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The results of a randomized phase II study using embolization with or without granulocyte-macrophage colony-stimulating factor (GM-CSF) in uveal melanoma patients with hepatic metastasis.

8577 Background: Immunoembolization of the hepatic artery with GM-CSF (IE) demonstrated potential efficacy in uveal melanoma (UM) patients with hepatic metastasis in a dose-escalating phase I study. To further investigate the effects of IE on hepatic metastasis from UM, a randomized, double blind phase II study was conducted.


METHODS
UM patients who had hepatic metastases (<50% liver involvement) without pre-existing extra-hepatic metastasis were enrolled. Patients were first stratified based on the volume of metastasis in the liver (<20% vs. >=20%) and HLA-A2 status. They were then randomized into either IE with 2,000 mcg of GM-CSF or embolization without GM-CSF (plain embolization, PE) in a double-blinded fashion. GM-CSF or normal saline solution was mixed with ethiodized oil and injected into one of the hepatic arteries, followed by infusion of gelatin sponge particles to achieve stasis. Patients were evaluated after every 2 treatments 4 weeks apart. Complete response (CR) and partial response (PR) of liver metastases were considered as the primary endpoint. Progression free survival (PFS) and overall survival (OS) were measured as secondary clinical endpoints.


RESULTS
A total of 52 patients (IE 25, PE 27) were enrolled. There were 5 PR and 12 stable disease (SD) responses in IE group, while 3 PR and 19 SD were recorded in PE group. OS and time to progression in extra-hepatic sites (PFS-S) tended to be longer in IE group although they were not statistically significant (median OS: 21.5 vs. 17.2 months; median PFS-S: 10.4 vs. 7.1 months). Interestingly, survival benefit of IE was most marked in patients who had relatively bulky metastases (20%-50% liver involvement) (OS: 18.2 vs. 16.0 months, p=0.07). In contrast, time to progression in liver metastases (PFS-L) was shorter in patients who received IE for small amount of tumors (<20%) (3.7 vs. 7.2 months, p=0.01).


CONCLUSIONS
IE showed a potential survival benefit in UM patients who have relatively bulky hepatic metastases. Unexpectedly, PFS-L was shorter in patients with small hepatic metastases treated with IE, possibly reflecting an ambivalence biological effect of GM-CSF.