 59.2% versus 9.3%, p < 0.001; modified RECIST: 67.6% versus 16.3%, p < 0.001) than the lenvatinib group. In addition, 14.1% and 21.1% of patients in the LeToHAIC group achieved complete response of all lesions and complete response of the intrahepatic target lesions per modified RECIST criteria, respectively. Grade 3/4 treatment-related adverse events that were more frequent in the LeToHAIC group than in the lenvatinib group included neutropenia (8.5% versus 1.2%), thrombocytopenia (5.6% versus 0), and nausea (5.6% versus 0). Lenvatinib, toripalimab, plus HAIC had acceptable toxic effects and might improve survival compared with lenvatinib alone in advanced hepatocellular carcinoma.
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