Peng Tzu-Rong, Wu Chao-Chuan, Chang Sou-Yi, Chen Yen-Chih, Wu Ta-Wei, Hsu Ching-Sheng
Department of Pharmacy, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan.
Department of Surgery, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan; School of Medicine, Tzu Chi University, Hualien, Taiwan.
Int Immunopharmacol. 2022 Nov;112:109223. doi: 10.1016/j.intimp.2022.109223. Epub 2022 Sep 7.
Immune checkpoint inhibitor therapy is the backbone of numerous combination regimens for improving the therapeutic response of patients with hepatocellular carcinoma (HCC). We aimed to investigate the therapeutic efficacy of nivolumab plus sorafenib therapy in patients with unresectable HCC.
Patients with unresectable HCC who received sorafenib and followed at Taipei Tzu Chi Hospital from January 2016 to May 2022 were selected for this study, and those treated with nivolumab plus sorafenib and those with sorafenib alone were propensity score matched. The primary outcome was overall survival (OS) presented as a hazard ratio calculated using Cox proportional hazards regression models.
In the analysis, 36 patients receiving nivolumab plus sorafenib and 36 receiving sorafenib alone were propensity score matched. The median OS for those receiving nivolumab plus sorafenib and sorafenib alone were 3.6 years and 1.2 years, respectively (p = 0.031). The hazard ratio of OS for nivolumab plus sorafenib compared to sorafenib alone was 0.36 (95 %CI, 0.19-0.70; p = 0.003). Furthermore, patients receiving nivolumab plus sorafenib with a baseline α-fetoprotein(AFP) < 10 ng/mL and early reduction in AFP had a 100 % objective response rate and disease control rate.
In patients with unresectable HCC, nivolumab plus sorafenib resulted in better OS outcomes than sorafenib.
免疫检查点抑制剂疗法是众多联合治疗方案的核心，用于改善肝细胞癌（HCC）患者的治疗反应。我们旨在研究纳武利尤单抗联合索拉非尼治疗不可切除HCC患者的疗效。
选取2016年1月至2022年5月在台北慈济医院接受索拉非尼治疗并随访的不可切除HCC患者进行本研究，对接受纳武利尤单抗联合索拉非尼治疗的患者和仅接受索拉非尼治疗的患者进行倾向评分匹配。主要结局是总生存期（OS），以使用Cox比例风险回归模型计算的风险比表示。
在分析中，36例接受纳武利尤单抗联合索拉非尼治疗的患者和36例仅接受索拉非尼治疗的患者进行了倾向评分匹配。接受纳武利尤单抗联合索拉非尼治疗和仅接受索拉非尼治疗的患者的中位OS分别为3.6年和1.2年（p = 0.031）。纳武利尤单抗联合索拉非尼与仅使用索拉非尼相比的OS风险比为0.36（95%CI，0.19 - 0.70；p = 0.003）。此外，基线甲胎蛋白（AFP）< 10 ng/mL且AFP早期下降的接受纳武利尤单抗联合索拉非尼治疗的患者的客观缓解率和疾病控制率为100%。
在不可切除的HCC患者中，纳武利尤单抗联合索拉非尼的总生存期结局优于索拉非尼。
