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Background: Programmed cell death protein‐1‐targeted immunotherapy has shown promising results in phase II studies of hepatocellular carcinoma.
背景：PD-1靶向免疫治疗肝细胞癌的II期研究取得了较具前景的结果。
Aim: To evaluate safety and efficacy of nivolumab and pembrolizumab in an international, multicentre, real‐world cohort of patients with advanced hepatocellular carcinoma.
目的：在一项国际性、多中心、真实世界晚期肝细胞癌患者队列中评估nivolumab和pembrolizumab的安全性和有效性。
Methods: Sixty‐five patients treated with nivolumab (n = 34) or pembrolizumab (n = 31) between July 10, and December 31, (>
方法：回顾性分析7月10日至12月31日（数据截断点）期间在奥地利和德国6个中心接受nivolumab (n = 34)或pembrolizumab (n = 31)治疗的65例患者的信息。
Results: Child‐Pugh class A/B/C was 32 (49%)/28 (43%)/5 (8%). Immunotherapy was used as systemic first‐/second‐/third‐/fourth‐line treatment in 9 (14%)/27 (42%)/26 (40%)/3 (5%) patients. Fifty‐four patients had at least one follow‐up imaging and were, therefore, available for radiological response assessment. The overall response and disease control rates were 12% and 49% respectively. Of 52 evaluable patients, four (8%) had hyperprogressive disease. Most common adverse events were infections (n = 7), rash (n = 6), pruritus (n = 3), fatigue (n = 3), diarrhoea (n = 3) and hepatitis (n = 3). Median time to progression was 5.5 (95% CI, 3.5‐7.4) months, median progression‐free survival was 4.6 (95% CI, 3.0‐6.2) months, and median overall survival was 11.0 (95% CI, 8.2‐13.8) months. Efficacy and safety results were comparable between Child‐Pugh A and B patients; however, median overall survival (OS) was shorter in Child‐Pugh B patients (16.7 vs 8.6 months; P = 0.065). There was no difference in terms of efficacy and adverse events between patients who received immunotherapy as first‐/second‐line and third‐/fourth‐line respectively.
结果：Child‐Pugh A/B/C级患者分别为32例(49%)/28例(43%)/5例(8%)。9例(14%)/27例(42%)/26例(40%)/3例(5%)患者分别使用免疫疗法作为全身一线/二线/三线/四线治疗。54例患者至少进行了一次影像学随访，以进行放射反应评估。总缓解率为12%，疾病控制率为49%。在52例可评估的患者中，4例(8%)出现了超进展。中位进展时间为5.5个月(95% CI, 3.5-7.4)，中位无进展生存期为4.6个月(95% CI, 3.0-6.2)，中位总生存为11.0个月(95% CI, 8.2-13.8)。最常见的不良事件是感染(n = 7)、皮疹(n = 6)、瘙痒(n = 3)、疲劳(n = 3)、腹泻(n = 3)和肝炎(n = 3)。Child‐Pugh A和B级患者治疗后的疗效和安全性相当；然而，Child‐Pugh B级患者的中位总生存(OS)较短(16.7个月vs . 8.6个月;P = 0.065)。接受免疫治疗作为一线/二线和三线/四线的患者在疗效和不良事件方面没有差异。
Conclusions: Programmed cell death protein‐1‐targeted immunotherapy with nivolumab or pembrolizumab showed promising efficacy and safety in patients with advanced hepatocellular carcinoma, including subjects with Child‐Pugh stage B and patients with intensive pretreatment.
结论：晚期肝细胞癌患者(包括Child‐Pugh B级患者和强化预处理患者)使用nivolumab或pembrolizumab进行PD-1靶向免疫治疗，显示出了良好的疗效和安全性。
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程序性死亡受体-1 (PD-1)靶向免疫治疗晚期肝细胞癌： 一项国际性多中心真实队列研究的疗效和安全性数据
