Vogel Arndt, Gupta Sanjay, Zeile Martin, von Haken Rebecca, Brüning Roland, Lotz Gösta, Vahrmeijer Alexander, Vogl Thomas, Wacker Frank
Department of Gastroenterology, Hepatology and Endocrinology, Medizinische Hochschule Hannover, Hannover, Germany.
Department of Anaesthesiology, University Hospital Southampton, Tremona Road, Southampton, Hampshire, UK.
Adv Ther. 2017 Jan;33(12):2122-2138. doi: 10.1007/s12325-016-0424-4. Epub 2016 Oct 31.
The Hepatic CHEMOSAT Delivery System is an innovative medical device for the treatment of patients with unresectable primary liver tumors or unresectable hepatic metastases from solid organ malignancies. This system is used to perform chemosaturation percutaneous hepatic perfusion (CS-PHP), a procedure in which a high dose of the chemotherapeutic agent melphalan is delivered directly to the liver while limiting systemic exposure. In a clinical trial program, CS-PHP with melphalan significantly improved hepatic progression-free survival in patients with unresectable hepatic metastases from ocular or cutaneous melanoma. Clinically meaningful hepatic responses were also observed in patients with hepatocellular carcinoma or neuroendocrine tumors. Furthermore, the results of published studies and case reports demonstrated that CS-PHP with melphalan resulted in favorable tumor response rates in a range of tumor histologies (ocular or cutaneous melanoma, colorectal cancer, and hepatobiliary tumors). Analyses of the safety profile of CS-PHP revealed that the most common adverse effects were hematologic events (thrombocytopenia, anemia, and neutropenia), which were clinically manageable. Taken together, these findings indicate that CS-PHP is a promising locoregional therapy for patients with primary and secondary liver tumors and has a acceptable safety profile.
Delcath Systems Inc., New York, NY, USA.
肝化学饱和递送系统是一种创新型医疗设备，用于治疗无法切除的原发性肝癌患者或实体器官恶性肿瘤的无法切除的肝转移患者。该系统用于进行化学饱和经皮肝灌注（CS-PHP），此过程中高剂量化疗药物美法仑直接输送至肝脏，同时限制全身暴露。在一项临床试验项目中，美法仑CS-PHP显著改善了眼或皮肤黑色素瘤无法切除的肝转移患者的无肝进展生存期。肝细胞癌或神经内分泌肿瘤患者也观察到具有临床意义的肝脏反应。此外，已发表研究和病例报告的结果表明，美法仑CS-PHP在一系列肿瘤组织学类型（眼或皮肤黑色素瘤、结直肠癌和肝胆肿瘤）中产生了良好的肿瘤反应率。对CS-PHP安全性的分析显示，最常见的不良反应是血液学事件（血小板减少、贫血和中性粒细胞减少），这些在临床上是可控的。综上所述，这些发现表明CS-PHP对于原发性和继发性肝癌患者是一种有前景的局部区域治疗方法，且具有可接受的安全性。
美国纽约州德尔卡斯系统公司。
