Kirstein Martha M, Marquardt Steffen, Jedicke Nils, Marhenke Silke, Koppert Wolfgang, Manns Michael P, Wacker Frank, Vogel Arndt
Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
Institute for Radiology, Hannover Medical School, Hannover, Germany.
J Cancer Res Clin Oncol. 2017 Oct;143(10):2113-2121. doi: 10.1007/s00432-017-2461-z. Epub 2017 Jun 20.
Chemosaturation with percutaneous hepatic perfusion (CS-PHP; hepatic CHEMOSAT delivery system; Delcath Systems Inc, USA) is a novel medical device, which delivers high doses of melphalan directly to the liver in patients with primary and secondary liver tumors while limiting systemic toxicity through hemofiltration of the hepatic venous blood. The aim of this study was to analyze the safety and efficacy of the second-generation CS-PHP after 54 treatments at Hannover Medical School, Germany.
Overall response rates (ORR) were assessed according to response evaluation criteria in solid tumors (RECIST1.1). Overall survival (OS), progression-free survival (PFS), and hepatic PFS (hPFS) were analyzed using the Kaplan-Meier estimation.
29 patients were treated with CS-PHP as last-line therapy up to five sessions. 19 patients had unresectable hepatic metastases from solid tumors [ocular melanoma (OM) n = 11; colorectal carcinoma n = 2; pancreatic adenocarcinoma n = 2; periampular carcinoma n = 2; breast and endometrial cancer each n = 1] and 10 patients were diagnosed with hepatocellular or cholangiocarcinoma (HCC/CCA). ORR was 19.2%. Patients with OM had the highest ORR (33.3%). Similar to patients with OM, patients with hepatobiliary tumors had durable disease stabilization (40%). Median OS, PFS, and hPFS were 261, 117, and 135 days, respectively. Tumor volume negatively correlated with OS. Complications and toxicities included thrombocytopenia, cardiovascular events, ulcerous bleeding, and edema.
Second-generation CS-PHP seems to be effective and tolerable. Patient selection based on tumor volume and entity is of importance. Particularly, patients with OM and hepatobiliary tumors represent promising candidates for CS-PHP.
经皮肝灌注化学饱和法（CS-PHP；肝化学饱和输送系统；美国Delcath系统公司）是一种新型医疗设备，可将高剂量美法仑直接输送至原发性和继发性肝肿瘤患者的肝脏，同时通过对肝静脉血进行血液滤过限制全身毒性。本研究的目的是分析德国汉诺威医学院进行54次治疗后第二代CS-PHP的安全性和有效性。
根据实体瘤疗效评价标准（RECIST1.1）评估总缓解率（ORR）。采用Kaplan-Meier估计法分析总生存期（OS）、无进展生存期（PFS）和肝脏无进展生存期（hPFS）。
29例患者接受CS-PHP作为最后一线治疗，最多接受5个疗程。19例患者有不可切除的实体瘤肝转移[眼黑色素瘤（OM）11例；结直肠癌2例；胰腺腺癌2例；壶腹周围癌2例；乳腺癌和子宫内膜癌各1例]，10例患者被诊断为肝细胞癌或胆管癌（HCC/CCA）。ORR为19.2%。OM患者的ORR最高（33.3%）。与OM患者相似，肝胆肿瘤患者有持久的疾病稳定（40%）。中位OS、PFS和hPFS分别为261天、117天和135天。肿瘤体积与OS呈负相关。并发症和毒性包括血小板减少、心血管事件、溃疡出血和水肿。
第二代CS-PHP似乎有效且耐受性良好。基于肿瘤体积和类型进行患者选择很重要。特别是，OM患者和肝胆肿瘤患者是CS-PHP的有希望的候选者。
