| 季洪兵,潘建基,刘文晖.外放疗联合仑伐替尼和卡瑞利珠单抗治疗不可切除肝癌的疗效与安全性评价[J].中国肿瘤,2024,33(5):420-427. |
| 外放疗联合仑伐替尼和卡瑞利珠单抗治疗不可切除肝癌的疗效与安全性评价 |
| Efficacy and Safety of External Beam Radiation Therapy Combined with Lenvatinib and Camrelizumab in Treatment of Unresectable Hepatocellular Carcinoma |
| 投稿时间：2024-03-23 |
| DOI：10.11735/j.issn.1004-0242.2024.05.A012 |
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| 中文关键词: 肝细胞癌 放射治疗 仑伐替尼 卡瑞利珠单抗 |
| 英文关键词:hepatocellular carcinoma radiation therapy lenvatinib camrelizumab |
| 基金项目:福州市科技计划项目（2021-S-112）；福建医科大学启航基金（2021QH1161） |
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| 中文摘要: |
| 摘 要：［目的］ 评价外放疗联合仑伐替尼和卡瑞利珠单抗治疗不可切除肝细胞癌（HCC）的疗效和安全性。［方法］ 回顾性分析福建医科大学孟超肝胆医院2018年5月1日至2021年3月1日收治85例不可切除的HCC病例，30例不可切除的HCC患者纳入外放疗联合仑伐替尼和卡瑞利珠单抗组（RT+LC），55例纳入仑伐替尼和卡瑞利珠单抗组（LC）。主要研究终点为无进展生存期（PFS）和总生存期（OS）。次要研究终点包括根据改良的实体肿瘤反应评估标准评估肿瘤治疗反应，以及采用不良事件通用术语标准5.0评估的治疗相关不良事件（TRAEs）。采用单因素和多因素Cox回归分析来确定独立的预后因素。［结果］ RT+LC组和LC组的中位PFS分别为11.61个月和7.25个月（P=0.036）。RT+LC组和LC组的中位OS分别为20.07个月和12.03个月（P=0.019）。Cox回归分析显示，联合RT是PFS和OS的独立因素（P均<0.05）。RT+LC组的客观缓解率（ORR）显著高于LC组（76.7% vs 45.5%，P=0.011），而疾病控制率（DCR）差异无统计学意义（93.3% vs 81.8%，P=0.258）。两组间TRAEs的差异无统计学意义（P均>0.05），安全性相当。［结论］ 外放疗联合仑伐替尼和卡瑞利珠单抗治疗不可切除HCC临床效果显著，不良反应可控，是一种安全、有效的治疗方法。 |
| 英文摘要: |
| Abstract：［Purpose］ To evaluate the efficacy and safety of external beam radiation therapy combined with lenvatinib and camrelizumab for unresectable hepatocellular carcinoma (HCC). ［Methods］ A retrospective analysis of 85 unresectable HCC cases were admitted to Mengchao Hepatobiliary Hospital of Fujian Medical University from May 1， 2018 to March 1， 2021. 30 cases with unresectable HCC patients were enrolled in external beam radiation therapy combined with lenvatinib and camrelizumab (RT+LC) group and 55 cases were enrolled in lenvatinib and camrelizumab group. Primary outcome was progression free survival(PFS) and overall survival(OS). Second outcome included tumor response evaluated in accordance with modified Response Evaluation Criteria in Solid Tumors， and treat-related adverse events (TRAEs) evaluated by Common Terminology Criteria for Adverse Events 5.0. Univariable and multivariable Cox regression analyses were used to identify independent prognostic factors. ［Results］ The median PFS was 11.61 months and 7.25 months for RT+LC group and LC group， respectively (P=0.036). The median OS was 20.07 months and 12.03 months for RT+LC group and LC group， respectively (P=0.019). Cox regression analyses indicated that the combination with radiation therapy was an independent factor for PFS and OS (all P<0.05). The objective response rate (ORR) of RT+LC group was significantly higher than LC group (76.7% vs 45.5%， P=0.011)， while the disease control rate (DCR) did not show significant difference (93.3% vs 81.8%， P=0.258). TRAEs was comparable between two groups(all P>0.05). ［Conclusion］ External beam radiation therapy combined with lenvatinib and camrelizumab is a safe and effective treatment for unresectable HCC with significant clinical effects and controllable adverse reactions. |
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