经肝动脉化疗栓塞术联合靶向及免疫药物治疗中国肝癌分期 Ⅱb/Ⅲa期肝细胞癌患者的有效性及安全性分析. (Chinese)

Efficacy and safety of transcatheter arterial chemoembolization combined with targeted therapy and immunotherapy in treatment of patients with stage Ⅱb/Ⅲa hepatocellular carcinoma based on China Liver Cancer Staging. (English)

Objective To evaluate the efficacy and safety of first-line transcatheter arterial chemoembolization (TACE) combined with targeted therapy and immunotherapy in the treatment of patients with stage Ⅱb/Ⅲa hepatocellular carcinoma (HCC) based on China Liver Cancer Staging (CNLC) . Methods A total of 198 patients who received first-line TACE combined with targeted therapy and immunotherapy or received TACE alone from January 2015 to December 2022 in the First Affiliated Hospital of Soochow University were enrolled in this study, and after propensity score matching, there were 50 patients in combination group and 50 patients in TACE group. The Kaplan-Meier method was used to calculate median overall survival (mOS) and median progression-free survival (mPFS) . Modified Response Evaluation Criteria in Solid Tumors was used to evaluate objective response rate (ORR) and disease control rate (DCR), and Common Terminology Criteria for Adverse Events v5.0 was used to evaluate adverse events. The chi-square test was used for comparison of categorical data between two groups； the t-test was used for comparison of normally distributed continuous data between two groups, and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between two groups. The Kaplan-Meier method was used to estimate survival time and calculate 95% confidence interval (CI), and the Log-rank test was used for comparison of mOS and mPFS between two groups. Results The combination group had an mOS of 30.1 months (95%CI：21.9—38.3), and the TACE group had an mOS of 14.5 months (95%CI：11.0 —18.0), with a significant difference between the two groups (χ² =17.8, P<0.001); the combination group had an mPFS of 10.3 months (95%CI：8.8—11.8), and the TACE group had an mPFS of 7.1 months (95%CI：5.8 — 8.4), with a significant difference between the two groups (χ² =10.4, P<0.001) . There were significant differences between the combination group and the TACE group in ORR (84% vs 58%, P<0.05) and DCR (94% vs 80%, P<0.05) . There was no significant difference between the combination group and the TACE group in the incidence rate of adverse events (24% vs 16%, P=0.317), and no adverse event-related deaths were observed in either group. Conclusion Compared with TACE alone, TACE combined with targeted therapy and immunotherapy has a better efficacy in the treatment of patients with CNLC stage Ⅱb/Ⅲa HCC, without increasing the incidence rate of severe adverse events. [ABSTRACT FROM AUTHOR]

目的 评估经肝动脉化疗栓塞术 (TACE) 一线联合靶向及免疫药物治疗中国肝癌分期 (CNLC) Ⅱb/Ⅲa 期肝细胞癌 (HCC) 的疗效及安全性。方法　选取2015年1月—2022年12月在苏州大学附属第一医院接受TACE一线联合靶向及免疫 药物治疗或单纯TACE治疗的患者共198例, 经倾向性评分匹配后, 分为联合组 (TACE联合靶免) 与单纯TACE组各50例, 采 用Kaplan-Meier法对中位生存期 (mOS) 、中位无进展生存期 (mPFS) 进行计算。依据改良实体瘤疗效评价标准 (mRECIST) 评 估两组客观缓解率 (ORR) 、疾病控制率 (DCR), 依据通用不良事件术语5. 0标准 (CTCAE v5. 0标准) 评估不良事件。计数资 料两组间比较采用χ² 检验。符合正态分布的计量资料两组间比较采用成组t检验, 不符合正态分布的计量资料两组间比较 采用Wilcoxon秩和检验。采用Kaplan-Meier法对生存时间进行估计并计算95%CI, 采用Log-rank检验对两组mOS以及mPFS 进行比较。结果　联合组mOS为30. 1个月 (95%CI：21. 9～38. 3), 单纯TACE组为14. 5个月 (95%CI：11. 0～18. 0), 差异有 统计学意义 (χ² =17. 8, P<0. 001); 联合组 mPFS 为 10. 3 个月 (95%CI：8. 8～11. 8), 单纯 TACE 组为 7. 1 个月 (95%CI：5. 8～ 8. 4), 差异有统计学意义 (χ² =10. 4, P<0. 001) 。联合组和单纯 TACE 组的 ORR 和 DCR 分别为 84%、94% 和 58%、80%, 两组 ORR及DCR比较差异均有统计学意义 (P值均<0. 05) 。两组严重不良反应发生率分别为24%和16%, 差异无统计学意义 (P= 0. 317), 且均未观察到不良反应所致的死亡。结论　与单纯TACE相比, TACE一线联合靶向及免疫药物治疗CNLC Ⅱb/Ⅲa期 HCC患者效果更好, 且不会增加严重不良反应。 [ABSTRACT FROM AUTHOR]

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