Chemosaturation with Percutaneous Hepatic Perfusion: Outcome and Safety in Patients with Metastasized Uveal Melanoma
Chemosaturation with Percutaneous Hepatic Perfusion: Outcome and Safety in Patients with Metastasized Uveal Melanoma
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DOI：
10.1055/a-1348-1932
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发表时间：
2021-02-03
影响因子：
1.8
通讯作者：
Wacker, Frank K.
中科院分区：
文献类型：
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作者：
Dewald, Cornelia Lieselotte Angelika;Hinrichs, Jan B.;Wacker, Frank K.
目的化学饱和经皮肝灌注（CS-PHP）允许选择性肝内递送大剂量细胞毒性美法仑治疗无法治愈的肝肿瘤患者，同时通过肝静脉血的血液滤过限制全身毒性。本研究旨在探讨CS-PHP手术治疗肝转移性葡萄膜黑色素瘤（UM）的疗效、生存率和安全性。材料与方法根据实体瘤疗效评价标准（RECIST1.1）评价总有效率（ORR）和疾病控制率（DCR）。使用Kaplan-Meier估计分析中位总生存期（mOS）、中位无进展生存期（mPFS）和肝脏无进展生存期（mhPFS）。结果2014年10月至2019年1月，共30例患者接受了70粒CS-PHP的挽救治疗。总体上，ORR和DCR分别为42.3%和80.8%。总体而言，mOS为12个月（95%置信区间（CI）7-15），mPFS和mhPFS分别为6个月（95% CI 4-10; 95% CI 4-13）。不良事件（AE）主要为明显但短暂的血液学毒性（87%为3/4级血小板减少症），其次为肝损害（3%）和心血管事件（3%），包括1例缺血性卒中。介入手术是安全的。严重肝脏和心血管事件虽然罕见，但需要仔细选择患者，并应密切监测。
Purpose Chemosaturation percutaneous hepatic perfusion (CS-PHP) allows selective intrahepatic delivery of high dose cytotoxic melphalan in patients with curatively untreatable liver tumors while limiting systemic toxicity through hemofiltration of the hepatic venous blood. Aim of this study was to investigate the response to therapy, survival and safety of the CS-PHP procedure in patients with liver-dominant metastatic uveal melanoma (UM).Materials and Methods Overall response rate (ORR) and disease control rate (DCR) were assessed according to Response Evaluation Criteria In Solid Tumors (RECIST1.1). Median overall survival (mOS), median progression-free survival (mPFS) and hepatic progression-free survival (mhPFS) were analyzed using Kaplan-Meier estimation. Adverse events were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v5.Results Overall, 30 patients were treated with 70 CS-PHP in a salvage setting from October 2014 to January 2019. In total, ORR and DCR were 42.3 % and 80.8 %, respectively. Overall, mOS was 12 (95% confidence interval (CI) 7-15) months, and both, mPFS and mhPFS were 6 months, respectively (95 % CI 4-10; 95 % CI 4-13). Adverse events (AE) most frequently included significant but transient hematologic toxicities (87 % of grade 3/4 thrombocytopenia), less frequent AEs were hepatic injury extending to liver failure (3 %), cardiovascular events including one case of ischemic stroke (3 %).Conclusion Salvage treatment with CS-PHP is effective in selected patients with UM. The interventional procedure is safe. Serious hepatic and cardiovascular events, although rare, require careful patient selection and should be closely monitored.