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纳武利尤单抗治疗晚期肝细胞癌的可行性和安全性:来自三个德国中心的真实世界经验。

Feasibility and safety of nivolumab in advanced hepatocellular carcinoma: real-life experience from three German centers.

机构信息

Department of Gastroenterology, Hepatology and Endocrinology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.

Department of Gastroenterology and Hepatology, University Hospital Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.

出版信息

J Cancer Res Clin Oncol. 2019 Jan;145(1):253-259. doi: 10.1007/s00432-018-2780-8. Epub 2018 Oct 29.

Abstract

INTRODUCTION

Nivolumab 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 METHODS

All patients with confirmed advanced HCC and nivolumab treatment from three large German centers were retrospectively analyzed. Clinical parameters and outcome were assessed.

RESULTS

A 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.

DISCUSSION

Nivolumab treatment seems safe and clinical efficacious. Patients with advanced liver disease require further prospective evaluation due to probable limited efficacy of nivolumab.

摘要

简介

纳武利尤单抗是首个被批准用于治疗晚期 HCC 患者的检查点抑制剂。纳武利尤单抗治疗 HCC 患者,尤其是晚期肝病患者的真实世界经验数据较为缺乏。

材料与方法

对来自三个德国大型中心的所有经证实的晚期 HCC 患者和纳武利尤单抗治疗患者进行回顾性分析。评估了临床参数和结局。

结果

共纳入 34 例患者。治疗开始时,5 例(14.7%)患者分别被归类为 BCLC B 期和 29 例(85.3%)BCLC C 期。25 例(73.5%)患者曾接受索拉非尼治疗。所有患者均存在肝硬化,即分别为 Child-Pugh 分级 A(56%)或 B(41%)。在患者评估时,34 例患者中有 20 例(58.8%)死亡。2 例(5.9%)患者发生 3 级毒性。4 例(11.8%)患者的最佳总体缓解为部分缓解,8 例(23.5%)患者为疾病稳定。全队列的中位总生存期为 7.5 周(范围 0-46)。治疗开始时为 Child-Pugh B 级疾病与不良结局显著相关。

讨论

纳武利尤单抗治疗似乎安全且具有临床疗效。由于纳武利尤单抗的疗效可能有限,晚期肝病患者需要进一步的前瞻性评估。

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