Guo Xu-Wei, Zhao Man, Duan Xiao-Ling, Han Guang-Jie, Wang Jin-Feng, Shi Jian-Fei, Han Xin, Yin Fei, Yang Guang
Department of Gastroenterology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
Department of Interventional Radiology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
Front Oncol. 2025 May 1;15:1541805. doi: 10.3389/fonc.2025.1541805. eCollection 2025.
Current large clinical trials mainly focus on Child-Pugh A (CP-A) stage hepatocellular carcinoma (HCC) patients, with limited data on CP-B patients especially those classified as B8-9, whose treatment needs remain inadequately addressed. This study aims to evaluate the safety efficacy of interventional treatments, with or without targeted-immunotherapy and characteristics of CP-B stage HCC patients receiving.
This single-center retrospective investigation incorporated 119 patients were stratified into two cohorts: the interventional therapy cohort (42) and the combined targeted immunotherapy cohort (77). The clinical data, overall survival (OS), progression-free survival (PFS), and therapeutic efficacy of both groups were meticulously recorded and comprehensively analyzed. Survival disparities were statistically compared employing the Kaplan-Meier survival analysis method and the log-rank test. Tumor remission was appraised in accordance with the RECIST 1.1 and mRECIST criteria. Independent influencing factors were discerned through multifactorial COX regression analysis. Subsequently, survival prediction models were constructed to generate column line graphs, and the safety profiles and adverse events associated with diverse treatment modalities were also evaluated.
119 patients with CP-B grade HCC were included, and the median survival (mOS) of patients who received combination therapy was 21.4 months (vs 13.2, P=0.038) superior to that of interventional therapy, and the median progression-free survival (mPFS) of 12.7 months (vs 10.9 months, P=0.183) was not significantly improved. The OS of patients in group B7 who received combination therapy was 24.6 months (vs 11.9, P=0.006) was superior to that of the intervention, while there was no significant improvement in patients in groups B8-9. The objective remission rate (ORR) was higher in the combination therapy than in the intervention group (RECIST: 32.5% vs 11.9%, P = 0.014; mRECIST: 48.1% vs 23.8%, P = 0.010). Except for Child-Pugh score progression (P = 0.003), there was no significant difference in the occurrence of all-grade and ≥grade 3 adverse events in the combination therapy group compared with the intervention group (P > 0.05).
Interventional therapy combined with targeted and immunotherapy can be a safe and effective treatment for patients with Child-Pugh grade B hepatocellular carcinoma in the setting of controlled liver function impairment.
目前的大型临床试验主要集中在Child-Pugh A（CP-A）期肝细胞癌（HCC）患者，关于CP-B患者尤其是分类为B8-9的患者的数据有限，其治疗需求仍未得到充分解决。本研究旨在评估介入治疗联合或不联合靶向免疫治疗的安全性、疗效以及接受治疗的CP-B期HCC患者的特征。
这项单中心回顾性研究纳入了119例患者，分为两个队列：介入治疗队列（42例）和联合靶向免疫治疗队列（77例）。详细记录并全面分析了两组的临床数据、总生存期（OS）、无进展生存期（PFS）和治疗效果。采用Kaplan-Meier生存分析方法和对数秩检验对生存差异进行统计学比较。根据RECIST 1.1和mRECIST标准评估肿瘤缓解情况。通过多因素COX回归分析识别独立影响因素。随后，构建生存预测模型以生成柱状线图，并评估与不同治疗方式相关的安全性和不良事件。
纳入119例CP-B级HCC患者，接受联合治疗的患者中位生存期（mOS）为21.4个月（对比介入治疗组的13.2个月，P = 0.038），优于介入治疗，而中位无进展生存期（mPFS）为12.7个月（对比10.9个月，P = 0.183），未显著改善。接受联合治疗的B7组患者OS为24.6个月（对比介入治疗组的11.9个月，P = 0.006），优于介入治疗，而B8-9组患者无显著改善。联合治疗组的客观缓解率（ORR）高于介入治疗组（RECIST标准：32.5%对比11.9%，P = 0.014；mRECIST标准：48.1%对比23.8%，P = 0.010）。与介入治疗组相比，联合治疗组在所有级别和≥3级不良事件的发生方面，除Child-Pugh评分进展外（P = 0.003），无显著差异（P > 0.05）。
在肝功能损害可控的情况下，介入治疗联合靶向和免疫治疗对于Child-Pugh B级肝细胞癌患者可能是一种安全有效的治疗方法。
