Feasibility and safety of nivolumab in advanced hepatocellular carcinoma: real-life experience from three German centers
Feasibility and safety of nivolumab in advanced hepatocellular carcinoma: real-life experience from three German centers
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DOI：
10.1007/s00432-018-2780-8
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发表时间：
2019-01-01
影响因子：
3.6
通讯作者：
Waidmann, Oliver
中科院分区：
文献类型：
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作者：
Finkelmeier, Fabian;Czauderna, Carolin;Waidmann, Oliver
Nivolumab是第一个被批准用于治疗晚期肝癌患者的检查点抑制剂。有关nivolumab治疗肝癌患者，特别是晚期肝病患者的真实经验数据很少。材料和方法对来自德国三个大型中心的所有确诊为晚期肝癌和nivolumab治疗的患者进行了回顾分析。对临床参数和结果进行评估。结果纳入34例患者。治疗开始时，BCLC B期5例(14.7%)，C期29例(85.3%)。25例(73.5)患者以前接受过索拉非尼治疗。所有患者均表现为肝硬变，即Child-Pugh分期分别为A级(56%)和B级(41%)。在患者评估时，34名患者中有20名(58.8%)已经死亡。发生3级毒副反应2例(5.9%)。部分缓解4例(11.8%)，病情稳定8例(23.5%)。整个队列的中位总生存期为7.5周(范围0-46)。治疗开始时的Child-Pugh B期疾病与不良的结果显著相关。由于nivolumab的疗效可能有限，晚期肝病患者需要进一步的前瞻性评估。
IntroductionNivolumab is the first checkpoint-inhibitor approved for the treatment of advanced HCC patients. Real-life experience data of nivolumab treatment in HCC patients, especially those with advanced liver disease, is scarce.Materials and methodsAll patients with confirmed advanced HCC and nivolumab treatment from three large German centers were retrospectively analyzed. Clinical parameters and outcome were assessed.ResultsA total of 34 patients were included. At the time of treatment initiation 5 patients (14.7%) were classified as stage BCLC B and 29 (85.3%) BCLC C, respectively. 25 (73.5) patients had received prior sorafenib treatment. All patients presented with cirrhosis, namely Child-Pugh stages A (56%) or B (41%), respectively. At time of patient's assessment, 20 out of 34 (58.8%) patients had died. Grade 3 toxicities occurred in two patients (5.9%). Best overall responses were partial response in four patients (11.8%) and stable disease in eight patients (23.5%). The median overall survival of the whole cohort was 7.5 weeks (range 0-46). Child-Pugh B stage disease at treatment start was significantly associated with poor outcome.DiscussionNivolumab treatment seems safe and clinical efficacious. Patients with advanced liver disease require further prospective evaluation due to probable limited efficacy of nivolumab.