Department of Biliary Surgery, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.
Department of Dermatology and Venereology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.
Surg Oncol. 2021 Dec;39:101663. doi: 10.1016/j.suronc.2021.101663. Epub 2021 Sep 24.
Sorafenib is the standard treatment for patients with advanced HCC with improvement in survival and radiologic progression of the disease. Recently, few studies have advocated the Sorafenib + HAIC combination therapy results in better overall survival and progression-free survival than Sorafenib monotherapy in patients with advanced HCC. Herein, we aim to identify the best possible treatment option among the above two lines of therapy for patients with advanced HCC.
The fixed effects and a random-effects model were used to perform a meta-analysis for overall response rate overall survival, and adverse events. Subgroup analysis of the data of univariate analysis in each included trial was performed to identify the specific patient population who could be benefitted from the combination therapy.
Four RCTs containing 609 patients were included in the final analysis. The overall response rate (OR: 3.81; 95% CI 1.01 to 14.42; P = 0.05) and overall survival (HR: 0.70; 95% CI 0.40 to 1.24; P > 0.05) were comparable. Subgroup analysis of OS showed that patients with Child-Pugh score B (HR: 0.30; 95% CI 0.13 to 0.72; P < 0.05) and AFP <400 ng/ml (HR: 0.72; 95% CI 0.52 to 0.99; P < 0.05) were associated with significantly improved survival in the Sorafenib + HAIC group. Bone marrow suppression (OR: 3.76; 95% CI 2.58 to 5.48; P < 0.001) was significantly higher in the Sorafenib + HAIC group, but hepatic function impairment, constitutional symptoms, gastrointestinal events, and dermatological events were comparable (p > 0.05).
Patients with Child-Pugh score B and AFP <400 ng/ml may be benefited most from Sorafenib + HAIC combination therapy.
索拉非尼是晚期 HCC 患者的标准治疗方法，可改善生存和疾病的影像学进展。最近，一些研究主张索拉非尼联合肝动脉化疗栓塞（HAIC）治疗晚期 HCC 患者的总生存期和无进展生存期优于索拉非尼单药治疗。在此，我们旨在为晚期 HCC 患者确定上述两种治疗方案中最佳的治疗选择。
使用固定效应和随机效应模型对总缓解率、总生存率和不良事件进行荟萃分析。对每个纳入试验的单变量分析数据进行亚组分析，以确定哪些特定患者人群可能从联合治疗中获益。
最终分析纳入了四项包含 609 例患者的 RCT。总缓解率（OR：3.81；95%CI 1.01 至 14.42；P=0.05）和总生存率（HR：0.70；95%CI 0.40 至 1.24；P>0.05）相当。OS 的亚组分析显示，Child-Pugh 评分 B（HR：0.30；95%CI 0.13 至 0.72；P<0.05）和 AFP<400ng/ml（HR：0.72；95%CI 0.52 至 0.99；P<0.05）的患者在索拉非尼联合 HAIC 组中生存获益显著。索拉非尼联合 HAIC 组骨髓抑制（OR：3.76；95%CI 2.58 至 5.48；P<0.001）显著升高，但肝功能损害、全身症状、胃肠道事件和皮肤事件相当（P>0.05）。
Child-Pugh 评分 B 和 AFP<400ng/ml 的患者可能从索拉非尼联合 HAIC 治疗中获益最多。
