Medizinische Universität Graz - Research portal
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SHR Neuro Cancer Cardio Lipid Metab Microb
Zager, JS; Orloff, M; Ferrucci, PF; Choi, J; Eschelman, DJ; Glazer, ES; Ejaz, A; Richtig, E; Ochsenreither, S; Reddy, SA; Lowe, MC; Beasley, GM; Gesierich, A; Gschnell, M; Dummer, R; Arance, A; Fenwick, SW; Sacco, JJ; John, J; Wheater, M; Ottensmeier, CH.
Subgroup analyses of the phase 3 FOCUS study of melphalan/hepatic delivery system in patients with unresectable metastatic uveal melanoma.
J Cancer Res Clin Oncol. 2025; 152(1): 25
Doi: 10.1007/s00432-025-06291-x
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- Richtig Erika
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- Abstract:
- PURPOSE: To assess efficacy and safety in subgroups of patients treated with Melphalan/Hepatic Delivery System (melphalan/HDS), a drug/device combination for liver-directed treatment of metastatic UM (mUM) patients. Previously reported FOCUS study results indicated melphalan/HDS treatment provides a clinically meaningful response rate and favorable benefit-risk ratio in patients with unresectable mUM. METHODS: Patients with mUM received treatment with melphalan (3.0 mg/kg ideal body weight) every 6-8 weeks for up to 6 cycles. Post hoc analyses of efficacy and safety were conducted for patient subgroups based on demographic and baseline disease characteristics. RESULTS: 102 patients with mUM were enrolled; treatment was attempted in 95 patients; 91 patients received treatment. Subgroup analyses showed consistent tumor response regardless of age, sex, geographic region, presence/absence of extrahepatic lesions, and prior therapy. Patients with lower tumor burden had better objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) than those with higher tumor burden (ORR: 51.1 vs. 22.2%, p = 0.008; mPFS: 11.3 vs. 5.8 months, p = 0.007; mOS: 26.7 vs. 15.4 months, p = 0.008). Patients with 1-25% liver involvement had higher mOS than those with 26-50% liver involvement (22.4 vs. 16.9 months; p = 0.030); patients with low or normal lactate dehydrogenase (LDH) had higher mOS than those with elevated LDH (23.5 vs. 15.3 months; p = 0.019). The overall safety profile was similar across subgroups without evidence of cumulative toxicity with successive treatment cycles. CONCLUSION: Results demonstrate a favorable benefit-risk profile for melphalan/HDS across clinically relevant subgroups. However, early treatment in patients with low tumor burden may offer best results.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Melphalan - administration & dosage, adverse effects
- Male - administration & dosage
- Female - administration & dosage
- Melanoma - drug therapy, pathology
- Middle Aged - administration & dosage
- Uveal Neoplasms - drug therapy, pathology
- Aged - administration & dosage
- Adult - administration & dosage
- Liver Neoplasms - secondary, drug therapy
- Antineoplastic Agents, Alkylating - administration & dosage, adverse effects
- Uveal Melanoma - administration & dosage
- Aged, 80 and over - administration & dosage
- Drug Delivery Systems - administration & dosage
- Find related publications in this database (Keywords)
- Metastatic uveal melanoma
- Percutaneous Hepatic Perfusion (PHP)
- Melphalan/Hepatic Delivery System
- Melphalan/HDS
- Liver-directed therapy
- Ocular melanoma