To investigate the outcome and safety data of chemosaturation with percutaneous hepatic perfusion (CS-PHP) of melphalan in patients with liver-dominant metastatic uveal melanoma.,This is a HIPAA compliant, IRB approved, retrospective study.,A total of 28 CS-PHPs were performed in 16 individual patients (six men and ten women, median age 63.1 years [range 49.1 to 78.7 years], one to six CS-PHP procedures per patient) for treatment of liver-dominant metastatic uveal melanoma between June, 2015 and December, 2018.,All patients received cross-sectional imaging at baseline and during follow-up.,CS-PHP was performed with the Hepatic CHEMOSAT® Delivery System (Delcath Systems, Inc., NY, USA) facilitating extracorporeal filtration of hepatic blood for melphalan removal.,Ideal body weight-adjusted melphalan doses were administered into the hepatic arteries.,Serious adverse events (SAE), progression-free survival based on response criteria in solid tumors, and overall survival were noted.,Survival data were analyzed using Kaplan-Meier estimates.,Partial response after first CS-PHP was observed in nine patients (60%), stable disease in five patients (33%) and progressive disease in one patient (7%).,Median overall survival was 27.4 months (95% CI 4.1 to 35.4 month) after first CS-PHP.,Median progression-free survival was 11.1 months after first CS-PHP (95% CI 4.9 to 23.6 months).,SAEs were observed in the majority of patients with most SAEs limited to grades one and two.,Thirteen SAEs of grades three and four were observed in seven individual patients.,No grade five SAE was observed.,CS-PHP is an efficacious and safe treatment for patients presenting with liver-dominant metastatic uveal melanoma.
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.,Funding: Delcath Systems Inc., New York, NY, USA.