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Abstract
Introduction. Metastatic uveal melanoma (mUM) has a poor prognosis and limited treatment options. Immune checkpoint inhibitors (ICIs) remain a primary systemic therapy despite their modest efficacy. Combining ICIs with local treatments like stereotactic body radiotherapy (SBRT) or melphalan-based isolated hepatic perfusion (IHP) may synergistically improve outcomes.
Aim. This study evaluates the efficacy and safety of anti-PD-1 monotherapy or anti-PD-1+anti-CTLA-4 combination with SBRT or IHP in mUM patients.
Materials and Methods. This ongoing non-comparative cohort study enrolled treatment-naïve mUM patients aged ≥ 18 years (ECOG 0–1) with ≥1 measurable lesion (RECIST 1.1). Patients received ICIs plus SBRT (for ≤ 3 metastases per organ) or IHP (for liver involvement < 50 %), allowing stable extrahepatic metastases.
Results. From September 2019 to April 2025, 43 patients were enrolled (SBRT group: n=21; IHP group: n=22). SBRT group: Objective response rate (ORR) 42.8 %, 6-month progression-free survival (PFS) 66.7 % (95 % CI 42.5–82.5), median PFS 8.6 months (95 % CI 4.4–13.8), median overall survival (OS) 44.7 months (95 % CI 16.9–NR (Not Reached). IHP group: ORR 45 %, 6-month PFS 72 % (95 % CI 48–86), median PFS 10.1 months (95 % CI 5.0–15.5), median OS not reached. Grade 3–5 adverse events occurred in 14.3 (SBRT) and 45.5 % (IHP).
Conclusion. The combination of ICIs with SBRT or IHP shows promising efficacy and acceptable toxicity in mUM, warranting further investigation.
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