Long-Term Clinical Data Validates Hepatic-Directed Treatment Strategy for Uveal Melanoma Metastases

A decade-long clinical experience from a specialized German medical center provides compelling evidence for percutaneous hepatic perfusion (PHP) as an effective intervention for patients with uveal melanoma that has metastasized to the liver. The findings, now published in the journal Cancers, represent outcomes from 38 consecutive patients who underwent 99 PHP procedures between 2014 and 2024.

Survival Metrics Demonstrate Extended Benefit

The research centered on high-dose melphalan delivery using a proprietary hepatic delivery system revealed a median overall survival of 29.1 months (95% confidence interval: 18.4–38.9 months) measured from the initial PHP treatment. Survival rates at key intervals showed 79.5% of patients alive at one year, declining to 53.2% at two years and 28.5% at three years—results that exceed previously reported benchmarks for this patient population.

A particularly significant finding emerged when comparing treatment intensity. Patients receiving three or more PHP cycles achieved a median survival of 29.8 months versus 21.4 months for those undergoing two or fewer procedures. This differential translated to approximately a 40% reduction in mortality risk with each successive treatment cycle, suggesting cumulative therapeutic benefit.

Treatment Safety and Patient Selection

The retrospective analysis underscored the safety profile of the intervention, with zero treatment-related deaths recorded across the entire cohort. Procedure-related adverse events graded as moderate or higher occurred in 10.5% of treatments, indicating manageable tolerability.

Patient selection criteria—including Eastern Cooperative Oncology Group performance status of 0-1, liver involvement not exceeding 70%, and limited extrahepatic disease—reflected appropriate stratification for optimal outcomes. These parameters provide a clinical reference point for institutions considering similar interventional approaches.

Implications for Interventional Oncology

The study underscores how institutional volume and specialized expertise can meaningfully optimize treatment outcomes in liver-dominant malignancies. The Delcath Systems hepatic delivery technology, marketed as CHEMOSAT in Europe and incorporated within HEPZATO KIT (melphalan combination product) in the United States, enables loco-regional chemotherapy administration while mitigating systemic toxicity through hepatic blood filtration during and after drug infusion.

HEPZATO KIT received FDA approval for treating adult patients with metastatic uveal melanoma presenting with unresectable liver involvement affecting less than 50% of hepatic tissue. European regulatory approval for the device-only CHEMOSAT configuration permits broader clinical application across various hepatic malignancies at specialized centers.

This 10-year clinical dataset contributes to the growing body of evidence supporting hepatic-perfusion strategies as a viable option for managing liver-dominant cancer presentations, particularly in cases where systemic chemotherapy options remain limited.