Isolated Hepatic Perfusion with Melphalan Improves Response Rate and PFS in Previously Untreated Patients with Isolated Liver Metastases from Uveal Melanoma
Source: ESMO, April 2023
In a first analysis of a randomised controlled phase III study conducted among previously untreated patients with isolated liver metastases from primary uveal melanoma, a single treatment with isolated hepatic perfusion with melphalan was well tolerated with manageable side effects and resulted in significantly higher overall response rate (ORR) and improved progression-free survival (PFS) and hepatic PFS (hPFS) compared with the investigator’s choice of available treatments. The first analysis of overall survival (OS), the primary endpoint of the study, is planned for 2023. The findings from the SCANDIUM study are published by Prof. Roger Olofsson Bagge of the University of Gothenburg and Sahlgrenska University Hospital in Gothenburg, Sweden and colleagues on 20 March 2023 in the Journal of Clinical Oncology.
Uveal melanoma accounts for approximately 3% of all melanomas. Approximately 50% of patients with uveal melanoma develop metastases that are strongly hepatotropic; isolated liver metastases are seen in over half of patients with metastatic disease. Among these patients, the median survival is approximately 10-12 months and only a few patients survive more than 5 years. In contrast to cutaneous melanoma, immune checkpoint inhibitors (ICIs) have been of only limited benefit in patients with uveal melanoma. A recent randomised phase III study of tebentafusp resulted in a significant improvement in OS. For patients with isolated liver metastases, several locoregional liver treatment strategies have been investigated.
Isolated hepatic perfusion with melphalan is a regional treatment where the liver is completely isolated from the systemic circulation to allow hepatic perfusion with high concentrations of chemotherapy, with minimal systemic exposure. In the SCANDIUM, multicentre, randomised, open-label, phase III study, patients with previously untreated isolated liver metastases from uveal melanoma were randomly assigned to receive an one-time treatment with isolated hepatic perfusion with melphalan or best alternative care. The primary endpoint was OS at 24 months. In the latest article published in the JCO, they reported the secondary outcomes of ORR according to RECIST v1.1 criteria, PFS, hPFS, and safety.