Choi Won-Mook, Lee Danbi, Shim Ju Hyun, Kim Kang Mo, Lim Young-Suk, Lee Han Chu, Yoo Changhoon, Park Sook Ryun, Ryu Min-Hee, Ryoo Baek-Yeol, Choi Jonggi
Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.
Cancers (Basel). 2020 Jul 20;12(7):1968. doi: 10.3390/cancers12071968.
Nivolumab has shown durable response and safety in patients with hepatocellular carcinoma (HCC) in previous trials. However, real-world data of nivolumab in HCC patients, especially those with Child-Pugh class B, are limited. To investigate the effectiveness and safety of nivolumab in a real-world cohort of patients with advanced HCC, we retrospectively evaluated 203 patients with HCC who were treated with nivolumab between July 2017 and February 2019. Of 203 patients, 132 patients were classified as Child-Pugh class A and 71 patients were Child-Pugh class B. Objective response rate was lower in patients with Child-Pugh class B than A (2.8% vs. 15.9%; = 0.010). Child-Pugh class B was an independent negative predictor for objective response. Median overall survival was shorter in Child-Pugh B patients (11.3 vs. 42.9 weeks; adjusted hazard ratio [AHR], 2.10; < 0.001). In Child-Pugh B patients, overall survival of patients with Child-Pugh score of 8 or 9 was worse than patients with Child-Pugh score of 7 (7.4 vs. 15.3 weeks; AHR, 1.93; < 0.020). In conclusion, considering the unsatisfactory response in Child-Pugh B patients, nivolumab may not be used in unselected Child-Pugh B patients. Further studies are needed in this patient population.
在既往试验中，纳武利尤单抗已在肝细胞癌（HCC）患者中显示出持久疗效和安全性。然而，纳武利尤单抗在HCC患者，尤其是Child-Pugh B级患者中的真实世界数据有限。为了研究纳武利尤单抗在晚期HCC真实世界队列患者中的有效性和安全性，我们回顾性评估了2017年7月至2019年2月期间接受纳武利尤单抗治疗的203例HCC患者。在203例患者中，132例患者被归类为Child-Pugh A级，71例患者为Child-Pugh B级。Child-Pugh B级患者的客观缓解率低于A级患者（2.8%对15.9%；P = 0.010）。Child-Pugh B级是客观缓解的独立负性预测因素。Child-Pugh B级患者的中位总生存期较短（11.3周对42.9周；调整后风险比[AHR]，2.10；P < 0.001）。在Child-Pugh B级患者中，Child-Pugh评分为8或9分的患者的总生存期比评分为7分的患者更差（7.4周对15.3周；AHR，1.93；P < 0.020）。总之，考虑到Child-Pugh B级患者的反应不理想，纳武利尤单抗可能不适用于未经选择的Child-Pugh B级患者。该患者群体需要进一步研究。
