Isolated Hepatic Perfusion With Melphalan for Patients With Isolated Uveal Melanoma Liver Metastases: A Multicenter,...

Area of Science:

• Oncology
• Medical Imaging
• Clinical Trials

Background:

• Metastatic uveal melanoma often presents with isolated liver metastases, carrying a poor prognosis with limited systemic treatment efficacy.
• Isolated hepatic perfusion (IHP) with melphalan is a regional therapy, but its efficacy and safety in this setting lack robust prospective data.

Purpose of the Study:

• To evaluate the efficacy and safety of isolated hepatic perfusion (IHP) with melphalan versus best alternative care for patients with isolated liver metastases from uveal melanoma.

Main Methods:

• A multicenter, randomized, open-label, phase III trial comparing one-time IHP with melphalan to best alternative care in previously untreated patients.
• Secondary outcomes included objective response rate (ORR), progression-free survival (PFS), hepatic PFS (hPFS), and safety assessments.

Main Results:

• IHP demonstrated significantly higher overall response rates (40% vs 4.5%, P < .0001) and improved median PFS (7.4 vs 3.3 months, P < .0001) and hPFS (9.1 vs 3.3 months, P < .0001) compared to the control group.
• The IHP group experienced 11 treatment-related serious adverse events and one treatment-related death, while the control group had seven.

Conclusions:

• Isolated hepatic perfusion (IHP) with melphalan provides superior efficacy in terms of response rate, hepatic progression-free survival, and progression-free survival compared to best alternative care for uveal melanoma with isolated liver metastases.